Medrol Side Effects

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

What is Medrol?

Medrol contains the active ingredient Methylprednisolone.

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

It is approved for:

• MEDROL is used to suppress severe allergic or hypersensitivity reactions, the immune system of the body, or inflammation associated with disease conditions or disorders that do not respond to other therapy
• It is used in conjunction with anti-cancer medicines and as replacement therapy in adrenal gland failure
• MEDROL may also be prescribed to treat conditions other than those listed above

Common side effects of Medrol

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.

Frequent side effects

• Round or moon-shaped face (Cushingoid)
• Sodium retention, which causes thirst due to dehydration
• Fluid retention, which causes swelling that may be widespread, or confined to a limb or part of a limb
• Diabetes or worsening of existing diabetes
• Muscular weakness
• Brittle bones (bones that break easily)
• Slowing of normal growth
• Poor wound healing
• Blood potassium decreased (determined by a blood test)

Less frequent side effects

• Increased number of white blood cells (leucocytosis), which will cause you to feel weak, tired, experience fever and pain
• Hypothalamic pituitary adrenal axis suppression – a short supply of one or more pituitary hormones. This can affect a number of things including growth (in children, poor overall growth and short height; in adults, reduced energy), blood pressure (may be lowered) and reproduction (in women, periods may stop; in men, decreased sperm production and loss of sexual function; in children, delayed puberty may occur)
• Metabolic acidosis – The blood becoming too acid. It may cause rapid breathing, confusion, tiredness, headache, jaundice, and increased heart rate
• Alkalosis – the blood becoming too alkaline. This may cause irritability, muscle twitching and cramps, and tingling in the fingers, toes and around the lips
• Alkalosis hypokalaemic – when the concentration of potassium in the blood is low
• Abnormal localised or tumour-like accumulations of fat in the tissues
• Increased appetite and weight gain
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or moods that go up and down (mood swings)
• Psychotic disorder including feeling, seeing or hearing things which are not there
• Feeling anxious, irritated or having problems sleeping
• Changes to personality and behaviour (the way you act), being confused
• Increase in the pressure in your head (brain); you may experience headache as a result
• Back pain or weakness (due to epidural lipomatosis, a disorder in which an abnormal amount of fat is deposited on or outside the lining of the spine). Pins and needles and paralysis may also be experienced
• Other nervous system side effects may include convulsions (fits/seizures), amnesia (loss of memory), changes in the way you think, dizziness and headache
• Cataracts; you may experience blurred, cloudy vision, difficulty with night vision, increased sensitivity to light
• Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches)
• Protruding of the eyeballs (exophthalmos)
• Blurred or distorted vision (due to a disease called central serous chorioretinopathy) with detachment of the retina
• A feeling of dizziness or spinning (vertigo)
• Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difficulty in breathing and palpitations (awareness of heartbeat) or irregular beating of the heart, irregular or very fast or slow pulse
• High blood pressure, symptoms of which are headaches, or generally feeling unwell
• Formation of a blood clot inside a blood vessel, obstructing the flow of blood through the circulatory system; you may experience pain, cramping or swelling in your leg near the thigh or calf and the skin might be warm or red in that area
• Low blood pressure, symptoms may include dizziness, fainting, light headedness, blurred vision, rapid or irregular heartbeat (palpitations)
• Hiccups
• Blockage of the main artery in the lung (pulmonary embolism); you may experience shortness of breath, chest pain and cough
• Ulcers, including perforated and bleeding ulcers
• Gut perforation – a hole develops in the wall of the intestines
• Feeling or being sick
• Inflammation of the oesophagus (oesophagitis) – the tube that leads from your throat to stomach, including ulcers of the oesophagus
• Indigestion
• Diarrhoea
• Bloated stomach
• Abdominal pain
• Thinning of skin, stretch marks
• Acne
• Increased hair on the body and face (hirsutism)
• Small purple/red patches/blisters on the skin
• Bruising
• Pale or darker patches on your skin or raised patches which are an unusual colour
• Increased sweating
• Rash, itching, hives, reddening of the skin
• Breakdown of bone due to poor circulation of blood, this causes pain in the hip
• Muscle wasting
• Bone fractures
• Joint pain
• Torn muscle tendons causing pain and/or swelling
• Muscle cramps or spasms
• Joint disease, pain or swelling
• Irregular or absent period (menstruation)
• Feeling tired or unwell
• The following will be determined through tests that your doctor will conduct: o Increase in the pressure in the eye o Abnormal liver functions o Increased levels of blood fats (cholesterol) o Carbohydrate tolerance decreased o Increased calcium in the urine, increase in the level of urea in the blood o Change normal reactions to skin tests, such as that for tuberculosis
• Tearing (rupturing) of tendons
• Fractures in the spine

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 hypersensitive (allergic) to methylprednisolone or any of the other ingredients of MEDROL (listed in section 6). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath
• if you have a certain type of fungal infection (systemic)
• if you have brain injury due to trauma
• if you have recently had or are about to have any vaccination Speak to your doctor or health care provider immediately if any of the above applies to you

