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Tracleer Side Effects summary

Total Tracleer reports: 563.
Tracleer FDA safety alerts: 2006 .
Reported deaths: 197    Reported hospitalizations: 278.
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Tracleer Side Effects: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, condition aggravated, anaemia, pulmonary hypertension, hepatic function abnormal, oedema peripheral, cardiac failure congestive, liver function test abnormal,
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Tracleer Side Effects reported to FDA

Showing 1-40 of 563 Next >

Tracleer Side Effects Report #5688202-8
Physician from BELGIUM reported TRACLEER problem on Mar 12, 2008. Male patient, 17 years of age, weighting 153.2 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abdominal pain, appendicectomy, burkitt's lymphoma, chest pain, enterectomy, oxygen saturation decreased. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with ROFERON, ZANTAC. Patient was hospitalized. Patient died on 03/12/2008.



Tracleer Side Effects Report #5688203-X
TRACLEER problem was reported by a Physician from FRANCE on Mar 13, 2008. Female patient, 76 years of age, weighting 99.21 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, atrial fibrillation, blood bilirubin increased, cardio-respiratory arrest, cardiopulmonary failure, culture urine positive, enterobacter infection, escherichia infection. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with AMIODARONE, PREVISCAN, ALDACTONE, NEXIUM, LASIX. Patient was hospitalized. Patient died on 06/15/2007.



Tracleer Side Effects Report #5688204-1
Physician from CANADA reported TRACLEER problem on Mar 14, 2008. Female patient, 30 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pregnancy. TRACLEER dosage: 125 MG, BID, ORAL. Patient recovered.



Tracleer Side Effects Report #5691588-1
TRACLEER problem was reported by a Physician from UNITED STATES on Mar 17, 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 problems/side effects: alanine aminotransferase increased, anaemia, aspartate aminotransferase increased, dyspnoea, ear pain, electrolyte imbalance, headache, hypokalaemia, hyponatraemia. 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 #5692061-7
Physician from AUSTRALIA reported TRACLEER problem 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 problems/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 #5692062-9
TRACLEER problem was reported by a Physician from SPAIN on Mar 14, 2008. Female patient, 36 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: paraesthesia, peripheral motor neuropathy, polyneuropathy. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient recovered.



Tracleer Side Effects Report #5616708-6
Health Professional from BELGIUM reported TRACLEER problem on Jan 22, 2008. Female patient, 81 years of age, weighting 160.7 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pneumonia. TRACLEER dosage: 125 MG, BID; ORAL; 62.5 MG, ORAL. During the same period patient was treated with HALDOL SOLUTAB, MARCUMAR, GLUCOPHAGE, VIAGRA, DUOVENT, SPIRIVA, SYMBICORT. Patient died on 01/08/2008.



Tracleer Side Effects Report #5616709-8
TRACLEER problem was reported by a Health Professional from BELGIUM on Jan 22, 2008. Female patient, 47 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 problems/side effects: transplant. TRACLEER dosage: 62.5 MG, BID, 125 MG, BID; ORAL. During the same period patient was treated with REMODULIN, VIAGRA, MARCUMAR, BUMETANIDE, ALDACTONE, PLAVIX, TRAZOLAN. Patient recovered.



Tracleer Side Effects Report #5616712-8
Consumer or non-health professional from SWEDEN reported TRACLEER problem on Jan 21, 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 problems/side effects: apathy, blood creatinine increased, cardiac failure, fatigue, hypoglycaemia, loss of consciousness, transaminases increased. TRACLEER dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL, 62.5 MG, BID. Patient was hospitalized. Patient recovered.




Tracleer Side Effects Report #5616713-X
TRACLEER problem 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 problems/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 #5617046-8
Consumer or non-health professional from PHILIPPINES reported TRACLEER problem on Jan 22, 2008. Female patient, 57 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: accidental overdose, international normalised ratio abnormal. TRACLEER dosage: 62.5 MG, BID; ORAL. During the same period patient was treated with COUMADIN, SILDENAFIL CITRATE. Patient was hospitalized. Patient died on 02/07/2007.



Tracleer Side Effects Report #5617119-X
TRACLEER problem was reported by a Pharmacist from UNITED KINGDOM on Jan 18, 2008. Female patient, 77 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 problems/side effects: mania. TRACLEER dosage: 125 MG, BID; ORAL, 62.5 MG, BID; ORAL. During the same period patient was treated with CANDESARTAN CILEXETIL, SPIRONOLACTONE, FUROSEMIDE, OMEPRAZOLE, PRAVASTATIN, DILTIAZEM, ACETAMINOPHEN. Patient recovered.



