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Review Tracleer Safety Reports submitted to FDA

Total Tracleer reports: 563.
Tracleer FDA safety alerts: 2006 .
Reported deaths: 197    Reported hospitalizations: 278.
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FDA Reported 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 Report #5528005-8
Physician from UNITED STATES reported TRACLEER problem on Nov 08, 2007. Female patient, 84 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, carotid artery disease, coronary artery disease, cough, dyspnoea, headache, nausea, ocular hyperaemia. TRACLEER dosage: unknown. During the same period patient was treated with VENTAVIS. Patient died on 11/02/2007.

Tracleer Side Effects Report #5528578-5
TRACLEER problem was reported by a Physician from JAPAN on Nov 07, 2007. Female patient, 70 years of age, weighting 112.9 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abdominal distension, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, condition aggravated, dyspnoea, gamma-glutamyltransferase increased, multi-organ failure. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with WARFARIN POTASSIUM, BERAPROST, FUROSEMIDE, OXYGEN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5528579-7
Physician from JAPAN reported TRACLEER problem on Nov 08, 2007. Female patient, 79 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: alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, blood alkaline phosphatase increased, cholangitis, eosinophil count increased, gamma-glutamyltransferase increased, hepatic enzyme increased, malaise. TRACLEER dosage: 62.5 MG, BID, ORAL; 62.5 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with LEVOTHYROXINE, ALLOPURINOL, LISINOPRIL, CILOSTAZOL, LANSOPRAZOLE, MELOXICAM. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5528580-3
TRACLEER problem was reported by a Consumer or non-health professional from GERMANY on Nov 08, 2007. Male 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: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with TORSEMIDE, SPIRIVA, ISO MACK, VIANI. Patient died.


Tracleer Side Effects Report #5531504-6
Physician from GERMANY reported TRACLEER problem on Nov 14, 2007. Female patient, 46 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 problems/side effects: jaundice cholestatic, liver injury. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, LEVOTHYROXINE, ALLOPURINOL, DIGOXIN, TORSEMIDE, NEXIUM. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5532731-4
TRACLEER problem was reported by a Pharmacist from UNITED STATES on Nov 14, 2007. 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: jaundice, liver function test abnormal. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5532732-6
Physician from UNITED STATES reported TRACLEER problem on Nov 14, 2007. Female patient, 75 years of age, weighting 297.8 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: angina unstable, hepatic failure, multi-organ failure, renal failure. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient died.

Tracleer Side Effects Report #5533992-8
TRACLEER problem 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 problems/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 #5534801-3
Physician from FRANCE reported TRACLEER problem on Nov 16, 2007. Male patient, 66 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: anaemia, hypersensitivity, parotid abscess, thrombocytopenia. TRACLEER dosage: unknown. During the same period patient was treated with VENTAVIS, LEXOMIL, SILDENAFIL CITRATE, GELOX, ALDACTONE, LASIX, DURAGESIC, AUGMENTIN. Patient was hospitalized. Patient recovered.


Tracleer Side Effects Report #5534804-9
TRACLEER problem was reported by a Health Professional from SPAIN on Nov 15, 2007. Female patient, 69 years of age, weighting 127.9 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 alkaline phosphatase increased, cholestasis, gamma-glutamyltransferase increased. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with SINTROM, COZAAR PLUS, ATORVASTATIN CALCIUM, NEXIUM, CARBAMAZEPINE, ACTONEL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5534808-6
Health Professional from JAPAN reported TRACLEER problem on Nov 01, 2007. Female patient, 78 years of age, weighting 104.5 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: diarrhoea, dysphoria, subileus. TRACLEER dosage: 62.5 MG, QD, ORAL, 62.5 MG, QD, ORAL. During the same period patient was treated with CEVIMELINE HYDROCHLORIDE, TOCOPHEROL, SARPOGRELATE, BIFIDOBACTERIUM BIFIDUM, LANSOPRAZOLE, DILTIAZEM, TRIMEBUTINE. Patient recovered.

