Tracleer and disease progression Patient Reports February 11, 2012

Tracleer Side Effects Report #5678203-8
Tracleer side effect was reported by a Health Professional from NETHERLANDS on Mar 06, 2008. Female patient, 69 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, extremity necrosis, skin ulcer. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with CALCIUM CHANNEL BLOCKERS, IBUPROFEN, ANTIBIOTICS. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5324701-6
Tracleer side effect was reported by a Physician from FRANCE on Apr 23, 2007. Male patient, 54 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, left ventricular failure, pericarditis, renal failure, respiratory failure, scleroderma . Tracleer dosage: unknown. During the same period patient was treated with CORTANCYL, CYCLOPHOSPHAMIDE, ILOMEDINE. Patient was hospitalized. Patient died on 01/01/2007.

Tracleer Side Effects Report #5362958-6
Tracleer side effect was reported by a Consumer or non-health professional from FRANCE on June 07, 2007. Male patient, 54 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, left ventricular failure, multi-organ failure, myocarditis, pericarditis constrictive, renal failure, respiratory failure, scleroderma . Tracleer dosage: 125 MG, BID, ORAL, 62.5 MG, BID,ORAL. During the same period patient was treated with PREDNISONE, CYCLOPHOSPHAMIDE, ILOMEDINE. Patient was hospitalized. Patient died on 02/25/2007.

Tracleer Side Effects Report #5385890-0
Tracleer side effect was reported by a Physician from NETHERLANDS on June 26, 2007. Female patient, 51 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac failure, cardiac tamponade, disease progression, iatrogenic infection, pancreatitis necrotising, pericardial effusion, respiratory failure, sepsis , systemic sclerosis. Tracleer dosage: 125 MG, BID, ORAL. Patient died on 05/13/2006.


Tracleer Side Effects Report #5037520-5
Tracleer side effect was reported by a Physician from NETHERLANDS on June 09, 2006. Female patient, 51 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac failure, cardiac perforation, cardiac tamponade, disease progression, iatrogenic injury, off label use, pancreatitis necrotising, pericardial effusion, respiratory failure. Tracleer dosage: 125 MG, BID, ORAL. Patient died on 05/13/2006.

Tracleer Side Effects Report #6036499-7
Tracleer side effect was reported by a Physician from ISRAEL on Dec 22, 2008. Female patient, 50 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anaemia, disease progression, haemoglobin decreased, necrosis, serum ferritin decreased, skin ulcer. Tracleer dosage: 125 MG BID ORAL; 62.5 MG BID ORAL. During the same period patient was treated with METHOTREXATE, CYCLOSPORINE, OMEPRAZOLE, AMLOPIN, FOLIC ACID. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6088091-6
Tracleer side effect was reported by a Physician from ISRAEL on Feb 05, 2009. Female patient, 50 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anaemia, disease progression, necrosis, skin ulcer. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with METHOTREXATE, CYCLOSPORINE, OMEPRAZOLE, AMLOPIN, FOLIC ACID. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5869468-8
Tracleer side effect was reported by a Physician from FRANCE on Aug 19, 2008. Female patient, 76 years of age, was diagnosed with scleroderma  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, off label use, scleroderma . Tracleer dosage: 125 MG, ORAL. Patient died.

Tracleer Side Effects Report #4727821-X
Tracleer side effect was reported by a Physician from GERMANY on July 21, 2005. Female patient, child 6 years of age, was diagnosed with pulmonary veno-occlusive disease and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, right ventricular failure. Tracleer dosage: 31.25 MG, BID, ORAL. During the same period patient was treated with OXYGEN, PREDNISONE. Patient died on 07/18/2005.


Tracleer Side Effects Report #5807963-8
Tracleer side effect was reported by a Physician from AUSTRALIA on June 25, 2008. Male patient, child 9 years of age, weighting 46.30 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: arrhythmia , disease progression, off label use, pulmonary hypertension . Tracleer dosage: 31.25 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient died on 06/11/2008.

Tracleer Side Effects Report #5832716-4
Tracleer side effect was reported by a Consumer or non-health professional from JAPAN on July 22, 2008. Female patient, 87 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: condition aggravated, disease progression, pulmonary embolism , pulmonary hypertension . Tracleer dosage: 62.5 MG, QD, ORAL. During the same period patient was treated with WARFARIN POTASSIUM, DILTIAZEM HYDROCHLORIDE, CANDESARTAN CILEXETIL. Patient died on 06/12/2008.

