GLUMETZA SIDE EFFECTS
- Generic Name: metformin hcl
- Brand Name: Glumetza
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Lactic Acidosis
- Vitamin B12 Deficiency
- Hypoglycemia
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials conducted in the U.S., over 1,000 patients with type 2 diabetes mellitus have been treated with GLUMETZA 1,500 to 2,000 mg/day in active-controlled and placebo-controlled studies with the 500 mg dosage form. In the add-on to sulfonylurea study, patients receiving background glyburide therapy were randomized to receive add-on treatment of either one of three different regimens of GLUMETZA or placebo. In total, 431 patients received GLUMETZA and glyburide and 144 patients received placebo and glyburide. Adverse reactions reported in greater than 5% of patients treated with GLUMETZA that were more common in the combined GLUMETZA and glyburide group than in the placebo and glyburide group are shown in Table 1. In 0.7% of patients treated with GLUMETZA and glyburide, diarrhea was responsible for discontinuation of study medication compared to no patients in the placebo and glyburide group.
Table 1: Adverse Reactions Reported by >5%* of Patients for the Combined GLUMETZA Groups Versus Placebo Group
| Adverse Reaction | GLUMETZA + Glyburide (n=431) |
Placebo + Glyburide (n=144) |
| Hypoglycemia | 14% | 5% |
| Diarrhea | 13% | 6% |
| Nausea | 7% | 4% |
| *Adverse reactions that were more common in the GLUMETZA-treated than in the placebo-treated patients. | ||
Laboratory Tests
Vitamin B12 Concentrations
In clinical trials of 29-week duration with metformin HCl tablets, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in approximately 7% of patients.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of GLUMETZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
SRC: NLM .