Tracleer Side Effects Report #5480952-1
TRACLEER problem was reported by a Consumer or non-health professional from GERMANY on Sept 18, 2007. Male patient, 71 years of age, weighting 180.8 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cough, dyspnoea, dyspnoea exertional, fluid retention, headache, hypersensitivity, joint swelling, nausea, oedema mucosal. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with PROVAS, METOPROLOL SUCCINATE, CLOPIDOGREL BISULPHATE, AZATHIOPRINE, DECORTIN, PROSPAN, ISU COMB. Patient recovered.

Tracleer Side Effects Report #5483116-0
Physician from FRANCE reported TRACLEER problem on Sept 21, 2007. Male 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: pneumonia. TRACLEER dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. Patient died on 08/01/2007.

Tracleer Side Effects Report #5483117-2
TRACLEER problem was reported by a Physician from FRANCE on Sept 21, 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 problems/side effects: pneumonia. TRACLEER dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. Patient died on 02/01/2007.


Tracleer Side Effects Report #5483129-9
Physician from GERMANY reported TRACLEER problem on Sept 21, 2007. Male patient, 74 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, colon adenoma, colonic polyp, dizziness, dysplasia, dyspnoea, gastritis, gastrointestinal haemorrhage, hepatic congestion. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with ACETYLSALICYLIC ACID SRT, CLOPIDOGREL, ESOMEPRAZOLE, KARVEZIDE, SIMVASTATIN, AMIODARONE HYDROCHLORIDE, NOVORAPID. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5483133-0
TRACLEER problem was reported by a Physician from NETHERLANDS on Sept 21, 2007. Female patient, 73 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. TRACLEER dosage: 125 MG, BID, 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL. Patient died on 06/28/2007.

Tracleer Side Effects Report #5486028-1
Physician from GERMANY reported TRACLEER problem on Sept 27, 2007. Male patient, 64 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: colitis ischaemic. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5486029-3
TRACLEER problem 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 problems/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 #5486032-3
Physician from JAPAN reported TRACLEER problem on Sept 27, 2007. Female patient, 79 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: anorexia, cholangitis, eosinophil count increased. TRACLEER dosage: 62.5 MG, BID, ORAL; 62.5 MG, QD, ORAL; 62.5 MG, QD, ORAL. During the same period patient was treated with LEVOTHYROXINE, ALLOPURINOL, LISINOPRIL, CILOSTAZOL, LANSOPRAZOLE, MELIXOCAM. Patient was hospitalized. Patient recovered.


Tracleer Side Effects Report #5486033-5
TRACLEER problem was reported by a Physician from GREECE on Oct 02, 2007. Male patient, 50 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 neoplasm malignant. TRACLEER dosage: 125 MG, ORAL. Patient recovered.

Tracleer Side Effects Report #5486034-7
Consumer or non-health professional from JAPAN reported TRACLEER problem on Sept 26, 2007. Female patient, 54 years of age, weighting 114.6 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: granulocytopenia, white blood cell count decreased. TRACLEER dosage: 65 MG, BID, ORAL, 31.25 MG, BID, ORAL. During the same period patient was treated with WARFARIN POTASSIUM, BERAPROST, ALENDRONATE, SPIRONOLACTONE, FUROSEMIDE, QUINAPRIL, PREDNISOLONE ACETATE. Patient recovered.

Tracleer Side Effects Report #5486172-9
TRACLEER problem 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 problems/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 #5486173-0
Physician from UNITED STATES reported TRACLEER problem on Sept 26, 2007. Female patient, 71 years of age, weighting 263.9 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: acute prerenal failure, arthralgia, cardiac failure congestive, condition aggravated, fall, fluid overload, renal failure acute. TRACLEER dosage: 125 MG, BID, ORAL. During the same period patient was treated with XOPENEX, ZOCOR, ZAROXOLYN, VITAMIN B, TIAZAC, TEARGEN, SYNTHROID. Patient was hospitalized. Patient died on 09/09/2006.

