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Fortamet Side Effects

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Common Fortamet Side Effects


The most commonly reported Fortamet side effects (click to view or check a box to report):

Death (47)
Lactic Acidosis (29)
Renal Failure Acute (11)
Renal Failure (9)
Diarrhoea (7)
Metabolic Acidosis (6)
Haemodialysis (6)
Hypoglycaemia (6)
Blood Glucose Increased (5)
Abdominal Pain (5)
Cardio-respiratory Arrest (5)
Vomiting (5)
Hypotension (4)
Haemolytic Anaemia (4)
Intentional Overdose (4)
Myocardial Infarction (4)
Pancreatitis (4)
Nausea (4)
Shock (3)
Unresponsive To Stimuli (3)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Fortamet Side Effects Reported to FDA



Fortamet Side Effect Report#9678242
Blood Glucose Increased, Protein Urine, Diabetic Neuropathy
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Fortamet Extended Release (watson Laboratories) (dosage: NA, start time: 201307), combined with:
  • Gabapentin (1200 Mg, Bid)
  • Lisinopril
and developed a serious reaction and side effect(s): Blood Glucose Increased, Protein Urine, Diabetic Neuropathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fortamet Extended Release (watson Laboratories) treatment in female patients, resulting in Blood Glucose Increased side effect.
Fortamet Side Effect Report#9447709
Diarrhoea, Nausea, Decreased Appetite, Pain, Abdominal Pain
This report suggests a potential Fortamet Diarrhoea side effect(s) that can have serious consequences. A 27-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: polycystic ovaries and used Fortamet (dosage: 500 Mg 2 Tabes Bid Po) starting
Jul 29, 2013. After starting Fortamet the patient began experiencing various side effects, including: Diarrhoea, Nausea, Decreased Appetite, Pain, Abdominal PainAdditional drugs used concurrently: NA. Although Fortamet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Fortamet Side Effect Report#9095307
Nausea, Vomiting, Incorrect Dose Administered, Respiratory Failure, Metabolic Acidosis, Hypotension, Unresponsive To Stimuli, Haemodialysis, Pulmonary Oedema
This Nausea problem was reported by a physician from US. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fortamet (dosage: NA). The following drugs were being taken at the same time: NA. When using Fortamet, the patient experienced the following unwanted symptoms/side effects: Nausea, Vomiting, Incorrect Dose Administered, Respiratory Failure, Metabolic Acidosis, Hypotension, Unresponsive To Stimuli, Haemodialysis, Pulmonary OedemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Fortamet Side Effect Report#9026037
Incorrect Dose Administered, Hypotension, Body Temperature Decreased, Respiratory Failure, Metabolic Acidosis, Unresponsive To Stimuli, Haemodialysis, Pulmonary Oedema
This Death side effect was reported by a physician from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fortamet (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fortamet the consumer reported adverse symptoms, such as: Incorrect Dose Administered, Hypotension, Body Temperature Decreased, Respiratory Failure, Metabolic Acidosis, Unresponsive To Stimuli, Haemodialysis, Pulmonary OedemaThese side effects may potentially be related to Fortamet.
Fortamet Side Effect Report#8799397
Nausea, Abdominal Pain
This is a report of a 56-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes, who was treated with Fortamet (dosage: NA, start time:
Sep 11, 2012), combined with: NA. and developed a serious reaction and side effect(s): Nausea, Abdominal Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fortamet treatment in female patients, resulting in Nausea side effect.
Fortamet Side Effect Report#8398194-9
Thyroid Neoplasm, Parathyroid Tumour
This report suggests a potential Fortamet Thyroid Neoplasm side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus,hypertension and used Fortamet (dosage: NA) starting
Dec 01, 2011. After starting Fortamet the patient began experiencing various side effects, including: Thyroid Neoplasm, Parathyroid TumourAdditional drugs used concurrently:
  • Benicar (Unk)
  • Victoza (1.4 Mg, Qd)
  • Lipitor
  • Losartan Potassium (Unk)
Although Fortamet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thyroid Neoplasm, may still occur.
Fortamet Side Effect Report#8026070-X
Disturbance In Attention, Blood Thyroid Stimulating Hormone Increased
This Disturbance In Attention problem was reported by a consumer or non-health professional from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 07, 2011 this consumer started treatment with Fortamet (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin
  • Synthroid (In Morning)
  • Synthroid (Lower Doses)
  • Gabapentin
  • Lipitor
  • Multivitamin Without Iron
  • Synthroid (In Morning)
  • Tricor
When using Fortamet, the patient experienced the following unwanted symptoms/side effects: Disturbance In Attention, Blood Thyroid Stimulating Hormone IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Disturbance In Attention, may become evident only after a product is in use by the general population.
Fortamet Side Effect Report#7828585-3
Product Odour Abnormal, Blood Glucose Decreased