Tracleer Side Effects Report #5168321-5
Tracleer side effect was reported by a Physician from GERMANY on Nov 20, 2006. Female patient, 74 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, hypoxia, off label use, pulmonary fibrosis , unevaluable event. Tracleer dosage: unknown. During the same period patient was treated with SILDENAFIL CITRATE. Patient died.

Tracleer Side Effects Report #4727814-2
Tracleer side effect was reported by a Health Professional from NETHERLANDS on July 15, 2005. Male patient, 74 years of age, weighting 176.4 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, interstitial lung disease. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with ACENOCOUMAROL, PREDNISONE, FUROSEMIDE, SPIRONOLACTONE, NIFEDIPINE, NEXIUM, AMARYL, ANDRIOL. Patient died on 06/27/2005.

Tracleer Side Effects Report #5097990-3
Tracleer side effect was reported by a Physician from AUSTRALIA on Aug 21, 2006. Female patient, 73 years of age, weighting 181.0 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, fall , pulmonary hypertension , rash erythematous, right ventricular failure. Tracleer dosage: 62.5 MG, BID, ORAL. Patient was hospitalized and became disabled. Patient recovered.


Tracleer Side Effects Report #5713879-8
Tracleer side effect was reported by a Physician from AUSTRIA on Apr 04, 2008. Male patient, 70 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, off label use, pulmonary hypertension , right ventricular failure. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with TREPROSTINIL. Patient died.

Tracleer Side Effects Report #5486172-9
Tracleer side effect was reported by a Physician from UNITED STATES on Sept 28, 2007. Female patient, 68 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: condition aggravated, disease progression, hepatic cirrhosis, pulmonary hypertension , renal impairment. Tracleer dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5533992-8
Tracleer side effect was reported by a Physician from UNITED STATES on Nov 16, 2007. Female patient, 68 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: ascites, disease progression, hepatic cirrhosis, pulmonary hypertension , renal impairment. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4591710-4
Tracleer side effect was reported by a Physician from on Feb 03, 2005. Female patient, 67 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, condition aggravated, disease progression, liver function test abnormal, pulmonary hypertension . Tracleer dosage: unknown. During the same period patient was treated with LASIX, POTASSIUM, COUMADIN, FERROUS SULPHATE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5170048-0
Tracleer side effect was reported by a Physician from UNITED STATES on Nov 20, 2006. Female patient, 66 years of age, weighting 209.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, chronic obstructive pulmonary disease, condition aggravated, disease progression. Tracleer dosage: unknown. During the same period patient was treated with LIPITOR, ASPIRIN, LASIX, IMDUR, PREDNISONE, ALBUTEROL, SPIRIVA. Patient died on 10/21/2006.


Tracleer Side Effects Report #5903362-9
Tracleer side effect was reported by a Physician from UNITED STATES on Sept 12, 2008. Female patient, 66 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, chronic obstructive pulmonary disease, condition aggravated, disease progression, hepatic enzyme increased, off label use. Tracleer dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5975131-5
Tracleer side effect was reported by a Physician from UNITED STATES on Nov 17, 2008. Female patient, 66 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, chronic obstructive pulmonary disease, condition aggravated, disease progression, hepatic enzyme increased, pulmonary arterial hypertension. Tracleer dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4896472-9
Tracleer side effect was reported by a Physician from UNITED STATES on Jan 11, 2006. Female patient, 66 years of age, weighting 145.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, apnoea, aspartate aminotransferase increased, bradycardia, cardiac arrest , disease progression, epistaxis, hypoxia, labile blood pressure. Tracleer dosage: unknown. During the same period patient was treated with LORAZEPAM, LASIX, LISINOPRIL, TAMOXIFEN CITRATE, PROCARDIA. Patient was hospitalized. Patient died on 06/28/2005.

Tracleer Side Effects Report #4592656-8
Tracleer side effect was reported by a Consumer or non-health professional from on Feb 03, 2005. Female patient, 65 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, pulmonary fibrosis , right ventricular failure. Tracleer dosage: unknown. During the same period patient was treated with CORTISONE, IMUREK, IDEOS, MARCUMAR, OXYGEN, PRAVASTATIN. Patient was hospitalized. Patient died on 11/01/2004.

