Glucophage XR Side Effects & Drug Interactions - Metformin

[Metformin]

ADVERSE REACTIONS

In a U. S. double-blind clinical study of GLUCOPHAGE in patients with type 2 diabetes, a total of 141 patients received GLUCOPHAGE therapy (up to 2550 mg per day) and 145 patients received place-bo. Adverse reactions reported in greater than 5% of the GLUCOPHAGE patients, and that were more common in GLUCOPHAGE-than placebo-treated patients, are listed in Table 11.

* Reactions that were more common in GLUCOPHAGE-than placebo-treated patients. Diarrhea led to discontinuation of study medication in 6% of patients treated with GLUCOPHAGE. Additionally, the following adverse reactions were reported in 1.0- 5.0% of GLUCOPHAGE patients and were more commonly reported with GLUCOPHAGE than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disor-der, chest discomfort, chills, flu syndrome, flushing, palpitation.

In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with GLUCOPHAGE XR in placebo-and active-controlled studies. In placebo-controlled trials, 781 patients were administered GLUCOPHAGE XR and 195 patients received placebo. Adverse reac-tions reported in greater than 5% of the GLUCOPHAGE XR patients, and that were more common in GLUCOPHAGE XR-than placebo-treated patients, are listed in Table 12.

* Reactions that were more common in GLUCOPHAGE XR-than placebo-treated patients Diarrhea led to discontinuation of study medication in 0.6% of patients treated with GLUCOPHAGE XR. Additionally, the following adverse reactions were reported in 1.0%- 5.0% of GLUCOPHAGE XR patients and were more commonly reported with GLUCOPHAGE XR than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/ heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.

Pediatric Patients

In clinical trials with GLUCOPHAGE in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.

Drug Interactions