Glucophage/Glucophage Forte/Glucophage XR Adverse Reactions

Glucophage/Glucophage Forte: The following undesirable effects may occur under treatment with metformin. Frequencies are defined as follows: very common: ≥1/10; common: ≥1/100, <1/10; uncommon: ≥1/1,000, <1/100; rare: ≥1/10,000, <1/1,000; very rare: <1/10,000; frequency not known: cannot be estimated from the available data.
Metabolism and nutrition disorders: Common: Vitamin B12 decrease/ deficiency (see Precautions).
Very rare: Lactic acidosis (see Precautions).
Nervous system disorders: Common: Taste disturbance.
Gastrointestinal disorders: Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions such as erythema, pruritus, urticaria.
Children from 10 years of age and adolescents: In published and post marketing data and in controlled clinical studies in a limited pediatric population aged 10 to 16 years treated during 1 year, adverse event reporting was similar in nature and severity to that reported in adults.
At the first sign of any adverse drug reaction, patient must seek medical attention immediately.
Glucophage XR: The following undesirable effects observed in patients treated with metformin (Glucophage XR) extended release tablets were similar in nature and severity to those observed in patients treated with metformin (Glucophage) immediate-release tablets. The following undesirable effects may occur under treatment with metformin. Frequencies are defined as follows: very common: ≥1/10; common: ≥1/100, <1/10; uncommon: ≥1/1,000, <1/100; rare: ≥1/10,000, <1/1,000; very rare: <1/10,000; frequency not known: cannot be estimated from the available data.
Metabolism and nutrition disorders: Common: Vitamin B12 decrease/deficiency (see Precautions). Very rare: Lactic acidosis (see Precautions).
Nervous system disorders: Common: Taste disturbance.
Gastrointestinal disorders: Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions such as erythema, pruritus, urticaria.
At the first sign of any adverse drug reaction, patient must seek medical attention immediately.