Tracleer Side Effects Report #4596282-6
Tracleer side effect was reported by a Consumer or non-health professional from on Feb 14, 2005. Female patient, 65 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, pulmonary fibrosis , right ventricular failure. Tracleer dosage: unknown. During the same period patient was treated with CORTISONE, IMUREK, IDEOS, MARCUMAR, OXYGEN, PRAVASTATIN. Patient was hospitalized. Patient died on 12/01/2004.


Tracleer Side Effects Report #4644658-0
Tracleer side effect was reported by a Physician from on Apr 12, 2005. Female patient, 64 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: blood thyroid stimulating hormone increased, disease progression, failure to thrive, hepatic neoplasm malignant, interstitial lung disease, malignant neoplasm progression, metastases to lymph nodes, ovarian cancer, respiratory failure. Tracleer dosage: unknown. Patient was hospitalized. Patient died on 03/19/2005.

Tracleer Side Effects Report #4929407-0
Tracleer side effect was reported by a Physician from AUSTRALIA on Feb 13, 2006. Female patient, 62 years of age, weighting 198.4 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac failure, disease progression, dyspnoea, hepatic failure, multi-organ failure, renal failure, scleroderma . Tracleer dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient died on 01/15/2006.

Tracleer Side Effects Report #6110615-0
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 26, 2009. Female patient, 61 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, disease progression, pulmonary arterial hypertension, respiratory failure. Tracleer dosage: 125 MG, BID, ORAL 62.5 MG, BID, ORAL. Patient died on 02/24/2009.

Tracleer Side Effects Report #4957752-1
Tracleer side effect was reported by a Physician from AUSTRALIA on Mar 09, 2006. Female patient, 59 years of age, weighting 202.8 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: antinuclear antibody positive, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, cardiomegaly, disease progression, dyspnoea, gamma-glutamyltransferase increased, haemoglobin decreased. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. Patient was hospitalized. Patient died on 11/25/2005.

Tracleer Side Effects Report #4850631-X
Tracleer side effect was reported by a Physician from NETHERLANDS on Dec 01, 2005. Female patient, 58 years of age, weighting 136.7 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, cholecystitis, disease progression, gamma-glutamyltransferase increased, jaundice , liver function test abnormal. Tracleer dosage: unknown. During the same period patient was treated with FUROSEMIDE, PLAQUENIL, CAPTOPRIL, EUCARDIC, SPIRONOLACTONE, ACENOCOUMAROL, PANTOPRAZOLE. Patient was hospitalized. Patient recovered.


Tracleer Side Effects Report #4867596-7
Tracleer side effect was reported by a Physician from UNITED STATES on Dec 15, 2005. Male patient, 55 years of age, weighting 149.0 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, anxiety , aspartate aminotransferase increased, cough, depression , disease progression, fatigue, pulmonary hypertension . Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with COZAAR, SILDENAFIL CITRATE, TRAMADOL, VITAMIN. Patient recovered.

Tracleer Side Effects Report #4644664-6
Tracleer side effect was reported by a Physician from on Apr 06, 2005. Female patient, 54 years of age, weighting 194.0 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cataract , diabetic retinopathy, disease progression, international normalised ratio increased, prothrombin time prolonged, retinal detachment, treatment noncompliance, vitreous haemorrhage. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with COUMADIN, AGRYLIN, PROTONIX, INSULIN, GLIPIZIDE, TOPROL, IMDUR, TORSEMIDE. Patient recovered.

Tracleer Side Effects Report #5305653-1
Tracleer side effect was reported by a Physician from AUSTRALIA on Mar 29, 2007. Female patient, 52 years of age, weighting 174.2 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: arrhythmia , disease progression, electrolyte imbalance, pulmonary hypertension , renal failure, scleroderma . Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with RALOXIFENE, OMEPRAZOLE, CALTRATE, LACTULOSE, WARFARIN, RHINOCORT. Patient died on 10/27/2004.

