Glucophage/Glucophage XR Adverse Reactions

Glucophage: During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended to take metformin in 2 or 3 daily doses and to increase slowly the doses.
The following adverse reactions 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.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Metabolism and nutrition disorders: Common: Vitamin B12 deficiency: Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia (see Precautions).
Very rare: Lactic acidosis (see Precautions).
Nervous system disorders: Common: Taste disturbance.
Gastrointestinal disorders: Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhoea, 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: Isolated reports of liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions such as erythema, pruritus, urticaria.
Paediatric population: In published and post marketing data and in controlled clinical studies in a limited paediatric population aged 10-16 years treated during 1 year, adverse event reporting was similar in nature and severity to that reported in adults.
Glucophage XR: In post marketing data and in controlled clinical studies, adverse event reporting in patients treated with Glucophage XR was similar in nature and severity to that reported in patients treated with Glucophage immediate release.
The following adverse reactions may occur with metformin.
Frequencies are defined as follows: very common >1/10; common ≥1/100, <1/10; uncommon ≥1/1000, <1/100; rare ≥1/10,000, <1/1000; very rare <1/10,000.
Nervous system disorders: Common: Taste disturbance.
Gastrointestinal disorders: Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. A slow increase of the dose may also improve gastrointestinal tolerability.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions such as erythema, pruritus, urticaria.
Metabolism and nutrition disorders: Common: Vitamin B12 deficiency. Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia (see Precautions).
Very rare: Lactic acidosis (see Precautions).
Hepatobiliary disorders: Very rare: Liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.