Tracleer and off label use Patient Reports February 11, 2012

Tracleer Side Effects Report #5713877-4
Tracleer side effect was reported by a Physician from GERMANY on Apr 08, 2008. Female patient, 54 years of age, was diagnosed with systemic sclerosis pulmonary and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac failure, condition aggravated, off label use, pleural effusion. Tracleer dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5679598-1
Tracleer side effect was reported by a Physician from GERMANY on Mar 11, 2008. Female patient, 67 years of age, weighting 117.9 lb, was diagnosed with systemic sclerosis and was treated with Tracleer. After drug was administered, patient experienced the following side effects: aspartate aminotransferase increased, blood alkaline phosphatase increased, clostridium difficile colitis, gamma-glutamyltransferase increased, off label use. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with OMEPRAZOLE, TELMISARTAN, AMLODIPINE, RAMIPRIL, INSULIN, RITUXAN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6138747-1
Tracleer side effect was reported by a Consumer or non-health professional from GERMANY on Mar 16, 2009. Female patient, 60 years of age, weighting 154.3 lb, was diagnosed with systemic sclerosis and was treated with Tracleer. After drug was administered, patient experienced the following side effects: oedema peripheral, off label use, pleural effusion, right ventricular failure. Tracleer dosage: 125 MG, QD; ORAL. Patient recovered.

Tracleer Side Effects Report #5128243-2
Tracleer side effect was reported by a Health Professional from UNITED KINGDOM on Sept 26, 2006. Female patient was diagnosed with systemic sclerosis and was treated with Tracleer. After drug was administered, patient experienced the following side effects: autoimmune disorder, off label use. Tracleer dosage: unknown. Patient recovered.


Tracleer Side Effects Report #5986342-7
Tracleer side effect was reported by a Physician from KOREA, REPUBLIC OF on Nov 19, 2008. Female patient, 31 years of age, weighting 114.6 lb, was diagnosed with systemic lupus erythematosus and was treated with Tracleer. After drug was administered, patient experienced the following side effects: azotaemia, off label use. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with AZATHIOPRINE, ENALAPRIL MALEATE. Patient died on 09/01/2008.

Tracleer Side Effects Report #4786105-4
Tracleer side effect was reported by a Consumer or non-health professional from SPAIN on Sept 21, 2005. Female patient, 71 years of age, weighting 112.4 lb, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: hepatic cyst, hepatitis toxic, off label use. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with LOSARTAN POTASSIUM, PREDNISONE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4843734-7
Tracleer side effect was reported by a Consumer or non-health professional from NETHERLANDS on Nov 21, 2005. Female patient, 64 years of age, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac arrest , off label use. Tracleer dosage: 125 MG, BID, ORAL. Patient died on 10/21/2005.

Tracleer Side Effects Report #4759282-9
Tracleer side effect was reported by a Consumer or non-health professional from AUSTRIA on Aug 18, 2005. Female patient, 52 years of age, weighting 116.8 lb, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: arthralgia, myalgia, off label use. Tracleer dosage: unknown. During the same period patient was treated with ACEMIN, PANTOLOC, NORVASC, METHYLPREDNISOLONE, TRANSTEC. Patient recovered.

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 #5660501-5
Tracleer side effect was reported by a Physician from GREECE on Feb 22, 2008. Male patient, 41 years of age, weighting 176.4 lb, was diagnosed with skin ulcer and was treated with Tracleer. After drug was administered, patient experienced the following side effects: laryngitis, off label use. Tracleer dosage: 125 MG, BID, ORAL; 125 MG, BID, ORAL. Patient was hospitalized and became disabled. Patient recovered.

Tracleer Side Effects Report #5843134-7
Tracleer side effect was reported by a Physician from FRANCE on July 28, 2008. Male patient, 79 years of age, was diagnosed with scleroderma  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anaemia, melaena, off label use. Tracleer dosage: 62.5 MG BID ORAL. During the same period patient was treated with MOPRAL, AMLODIPINE BESYLATE, PLAVIX, KARDEGIC. 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 #5616713-X
Tracleer side effect was reported by a Consumer or non-health professional from FRANCE on Jan 17, 2008. Female patient, 56 years of age, was diagnosed with scleroderma  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abdominal pain upper, cytolytic hepatitis, off label use. Tracleer dosage: 125 MG, BID; ORAL. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4771018-4
Tracleer side effect was reported by a Physician from FRANCE on Aug 29, 2005. Female patient, 46 years of age, was diagnosed with scleroderma  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cutaneous vasculitis, disease recurrence, off label use, pyrexia, subcutaneous nodule. Tracleer dosage: unknown. During the same period patient was treated with SANDOSTATIN, FONZYLANE, ERYTHROMYCIN, PANTOPRAZOLE, LEVOTHYROXINE, POTASSIUM CHLORIDE, GAVISCON, MOVICOL. Patient was hospitalized. Patient recovered.