Tracleer Side Effects Report #5491328-5
TRACLEER problem was reported by a Health Professional from PORTUGAL on Oct 02, 2007. Female patient, 50 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 problems/side effects: hepatitis cholestatic. TRACLEER dosage: 500 MG, OD, ORAL. During the same period patient was treated with DIGOXIN, FUROSEMIDE, ILOPROST TROMETAMOL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5491339-X
Health Professional from BELGIUM reported TRACLEER problem on Oct 08, 2007. Female patient, 53 years of age, weighting 112.4 lb, was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: lung transplant. TRACLEER dosage: 62.5 MG, BID, ORAL, 125 MG, BID, ORAL. During the same period patient was treated with BUMETANIDE, ALDACTONE, ENOXAPARIN, ADALAT, LEVOTHYROXINE, FLOLAN. Patient recovered.

Tracleer Side Effects Report #5491340-6
TRACLEER problem was reported by a Consumer or non-health professional from SPAIN on Mar 23, 2007. 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: hepatitis. TRACLEER dosage: 62.5 MG, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5491341-8
Consumer or non-health professional from JAPAN reported TRACLEER problem on Oct 01, 2007. Female patient, 60 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: condition aggravated, interstitial lung disease, pulmonary hypertension. TRACLEER dosage: 62.5 MG, TID, 62.5 MG, BID, 62.5 MG, QID. During the same period patient was treated with OXYGEN, BERAPROST, RISEDRONATE, RABEPRAZOLE, ASPIRIN, AMLODIPINE BESYLATE. Patient was hospitalized. Patient died on 07/25/2007.

Tracleer Side Effects Report #5491342-X
TRACLEER problem was reported by a Physician from GERMANY on Oct 02, 2007. Male patient, 74 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: colonic polyp, dizziness, dyspnoea, gastritis, gastrointestinal angiodysplasia, hepatic congestion, melaena, normochromic normocytic anaemia, right ventricular failure. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with ACETYLSALICYLIC ACID SRT, CLOPIDOGREL, ESOMEPRAZOLE, KARVEZIDE, SIMVASTATIN, AMIODARONE HYDROCHLORIDE, NOVORAPID. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5491343-1
Health Professional from BELGIUM reported TRACLEER problem on Oct 08, 2007. Female patient, 53 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 problems/side effects: eosinophilic pneumonia, lung infiltration, pleural fibrosis. TRACLEER dosage: 62.5 MG, BID, ORAL, 125 MG, BID, ORAL. During the same period patient was treated with VIAGRA, BUMETANIDE, ALDACTONE, CITALOPRAM HYDROBROMIDE, LORAMET, DILTIAZEM HYDROCHLORIDE, MARCUMAR. Patient recovered.

Tracleer Side Effects Report #5493854-1
TRACLEER problem was reported by a Physician from UNITED STATES on Oct 04, 2007. Female patient, 40 years of age, weighting 257.9 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, cardiac failure congestive, rash, respiratory failure. TRACLEER dosage: 125 MG, BID; ORAL, 62.5 MG, BID; ORAL, 125 MG, OD; ORAL,. Patient died on 09/18/2007.

Tracleer Side Effects Report #5498385-0
Physician from UNITED STATES reported TRACLEER problem on Oct 08, 2007. Female patient, 53 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pericardial effusion. TRACLEER dosage: unknown. Patient recovered.

Tracleer Side Effects Report #5498386-2
TRACLEER problem was reported by a Health Professional from UNITED STATES on Oct 03, 2007. Female patient, 76 years of age, weighting 175.0 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. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with PRILOSEC, ASPIRIN, CALCIUM, GLUCOSAMINE, TRAVATAN, PREMARIN, LEVOXYL. Patient recovered.

Tracleer Side Effects Report #5500083-1
Consumer or non-health professional from NETHERLANDS reported TRACLEER problem on Oct 09, 2007. Female patient, 86 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, organ failure, pulmonary hypertension. TRACLEER dosage: unknown. Patient died.

