Methotrexate has been reported to cause impairment of fertility, insufficient spermatozoa in the semen, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy. Therefore the possible risks of effects should be discussed before use with patients planning to be pregnant or are pregnant.
Methotrexate may cause systemic toxicity. Patients undergoing therapy should be subject to appropriate supervision to identify signs of toxicity.
Methotrexate should be used with extreme caution in the presence of infection, ulcer of the mucous membrane lining of the alimentary tract, chronic inflammatory disease of the large intestine and rectum, feebleness, and in youth and old age.
Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.
Skin and sub-cutaneous tissue disorders: Stevens-Johnson syndrome, epidermal necrolysis, rashes, itching, hives, photosensitivity, pigmentary changes, baldness, bruise, telangiectasia, acne, furunculosis.
Blood disorders: Bone marrow depression, abnormal lowering of the white blood cell count, platelets, red blood cells and gamma globulin, haemorrhage, blood poisoning.
Gastrointestinal tract disorder: Inflammation of the gums, pharynx, intestine and mucous membrane of the mouth, loss of appetite, vomiting, diarrhoea, Vomiting blood, dark tarry feces containing blood, gastrointestinal ulceration and bleeding.
Hepatic disorders: Hepatic toxicity resulting in significant elevations of liver enzymes, acute liver atrophy, necrosis, fatty metamorphosis, periportal fibrosis or cirrhosis or death
Renal System: Renal failure, uraemia, Inflammation of the urinary bladder and ureters, presence of blood in the urine, nephropathy
Reproductive system disorder: defective development of ova or spermatozoa, transient insufficient spermatozoa in the semen, menstrual dysfunction, infertility, abortion, foetal defects, severe nephropathy, inflammation of the vagina, vaginal ulcers
Respiratory tract disorder: Acute or chronic interstitial pneumonitis, acute pulmonary oedema, pulmonary fibrosis
Central Nervous System: Headaches, drowsiness, blurred vision, inability to use or understand language, hemiparesis, fits, partial paralysis, Guillain-Barre syndrome and increased cerebrospinal fluid pressure