This Product Odour Abnormal side effect was reported by a consumer or non-health professional from United States. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Fortamet (drug dosage: 1), which was initiated on
Sep 01, 2011. Concurrently used drugs: NA..After starting to take Fortamet the consumer reported adverse symptoms, such as: Product Odour Abnormal, Blood Glucose DecreasedThese side effects may potentially be related to Fortamet.
Fortamet Side Effect Report#7495146-8
Pancreatitis
This is a report of a 75-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Fortamet (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pancreatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fortamet treatment in female patients, resulting in Pancreatitis side effect. The patient was hospitalized.
Fortamet Side Effect Report#7454073-2
Pancreatitis
This report suggests a potential Fortamet Pancreatitis side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: diabetes mellitus and used Fortamet (dosage: Unk) starting NS. After starting Fortamet the patient began experiencing various side effects, including: PancreatitisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Fortamet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancreatitis, may still occur.
Fortamet Side Effect Report#7438252-6
Pain, Hepatic Enzyme Increased, Gallbladder Disorder, Cholecystitis Chronic
This Pain problem was reported by a consumer or non-health professional from United States. A 26-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On
Jan 01, 2008 this consumer started treatment with Fortamet (dosage: Unk). The following drugs were being taken at the same time:
  • Yasmin (Unk)
  • Xyoline Cream
  • Cleocin
  • Lisinopril (Unk)
  • 4% Hq
  • Yasmin (Unk)
  • Ocella (Unk)
  • Clindamycin
When using Fortamet, the patient experienced the following unwanted symptoms/side effects: Pain, Hepatic Enzyme Increased, Gallbladder Disorder, Cholecystitis ChronicAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Fortamet Side Effect Report#7397068-X
Coronary Artery Disease, Arteriosclerosis, Myocardial Infarction, Cardiac Failure Congestive, Ischaemic Cardiomyopathy
This Coronary Artery Disease side effect was reported by a consumer or non-health professional from United States. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fortamet (drug dosage: NA), which was initiated on
Jul 01, 2004. Concurrently used drugs:
  • Avandia (4mg Per Day)
  • Metformin
  • Amaryl
  • Avandaryl
  • Avandamet
  • Lisinopril
  • Crestor
.After starting to take Fortamet the consumer reported adverse symptoms, such as: Coronary Artery Disease, Arteriosclerosis, Myocardial Infarction, Cardiac Failure Congestive, Ischaemic CardiomyopathyThese side effects may potentially be related to Fortamet. The patient was hospitalized.
Fortamet Side Effect Report#7357758-1
Nausea, Diarrhoea, Vomiting, Blood Glucose Increased
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Fortamet (dosage: NA, start time:
Jun 19, 2010), combined with:
  • Glumetza (500mg Twice A Day Orally)
  • Metformin Hcl (1000mg Twice A Day Orally)
and developed a serious reaction and side effect(s): Nausea, Diarrhoea, Vomiting, Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fortamet treatment in female patients, resulting in Nausea side effect.
Fortamet Side Effect Report#7333127-5
Lactic Acidosis, Renal Failure
This report suggests a potential Fortamet Lactic Acidosis side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from Italy was diagnosed with the following symptoms/conditions: diabetes mellitus,hiv infection and used Fortamet (dosage: Unk) starting NS. After starting Fortamet the patient began experiencing various side effects, including: Lactic Acidosis, Renal FailureAdditional drugs used concurrently:
  • Tenofovir (Unk)
The patient was hospitalized. Although Fortamet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lactic Acidosis, may still occur.
Fortamet Side Effect Report#7129337-2
Renal Failure
This Renal Failure problem was reported by a health professional from United Kingdom. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: blood glucose increased. On NS this consumer started treatment with Fortamet (dosage: 2 G, Unk). The following drugs were being taken at the same time:
  • Furosemide (watson Laboratories)
  • Lisinopril
  • Exenatide (10 Mcg, Bid)
  • Exenatide (5 Mcg, Bid)
  • Spironolactone (25 Mg, Unk)
When using Fortamet, the patient experienced the following unwanted symptoms/side effects: Renal FailureThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure, may become evident only after a product is in use by the general population.
Fortamet Side Effect Report#7129331-1
Dysphagia, Thyroid Operation
This Dysphagia side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Fortamet (drug dosage: 1000 Mg In The Morning And 1000 Mg In The Evening), which was initiated on
Sep 01, 2010. Concurrently used drugs: NA..After starting to take Fortamet the consumer reported adverse symptoms, such as: Dysphagia, Thyroid OperationThese side effects may potentially be related to Fortamet. The patient was hospitalized.
Fortamet Side Effect Report#7091750-X
Hepatorenal Syndrome, Lactic Acidosis, Multi-organ Failure
