Methotrexate Side Effects

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Answer the side-effect intent for methotrexate without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is methotrexate?

Methotrexate contains the active ingredient Methotrexate.

• Active ingredient — Methotrexate
• Registration holder — Pfizer Laboratories (Pty) Ltd

It is approved for:

• Keep this leaflet
• You may need to read it again
• If you have any questions, consult your doctor, pharmacist or other health care professional for advice
• This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. This medicine is only available with a doctor’s prescription

Common side effects of methotrexate

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• birth defects and death of the unborn child
• serious anaemia, lower white cells, red cells, and platelets in your blood
• damage to kidneys, liver, heart, bones or nervous system
• ulcers in the mouth, throat, or intestines
• severe skin reactions
• diabetes
• inflammation of the blood vessels
• change in mood
• seizures
• change in vision including temporary blindness
• low blood pressure
• lung disease
• cancer of the lymph system (lymphoma)
• severe skin reactions and rashes
• opportunistic infections such as Pneumocystis carini pneumonia
• soft tissue and bone damage if you are getting radiation therapy at the same time you are taking METHOTREXATE*-LEDERLE 2,5 The most common side-effects of METHOTREXATE*-LEDERLE 2,5 include:
• mouth sores
• low white blood cells
• nausea, upset stomach
• feeling poorly
• unusual weakness or tiredness, chills, fever or cough, dizziness
• higher chance for getting infections
• diarrhoea, vomiting, abdominal pain
• hair loss
• easy bruising
• yellow colour of eyes or skin
• rash
• bleeding
• severe headache Stop taking METHOTREXATE*-LEDERLE 2,5 and call your doctor immediately if you get diarrhoea, mouth sores, a fever, dehydration, cough, bleeding, shortness of breath, any signs of infection, or a skin rash. If you have any questions about these or other side-effects, talk to your doctor
• These are not all the side-effects of METHOTREXATE*-LEDERLE 2,5. Ask you doctor or pharmacist for more information. Not all side effects reported for this medicine are included in this leaflet. If you notice any other side effects

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are allergic (hypersensitive) to METHOTREXATE*- LEDERLE 2,5 or any of the other ingredients in the formulation
• if you are breast-feeding or if you intend to breast-feed
• if you are pregnant or intend to become pregnant. METHOTREXATE*-LEDERLE 2,5 may cause birth defects if either the male or female is taking it before, during, or after pregnancy. Both men and women must use effective birth control all the time while taking METHOTREXATE*-LEDERLE 2,5 and after they stop taking it. Consult your health care professional if you become pregnant or wish to become pregnant. Applies to patients with psoriasis or rheumatoid arthritis only:
• Do not take METHOTREXATE*-LEDERLE 2,5
• if you suffer from alcoholism, alcoholic liver disease, or other chronic liver disease
• if you have a disorder of the immune system, such as AIDS
• if you have preexisting blood diseases (you must discuss this with your healthcare professional)
• Take special care with METHOTREXATE*-LEDERLE 2,5 and notify your healthcare professional immediately
• if you have serious infections or skin reactions
• if you develop cough or shortness of breath
• if you are exposed to chicken pox or shingles and have not had these diseases in the past
• if you notice unusual bleeding or bruising, blood in urine or stools, or red spots on your skin
• if you are taking vaccines. Certain vaccines may not work well while you are on METHOTREXATE*- LEDERLE 2,5 and “live” virus vaccines should be avoided; discuss this with your healthcare professional. METHOTREXATE*-LEDERLE 2,5 may make your skin sensitive to the sun, so avoid long exposure to the sun and do not use a sunlamp without first discussing its use with your healthcare professional

Interactions and medicines to check

The approved leaflet names these interactions.

• Taking METHOTREXATE*-LEDERLE 2,5 with food and drink While taking METHOTREXATE*-LEDERLE 2,5 you should avoid drinking alcohol, since this may increase the chance of side effects, especially on the liver. Your healthcare professional may tell you to drink extra fluids. This will help the drug to pass from the body and to prevent kidney problems

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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