Tracleer Side Effects Report #5500084-3
TRACLEER problem was reported by a Consumer or non-health professional from GERMANY on Oct 08, 2007. Male patient, 68 years of age, weighting 180.8 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cough, dyspnoea, fluid retention, headache, hypersensitivity, joint swelling, nausea, oedema mucosal, stomach discomfort. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with PROVAS, METOPROLOL SUCCINATE, CLOPIDOGREL BISULPHATE, AZATHIOPRINE, DECOTRIN, PROSPAN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5500085-5
Physician from FRANCE reported TRACLEER problem on Oct 11, 2007. 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: cholestasis, cytolytic hepatitis, hepatic congestion. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with FLOLAN, LEVOTHYROXINE, LASIX, COUMADIN, POTASSIUM CHLORIDE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5500086-7
TRACLEER problem was reported by a Consumer or non-health professional from BELGIUM on Oct 08, 2007. Male patient, 76 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: neoplasm malignant. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. Patient died on 09/16/2006.

Tracleer Side Effects Report #5500088-0
Consumer or non-health professional from PORTUGAL reported TRACLEER problem on Oct 11, 2007. Female patient, 36 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 problems/side effects: caesarean section, foetal distress syndrome, pregnancy, premature baby. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with ILOPROST, SILDENAFILLET, TREPROSTINIL. Patient recovered.

Tracleer Side Effects Report #5500089-2
TRACLEER problem was reported by a Physician from SPAIN on Oct 09, 2007. Female patient was diagnosed with skin ulcer and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: biliary cirrhosis primary, cholestasis, cytolytic hepatitis. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5500090-9
Physician from FRANCE reported TRACLEER problem on Oct 12, 2007. Female patient was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: condition aggravated, haematoma, haemorrhage, pulmonary hypertension, skin ulcer, superinfection. TRACLEER dosage: 125 MG, BID, ORAL. During the same period patient was treated with PLATELET AGGREGATION INHIBITORS, CORTICOSTEROIDS NOS. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5501342-9
TRACLEER problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 17, 2007. 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: myocardial infarction. TRACLEER dosage: unknown. Patient died on 08/12/2007.

Tracleer Side Effects Report #5504702-5
Health Professional from BELGIUM reported TRACLEER problem on Oct 22, 2007. Female patient, 53 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 problems/side effects: extremity necrosis, lung transplant, pulmonary fibrosis, subdural haematoma. TRACLEER dosage: 62.5 MG, BID, ORAL, 125 MG, BID, ORAL. During the same period patient was treated with BUMETANIDE, ALDACTONE, ENOXAPARIN, ADALAT, LEVOTHYROXINE, FLOLAN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5504703-7
TRACLEER problem was reported by a Health Professional from BELGIUM on Oct 22, 2007. Female patient, 53 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 problems/side effects: pleural fibrosis, pneumonia bacterial. TRACLEER dosage: 62.5 MG, BID, ORAL, 125 MG, BID, ORAL. During the same period patient was treated with VIAGRA, BUMETANIDE, ALDACTONE, CITALOPRAM HYDROBROMIDE, LORAMET, DILTIAZEM HYDROCHLORIDE, MARCUMAR. Patient recovered.

Tracleer Side Effects Report #5504704-9
Consumer or non-health professional from JAPAN reported TRACLEER problem on Oct 18, 2007. Female patient, 74 years of age, weighting 68.34 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: anaemia, cardiac failure. TRACLEER dosage: 15.625 MG, BID, ORAL, 15.625 MG, QD, ORAL, 31.25 MG, BID, ORAL, 46.875 MG, BID, ORAL. During the same period patient was treated with BERAPROST, WARFARIN POTASSIUM, OMEPRAZOLE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5504705-0
TRACLEER problem was reported by a Health Professional from BELGIUM on Oct 22, 2007. Male patient, 77 years of age, was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient died on 09/22/2007.