Tracleer Side Effects Report #5062177-7
Tracleer side effect was reported by a Physician from BELGIUM on July 12, 2006. Male patient, 52 years of age, weighting 143.3 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: condition aggravated, disease progression. Tracleer dosage: unknown. During the same period patient was treated with ACENOCOUMAROL, CHLORTHALIDONE, DORMONOCT, ACETYLCYSTEINE, CORDARONE, CALCIUM, SPIRIVA. Patient died on 06/19/2006.

Tracleer Side Effects Report #5097909-5
Tracleer side effect was reported by a Physician from AUSTRALIA on Aug 23, 2006. Female patient, 51 years of age, weighting 112.4 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, gastrointestinal motility disorder, intestinal obstruction, pulmonary hypertension , rectal cancer, right ventricular failure, scleroderma . Tracleer dosage: unknown. Patient died on 08/11/2006.


Tracleer Side Effects Report #5835434-1
Tracleer side effect was reported by a Health Professional from UNITED STATES on July 23, 2008. Female patient, 51 years of age, weighting 125.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, disease progression, liver function test abnormal, pulmonary hypertension . Tracleer dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with LASIX, POTASSIUM CHLORIDE, COUMADIN, BUMEX, POTASSIUM CHLORIDE, PROTONIX. Patient died on 06/08/2008.

Tracleer Side Effects Report #5931087-2
Tracleer side effect was reported by a Consumer or non-health professional from JAPAN on Oct 15, 2008. Female patient, 51 years of age, weighting 97.00 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, altered state of consciousness, aspartate aminotransferase increased, cardiac failure, chest pain , depressive symptom, disease progression, hepatic function abnormal, intentional overdose. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL; 62.5 MG, QD, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with WARFARIN POTASSIUM, CLOTIAZEPAM, PAROXETINE, FLUNITRAZEPAM. Patient was hospitalized. Patient died.

Tracleer Side Effects Report #5678172-0
Tracleer side effect was reported by a Physician from CZECH REPUBLIC on Mar 05, 2008. Female patient, 49 years of age, weighting 152.1 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: arrhythmia , disease progression, pulmonary hypertension . Tracleer dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient died on 03/03/2008.

Tracleer Side Effects Report #5220981-6
Tracleer side effect was reported by a Consumer or non-health professional from JAPAN on Jan 10, 2007. Female patient, 47 years of age, weighting 116.8 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, anaemia, aspartate aminotransferase increased, blood alkaline phosphatase increased, condition aggravated, disease progression, hepatic congestion, hepatic function abnormal, pulmonary hypertension . Tracleer dosage: 31.25 MG, BID, ORAL; 62.5 MG, BID. During the same period patient was treated with FERROUS CITRATE, EPOPROSTENOL, BERAPROST, WAFARIN POTASSIUM, OXYGEN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5069924-9
Tracleer side effect was reported by a Physician from TAIWAN, PROVINCE OF CHINA on July 17, 2006. Female patient, 47 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, cardiac failure, disease progression, dyspnoea, exercise tolerance decreased, interstitial lung disease, liver function test abnormal. Tracleer dosage: 125 MG, BID, ORAL ; 62.5 MG, BID, ORAL. During the same period patient was treated with OXYGEN, BRONCHODILATORS, NITROUS OXIDE W, ACE INHIBITOR, COUMADIN. Patient was hospitalized. Patient died on 04/01/2006.


Tracleer Side Effects Report #4787041-X
Tracleer side effect was reported by a Physician from UNITED STATES on Sept 14, 2005. Female patient, 47 years of age, weighting 142.0 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abdominal distension, blood bilirubin increased, blood creatinine increased, blood immunoglobulin g increased, blood immunoglobulin m increased, disease progression, hepatic congestion, legionella serology positive, multi-organ failure. Tracleer dosage: unknown. During the same period patient was treated with FOLIC ACID, DIGOXIN, SPIRONOLACTONE, LASIX, COUMADIN, PREDNISONE. Patient died on 05/04/2005.

Tracleer Side Effects Report #5581087-X
Tracleer side effect was reported by a Physician from UNITED STATES on Dec 20, 2007. Female patient, 44 years of age, weighting 134.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abdominal pain , chest pain , diarrhoea, disease progression, hepatic fibrosis, pulmonary hypertension . Tracleer dosage: unknown. During the same period patient was treated with VENTAVIS, PREDNISONE, VIAGRA, NEXIUM, FUROSEMIDE, POTASSIUM CHLORIDE, METHOTREXATE, METOLAZONE. Patient died on 01/01/2007.

