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Metformin Extended-Release (Metformin Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with metformin hydrochloride extended-release tablets in placebo- and active-controlled studies. In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets and 195 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release patients, and that were more common in metformin hydrochloride extended-release tablet-than placebo-treated patients, are listed in Table 6.

Table 6. Most Common Adverse Reactions (> 5%) In Placebo-Controlled Studies of Metformin Hydrochloride Extended-Release Tablets*
Metformin Hydrochloride Extended-Release Tablets n = 781 Placebo n = 195
Adverse Reaction % of Patients
Diarrhea9.62.6
Nausea/Vomiting6.51.5

* Reactions that were more common in metformin hydrochloride extended-release tablet-than placebo-treated patients.

Diarrhea led to discontinuation of study medication in 0.6% of patients treated with metformin hydrotablets. Additionally, the following adverse reactions were reported in ≥ 1% to ≤ 5% of metformin hydrochloride extended-release tablet patients and were more commonly reported with metformin hydrochloride extended-release tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.

Pediatric Patients

Safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established.

Drug label data at the top of this Page last updated: 2007-03-23

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