Tracleer Side Effects Report #5504706-2
Consumer or non-health professional from GERMANY reported TRACLEER problem on Oct 18, 2007. Female patient, 36 years of age, was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cerebral vasoconstriction. TRACLEER dosage: unknown. During the same period patient was treated with SILDENAFIL. Patient recovered.

Tracleer Side Effects Report #5504707-4
TRACLEER problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 17, 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 problems/side effects: dysphagia, feeling abnormal, infection. TRACLEER dosage: unknown. Patient recovered.

Tracleer Side Effects Report #5504718-9
Physician from AUSTRALIA reported TRACLEER problem on Oct 17, 2007. Female patient, 51 years of age, weighting 112.2 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, blood alkaline phosphatase increased, gallbladder polyp, gamma-glutamyltransferase increased, hepatic steatosis, liver function test abnormal. TRACLEER dosage: 62.5 MG, BID, ORAL, 125 MG, BID, ORAL. During the same period patient was treated with TELMISARTAN, ASPIRIN, PREDNISONE, OMEPRAZOLE. Patient recovered.

Tracleer Side Effects Report #5504719-0
TRACLEER problem was reported by a Consumer or non-health professional from JAPAN on Oct 19, 2007. Female patient, 57 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: anaemia. TRACLEER dosage: 31.25 MG, QD, ORAL, 31.25 MG, BID, ORAL, 46.875 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with DOMPERIDONE, TOCOPHERYL NICOTINATE, FAMOTIDINE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5504881-X
Physician from UNITED STATES reported TRACLEER problem on Oct 17, 2007. Female patient, 60 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, fluid retention, liver transplant, portopulmonary hypertension. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5449429-3
TRACLEER problem was reported by a Physician from NETHERLANDS on Aug 23, 2007. Female patient, 25 years of age, 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 #5449430-X
Consumer or non-health professional from GERMANY reported TRACLEER problem on Aug 27, 2007. Male patient, 74 years of age, was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: anaemia, gastrointestinal haemorrhage. TRACLEER dosage: unknown. During the same period patient was treated with ACETYLSALICYLIC ACID SRT. Patient recovered.

Tracleer Side Effects Report #5449436-0
TRACLEER problem was reported by a Consumer or non-health professional from NETHERLANDS on Aug 24, 2007. Female patient, 86 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, organ failure, pulmonary hypertension. TRACLEER dosage: unknown. Patient died.

Tracleer Side Effects Report #5449564-X
Physician from UNITED STATES reported TRACLEER problem on Aug 24, 2007. Female patient was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: bone marrow failure. TRACLEER dosage: unknown. Patient recovered.

Tracleer Side Effects Report #5453484-4
TRACLEER problem was reported by a Physician from UNITED STATES on Aug 30, 2007. Female patient, 66 years of age, weighting 162.0 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: coronary artery occlusion, decreased appetite, glossodynia, iron deficiency anaemia, oedema peripheral, pain in extremity, pain in jaw. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with VENTAVIS, ZETIA, ASPIRIN, PLAVIX, LASIX, POTASSIUM CHLORIDE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5453485-6
Health Professional from UNITED STATES reported TRACLEER problem on Aug 28, 2007. Female patient was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: lung transplant. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5453543-6
TRACLEER problem was reported by a Physician from JAPAN on Aug 31, 2007. Female 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: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, condition aggravated, hepatic enzyme increased, hepatic function abnormal, right ventricular failure. TRACLEER dosage: 125 MG, BID, ORAL; 31.25 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with BERAPROST, FUROSEMIDE, WARFARIN, OXYGEN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5453558-8
Physician from SWEDEN reported TRACLEER problem on Aug 30, 2007. Female patient, 77 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, gamma-glutamyltransferase increased. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5455162-4
TRACLEER problem was reported by a Physician from PORTUGAL on Aug 29, 2007. Female patient was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pregnancy. TRACLEER dosage: unknown. During the same period patient was treated with SILDENAFILLET. Patient recovered.

