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Competact Side Effects submitted to FDA

Total Competact reports: 34.
Competact FDA safety alerts: No.
Reported deaths: 5    Reported hospitalizations: 27.
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FDA Reported Competact Side Effects: weight increased, respiratory tract infection, pulmonary hypertension, pulmonary fibrosis, pneumonia, oedema peripheral, blood pressure fluctuation, emphysema, circulatory collapse, angioedema, dysphagia,
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Competact Side Effects Report #5657897-7
Consumer or non-health professional from GERMANY reported COMPETACT problem on Feb 21, 2008. Female patient, 69 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus inadequate control. COMPETACT dosage: PIOGLITAZONE 15 MG/METFORMIN 850 MG, PER ORAL. During the same period patient was treated with ACE INHIBITOR NOS. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5663631-7
COMPETACT problem was reported by a Consumer or non-health professional from FRANCE on Feb 26, 2008. Male patient, 47 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: prostate cancer. COMPETACT dosage: unknown. During the same period patient was treated with ACTOS. Patient recovered.



Competact Side Effects Report #5677729-0
Consumer or non-health professional from GERMANY reported COMPETACT problem on Mar 06, 2008. Female patient, 69 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus inadequate control, glycosylated haemoglobin increased, hypertensive crisis, microalbuminuria. COMPETACT dosage: PIOGLITAZONE 15 MG, PER ORAL, METFORMIN 850 MG. During the same period patient was treated with ACE INHIBITOR NOS, GLIMEPIRIDE. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5616537-3
COMPETACT problem was reported by a Consumer or non-health professional from SWITZERLAND on Jan 21, 2008. Male patient, 68 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: abdominal infection, acute respiratory distress syndrome, cardiac failure, condition aggravated, disease complication, pneumonia, renal failure, septic shock, weight increased. COMPETACT dosage: 15 MG PIOGLITAZONE AND 850 MG METFORMIN PER ORAL. During the same period patient was treated with ASPIRIN, OLMESARTAN MEDOXOMIL, ALDACTONE, PLAVIX, CONCOR, ZOCOR, LASIX. Patient was hospitalized. Patient died.




Competact Side Effects Report #5621915-2
Consumer or non-health professional from SWITZERLAND reported COMPETACT problem on Jan 21, 2008. Male patient, 68 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: abdominal infection, acute respiratory distress syndrome, cardiac failure, haemodynamic instability, pneumonia, pulmonary sepsis, renal failure, renal failure acute, septic shock. COMPETACT dosage: 15 MG PIOGLITAZONE AND 850 MG METFORMIN PER ORAL. During the same period patient was treated with ASPIRIN, OLMESARTAN MEDOXOMIL, ALDACTONE, PLAVIX, CONCOR, ZOCOR, LASIX. Patient was hospitalized. Patient died.



Competact Side Effects Report #5621920-6
COMPETACT problem was reported by a Consumer or non-health professional from GERMANY on Jan 24, 2008. Female patient, 65 years of age, was diagnosed with type 1 diabetes mellitus, pyelonephritis and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: idiopathic thrombocytopenic purpura, thrombocytopenia. COMPETACT dosage: 15 MG PER ORAL. During the same period patient was treated with LEVOFLOXACIN, COTRIMTE, NOVONORM, RAMIPRIL, DOXEPIN, BASAL INSULIN. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5599806-5
Consumer or non-health professional from FRANCE reported COMPETACT problem on Jan 07, 2008. Female patient, 67 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, fall, loss of consciousness, malaise, nausea, vomiting. COMPETACT dosage: unknown. During the same period patient was treated with DIAMICRON, ATENOLOL, ASPEGIC, MOLSIDOMINE, ZOCOR. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5599871-5
COMPETACT problem was reported by a Consumer or non-health professional from ITALY on Jan 03, 2008. Female patient, 65 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: hypertensive crisis, palpitations, tachycardia. COMPETACT dosage: 30 MG/ 1700 MG (2 IN 1 D) ORAL. During the same period patient was treated with ACETYLSALICYLIC ACID SRT. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5614110-4
Consumer or non-health professional from GERMANY reported COMPETACT problem on Jan 23, 2008. Male patient was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, treatment noncompliance. COMPETACT dosage: PIOGLIAZONE 15 MG PLUS METFORMIN 850 MG. Patient was hospitalized. Patient recovered.




