The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse effects are malaise, undue fatigue, chills and fever, dizziness, and decreased resistance to infection. Ulcerations of the oral mucosa are usually the earliest signs of toxicity.
Other adverse reactions that have been reported with methotrexate are listed as follows by organ system and by frequency. In the oncology setting, concomitant treatment and the underlying disease make specific attribution of a reaction to methotrexate difficult. See Precautions for specific reference to medically important and long term events including those following long term treatment or high cumulative doses (e.g., hepatic toxicity).
Frequency categories are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). (See table.)
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