Tracleer Side Effects Report #5460688-3
Physician from JAPAN reported TRACLEER problem on Sept 06, 2007. Female patient, 74 years of age, weighting 68.34 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: anaemia, cardiac failure. TRACLEER dosage: 15.625 MG, BID, ORAL; 15.625 MG, BID, ORAL; 31.25 MG. BID, ORAL; 46875 MG, BID, ORAL. During the same period patient was treated with BERAPROST, WARFARIN, OMEPRAZOLE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5460689-5
TRACLEER problem was reported by a Consumer or non-health professional from AUSTRIA on Sept 03, 2007. Female patient, 61 years of age, weighting 132.3 lb, was diagnosed with skin ulcer and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, nausea. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with OXYCODONE, ACETYLSALICYLIC ACID SRT, PANTOPRAZOLE, PRAVASTATIN, ALLOPURINOL, ALENDRONATE. Patient was hospitalized and became disabled. Patient recovered.

Tracleer Side Effects Report #5463786-3
Physician from UNITED STATES reported TRACLEER problem on Sept 07, 2007. Female patient, 32 years of age, weighting 183.0 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: back pain, burning sensation, central line infection, deep vein thrombosis, diarrhoea, dyspnoea, erythema, eye irritation, fatigue. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with FLOLAN, LASIX, COUMADIN, PERCOCET. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5465196-1
TRACLEER problem was reported by a Physician from UNITED STATES on Sept 05, 2007. Male patient, 54 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abdominal distension, dizziness, fatigue, hyperlipidaemia, oedema, palpitations, pleural effusion. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with REVATIO, FLOLAN, DIURETICS, OXYGEN, DIGOXIN, ANTIDEPRESSANTS, OXYCODONE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5466836-3
Health Professional from BELGIUM reported TRACLEER problem on Sept 07, 2007. Female patient, 48 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pulmonary haemorrhage. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with CORDARONE, FLUTICASONE PROPIONATE, BURNEX, ALDACTONE, XANAX, MARCUMAR. Patient died on 08/22/2007.

Tracleer Side Effects Report #5466927-7
TRACLEER problem was reported by a Physician from JAPAN on Sept 04, 2007. 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: anaemia. TRACLEER dosage: 125 MG, QD, ORAL; ORAL. During the same period patient was treated with DOMPERIDONE, TOCOPHERYL NICOTINATE, FAMOTIDINE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5468294-1
Physician from NETHERLANDS reported TRACLEER problem on Sept 12, 2007. Female patient, 25 years of age, 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 #5468295-3
TRACLEER problem was reported by a Health Professional from BELGIUM on Sept 07, 2007. Female patient, 53 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 problems/side effects: eosinophilic pneumonia, pleural disorder, pleural fibrosis. TRACLEER dosage: 62.5 MG, BID, ORAL, 125 MG, BID, ORAL. During the same period patient was treated with VIAGRA, BUMETANIDE, ALDACTONE, CITALOPRAM HYDROBROMIDE, LORAMET, DILTIAZEM HYDROCHLORIDE, MARCUMAR. Patient recovered.

Tracleer Side Effects Report #5468296-5
Health Professional from JAPAN reported TRACLEER problem on Sept 10, 2007. Male patient, 69 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 problems/side effects: low cardiac output syndrome, renal impairment. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with AZOSEMIDE, ASPIRIN, FUROSEMIDE, CANDESARTAN CILEXETIL, SPIRONOLACTONE, ALLOPURINOL, PIMOBENDAN, WARFARIN. Patient recovered.

Tracleer Side Effects Report #5468297-7
TRACLEER problem was reported by a Health Professional from JAPAN on Sept 10, 2007. Female patient, 42 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 problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, coagulation test abnormal, hepatic function abnormal. TRACLEER dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL, 93.75 MG, BID, ORAL. During the same period patient was treated with WARFARIN POTASSIUM, BERAPROST, FERRIC PYROPHOSPHATE, THYROID PREPARATIONS, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5468308-9
Physician from GERMANY reported TRACLEER problem on Sept 13, 2007. Female patient, 24 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abortion induced, pregnancy on oral contraceptive, sterilisation, treatment noncompliance. TRACLEER dosage: unknown. Patient recovered.