Competact Side Effects Report #5542049-1
COMPETACT problem was reported by a Consumer or non-health professional from SWITZERLAND on Nov 26, 2007. Male patient, 68 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cardiac failure, renal failure. COMPETACT dosage: 15 MG PIOGLITAZONE AND 850 MG METFORMIN PER ORAL. During the same period patient was treated with ASPIRIN, OLMESARTAN MEDOXOMIL, ALDACTONE, PLAVIX, CONCOR, ZOCOR, LASIX. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5564239-4
Consumer or non-health professional from ITALY reported COMPETACT problem on Dec 04, 2007. Female patient, 65 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: hypertensive crisis, palpitations. COMPETACT dosage: 10 MG/1700 MG (23 IN 1 D) ORAL. During the same period patient was treated with ASPIRIN. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5564250-3
COMPETACT problem was reported by a Consumer or non-health professional from FRANCE on Sept 26, 2007. Male patient, 66 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cardiac failure. COMPETACT dosage: 15 MG, D, ORAL. Patient was hospitalized. Patient died.



Competact Side Effects Report #5567428-8
Pharmacist from GERMANY reported COMPETACT problem on Dec 07, 2007. Female patient was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: haematoma, infection, thrombocytopenia. COMPETACT dosage: 15 MG PIOGLITAZONE AND 850 MG METFORMIN. During the same period patient was treated with ANTIBIOTICS. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5567430-6
COMPETACT problem was reported by a Physician from SWITZERLAND on Dec 04, 2007. Male patient, 68 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cardiac failure, condition aggravated, renal failure. COMPETACT dosage: 15 MG PIOGLITAZONE AND 850 MG METFORMIN. During the same period patient was treated with ASPIRIN, OLMESARTAN MEDOXOMIL, ALDACTONE, PLAVIX, CONCOR, ZOCOR, LASIX. Patient was hospitalized. Patient died.




Competact Side Effects Report #5572274-5
Consumer or non-health professional from GERMANY reported COMPETACT problem on Dec 11, 2007. Female patient, 68 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: acidosis, anaemia, aphonia, bradycardia, cardiac arrest, cardiovascular insufficiency, diabetic nephropathy, dizziness, dry skin. COMPETACT dosage: PIOGLITAZONE 15 MG /METFORMIN 850 MG PER ORAL. During the same period patient was treated with GLYBURIDE, LISI PLUS, METOPROLOL TARTRATE, ACETYLSALICYLIC ACID SRT. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5572275-7
COMPETACT problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Dec 03, 2007. Male patient, 59 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: dyspnoea exertional, fluid retention, left ventricular dysfunction, left ventricular failure. COMPETACT dosage: 15MG PIOGLITAZONE AND 850MG METFORMIN TWICE DAILY. During the same period patient was treated with AMLODIPINE, BISOPROLOL FUMARATE, DOXAZOSIN MESYLATE, ASPIRIN, LANTUS, NICORANDIL, VALSARTAN. Patient recovered.



Competact Side Effects Report #5574048-8
Consumer or non-health professional from FRANCE reported COMPETACT problem on Dec 14, 2007. Male patient, 80 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cardiac failure, dialysis, renal failure. COMPETACT dosage: 15 MG, D ORAL. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5574050-6
COMPETACT problem was reported by a Consumer or non-health professional from FRANCE on Dec 14, 2007. Male patient, 66 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cardiac failure. COMPETACT dosage: 1 MG, D, ORAL. Patient was hospitalized. Patient died.



Competact Side Effects Report #5580078-2
Consumer or non-health professional from FRANCE reported COMPETACT problem on Dec 18, 2007. Female patient, 67 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: malaise, nausea, syncope, vomiting. COMPETACT dosage: unknown. Patient was hospitalized. Patient recovered.




Competact Side Effects Report #5582968-3
COMPETACT problem was reported by a Consumer or non-health professional from GERMANY on Dec 18, 2007. Male patient was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: bladder neoplasm, haematuria. COMPETACT dosage: 15 MG PIOGLITAZONE AND 850 MG METFORMIN PER ORAL. During the same period patient was treated with MARCUMAR. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5515387-6
Consumer or non-health professional from FRANCE reported COMPETACT problem on Oct 31, 2007. Female patient, 64 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: bone fissure, pain, pelvic pain. COMPETACT dosage: 45 MG (15 MG, 3 IN 1 D). During the same period patient was treated with AMARYL, DAFLON, LEVOTHYROXINE. Patient recovered.



Competact Side Effects Report #5481095-3
COMPETACT problem was reported by a Consumer or non-health professional from FRANCE on Sept 26, 2007. Male patient, 80 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cardiac failure, dialysis, renal failure. COMPETACT dosage: (15 MG, D) ORAL. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5488999-6
Consumer or non-health professional from UNITED KINGDOM reported COMPETACT problem on Oct 04, 2007. Female patient, 56 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: body mass index increased, dyspnoea, malaise, sensation of heaviness, weight increased. COMPETACT dosage: 30MG PIOGLITAZONE PLUS 1700MG METFORMIN, ORAL. During the same period patient was treated with RAPAGLINIDE, LISINOPRIL. Patient recovered.