Tracleer Side Effects Report #5619067-8
Physician from UNITED STATES reported TRACLEER problem on Jan 21, 2008. Female patient, 40 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cough, heart rate increased, hepatic failure, hypotension. TRACLEER dosage: unknown. During the same period patient was treated with VENTAVIS. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5619161-1
TRACLEER problem was reported by a Health Professional from UNITED STATES on Dec 17, 2007. Female patient, 74 years of age, weighting 173.1 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abscess, abscess limb, alanine aminotransferase increased, anxiety, aspartate aminotransferase increased, blister, blood alkaline phosphatase increased, blood bilirubin increased. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with EZETIMIBE, LEXAPRO, WARFARIN, FUROSEMIDE, METOPROLOL TARTRATE, POTASSIUM CHLORIDE, ROPINIROLE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.




Tracleer Side Effects Report #5622286-8
Physician from THAILAND reported TRACLEER problem on Jan 23, 2008. Male patient, 45 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with VIAGRA, ALDACTONE, LASIX, LANOXIN, POTASSIUM CHLORIDE, CALCIUM CARBONATE. Patient recovered.



Tracleer Side Effects Report #5622289-3
TRACLEER problem was reported by a Physician from JAPAN on Jan 24, 2008. Female patient, 59 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus infection, pancytopenia, pleural effusion. TRACLEER dosage: 62.5 MG, QD, ORAL. During the same period patient was treated with SULFAMETHOXAZOLE W, AMLODIPINE, PITAVASTATIN CALCIUM, ANTIBIOTICS, URSODIOL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5625428-3
Physician from UNITED STATES reported TRACLEER problem on Jan 24, 2008. Female patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, condition aggravated, dizziness, fluid retention, oedema peripheral, renal failure chronic. TRACLEER dosage: unknown. During the same period patient was treated with SILDENAFIL CITRATE, REMODULIN. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5625429-5
TRACLEER problem was reported by a Health Professional from UNITED STATES on Jan 30, 2008. Male patient, 17 years of age, weighting 116.4 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: intermediate uveitis, vitreous haemorrhage. TRACLEER dosage: 125 MG,BID,ORAL; 62.5 MG,BID,ORAL. During the same period patient was treated with SILDENAFIL, LASIX, ASPIRIN. Patient recovered.



Tracleer Side Effects Report #5625824-4
Consumer or non-health professional from JAPAN reported TRACLEER problem on Jan 28, 2008. Female patient, child 4 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: ileus paralytic. TRACLEER dosage: unknown. Patient recovered.




Tracleer Side Effects Report #5625825-6
TRACLEER problem was reported by a Consumer or non-health professional from JAPAN on Jan 31, 2008. Female patient, 42 years of age, weighting 90.39 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: autoimmune thrombocytopenia, endometrial hyperplasia, hyperthyroidism. TRACLEER dosage: unknown. During the same period patient was treated with EPOPROSTENOL, FUROSEMIDE, DIGOXIN, SILDENAFIL CITRATE. Patient died on 01/01/2008.



Tracleer Side Effects Report #5626432-1
Health Professional from NETHERLANDS reported TRACLEER problem on Jan 30, 2008. Female patient, 69 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. Patient died on 12/14/2007.



Tracleer Side Effects Report #5626441-2
TRACLEER problem was reported by a Health Professional from NETHERLANDS on Jan 29, 2008. Female patient, 56 years of age, was treated with TRACLEER. TRACLEER dosage: unknown. Patient died on 12/06/2007.



Tracleer Side Effects Report #5626442-4
Physician from THAILAND reported TRACLEER problem on Jan 28, 2008. Female patient was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: epistaxis, fatigue, haemoptysis, multiple myeloma. TRACLEER dosage: 672.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5626456-4
TRACLEER problem was reported by a Physician from AUSTRALIA on Feb 04, 2008. Female patient, 53 years of age, weighting 160.9 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, dyspnoea, sepsis. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with METHOTREXATE, MYFORTIC. Patient was hospitalized. Patient died on 09/23/2007.