Use with care, and tell your doctor, if

• if you have chickenpox, measles or shingles. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them
• if you have tuberculosis (TB) or have suffered tuberculosis in the past
• if you have Kaposi’s sarcoma (a type of skin cancer)
• if you have unusual stress
• if you have Cushing’s disease (condition caused by an excess of cortisol hormone in your body)
• if you have hypothyroidism (an under-active thyroid)
• if you have sugar diabetes (or if there is a family history of diabetes)
• if you have severe depression, manic depression (bipolar disorder) or psychoses. This includes having had depression previously while taking steroid medicines like MEDROL or having a family history of these illnesses
• if you have epilepsy, fits or seizures
• if you have myasthenia gravis (a condition causing tired and weak muscles)
• if you have glaucoma (increased pressure in the eye) or if there is a family history of glaucoma. You should have your eyes examined regularly
• if you have recently suffered a heart attack
• if you have heart problems, including heart failure
• if you have thrombosis (formation of blood clots inside a blood vessel)
• if you have hypertension (high blood pressure)
• if you have pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen and back)
• if you have peritonitis (inflammation of the thin lining (peritoneum) around the gut and stomach)
• if you have stomach ulcer or other serious stomach or intestinal problems (ulcerative colitis)
• if you have liver failure
• if you have muscle problems (pain or weakness) that have happened while taking steroid medicines in the past
• Scleroderma (also known as systemic sclerosis, an autoimmune disorder), because the risk of a serious complication called scleroderma renal crisis may be increased. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production
• if you have kidney disease
• if you have pheochromocytoma (a tumour of your adrenal gland)
• if you have head injury or stroke Tumour lysis syndrome (TLS) can occur after treatment of a fast-growing cancer, such as blood cancers or solid tumours. Symptoms of TLS include muscle cramping, muscle weakness, confusion, irregular heartbeat, visual loss or visual disturbances, and shortness of breath. Your health care provider will monitor you closely, especially if you are at high risk of developing tumour lysis syndrome. Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine. Mental problems while taking MEDROL Mental health problems can happen while taking steroids like MEDROL
• These illnesses can be serious
• Usually they start within a few days or weeks of starting MEDROL
• Most of these problems go away if the dose is lowered or MEDROL is stopped. However, if the problems persist treatment might be required. Talk to a doctor or health care provider if you show any signs of mental problems
• This is particularly important if you are depressed or might be thinking about suicide. In a few cases mental problems have happened when doses are being lowered or stopped. Children and adolescents Your doctor will monitor the growth of your child while on treatment with MEDROL. Tell your doctor if you notice that your child is disorientated, confused or experiencing headaches, as this may be a sign of raised pressure around their brain. Tell your doctor if your child complains of stomach pain, fever, nausea and vomiting, as this may indicate inflammation of the pancreas

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• Safety in pregnancy and lactation has not been proven
• Cataracts and low birth weight have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy
• Small amounts of corticosteroid medicines may get into your breast milk
• This may suppress growth and harm your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• Antibiotics (such as isoniazid, erythromycin, clarithromycin and troleandomycin)
• Antibiotics used to treat tuberculosis (TB) such as rifampicin
• Medicines used to ‘thin’ the blood (anticoagulants) such as warfarin
• Medicines used to treat epilepsy such as carbamazepine, phenytoin and phenobarbital (phenobarbitone)
• Medicines called neuromuscular blocking medicines which are used in some surgical procedures such as pancuronium and vecuronium
• Medicines used to help block involuntary muscle movement associated with disease called anticholinergics
• Medicines used to treat myasthenia gravis (a muscle condition) called anticholinesterases (such as distigmine or neostigmine)
• Medicines used to treat high blood sugar (antidiabetics)
• Medicines used to stop you being sick called antiemetics (such as aprepitant and fosaprepitant)
• Medicines used to treat fungal infections such as ketoconazole or itraconazole
• Medicines used to treat HIV infections called HIV-protease inhibitors (such as indinavir and ritonavir)
• Medicines used for treating cancer such as aminoglutethimide
• Medicines used for heart problems or high blood pressure such as diltiazem
• Oral contraceptives such as ethinyl estradiol and norethindrone
• Medicines used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant such as ciclosporin
• Medicines used following an organ transplant to prevent rejection of the organ such as tacrolimus
• Medicines used to treat mild to moderate pain such as aspirin and other non-steroidal anti-inflammatory drugs (also called NSAIDs)
• Medicines used to increase the excretion of urine called diuretics (sometimes called water tablets)
• Medicines used to treat asthma such as xanthines or beta2 agonists If you are being treated for sugar diabetes, high blood pressure, heart failure or other causes of water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions. Before you have any operation, tell your doctor or health care provider that you are taking MEDROL. If you require a test to be carried out by your doctor or in hospital, it is important that you tell the doctor or health care provider that you are taking MEDROL as this medicine can affect the results of some tests. MEDROL with food and drink Do not drink grapefruit juice while taking MEDROL

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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