Tracleer Side Effects Report #4810567-7
Tracleer side effect was reported by a Physician from FRANCE on Oct 13, 2005. Female patient, 46 years of age, was diagnosed with scleroderma  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: arthralgia, cutaneous vasculitis, disease recurrence, off label use, pyrexia, skin inflammation, subcutaneous nodule, vascular purpura. Tracleer dosage: unknown. During the same period patient was treated with SANDOSTATIN, FONZYLANE, ERYTHROMYCIN, PANTOPRAZOLE, LEVOTHYROXINE, POTASSIUM CHLORIDE, GAVISCON. Patient was hospitalized. Patient recovered.

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 #6099363-3
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 17, 2009. Male patient, 85 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cough, dizziness , dyspnoea, myelodysplastic syndrome, normochromic normocytic anaemia, off label use, pancytopenia, rhinitis. Tracleer dosage: unknown. During the same period patient was treated with LIPITOR, MECLIZINE, LASIX, FOSAMAX, FOLIC ACID. Patient recovered.

Tracleer Side Effects Report #4671214-0
Tracleer side effect was reported by a Health Professional from on May 02, 2005. Female patient, 84 years of age, weighting 110.2 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, liver function test abnormal, off label use. Tracleer dosage: unknown. During the same period patient was treated with LASIX, ACENOCOUMAROL, ZESTRIL, SEREVENT, FLIXOTIDE. Patient recovered.

Tracleer Side Effects Report #6106713-8
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 23, 2009. Female patient, 83 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: cardiac failure congestive, condition aggravated, off label use, pneumonia , pulmonary veno-occlusive disease. Tracleer dosage: 62.5 MG, BID, ORAL; 62.5 MG, QD, ORAL. Patient was hospitalized. Patient recovered.


Tracleer Side Effects Report #5168313-6
Tracleer side effect was reported by a Physician from JAPAN on Nov 16, 2006. Female patient, 82 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 bilirubin increased, condition aggravated, hepatic function abnormal, multi-organ failure, off label use, pulmonary hypertension . Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with EPOPROSTENOL, BERAPROST, FUROSEMIDE, OXYGEN. Patient died on 12/27/2005.

Tracleer Side Effects Report #4654414-5
Tracleer side effect was reported by a Physician from on Apr 21, 2005. Male patient, 82 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: epistaxis, ileus, off label use. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with SINTROM, DIGOXIN, LASIX, ALDACTONE, PULMICORT, ATROVENT, ZINACEF. Patient recovered.

Tracleer Side Effects Report #5826829-0
Tracleer side effect was reported by a Physician from UNITED STATES on July 09, 2008. Female patient, 78 years of age, weighting 179.9 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: autoimmune hepatitis, interstitial lung disease, metastases to lung, mixed connective tissue disease, neutrophil percentage increased, off label use. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with ZETIA, AMARYL, METFORMIN, TYLENOL ARTHRITIS, ASPIRIN, FERROUS SULPHATE, JANUVIA. Patient recovered.

Tracleer Side Effects Report #4551930-1
Tracleer side effect was reported by a Consumer or non-health professional from on Dec 30, 2004. Female patient, 75 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: off label use, respiratory failure. Tracleer dosage: unknown. Patient recovered.

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 #5985243-8
Tracleer side effect was reported by a Physician from UNITED STATES on Nov 19, 2008. Male 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: agitation, blood pressure decreased, confusional state, dizziness , dyspnoea, lethargy, oedema peripheral, off label use, weight increased. Tracleer dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with REVATIO. Patient recovered.

Tracleer Side Effects Report #5692061-7
Tracleer side effect was reported by a Physician from AUSTRALIA on Mar 19, 2008. Female patient, 72 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: atelectasis, back pain , cardiomegaly, condition aggravated, off label use, pleural effusion, renal impairment, right ventricular failure, tricuspid valve incompetence. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. Patient was hospitalized. Patient died.

Tracleer Side Effects Report #5646478-7
Tracleer side effect was reported by a Physician from NETHERLANDS on Feb 15, 2008. Male patient, 71 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alcoholism , off label use. Tracleer dosage: unknown. Patient died.