Tracleer Side Effects Report #5469927-6
TRACLEER problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 11, 2007. 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: liver function test abnormal. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5472183-6
Physician from UNITED STATES reported TRACLEER problem on Sept 13, 2007. Female patient, 83 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5472184-8
TRACLEER problem 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 problems/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 #5472388-4
Physician from UNITED STATES reported TRACLEER problem on Sept 20, 2007. Female patient was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pericarditis. TRACLEER dosage: unknown. During the same period patient was treated with REVATIO. Patient recovered.

Tracleer Side Effects Report #5472389-6
TRACLEER problem was reported by a Health Professional from UNITED STATES on Sept 20, 2007. Female patient, 64 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5472390-2
Physician from UNITED STATES reported TRACLEER problem on Sept 14, 2007. Male patient, 64 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, cough, diarrhoea, hepatitis acute, renal failure, shock. TRACLEER dosage: 125 MG, BID, ORAL. During the same period patient was treated with ALCOHOL, DIGOXIN, SILDENAFIL CITRATE, ADVAIR, COMBIVENT, DIOVAN, ASPIRIN, PLAVIX. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5472619-0
TRACLEER problem was reported by a Physician from GERMANY on Sept 18, 2007. Male patient, 25 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, right ventricular failure, thrombocytopenia. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with JODTHYROX, ISOPTIN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5472620-7
Physician from SWEDEN reported TRACLEER problem on Sept 12, 2007. Female patient, 77 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, gamma-glutamyltransferase increased. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL; 62.5 MG, BID, ORAL; 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5404721-3
TRACLEER problem was reported by a Health Professional from BELGIUM on July 23, 2007. Female patient, 23 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: organ transplant. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with ASPEGIC, EFFEXOR, LANOXIN, ALLOPURINOL, TEGRETOL, TRAMADOL, REMODULIN. Patient died on 07/20/2007.

Tracleer Side Effects Report #5404723-7
Physician from BELGIUM reported TRACLEER problem on July 19, 2007. Female patient, 67 years of age, weighting 191.8 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased, multi-organ failure, pulmonary hypertension, right ventricular failure. TRACLEER dosage: 250 MG, BID, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient was hospitalized and became disabled. Patient died on 07/13/2007.

Tracleer Side Effects Report #5404724-9
TRACLEER problem was reported by a Physician from GERMANY on July 23, 2007. Male patient, 68 years of age, was treated with TRACLEER. TRACLEER dosage: unknown. Patient died.

Tracleer Side Effects Report #5407458-X
Physician from FRANCE reported TRACLEER problem on July 18, 2007. 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: atrial fibrillation, cardio-respiratory arrest, cardiopulmonary failure, enterobacter infection, escherichia urinary tract infection, fall, head injury, hypovolaemia, international normalised ratio increased. 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 #5407961-2
TRACLEER problem was reported by a Physician from UNITED STATES on July 25, 2007. Female patient, 87 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, anorexia, aspartate aminotransferase increased, blood bilirubin increased, nausea. TRACLEER dosage: 62.5 MG, BID, ORAL; 62.5 MG. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5410289-8
Physician from UNITED STATES reported TRACLEER problem on July 24, 2007. Female patient, 79 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, blood bilirubin increased, diarrhoea, vomiting. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5411161-X
TRACLEER problem was reported by a Consumer or non-health professional from GERMANY on July 25, 2007. Male patient, 70 years of age, was treated with TRACLEER. TRACLEER dosage: unknown. Patient died.

Tracleer Side Effects Report #5411162-1
Consumer or non-health professional from GERMANY reported TRACLEER problem on July 24, 2007. Female patient was treated with TRACLEER. TRACLEER dosage: unknown. Patient died.