Tracleer Side Effects Report #5631567-3
Physician from UNITED STATES reported TRACLEER problem on Jan 30, 2008. Female patient, 72 years of age, weighting 116.4 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, diarrhoea, feeling abnormal, gastrointestinal haemorrhage, hallucination, liver function test abnormal. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with REVIA, REVATIO, SYNTHROID, DIGOXIN, CALCIUM, ACTONEL, QUESTRAN, LOMOTIL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5631568-5
TRACLEER problem 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 problems/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 #5632701-1
Physician from UNITED STATES reported TRACLEER problem 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 problems/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 #5632706-0
TRACLEER problem was reported by a Physician from UNITED STATES on Feb 01, 2008. Male patient, 81 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: decreased activity, dysuria, feeling abnormal, malaise, oedema peripheral, pulmonary embolism, thrombosis, urinary retention, urine flow decreased. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5632707-2
Physician from UNITED STATES reported TRACLEER problem on Jan 30, 2008. Female patient, 72 years of age, weighting 138.5 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, diarrhoea, feeling abnormal, gastrointestinal haemorrhage, hallucination. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with REVIA, REVATIO, SYNTHROID, DIGOXIN, CALCIUM, ACTONEL, COUMADIN. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5632884-3
TRACLEER problem was reported by a Health Professional from BELGIUM on Feb 05, 2008. Female patient, 47 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 problems/side effects: heart and lung transplant. TRACLEER dosage: 62.5 MG, BID; 125 MG, BID, ORAL. During the same period patient was treated with REMODULIN, VIAGRA, MARCUMAR, BUMETANIDE, ALDACTONE, PLAVIX, TRAZOLAN. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5632885-5
Consumer or non-health professional from GERMANY reported TRACLEER problem on Jan 28, 2008. Female patient, 27 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, hepatitis toxic. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL;62.5 MG, TID; 31.25 MG, BID. During the same period patient was treated with MARCUMAR. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5632887-9
TRACLEER problem was reported by a Consumer or non-health professional from JAPAN on Feb 04, 2008. Female patient, 58 years of age, weighting 94.80 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated, nasopharyngitis, pancytopenia. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with RANITIDINE, METHOTREXATE, BERAPROST, FUROSEMIDE, SPIRONOLACTONE, LANSOPRAZOLE, OXYGEN, NEOPHAGEN. Patient recovered.



Tracleer Side Effects Report #5634182-0
Consumer or non-health professional from SWEDEN reported TRACLEER problem 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 problems/side effects: alanine aminotransferase increased, apathy, aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased, cardiovascular disorder, fatigue, hypoglycaemia, liver function test abnormal. 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 #5634188-1
TRACLEER problem was reported by a Consumer or non-health professional from JAPAN on Feb 04, 2008. Female patient, 18 years of age, weighting 85.98 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pulmonary haemorrhage, vascular pseudoaneurysm. TRACLEER dosage: unknown. During the same period patient was treated with BERAPROST, DIGOXIN, OXYGEN. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5640797-6
Physician from AUSTRALIA reported TRACLEER problem on Feb 07, 2008. Male patient, child 12 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: suicidal ideation. TRACLEER dosage: unknown. Patient recovered.



Tracleer Side Effects Report #5640813-1
TRACLEER problem 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 problems/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 #5640817-9
Health Professional from GERMANY reported TRACLEER problem on Feb 12, 2008. Female patient, child 1 years of age, weighting 22.71 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood alkaline phosphatase increased, dermatitis diaper, infection, liver function test abnormal, polycythaemia, thrombocytopenia. TRACLEER dosage: 6 MG, BID, ORAL; 4.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, ESIDRIX. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5640822-2
TRACLEER problem was reported by a Health Professional from GERMANY on Feb 08, 2008. Female patient, 59 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 problems/side effects: scar, skin ulcer, vasculitis necrotising. TRACLEER dosage: 125 MG, BID, ORAL. During the same period patient was treated with OMEPRAZOLE, SALAGEN. Patient recovered.



Tracleer Side Effects Report #5640825-8
Health Professional from AUSTRALIA reported TRACLEER problem on Feb 13, 2008. Female patient, 42 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: lung disorder, overdose. TRACLEER dosage: unknown. Patient died on 01/08/2008.



Tracleer Side Effects Report #5643270-4
TRACLEER problem was reported by a Consumer or non-health professional from SPAIN on Feb 18, 2008. Female patient, 36 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: paraesthesia, polyneuropathy. TRACLEER dosage: unknown. Patient recovered.



Showing 1-40 of 563 Next >


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, Tracleer was diagnosed with pulmonary hypertension and Tracleer was diagnosed with pulmonary hypertension and