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 #5956166-5
Tracleer side effect was reported by a Physician from UNITED STATES on Oct 30, 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: atrial fibrillation , atrial flutter, dyspnoea, heart rate increased, off label use, respiratory failure. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with ZOCOR, PREDNISOLONE ACETATE, ATENOLOL, PLAVIX, ASPIRIN, SPIRONOLACTONE. Patient was hospitalized. Patient died on 04/14/2007.


Tracleer Side Effects Report #5876156-0
Tracleer side effect was reported by a Physician from UNITED STATES on Aug 25, 2008. Female patient, 69 years of age, weighting 250.0 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: abasia, anaphylactic reaction, dyspnoea, eye swelling, muscular weakness, oedema mouth, oedema peripheral, off label use, swollen tongue. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with COUMADIN, DIOVAN, VERAPAMIL, NEXIUM, ADVAIR DISKUS, POTASSIUM CHLORIDE, LASIX, CELEBREX. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6073074-2
Tracleer side effect was reported by a Physician from JAPAN on Jan 22, 2009. Male patient, 69 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, off label use, pulmonary arterial hypertension, right ventricular systolic pressure increased. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with WARFARIN, TIPEPIDINE HIBENZATE. Patient died on 01/22/2009.

Tracleer Side Effects Report #5574090-7
Tracleer side effect was reported by a Physician from FRANCE on Dec 14, 2007. Male 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: off label use, pneumonia . Tracleer dosage: 125 MG,BID,ORAL; 62.5 MG,BID,ORAL. During the same period patient was treated with DIURETICS. Patient died on 02/01/2007.

Tracleer Side Effects Report #5711260-9
Tracleer side effect was reported by a Consumer or non-health professional from GERMANY on Apr 01, 2008. Female patient, 67 years of age, weighting 117.9 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, bronchopneumonia, clostridium difficile colitis, dehydration, gamma-glutamyltransferase increased, off label use. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with CIPROFLOXACIN, OMEPRAZOLE, TELMISARTAN, AMLODIPINE, RAMIPRIL, INSULIN, RITUXAN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6003594-8
Tracleer side effect was reported by a Health Professional from FRANCE on Nov 28, 2008. Male 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: gastroenteritis radiation, normochromic normocytic anaemia, off label use, rectal haemorrhage. Tracleer dosage: 125 MG, BID, ORAL : 62 MG, BID, ORAL. During the same period patient was treated with PREVISCAN, KARDEGIC, RAMIPRIL, LASIX, BISOPROLOL FUMARATE, PRAVASTATIN. Patient was hospitalized. Patient recovered.


Tracleer Side Effects Report #4609446-X
Tracleer side effect was reported by a Consumer or non-health professional from on Mar 02, 2005. Male patient, 67 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: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, off label use. Tracleer dosage: unknown. During the same period patient was treated with ACENOCOUMAROL. Patient recovered.

Tracleer Side Effects Report #4850633-3
Tracleer side effect was reported by a Physician from AUSTRIA on Nov 29, 2005. Female patient, 67 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: cardiac tamponade, off label use, pericardial effusion, pericardial haemorrhage, transitional cell carcinoma. Tracleer dosage: unknown. During the same period patient was treated with WARFARIN, ATACAND, NOVONORM, BISOPROLOL, PANTOPRAZOLE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5859101-3
Tracleer side effect was reported by a Physician from GERMANY on Aug 11, 2008. Male patient, 66 years of age, weighting 172.6 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: hepatitis toxic, off label use. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with AMIODARONE HYDROCHLORIDE, TORSEMIDE, XIPAMIDE, QUINAPRIL, DIGITOXIN, SIMVASTATIN, AMLODIPINE, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4635341-6
Tracleer side effect was reported by a Consumer or non-health professional from on Mar 31, 2005. 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: haemoptysis, off label use. Tracleer dosage: 125 MG, BID, ORAL. Patient died on 01/18/2005.

Tracleer Side Effects Report #4654417-0
Tracleer side effect was reported by a Physician from on Apr 26, 2005. 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: haemoptysis, off label use. Tracleer dosage: 125 MG, BID, ORAL. Patient died on 01/18/2005.


