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Review Fortamet Safety Reports submitted to FDA

Total Fortamet reports: 37.
Fortamet FDA safety alerts: No.
Reported deaths: 18    Reported hospitalizations: 16.
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FDA Reported Fortamet Side Effects: death, lactic acidosis, foreign body trauma, renal failure acute, diarrhoea, vomiting, pneumoperitoneum, ill-defined disorder, hepatic steatosis, alcoholism, abdominal discomfort.
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Fortamet Side Effects Report #5631319-4
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Female patient, 37 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with DIAZEPAM, GLIPIZIDE, GABAPENTIN, HYDROCODONE BITARTRATE, VENLAFAXINE, RAMIPRIL, ANITHISTAMINE. Patient died.

Fortamet Side Effects Report #5631334-0
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Male patient, 64 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with POTASSIUM CHLORIDE, FIORICET, BUMETANIDE, EZETIMIBE. Patient died.

Fortamet Side Effects Report #5631339-X
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Male patient, 44 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with GLIPIZIDE, LISINOPRIL, NORTRIPTYLINE HYDROCHLORIDE, DULOXETINE. Patient died.

Fortamet Side Effects Report #5631343-1
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Female patient, 50 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with GLIPIZIDE, FIORICET, METOPROLOL TARTRATE. Patient died.


Fortamet Side Effects Report #5631361-3
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Female patient, 58 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. Patient died.

Fortamet Side Effects Report #5631365-0
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Male patient, 56 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with NONSTEROIDAL ANTI. Patient died.

Fortamet Side Effects Report #5631370-4
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Female patient, 69 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. Patient died.

Fortamet Side Effects Report #5631375-3
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Female patient, 60 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with LISINOPRIL, THIAZOLIDINEDIONE. Patient died.

Fortamet Side Effects Report #5631378-9
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Female patient, 50 years of age, was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest. FORTAMET dosage: unknown. During the same period patient was treated with ATENOLOL, VENLAFAXINE, VALPROIC ACID. Patient died.


Fortamet Side Effects Report #5631380-7
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Male patient, 53 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. Patient died.

Fortamet Side Effects Report #5631385-6
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Male patient, 49 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. Patient died.

Fortamet Side Effects Report #5631394-7
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Male patient, 49 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with FIORICET, COCAINE, OPIOIDS. Patient died.

Fortamet Side Effects Report #5631418-7
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Female patient, 22 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. Patient died.

Fortamet Side Effects Report #5631419-9
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Female patient, 52 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. Patient died.


Fortamet Side Effects Report #5631420-5
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Male patient, 77 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. Patient died.

Fortamet Side Effects Report #5631422-9
FORTAMET problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Male patient, 72 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with FIORICET. Patient died.

Fortamet Side Effects Report #5631447-3
Physician from UNITED STATES reported FORTAMET problem on Feb 04, 2008. Male patient, 54 years of age, was treated with FORTAMET. FORTAMET dosage: unknown. During the same period patient was treated with REPAGLINIDE, ETHANOL, ATORVASTATIN CALCIUM. Patient died.

Fortamet Side Effects Report #5607758-4
FORTAMET problem was reported by a Health Professional from SPAIN on Jan 14, 2008. Male patient, 82 years of age, was diagnosed with type 2 diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: haemodialysis, lactic acidosis, renal failure acute. FORTAMET dosage: unknown. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5581493-3
Health Professional from UNITED STATES reported FORTAMET problem on Dec 17, 2007. Female patient, 78 years of age, was diagnosed with type 2 diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: anion gap increased, dialysis, lactic acidosis, metabolic acidosis, renal injury. FORTAMET dosage: 1500 MG, BID. During the same period patient was treated with GLYBURIDE, ROFECOXIB, FUROSEMIDE, LEVOTHYROXINE, PREDNISONE, AZATHIOPRINE, PROPRANOLOL. Patient was hospitalized. Patient recovered.