Tracleer Side Effects Report #5632701-1
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 01, 2008. Female patient, 44 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, anaemia, aspartate aminotransferase increased, disease progression, ear pain, electrolyte imbalance, haematuria, headache . Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with METOLAZONE, PROTONIX, LORTAB, POTASSIUM CHLORIDE, PHENERGAN, COLACE, PAXIL, TRAMADOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5640813-1
Tracleer side effect was reported by a Consumer or non-health professional from SWEDEN on Feb 10, 2008. Female patient, 44 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, apathy, aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased, condition aggravated, disease progression, fatigue, hypoglycaemia. Tracleer dosage: 125 MG , BID, ORAL; 62.5 MG, BID, ORAL; 62.5 MG, BID. During the same period patient was treated with FUROSEMIDE, SPIRONOLACTONE, FRAGMIN, ZAROXOLYN, CEFADROXIL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5659578-2
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 19, 2008. Female patient, 44 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, anaemia, aspartate aminotransferase increased, disease progression, dyspnoea, ear pain, electrolyte imbalance, headache . Tracleer dosage: 125 MG,BID,ORAL. During the same period patient was treated with METOLAZONE, PROTONIX, LORTAB, POTASSIUM CHLORIDE, PHENERGAN, COLACE, PAXIL, TRAMADOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5760465-X
Tracleer side effect was reported by a Physician from UNITED STATES on May 01, 2008. Male patient, 43 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: atrial fibrillation , disease progression, hypotension, ischaemic hepatitis, off label use, pulmonary hypertension , right ventricular failure. Tracleer dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5631568-5
Tracleer side effect was reported by a Physician from UNITED STATES on Jan 29, 2008. Female patient, 39 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: condition aggravated, disease progression, pulmonary hypertension , sarcoidosis. Tracleer dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient died.

Tracleer Side Effects Report #5427661-2
Tracleer side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 08, 2007. Male patient, 38 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: amputation, anaemia, cyanosis, disease progression, gangrene, infarction, ischaemia, microangiopathy, sclerodactylia. Tracleer dosage: 62.5 MG, BID, ORAL; 125 MG, BID. During the same period patient was treated with VENTAVIS, NIFEDIPINE, CLOPIDOGREL, FLUOXETINE, LANSOPRAZOLE, METHYLPREDNISOLONE, CYCLOPHOSPHAMIDE, LOSARTAN POTASSIUM. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4554670-8
Tracleer side effect was reported by a Physician from on Jan 05, 2005. Female patient, 37 years of age, weighting 141.1 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abscess , agranulocytosis, depression , disease progression, epistaxis, microcytic anaemia, platelet count decreased, subcutaneous abscess. Tracleer dosage: unknown. During the same period patient was treated with CITALOPRAM, ALPRAZOLAM, PREDNISOLONE, SALMETEROL, ACENOCOUMAROL, FUROSEMIDE. Patient was hospitalized. Patient died.

Tracleer Side Effects Report #4559573-0
Tracleer side effect was reported by a Physician from on Jan 05, 2005. Female patient, 37 years of age, weighting 141.1 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abscess limb, agranulocytosis, depression , disease progression, epistaxis, malaise, microcytic anaemia, platelet count decreased, pyrexia. Tracleer dosage: unknown. During the same period patient was treated with CITALOPRAM, ALPRAZOLAM, PREDNISOLONE, SALMETEROL, ACENOCOUMAROL, FUROSEMIDE. Patient was hospitalized. Patient died.


Tracleer Side Effects Report #5239194-7
Tracleer side effect was reported by a Physician from SWEDEN on Jan 30, 2007. Male patient, 34 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, pulmonary hypertension , right ventricular failure, shock. Tracleer dosage: unknown. Patient died on 01/14/2007.

Tracleer Side Effects Report #4975720-0
Tracleer side effect was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Mar 27, 2006. Female patient, 34 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abdominal pain upper, activities of daily living impaired, blood pressure abnormal, bradycardia, cyanosis, dehydration, disease progression, dyspnoea. Tracleer dosage: unknown. Patient was hospitalized. Patient died on 02/22/2006.

