Table 1 Most common adverse events (AEs) attributed to methotrexate (MTX) and permanent discontinuation due to toxicity in patients with rheumatoid arthritis (RA): pooled results from 21 prospective cohorts (level of evidence 2b)424
PatientsMean dose of MTX (mg/week)Mean duration of MTX (months)Number of all AEsPermanent discontinuationGastro-intestinalLiverSkin/hairCentral nervous systemCytopeniaLung
Number34638.836.52524315/3007*106564030919117984 (15†)
%72.910.530.818. (0.43)†
  • *Total number of patients in studies with data available concerning permanent discontinuation of MTX.

  • Gastrointestinal (GI): stomatitis, ulcer, abdominal pain, GI bleed, dyspepsia, nausea, vomiting, diarrhoea, weigh loss, appetite loss; liver toxicity: increase of aspartate aminotransferase and/or alanine aminotransferase upper limit of normal; skin/hair: ulcer, pruritis, skin rash, alopecia, skin itching, moon face, eczema; central nervous system: headache, depression, blurred vision, transient ischemic attack, stroke, vertigo, lethargy, malaise, fatigue; cytopenia: haemoglobin decreased >2 gm/dl or platelets <150 000/mm3, white blood cells <3500/mm3; lung: MTX pneumonitis (†), pulmonary dysfunction, cough and unspecified pulmonary adverse drug reactions.