Fortamet Side Effects Report #5583646-7
FORTAMET problem was reported by a Health Professional from UNITED STATES on Dec 17, 2007. Female patient, 64 years of age, was diagnosed with type 2 diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: haemodialysis, lactic acidosis, metabolic acidosis, renal impairment, renal injury. FORTAMET dosage: 500 MG, BID. During the same period patient was treated with LISINOPRIL, IBUPROFEN. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5527422-X
Health Professional from UNITED STATES reported FORTAMET problem on Nov 12, 2007. Male patient, 63 years of age, was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: cholangitis, hepatic fibrosis, hepatic necrosis, hepatitis, portal triaditis. FORTAMET dosage: 500 MG, BID X 4 WEEKS, ORAL. During the same period patient was treated with GLYBURIDE, ALLOPURINOL, ASPIRIN. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5528413-5
FORTAMET problem was reported by a Health Professional from TAIWAN, PROVINCE OF CHINA on Nov 13, 2007. Female patient, 65 years of age, was diagnosed with type 2 diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: anaemia megaloblastic, deep vein thrombosis, hyperhomocysteinaemia, vitamin b12 deficiency. FORTAMET dosage: 500 MG, BID. During the same period patient was treated with GLYBURIDE, PYRIDOSTIGMINE. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5420835-6
Health Professional from TURKEY reported FORTAMET problem on Aug 07, 2007. Male patient, 52 years of age, was diagnosed with diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity, lactic acidosis. FORTAMET dosage: 850 MG, DAILY. During the same period patient was treated with VERAPAMIL, ACETYLSALICYLIC ACID SRT. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5424457-2
FORTAMET problem was reported by a Health Professional from UNITED KINGDOM on Aug 07, 2007. Male patient, 30 years of age, was diagnosed with type 2 diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, alcoholism, diarrhoea, hepatic steatosis, ill-defined disorder, pneumoperitoneum, vomiting. FORTAMET dosage: unknown. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5759667-8
Consumer or non-health professional from UNITED STATES reported FORTAMET problem on May 27, 2008. Female patient, weighting 99.21 lb, was diagnosed with diabetes mellitus, osteoporosis and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, loss of consciousness. FORTAMET dosage: unknown. During the same period patient was treated with GLYBURIDE, LASOFOXIFENE, CALCIUM W, NITROFURAZONE, LOSARTAN POTASSIUM, VITAMIN B. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5729103-6
FORTAMET problem was reported by a Health Professional from UNITED STATES on Apr 18, 2008. Female patient, 49 years of age, was diagnosed with type 2 diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: haemodialysis, lactic acidosis, myocardial infarction. FORTAMET dosage: unknown. During the same period patient was treated with NIFEDIPINE, BICARBONATE IN PLASTIC CONTAINER, SEVELAMER. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5730986-4
Health Professional from UNITED STATES reported FORTAMET problem on Apr 18, 2008. Male patient, 71 years of age, was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: lactic acidosis, renal failure acute. FORTAMET dosage: unknown. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5731261-4
FORTAMET problem was reported by a Health Professional from UNITED STATES on Apr 18, 2008. Female patient, 77 years of age, was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, haemodialysis, lactic acidosis, renal failure acute. FORTAMET dosage: unknown. During the same period patient was treated with GLUCOTROL, ASPIRIN, PIOGLITAZONE, DIOVAN HCT, CARDIZEM. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5740222-0
Consumer or non-health professional from UNITED KINGDOM reported FORTAMET problem on May 09, 2008. Female patient, 33 years of age, was diagnosed with diabetes mellitus, uveitis and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: aneurysm, diabetes mellitus inadequate control, macular oedema. FORTAMET dosage: unknown. During the same period patient was treated with PIOGLITAZONE, PREDNISOLONE. Patient recovered.

Fortamet Side Effects Report #5751084-X
FORTAMET problem was reported by a Physician from UNITED STATES on May 19, 2008. Female patient, 50 years of age, was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: lactic acidosis, pancreatitis acute, renal impairment. FORTAMET dosage: unknown. During the same period patient was treated with HYDROCHLOROTHIAZIDE, CELECOXIB, CANDESARTAN, ACETAMINOPHEN W, ASPIRIN, SIMVASTATIN, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5751085-1
Consumer or non-health professional from UNITED STATES reported FORTAMET problem on May 19, 2008. Female patient was diagnosed with diabetes mellitus, osteoporosis and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: convulsion, hypoglycaemia. FORTAMET dosage: unknown. During the same period patient was treated with INSULIN, OSCAL, ATORVASTATIN CALCIUM, ASPIRIN, ATENOLOL, RANITIDINE, LOSARTAN POTASSIUM. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5699445-1
FORTAMET problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 07, 2008. Male patient, weighting 200.0 lb, was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: diarrhoea. FORTAMET dosage: 1000MG ONE DAILY ORAL. Patient recovered.

Fortamet Side Effects Report #5709358-4
Consumer or non-health professional from UNITED STATES reported FORTAMET problem on Apr 17, 2008. Male patient, 54 years of age, weighting 211.0 lb, was diagnosed with hyperlipidaemia, diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, anxiety, emotional disorder, nervous system disorder, urine colour abnormal. FORTAMET dosage: unknown. During the same period patient was treated with FORTAMET ER, FORTAMET ER, LIPITOR. Patient recovered.

Fortamet Side Effects Report #5710525-4
FORTAMET problem was reported by a Physician from UNITED STATES on Mar 31, 2008. Male patient, 69 years of age, weighting 180.8 lb, was diagnosed with glioblastoma multiforme and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: asthenia, back pain, blood glucose decreased, blood glucose increased, cerebral haemorrhage, cerebral ischaemia, cerebrovascular accident, confusional state, deep vein thrombosis. FORTAMET dosage: unknown. During the same period patient was treated with PREDNISONE, IRINOTECAN, BEVACIZUMAB, ENOXAPARIN, FLUDRICORTISONE, OXYCODONE, OXYCONTIN, PAXIL. Patient was hospitalized. Patient died on 01/30/2008.

Fortamet Side Effects Report #5721268-5
Health Professional from UNITED KINGDOM reported FORTAMET problem on Apr 10, 2008. Male patient, 78 years of age, was diagnosed with type 2 diabetes mellitus and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: neuropathy peripheral, vitamin b12 deficiency. FORTAMET dosage: unknown. During the same period patient was treated with GLICLAZILE. Patient recovered.

Fortamet Side Effects Report #5371090-7
FORTAMET problem was reported by a Physician from UNITED KINGDOM on June 11, 2007. Female patient, 61 years of age, was diagnosed with diabetes mellitus, procedural pain and was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: aortic valve replacement, lactic acidosis, prothrombin time prolonged, renal failure, therapeutic agent toxicity. FORTAMET dosage: unknown. During the same period patient was treated with ROFECOXIB, ACENOCOUMAROL, FUROSEMIDE, RAMIPRIL. Patient was hospitalized. Patient recovered.

Fortamet Side Effects Report #5293961-2
Physician from UNITED STATES reported FORTAMET problem on Mar 20, 2007. Female patient, 60 years of age, was treated with FORTAMET. After drug was administered, patient experienced the following problems/side effects: campylobacter intestinal infection, dehydration, renal failure acute. FORTAMET dosage: unknown. During the same period patient was treated with COZAAR, DIURETICS, AGGRENOX, MICARDIS, CLOPIDOGREL. Patient was hospitalized. Patient recovered.


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