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: Very rare: Lactic acidosis.
Decrease of vitamin B12 absorption with decrease of serum levels during long term use of metformin hydrochloride.
Consideration of such etiology is recommended if a patient present with megaloblastic anemia.
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 Hydrochloride 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 test abnormalities or hepatitis resolving upon metformin hydrochloride discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions such as erythema, pruritus, urticaria.
Pediatric population: In published and post marketing data and in controlled clinical studies in a limited pediatric population aged 10-16 years treated during 1 year, adverse event reporting was similar in nature and severity to the reported in adults.
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