Tracleer Side Effects Report #5764438-2
Tracleer side effect was reported by a Physician from UNITED STATES on May 23, 2008. Female patient, 63 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anaemia, liver function test abnormal, off label use, presyncope, tachycardia. Tracleer dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with REVATIO. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5127924-4
Tracleer side effect was reported by a Physician from FRANCE on Sept 26, 2006. 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: ascites, breast cancer recurrent, cardiac failure, localised oedema, oedema peripheral, off label use, post procedural haematoma, transaminases increased. Tracleer dosage: unknown. During the same period patient was treated with ORAL ANTIGOAGULANTS. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6103532-3
Tracleer side effect was reported by a Physician from JAPAN on Feb 19, 2009. Female patient, 61 years of age, weighting 105.8 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatic function abnormal, off label use. Tracleer dosage: unknown. During the same period patient was treated with WARFARIN POTASSIUM, TORSEMIDE, AZELNIDIPINE, SPIRONOLACTONE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4831113-8
Tracleer side effect was reported by a Consumer or non-health professional from AUSTRIA on Nov 04, 2005. Female patient, 60 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: diverticular perforation, diverticulitis, multi-organ failure, off label use, renal failure. Tracleer dosage: unknown. During the same period patient was treated with FUROSEMIDE, SPIRONOLACTONE, ALLOPURINOL, AMLODIPINE, THEOPHYLLINE, ZYRTEC, WARFARIN. Patient died on 11/01/2004.

Tracleer Side Effects Report #4831115-1
Tracleer side effect was reported by a Consumer or non-health professional from AUSTRIA on Nov 04, 2005. Male patient, 60 years of age, weighting 196.2 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: heart transplant , off label use. Tracleer dosage: 125 MG BID ORAL. During the same period patient was treated with CARVEDILOL, ATORVASTATIN CALCIUM, PLAVIX, CAPOZIDE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6001992-X
Tracleer side effect was reported by a Physician from UNITED STATES on Nov 30, 2008. Male patient, child 6 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiac failure congestive, liver function test abnormal, meningococcal bacteraemia, off label use, respiratory tract infection. Tracleer dosage: unknown. During the same period patient was treated with SILDENAFIL CITRATE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6052866-X
Tracleer side effect was reported by a Physician from UNITED STATES on Jan 09, 2009. Female patient, 59 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: anaemia, off label use. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with WARFARIN, LEXAPRO, SYNTHROID, NEURONTIN, XANAX, NEXIUM, AMERGE. Patient died.

Tracleer Side Effects Report #6103507-4
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 13, 2009. Female patient, 59 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: off label use, pneumonia , respiratory tract congestion, sinusitis . Tracleer dosage: unknown. During the same period patient was treated with DIOVAN, PREDNISONE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4554665-4
Tracleer side effect was reported by a Consumer or non-health professional from on Jan 04, 2005. Male patient, 50 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 bilirubin increased, cardiopulmonary failure, off label use. Tracleer dosage: unknown. During the same period patient was treated with RAMIPRIL, TOREM, POLAMIDON, COTRIM, BERODUAL, SYMBICORT, SPIRIVA. Patient died on 10/12/2004.

Tracleer Side Effects Report #4701376-8
Tracleer side effect was reported by a Physician from on June 14, 2005. Male patient, 50 years of age, weighting 185.4 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardiopulmonary failure, dyspnoea exertional, fatigue, lung injury, off label use, post procedural complication, reperfusion injury, right ventricular failure. Tracleer dosage: 125 MG, BID, ORAL. Patient died on 02/16/2005.


Tracleer Side Effects Report #5820250-7
Tracleer side effect was reported by a Physician from UNITED STATES on July 10, 2008. Male patient, 49 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, off label use. Tracleer dosage: 62.5 MG, BID OTHER. Patient died.

Tracleer Side Effects Report #6020662-5
Tracleer side effect was reported by a Physician from NETHERLANDS on Dec 10, 2008. Female patient, 48 years of age, weighting 110.2 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: off label use, operative haemorrhage. Tracleer dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with EPOPROSTENOL, FUROSEMIDE, SPIRONOLACTONE, HYDROXYCHLOROQUINE SULPHATE, PREDNISONE, REVATIO. Patient died on 10/06/2008.

Tracleer Side Effects Report #4635340-4
Tracleer side effect was reported by a Consumer or non-health professional from on Mar 31, 2005. Female patient, 45 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: off label use, transplant. Tracleer dosage: 125 MG, BID, ORAL. 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 #4635339-8
Tracleer side effect was reported by a Consumer or non-health professional from on Mar 31, 2005. Female 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: off label use, transplant. Tracleer dosage: 125 MG, BID, ORAL. Patient recovered.