Tracleer Side Effects Report #5239192-3
Tracleer side effect was reported by a Physician from JAPAN on Jan 29, 2007. Female patient, 33 years of age, weighting 108.0 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, disease progression, dyspnoea exertional, electromechanical dissociation, flushing, gamma-glutamyltransferase increased, haemoptysis. Tracleer dosage: unknown. Patient was hospitalized. Patient died on 04/29/2006.

Tracleer Side Effects Report #5472184-8
Tracleer side effect was reported by a Physician from UNITED STATES on Sept 12, 2007. Female patient, 32 years of age, was diagnosed with pulmonary hypertension , polymyositis and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abortion induced, disease progression, placental disorder, pregnancy , syncope. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with CYTOXAN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5727510-9
Tracleer side effect was reported by a Physician from UNITED STATES on Apr 14, 2008. Male patient, 28 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: coagulopathy, complications of transplant surgery, disease progression, haemorrhage, heart and lung transplant, pulmonary arterial hypertension, renal failure. Tracleer dosage: unknown. Patient was hospitalized. Patient died on 04/12/2008.

Tracleer Side Effects Report #5738399-6
Tracleer side effect was reported by a Physician from UNITED STATES on Apr 29, 2008. Male patient, 28 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: coagulopathy, continuous haemodiafiltration, disease progression, heart and lung transplant, hepatic congestion, hepatic function abnormal, hepatic ischaemia, international normalised ratio increased, intestinal ischaemia. Tracleer dosage: unknown. During the same period patient was treated with COUMADIN. Patient was hospitalized. Patient died on 04/12/2008.

Tracleer Side Effects Report #5311064-5
Tracleer side effect was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Apr 09, 2007. Female patient, 26 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, pneumonia , pulmonary hypertension , septic shock. Tracleer dosage: unknown. Patient died on 02/18/2007.

Tracleer Side Effects Report #5486029-3
Tracleer side effect was reported by a Physician from AUSTRALIA on Sept 28, 2007. Female patient, 25 years of age, weighting 149.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac failure congestive, disease progression, left ventricular failure, pulmonary hypertension , pulmonary oedema. Tracleer dosage: 62.5 MG, BID, ORAL. Patient recovered.

Tracleer Side Effects Report #4652072-7
Tracleer side effect was reported by a Physician from on Apr 15, 2005. Female patient, 23 years of age, weighting 110.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: caesarean section, disease progression, dizziness , nausea , pregnancy , pulmonary hypertension , vaginal haemorrhage. Tracleer dosage: unknown. During the same period patient was treated with FLOLAN, PROTONIX. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4891940-8
Tracleer side effect was reported by a Physician from UNITED STATES on Jan 09, 2006. Female patient, 23 years of age, weighting 110.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: caesarean section, disease progression, dizziness , headache , pregnancy , premature labour, pulmonary hypertension , vaginal haemorrhage. Tracleer dosage: unknown. During the same period patient was treated with FLOLAN, PROTONIX, PRENATAL, HEPARIN, BETAMETHASONE. Patient was hospitalized. Patient recovered.


Tracleer Side Effects Report #5194966-2
Tracleer side effect was reported by a Physician from UNITED STATES on Dec 11, 2006. Female patient, 21 years of age, weighting 121.0 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abortion induced, cardiac disorder, decreased activity, disease progression, dyspnoea, nausea , pregnancy , pulmonary hypertension . Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with COUMADIN, FLOLAN. Patient died on 12/19/2006.

Tracleer Side Effects Report #5134273-7
Tracleer side effect was reported by a Physician from FRANCE on Oct 01, 2006. Male patient, 76 years of age, was diagnosed with pulmonary fibrosis  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: blood pressure systolic decreased, cardiac arrest , cardiovascular disorder, chronic respiratory failure, disease progression, off label use, pulmonary fibrosis , respiratory distress. Tracleer dosage: unknown. Patient was hospitalized. Patient died on 10/09/2006.

Tracleer Side Effects Report #6047118-8
Tracleer side effect was reported by a Physician from UNITED STATES on June 26, 2008. Female patient, 87 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, pulmonary hypertension , right ventricular failure. Tracleer dosage: unknown. Patient died.