Tracleer Side Effects Report #5412056-8
TRACLEER problem was reported by a Physician from UNITED STATES on Aug 01, 2007. Male patient, 48 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: fluid retention, liver disorder. TRACLEER dosage: 125 MG, BID, ORAL. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5413093-X
Health Professional from BELGIUM reported TRACLEER problem on July 27, 2007. Female patient, 67 years of age, weighting 191.8 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 alkaline phosphatase increased, blood bilirubin increased, multi-organ failure, pulmonary hypertension, right ventricular failure. TRACLEER dosage: 250 MG, BID, ORAL; 62.5 MG, BID, ORAL; 125 MG,BID,ORAL; 125MG, BID; 93.75 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient was hospitalized and became disabled. Patient died on 07/13/2007.

Tracleer Side Effects Report #5413094-1
TRACLEER problem was reported by a Health Professional from GERMANY on July 29, 2007. Female patient, 24 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abortion induced, pregnancy. TRACLEER dosage: unknown. Patient recovered.

Tracleer Side Effects Report #5413095-3
Health Professional from BELGIUM reported TRACLEER problem on July 31, 2007. Female patient, 23 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: heart and lung transplant. TRACLEER dosage: 125 MG, BID,ORAL; 62.5 MG, BID,ORAL. During the same period patient was treated with ASPEGIC, EFFEXOR, LANOXIN, ALLOPURINOL, TEGRETOL, TRAMADOL, REMODULIN. Patient died on 07/20/2007.

Tracleer Side Effects Report #5413315-5
TRACLEER problem was reported by a Physician from JAPAN on July 31, 2007. Female patient, 54 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: granulocytopenia, white blood cell count decreased. TRACLEER dosage: 135 MG, QD, ORAL; 65 MG, QD, ORAL. Patient recovered.

Tracleer Side Effects Report #5413523-3
Health Professional from UNITED STATES reported TRACLEER problem on May 01, 2007. Female patient, 60 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5420960-X
TRACLEER problem was reported by a Physician from UNITED STATES on Aug 08, 2007. Female patient, 63 years of age, was diagnosed with pulmonary fibrosis and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, fatigue, feeling abnormal, headache, heart rate irregular, hot flush, hypotension, mental status changes, pharyngolaryngeal pain. TRACLEER dosage: 62.5MG, BID, ORAL. Patient recovered.

Tracleer Side Effects Report #5421884-4
Physician from AUSTRALIA reported TRACLEER problem on Aug 01, 2007. Male patient, 71 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 problems/side effects: aortic arteriosclerosis, aortic valve stenosis, atrial flutter, atrioventricular block first degree, cardiac arrest, cardiac failure, dilatation ventricular, dyspnoea, electrocardiogram abnormal. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with ESOMEPRAZOLE, LIPITOR. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5427661-2
TRACLEER problem 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 problems/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 #5427662-4
Consumer or non-health professional from GERMANY reported TRACLEER problem on Aug 07, 2007. Male patient, 62 years of age, weighting 183.0 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cardiac failure. TRACLEER dosage: 125 MG, BID, ORAL; 62.25 MG, BID, ORAL. During the same period patient was treated with SILDENAFILLET, ATACAND, EUPHYLLIN N, TOREM, NEBIVOLOL, DIGITOXIN. Patient died on 07/03/2007.

Tracleer Side Effects Report #5427664-8
TRACLEER problem was reported by a Physician from GERMANY on Aug 08, 2007. Male patient, 25 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, haemoglobin abnormal, hypoglycaemia, thrombocytopenia. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5427665-X
Physician from JAPAN reported TRACLEER problem on Aug 09, 2007. Female patient, 60 years of age, 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, multi-organ failure, pulmonary hypertension, sepsis. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. During the same period patient was treated with BERAPROST. Patient was hospitalized. Patient died on 05/21/2007.

Tracleer