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Generally, the frequency and severity of adverse reactions are dependent on the size of the dose, the dosing frequency, the method of administration, and the duration of exposure.
In the antineoplastic treatment, myelosuppression and mucositis are the predominant dose-limiting toxic effects of methotrexate. The severity of these reactions depends on the dose, mode, and duration of application of methotrexate. Mucositis generally appears about 3 to 7 days after methotrexate application, leucopenia and thrombocytopenia follow a few days later. In patients with unimpaired elimination mechanisms, myelosuppression, and mucositis are generally reversible within 14 to 28 days.
Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock, and Stevens-Johnson syndrome.
Most frequently observed (very common) adverse reactions of methotrexate include gastrointestinal disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver function tests (e.g. increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase). Other frequently occurring (common) adverse reactions are leukopenia, anemia, thrombocytopenia, headache, tiredness, drowsiness, pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia, oral ulcers, diarrhea, exanthema, erythema, and pruritus.
The occurrence and severity of adverse reactions depend on dosage level and frequency of administration of methotrexate. However, as severe adverse reactions may occur even at low doses, it is essential for the treating physician to monitor patients closely.
Tabulated list of adverse reactions: The frequencies of the adverse reactions are classified as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10000), not known (cannot be estimated from the available data). (See Tables 2a and 2b.)


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Immediately notify a doctor or pharmacist of any adverse reactions that may be encountered when using the drug.