Competact Side Effects Report #5489000-0
COMPETACT problem was reported by a Consumer or non-health professional from FRANCE on Oct 08, 2007. Female patient, 65 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, pancreatitis. COMPETACT dosage: unknown. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5504676-7
Consumer or non-health professional from FRANCE reported COMPETACT problem on Oct 23, 2007. Female patient was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: pelvic fracture, pelvic pain. COMPETACT dosage: 15 MG, 1 D, ORAL. Patient recovered.



Competact Side Effects Report #5445789-8
COMPETACT problem was reported by a Consumer or non-health professional from GERMANY on Aug 20, 2007. Male patient, 70 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: angioedema, circulatory collapse, emphysema, pneumonia, pulmonary fibrosis, pulmonary hypertension, respiratory tract infection, weight increased. COMPETACT dosage: 15 MG PIOGLITAZONE / 850 MG METFORMIN PER ORAL. During the same period patient was treated with METFORMIN, METOPROLOL TARTRATE, ENALAPRIL, ISOSORBIDE DINITRATE, ACETYLSALICYLIC ACID, PRAVASTATIN, ALLOPURINOL, ALVESCO. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5472499-3
Consumer or non-health professional from GERMANY reported COMPETACT problem on Sept 20, 2007. Male patient, 67 years of age, was diagnosed with diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: blood pressure fluctuation, oedema peripheral. COMPETACT dosage: PIOGLITAZONE 15 MG/METFORMIN 850 MG PER ORAL. During the same period patient was treated with OMEPRAZOLE, NOVONORM, METOTHEXAL, DIOVAN HCT, NITRO, ACETYLSALICYLIC ACID. Patient recovered.



Competact Side Effects Report #5409110-3
COMPETACT problem was reported by a Consumer or non-health professional from GERMANY on July 26, 2007. Male patient, 76 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. COMPETACT dosage: PIOGLITAZONE 15 MG/METFORMIN 850 MG PER ORAL. During the same period patient was treated with GLYBURIDE, DIURETICS, ANTIHYPERTENSIVES. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5416678-X
Health Professional from GERMANY reported COMPETACT problem on July 31, 2007. Male patient was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: lip swelling, no therapeutic response, oedema peripheral, pneumonia, pulmonary fibrosis, pulmonary hypertension, respiratory tract infection, weight increased. COMPETACT dosage: unknown. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5416679-1
COMPETACT problem was reported by a Physician from GERMANY on Aug 01, 2007. Female patient was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, cardiac failure. COMPETACT dosage: unknown. During the same period patient was treated with GLYBURIDE, AMLOBETA, SIMVAHEXAL, METOHEXAL, ALLOPURINOL. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5420680-1
Consumer or non-health professional from GERMANY reported COMPETACT problem on Aug 10, 2007. Male patient was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: cerebral infarction, dysphagia, hypertension. COMPETACT dosage: PIOGLITAZONE 15 MG/METFORMIN 850 MG PER ORAL. During the same period patient was treated with GLYBURIDE, METOPROLOL TARTRATE, DIURETICS, DIGITOXIN, ENAHEXAL COMP, NITRENDIPINE. Patient was hospitalized and became disabled. Patient recovered.



Competact Side Effects Report #5794542-4
COMPETACT problem was reported by a Consumer or non-health professional from GERMANY on June 18, 2008. Male patient, 58 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. COMPETACT dosage: PIOGLITAZONE 15 MG AND 850 MG METFORMIN, PER ORAL. Patient was hospitalized. Patient recovered.



Competact Side Effects Report #5737981-X
Physician from FRANCE reported COMPETACT problem on May 02, 2008. Male patient, 58 years of age, was diagnosed with type 2 diabetes mellitus and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: pulmonary arterial hypertension. COMPETACT dosage: unknown. During the same period patient was treated with VITAMIN K ANTAGONIST. Patient recovered.



Competact Side Effects Report #5313748-1
COMPETACT problem was reported by a Consumer or non-health professional from GERMANY on Apr 13, 2007. Female patient, 70 years of age, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with COMPETACT. After drug was administered, patient experienced the following problems/side effects: arterial thrombosis limb, pulmonary embolism. COMPETACT dosage: PIOGLITAZONE 15 MG; 850 MG METFORMIN PER ORAL. During the same period patient was treated with ENABETA COMP, SIMVASTATIN, LEVOTHYROXINE. Patient was hospitalized. Patient recovered.




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, Competact was diagnosed with diabetes mellitus and Competact was diagnosed with type 2 diabetes mellitus and