This is a report of a 36-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Fortamet (dosage: 500 Mg, Bid, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hepatorenal Syndrome, Lactic Acidosis, Multi-organ Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fortamet treatment in male patients, resulting in Hepatorenal Syndrome side effect.
Fortamet Side Effect Report#7031415-3
Lactic Acidosis, Pancreatitis Acute, Renal Failure Acute
This report suggests a potential Fortamet Lactic Acidosis side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus,gastrooesophageal reflux disease and used Fortamet (dosage: Unk) starting NS. After starting Fortamet the patient began experiencing various side effects, including: Lactic Acidosis, Pancreatitis Acute, Renal Failure AcuteAdditional drugs used concurrently:
  • Cimetidine
The patient was hospitalized. Although Fortamet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lactic Acidosis, may still occur.
Fortamet Side Effect Report#7016163-8
Lactic Acidosis, Myocardial Infarction, Po2 Abnormal, Renal Failure Acute
This Lactic Acidosis problem was reported by a health professional from Italy. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On NS this consumer started treatment with Fortamet (dosage: 850 Mg, Tid). The following drugs were being taken at the same time: NA. When using Fortamet, the patient experienced the following unwanted symptoms/side effects: Lactic Acidosis, Myocardial Infarction, Po2 Abnormal, Renal Failure AcuteThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lactic Acidosis, may become evident only after a product is in use by the general population.
Fortamet Side Effect Report#7006339-8
Blood Creatinine Increased, Metabolic Acidosis
This Blood Creatinine Increased side effect was reported by a physician from United Kingdom. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Fortamet (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fortamet the consumer reported adverse symptoms, such as: Blood Creatinine Increased, Metabolic AcidosisThese side effects may potentially be related to Fortamet. The patient was hospitalized.
Fortamet Side Effect Report#6989330-7
Hypophosphataemia, Infection, Overdose
This is a report of a 67-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Fortamet (dosage: 850 Mg, Tid, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hypophosphataemia, Infection, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fortamet treatment in female patients, resulting in Hypophosphataemia side effect.
Fortamet Side Effect Report#6934508-1
Blood Glucose Increased, Hyperkalaemia, Metabolic Acidosis, Renal Failure
This report suggests a potential Fortamet Blood Glucose Increased side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: diabetes mellitus,back pain,hypertension and used Fortamet (dosage: 850 Mg, Tid) starting NS. After starting Fortamet the patient began experiencing various side effects, including: Blood Glucose Increased, Hyperkalaemia, Metabolic Acidosis, Renal FailureAdditional drugs used concurrently:
  • Diclofenac (50 Mg, Unk)
  • Enalapril (watson Laboratories) (20 Mg , Unk)
The patient was hospitalized. Although Fortamet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Glucose Increased, may still occur.
Fortamet Side Effect Report#6909525-8
Hepatotoxicity
This Hepatotoxicity problem was reported by a pharmacist from Senegal. A 61-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fortamet (dosage: 500 Mg, Bid). The following drugs were being taken at the same time:
  • Simvastatin
  • Niaspan
When using Fortamet, the patient experienced the following unwanted symptoms/side effects: HepatotoxicityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatotoxicity, may become evident only after a product is in use by the general population.
Fortamet Side Effect Report#6654310-8
This Death side effect was reported by a health professional from United States. A 26-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fortamet (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Oxycodone Hcl (Unk)
.After starting to take Fortamet the consumer reported adverse symptoms, such as: These side effects may potentially be related to Fortamet.
Fortamet Side Effect Report#6654306-6
This is a report of a 54-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Fortamet (dosage: Unk, start time: NS), combined with:
  • Glyburide
  • Insulin
  • Rosiglitazone
and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fortamet treatment in male patients, resulting in Death side effect.


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The appearance of Fortamet on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Fortamet reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Fortamet Safety Alerts, Active Ingredients, Usage Information

    NDC54868-2894
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameFortamet
    Namemetformin hydrochloride
    Dosage FormTABLET, EXTENDED RELEASE
    RouteORAL
    On market since20100218
    LabelerPhysicians Total Care, Inc.
    Active Ingredient(s)METFORMIN HYDROCHLORIDE
    Strength(s)1000
    Unit(s)mg/1
    Pharma ClassBiguanide [EPC],Biguanides [Chemical/Ingredient]

    Fortamet Dosage, Warnings, Usage.

    Side Effects reported to FDA: 124

    Fortamet safety alerts: No

    Reported deaths: 57

    Reported hospitalizations: 41

    Latest Fortamet clinical trials