Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS In a US double-blind clinical study of Metformin Hydrochloride Tablets USP in patients with type 2 diabetes, a total of 141 patients received Metformin Hydrochloride Tablets USP therapy (up to 2550 mg per day) and 145 patients received placebo.
Adverse reactions reported in greater than 5% of the Metformin Hydrochloride Tablets USP patients, and that were more common in Metformin Hydrochloride Tablets USP- than placebo-treated patients, are listed in Table 9 .
Table 9: Most Common Adverse Reactions (>5.0 Percent) in a Placebo-Controlled Clinical Study of Metformin Hydrochloride Tablets Monotherapy * Adverse Reaction Metformin Hydrochloride Tablets Monotherapy (n=141) Placebo (n=145) % 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 * Reactions that were more common in metformin hydrochloride tablets than placebo-treated patients.
Diarrhea led to discontinuation of study medication in 6% of patients treated with Metformin Hydrochloride Tablets USP.
Additionally, the following adverse reactions were reported in ≥1.0 to ≤5.0% of Metformin Hydrochloride Tablets USP patients and were more commonly reported with Metformin Hydrochloride Tablets USP than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
Pediatric Patients In clinical trials with Metformin Hydrochloride Tablets USP in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.
WARNINGS Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Metformin Hydrochloride Tablets USP;
when it occurs, it is fatal in approximately 50% of cases.
Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia.
Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio.
When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found.
Like all medications, Metformin Hcl can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: