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 |
Diarrhea | 9.6 | 2.6 |
Nausea/Vomiting | 6.5 | 1.5 |
* 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.
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