Tracleer Side Effects Report #6111417-1
Tracleer side effect was reported by a Physician from JAPAN on Feb 19, 2009. Female patient, 87 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anorexia, cardiac arrest , condition aggravated, disease progression, pulmonary arterial hypertension, respiratory arrest. Tracleer dosage: 62.5 MG, QD, ORAL. During the same period patient was treated with WARFARIN, DILTIAZEM, FUROSEMIDE, OXYGEN. Patient died on 06/12/2008.

Tracleer Side Effects Report #5808028-1
Tracleer side effect was reported by a Consumer or non-health professional from BELGIUM on June 24, 2008. Male patient, 82 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiopulmonary failure, disease progression, pulmonary hypertension , renal failure acute, right ventricular failure. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with REVATIO, ALDACTONE, BUMETANIDE, SINTROM, SPIRIVA, COMBIVENT. Patient was hospitalized. Patient died on 04/28/2008.

Tracleer Side Effects Report #6002189-X
Tracleer side effect was reported by a Physician from UNITED STATES on Dec 03, 2008. Male patient, 75 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abdominal pain upper, cardiac arrest , disease progression, liver function test abnormal, pulmonary hypertension . Tracleer dosage: unknown. During the same period patient was treated with HERBAL PREPARATION, VITAMINS NOS. Patient died on 11/28/2008.

Tracleer Side Effects Report #6110625-3
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 25, 2009. Female patient, 71 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anaemia, disease progression, gastrointestinal haemorrhage, hepatic failure, mental status changes, packed red blood cell transfusion, pneumonia , pulmonary arterial hypertension. Tracleer dosage: 32.5 MG, QD, ORAL. During the same period patient was treated with REVATIO, RAPAMUNE, AMIODARONE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, ROCALTROL. Patient was hospitalized. Patient died on 12/10/2008.

Tracleer Side Effects Report #6005490-9
Tracleer side effect was reported by a Physician from JAPAN on Nov 28, 2008. Male patient, child 7 years of age, weighting 39.68 lb, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anorexia, brain natriuretic peptide increased, cardiac failure, cardiomegaly, condition aggravated, disease progression, face oedema. Tracleer dosage: 27 MG, BID, ORAL : 9 MG, BID, ORAL : 18 MG, BID, ORAL : 17.5 MG, BID, ORAL. During the same period patient was treated with EPOPROSTENOL, FUROSEMIDE, SPIRONOLACTONE, AMLODIPINE BESYLATE, KETOTIFEN FUMARATE. Patient was hospitalized. Patient died on 10/18/2008.

Tracleer Side Effects Report #6094195-4
Tracleer side effect was reported by a Physician from JAPAN on Feb 09, 2009. Male patient, child 7 years of age, weighting 39.68 lb, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anorexia, brain natriuretic peptide increased, cardiac failure, cardiomegaly, disease progression, face oedema, hepatomegaly. Tracleer dosage: 27 MG, BID, ORAL; 9 MG, BID, ORAL; 18 MG, BID, ORAL; 17.5 MG, BID, ORAL. During the same period patient was treated with EPOPROSTENOL, FUROSEMIDE, SPIRONOLACTONE, AMLODIPINE BESYLATE, KETOTIFEN FUMARATE. Patient was hospitalized. Patient died on 10/18/2006.

Tracleer Side Effects Report #5950843-8
Tracleer side effect was reported by a Physician from JAPAN on Oct 28, 2008. Female patient, 68 years of age, weighting 158.7 lb, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: acute right ventricular failure, condition aggravated, cor pulmonale, disease progression, iron deficiency anaemia, neck pain, pulmonary arterial hypertension. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with BERAPROST, WARFARIN POTASSIUM, FUROSEMIDE, ASPARTATE POTASSIUM, TULOBUTEROL, LANSOPRAZOLE, PREDNISONE, SALBUTAMOL SULPHATE. Patient died on 01/05/2008.


Tracleer Side Effects Report #5988495-3
Tracleer side effect was reported by a Physician from JAPAN on Nov 26, 2008. Female patient, 66 years of age, weighting 158.7 lb, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: acute right ventricular failure, condition aggravated, cor pulmonale, disease progression, iron deficiency anaemia, neck pain, pulmonary arterial hypertension. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with BERAPROST, WARFARIN, FUROSEMIDE, ASPARTATE POTASSIUM, TULOBUTEROL, LANSOPRAZOLONE, PREDNISOLONE, SALBUTAMOL SULPHATE. Patient died on 01/05/2008.