Tracleer Side Effects Report #4654420-0
Tracleer side effect was reported by a Consumer or non-health professional from on Apr 26, 2005. Female 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: lung transplant , off label use. Tracleer dosage: 125 MG, BID, ORAL. Patient recovered.

Tracleer Side Effects Report #5988498-9
Tracleer side effect was reported by a Physician from JAPAN on Nov 27, 2008. 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: cardiac output decreased, central venous pressure increased, laryngeal oedema, off label use, pulmonary hypertension , tachypnoea, vocal cord paralysis. Tracleer dosage: unknown. During the same period patient was treated with WARFARIN, BERAPROST, DIURETICS, EPOPROSTENOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6001996-7
Tracleer side effect was reported by a Physician from UNITED STATES on Nov 30, 2008. Male patient, child 3 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: liver function test abnormal, off label use, respiratory tract infection. Tracleer dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #4599133-9
Tracleer side effect was reported by a Consumer or non-health professional from on Feb 17, 2005. Female patient, 29 years of age, weighting 132.3 lb, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: asthenia, dyspnoea, hepatic failure, hepatic infarction, hypoxia, ischaemic hepatitis, off label use, pulmonary oedema, pulmonary veno-occlusive disease. Tracleer dosage: 125 MG, BID, ORAL. During the same period patient was treated with LASILIX, PREVISCAN, POTASSIUM CHLORIDE, OXYGEN, ACETAMINOPHEN, DEROXAT. Patient was hospitalized. Patient died on 01/01/2005.

Tracleer Side Effects Report #6021818-8
Tracleer side effect was reported by a Physician from UNITED STATES on Dec 12, 2008. Male patient, child 11 years of age, was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, liver function test abnormal, multi-organ failure, off label use. Tracleer dosage: 31.25 MG, BID, ORAL; 31.25 MG, QD, ORAL. During the same period patient was treated with SILDENAFIL. Patient was hospitalized. Patient died on 04/15/2008.


Tracleer Side Effects Report #5892234-4
Tracleer side effect was reported by a Physician from UNITED STATES on Sept 09, 2008. Male patient was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: off label use, viral infection . Tracleer dosage: unknown. Patient was hospitalized. Patient died on 09/06/2008.

Tracleer Side Effects Report #6003704-2
Tracleer side effect was reported by a Physician from JAPAN on Nov 26, 2008. Female patient was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: adrenal insufficiency, autoimmune disorder, decreased appetite, hyponatraemia, malaise, off label use, pancytopenia. Tracleer dosage: unknown. During the same period patient was treated with EPOPRPSTENOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6066136-7
Tracleer side effect was reported by a Physician from FRANCE on Jan 21, 2009. Male patient was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: extrasystoles, off label use. Tracleer dosage: 125 MG, BID, ORA,; 62.5 MG, BID, ORAL. During the same period patient was treated with LASIX, THEOPHYLLINE. Patient recovered.

Tracleer Side Effects Report #4727809-9
Tracleer side effect was reported by a Physician from GERMANY on July 21, 2005. Male patient was diagnosed with pulmonary hypertension  and was treated with Tracleer. After drug was administered, patient experienced the following side effects: off label use, respiratory failure. Tracleer dosage: 16 MG, OD, ORAL. During the same period patient was treated with SILDENAFIL, ILOMEDIN, PREDNISONE, THEOPHYLLINE, CORTICOSTEROIDS. Patient died on 07/14/2005.

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 #5971802-5
Tracleer side effect was reported by a Consumer or non-health professional from JAPAN on Nov 07, 2008. Male patient, 25 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, hypoxia, lung transplant , off label use, shock. Tracleer dosage: unknown. During the same period patient was treated with SILDENAFIL CITRATE, EPOPROSTENOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #6083385-2
Tracleer side effect was reported by a Physician from UNITED STATES on Feb 03, 2009. Female patient, 50 years of age, was diagnosed with left ventricular dysfunction 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, nausea , off label use. Tracleer dosage: 125 MG, BID, ORAL. 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 #5923942-4
Tracleer side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 01, 2008. Female patient, 51 years of age, was diagnosed with eisenmenger's syndrome and was treated with Tracleer. After drug was administered, patient experienced the following side effects: brain abscess, c-reactive protein increased, eosinophil count decreased, lymphocyte count decreased, neutropenia, off label use, white blood cell count decreased. Tracleer dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with SULFASALAZINE, CEFTRIAXONE, METRONIDAZOLE, WARFARIN, LANSOPRAZOLE, LORATADINE, MEBEVERINE, METOCLOPRAMIDE. Patient was hospitalized and became disabled. Patient recovered.