Fortamet Side Effects
Generic Name: glucophage,metformin,metformin hydrochloride
Please note - some side effects for Fortamet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Fortamet Side Effects - for the Professional
Fortamet
Fortamet® Clinical Studies
In the controlled clinical studies of Fortamet® in patients with type 2 diabetes, a total of 424 patients received Fortamet® therapy (up to 2500 mg/day) and 430 patients received immediate-release metformin. Adverse reactions reported in ≥5% of the Fortamet® or immediate-release metformin patients are listed in Table 6. These pooled results show that the most frequently reported adverse reactions in the Fortamet® group were infection, diarrhea, and nausea. Similar incidences of these adverse reactions were seen in the immediate-release metformin group.
| Fortamet® (n = 424) |
Immediate-Release Metformin (n = 430) |
|||
|---|---|---|---|---|
| Body System Preferred Term |
n | (%) | n | (%) |
| Body as aWhole | ||||
| Accidental Injury | 31 | (7.3) | 24 | (5.6) |
| Headache | 20 | (4.7) | 22 | (5.1) |
| Infection | 87 | (20.5) | 90 | (20.9) |
| Digestive System | ||||
| Diarrhea | 71 | (16.7) | 51 | (11.9) |
| Dyspepsia | 18 | (4.2) | 22 | (5.1) |
| Nausea | 36 | (8.5) | 32 | (7.4) |
| Respiratory System | ||||
| Rhinitis | 18 | (4.2) | 24 | (5.6) |
The most frequent adverse events thought to be related to Fortamet® were diarrhea, nausea, dyspepsia, flatulence, and abdominal pain. The frequency of dyspepsia was 4.2% in the Fortamet® group compared to 5.1% in the immediate-release group, the frequency of flatulence was 3.5% in the Fortamet® group compared to 3.7% in the immediate-release group, and the frequency of abdominal pain was 3.3% in the Fortamet® group compared to 4.4% in the immediate-release group.
In the controlled studies, 4.7% of patients treated with Fortamet® and 4.9% of patients treated with immediate-release metformin were discontinued due to adverse events.
Immediate-Release Metformin
Immediate-Release Metformin Phase III Clinical StudiesIn a U.S. double-blind clinical study of immediate-release metformin in patients with type 2 diabetes, a total of 141 patients received immediate-release metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the immediate-release metformin patients, and that were more common in immediate-release metformin than placebo-treated patients, are listed in Table 7.
| Immediate-Release Metformin Monotherapy (n = 141) |
Placebo (n = 145) |
|
|---|---|---|
| Adverse Reaction | % of Patients | |
|
||
| Diarrhea | 53.2 | 11.7 |
| Nausea/Vomiting | 25.5 | 8.3 |
| Flatulence | 12.1 | 5.5 |
| Asthenia | 9.2 | 5.5 |
| Indigestion | 7.1 | 4.1 |
| Abdominal Discomfort | 6.4 | 4.8 |
| Headache | 5.7 | 4.8 |
Diarrhea led to discontinuation of study medication in 6% of patients treated with immediate-release metformin. Additionally, the following adverse reactions were reported in ≥1.0 - ≤5.0% of immediate-release metformin patients and were more commonly reported with immediate-release metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
Pediatric Patients
No pediatric clinical studies have been conducted with Fortamet®. In clinical trials with immediate-release metformin in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.
TopSide Effects by Body System - for Healthcare Professionals
General
Metformin has been generally well tolerated. About 20% of patients experienced mild, transient side effects sometime during therapy.
Metabolic
Lactic acidosis is a medical emergency requiring immediate evaluation and treatment. The case fatality rate may be as high as 50.3%. Patients taking metformin who present with even vague medical illnesses such as myalgia, malaise, somnolence, abdominal discomfort, and so forth, should be evaluated for a metabolic etiology like lactic acidosis.
Signs and symptoms of severe acidosis may include vomiting, abdominal pain, nausea, dyspnea, hypothermia, hypotension, and bradycardia.
Laboratory evaluation of metformin-induced lactic acidosis generally includes determination of the following: blood glucose concentration, lactic acid concentration, serum electrolytes, blood pH, metformin concentration, and exclusion of ketoacidosis.
If lactic acidosis is present, immediate institution of general supportive care is indicated. Prompt hemodialysis is also generally recommended in order to correct the acidosis and remove metformin. Hemodialysis often results in rapid improvement. Some investigators have suggested that dialysis with a bicarbonate-buffered dialysate may be particularly effective.
Metabolic side effects have included lactic acidosis, which is a potentially fatal metabolic complication. The incidence of lactic acidosis has been about 1.5 cases per 10,000 patient years. The risk of lactic acidosis has been particularly high in patients with underlying renal insufficiency. Cases of lactic acidosis occurring in patients with normal renal function have been rarely reported. Concomitant cardiovascular or liver disease, sepsis, and hypoxia have also increased the risk of lactic acidosis.
Hypoglycemia occurred uncommonly in patients receiving metformin as monotherapy. Strenuous exercise, decreased caloric intake, general debilitation, adrenal insufficiency, pituitary insufficiency, and ethanol use have increased the risk of hypoglycemia.
Gastrointestinal
Gastrointestinal effects have included nausea, anorexia, metallic taste, diarrhea, dyspepsia, flatulence, and abdominal pain. One study has reported a 20% incidence of diarrhea.
Hematologic
Hematologic side effects have included malabsorption of vitamin B12, due to intrinsic factor deficiency and possibly other mechanisms, in as many as 30% of treated patients. Megaloblastic anemia has occurred. Discontinuation of metformin or supplementation with vitamin B12 has been necessary.
Other
Other side effects include a single case of leukocytoclastic vasculitis with pneumonitis.
Hepatic
Hepatic side effects have included at least two cases of hepatitis associated with metformin use.
A 52-year-old female with a history of type II diabetes mellitus and hypertension developed lethargy, fatigue, and diarrhea after taking metformin for more than 2 weeks. After continuing metformin for a total of four weeks, her sclera became icteric and she was hospitalized. Aside from a soft systolic ejection fracture and a moderate degree of bilateral lower extremity edema, her physical examination was unremarkable. Laboratory data showed grossly elevated total bilirubin, AST, ALT, and alkaline phosphatase. Several days after her initial presentation all of her medications were discontinued. Her signs and symptoms significantly improved over the following several days, and she was discharged within two weeks of her hospitalization. The patient's presentation was considered consistent with drug-induced toxicity attributed to metformin.
Other
Other side effects have included reports of a distinct drug odor. The odor is generally described as "fish or fishy". The odor report varies considerably between generic versions and seems to be less noticeable with film-coated formulations.
TopMore Fortamet resources
- Fortamet Prescribing Information (FDA)
- Fortamet Advanced Consumer (Micromedex) - Includes Dosage Information
- Glucophage Consumer Overview
- Glucophage MedFacts Consumer Leaflet (Wolters Kluwer)
- Glucophage Prescribing Information (FDA)
- Glucophage XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Glucophage XR Prescribing Information (FDA)
- Glumetza Prescribing Information (FDA)
- Metformin Prescribing Information (FDA)
- Metformin Hydrochloride Monograph (AHFS DI)
- Riomet Prescribing Information (FDA)
- Riomet Consumer Overview
- Riomet Solution MedFacts Consumer Leaflet (Wolters Kluwer)
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
