Side Effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Stop taking methotrexate and see a doctor or go to a hospital straight away if you notice the following serious side effect – you may need urgent medical treatment: ■ allergic reaction – the signs may include swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, severe itching of your skin with raised lumps. ■ the first signs of life-threatening complications can be: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nose bleeds and bruising. ■ serious heart problems where fluid is filling around the heart affecting the heartbeat ■ sepsis, whole body inflammation that can be life-threatening. Tell your doctor straight away if you have any of the following side effects: ■ a severe skin rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson Syndrome) and a more severe form causing severe skin peeling (Toxic Epidermal Necrolysis). Your doctor will stop your treatment in these cases. This is an uncommon side effect. ■ persistent dry irritating cough, pain or difficulty breathing or becoming breathless as methotrexate can cause inflammation of the lungs. Symptoms can also include a general feeling of illness, chest pain or fever. This is an uncommon side effect but can be very serious. ■ spitting or coughing blood (has been reported for methotrexate used in patients with underlying rheumatologic disease). ■ unusual bleeding (including vomiting blood), black or tarry stools, blood in the urine, bruising or nose bleeds ■ skin rash, red or purple spots on the skin, fever and swollen glands, particularly in the first two months of treatment, as these may be signs of a hypersensitivity reaction. ■ nausea, vomiting, abdominal discomfort or severe diarrhoea ■ pain or difficulty passing urine ■ thirst and/or frequent urination ■ blurred or restricted vision ■ loss of coordination, loss of ability to speak or understand speech, weakness and inability to move one side of the body, or the whole body, severe fatigue (tiredness), unconsciousness, convulsions or fits. ■ swelling of the hands, ankles or feet, which may be a sign of kidney damage ■ yellowing of the skin and whites of the eye, a sign of liver damage ■ rapid expansion of the large intestines (toxic megacolon). Symptoms may come on suddenly and may include: abdominal pain, bloating of the abdomen, abdominal tenderness, fever, rapid heart rate, shock, bloody diarrhoea. This is a very rare side effect. The following side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor. Very common (may affect more than 1 in 10 people): ■ loss of appetite, feeling sick (nausea), vomiting, abdominal pain, indigestion, inflammation and ulcers of the mouth and throat ■ blood test showing raised liver enzymes. Common: affects 1 to 10 users in 100 ■ infections ■ decrease in white blood cell count which increases the risk of infection, decrease in red cells which can cause anaemia and decrease in platelets which can cause bleeding ■ headache, dizziness and tiredness ■ mild, red itchy skin rash, hair loss. Uncommon: affects 1 to 10 users in 1,000 ■ lymphoma (lump in neck, groin or armpits with associated backache, weight loss or night sweats) ■ severe allergic reactions ■ diabetes ■ depression ■ dizziness, confusion, seizures ■ lung damage ■ liver diseases, reduced content of blood proteins ■ nettle rash, skin reaction in strong light, brown discoloration of the skin, hair loss, increased number of rheumatic nodules, shingles, painful psoriasis, slow wound healing ■ joint or muscle pain, osteoporosis (reduction in bone strength) ■ kidney problems including kidney failure, inflammation or ulcers of the bladder (possibly also with blood in the urine), painful urination ■ irritation or swelling of the vaginal tissues. Rare: affects 1 to 10 users in 10,000 ■ chickenpox (herpes zoster) ■ production of very large red blood cells which leads to tiredness, muscle weakness, weight loss, feeling sick, fast heart beat and tingling or numbness in the hands and feet ■ increased risk of diabetes ■ severe vision problems ■ mood swings, feeling depressed or confused ■ inflammation of the heart sac, accumulation of fluid in the heart sac ■ weakness and loss of movement, sometimes on one side of the body ■ fits ■ low blood pressure, high blood pressure, blood clots that can lead to strokes, breathlessness ■ swelling at the back of the throat, swollen and bleeding gums, swollen tongue, ulcers and bleeding from the bowel, inflamed pancreas ■ fatty liver, hepatitis, cirrhosis of the liver, jaundice and serious liver disorders ■ tonsillitis, stopping breathing, asthma ■ kidney failure, breakdown of the kidney tissue which may show as back pain, reduction or lack of urine production, abnormal levels of electrolytes in blood ■ skin sensitivity to light, acne, flaking inflamed skin, changes in skin colour, red or purple spots on the skin, skin lesions, skin ulcers and breakdown of inflamed areas in patients with psoriasis, discolouration of the nails ■ inflammation of the pancreas, inflammation of the digestive tract, bloody stools, inflamed gums, indigestion ■ worsening of psoriasis during treatment with UV therapy ■ skin lesions resembling sunburn or dermatitis after radiotherapy ■ increase in lumps under the skin that are caused in Rheumatoid Arthritis ■ loss of interest in or inability to have sex, impaired sperm production, problems with your periods. Very rare: affects less than 1 user in 10,000 ■ viral, fungal or bacterial systemic infections ■ serious disorder of bone marrow (anaemia), swollen glands ■ herpes simples (cold sores), hepatitis ■ an immune disorder that reduces antibodies that fight infection. Symptoms include pain, unable to sleep, tiredness and feeling depressed and anxious. ■ pain, muscle weakness, changes in the sense of taste (metallic taste), inflammation of the membrane lining the brain resulting in paralysis or vomiting, sensation of numbness or tingling/having less sensitivity to stimulation than normal ■ mixing words up when speaking and impaired thinking, loss of contact with reality (psychosis), tingly sensations in the head, pain in the head caused by swelling, ringing in the ears ■ conjunctivitis (red eyes), blurred vision caused by damage to the retina (back of the eye) ■ vomiting blood, severe complications in the digestive tract ■ liver failure ■ fingernail infections, detachment of the nail from the nail bed, boils, widening of small blood vessels, damage to the blood vessels of the skin, allergic inflammation of blood vessels ■ weakening or softening of the bones ■ accumulation of fluid in the lung, lung infections ■ protein in the urine ■ vaginal bleeding or discharge, loss of sex drive, erection problems, infertility, enlargement of the breasts in men (gynaecomastia), swelling of the breasts, particularly in men ■ lymphoproliferative disorders (excessive growth of white blood cells) ■ fever. Not known: ■ pathological change of the white matter of the brain (leukoencephalopathy) ■ wide spread cold sores and infections ■ haemorrhages and bleeding problems ■ bleeding from the lungs (has been reported for methotrexate used in patients with underlying rheumatologic disease) ■ bone damage in the jaw (secondary to excessive growth of white blood cells) ■ redness and shedding of skin ■ swelling. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.