Tracleer Side Effects Report #5776016-X
Tracleer side effect was reported by a Physician from UNITED STATES on May 30, 2008. Female patient, 56 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac failure, chest discomfort, chest pain , disease progression, electrocardiogram t wave inversion, fatigue, joint swelling, oedema peripheral, pruritus. Tracleer dosage: 62.5 MG, BID, ORAL, ORAL. During the same period patient was treated with PLAVIX. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6130432-5
Tracleer side effect was reported by a Health Professional from UNITED STATES on Mar 09, 2009. Female patient, 46 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, pain in extremity, post procedural infection, pulmonary arterial pressure abnormal, pulmonary hypertension . Tracleer dosage: unknown. During the same period patient was treated with REMODULIN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5844499-2
Tracleer side effect was reported by a Consumer or non-health professional from BELGIUM on July 29, 2008. Female patient, 40 years of age, weighting 121.3 lb, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, lung transplant , pulmonary hypertension . Tracleer dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with SINOTROM, ALDACTONE, DEPAKINE, LAMICTAL, BUMETANIDE, SIPRALEXA, MOVICOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5988332-7
Tracleer side effect was reported by a Physician from UNITED STATES on Nov 20, 2008. Female patient, 37 years of age, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: blood bilirubin increased, cardiac failure, disease progression, hepatomegaly, hypokalaemia, hyponatraemia, lung disorder, nausea , pulmonary arterial hypertension. Tracleer dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5950918-3
Tracleer side effect was reported by a Health Professional from UNITED STATES on Oct 27, 2008. Female patient, 30 years of age, weighting 155.2 lb, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abortion induced, colitis ischaemic, disease progression, hepatic failure, lactic acidosis, pericardial effusion, pleural effusion. Tracleer dosage: unknown. During the same period patient was treated with REVATIO, REMODULIN, LASIX, COUMADIN, MISOPROSTOL. Patient was hospitalized. Patient died on 07/19/2008.

Tracleer Side Effects Report #5832703-6
Tracleer side effect was reported by a Physician from JAPAN on July 23, 2008. Female patient, 14 years of age, weighting 97.00 lb, was diagnosed with pulmonary arterial hypertension and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, bradycardia, cardiac failure, cyanosis, disease progression, hepatic function abnormal, pulmonary hypertension . Tracleer dosage: 31.25 MG, BID, ORAL, 46.875 MG, BID, ORAL, 31.25 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with DIGOXIN, OXYGEN, PRAZOSIN GITS, ALLOPURINOL. Patient recovered.

Tracleer Side Effects Report #5694383-2
Tracleer side effect was reported by a Consumer or non-health professional from GERMANY on Mar 20, 2008. Male patient, 52 years of age, was diagnosed with idiopathic pulmonary fibrosis and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, idiopathic pulmonary fibrosis, off label use. Tracleer dosage: unknown. Patient died.

Tracleer Side Effects Report #5148559-3
Tracleer side effect was reported by a Health Professional from BELGIUM on Oct 27, 2006. Female patient, 55 years of age, was diagnosed with connective tissue disorder  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, lung transplant . Tracleer dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5850973-5
Tracleer side effect was reported by a Physician from NETHERLANDS on Aug 06, 2008. Female patient, 80 years of age, was treated with Tracleer. After drug was administered, patient experienced the following side effects: condition aggravated, disease progression, pulmonary fibrosis . Tracleer dosage: unknown. Patient died.


Tracleer Side Effects Report #5909113-6
Tracleer side effect was reported by a Health Professional from AUSTRALIA on Sept 10, 2008. Female patient, 78 years of age, was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression. Tracleer dosage: unknown. Patient died.

Tracleer Side Effects Report #5713874-9
Tracleer side effect was reported by a Health Professional from AUSTRIA on Apr 04, 2008. Female patient, 72 years of age, was treated with Tracleer. After drug was administered, patient experienced the following side effects: disease progression, right ventricular failure. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with TREPROSTINIL, VENTAVIS. Patient died on 12/01/2006.