Steroids Side Effects

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

What is steroids?

Corticosteroids covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• prednisone — PANAFCORT, Adcock Ingram Limited (TABLETS)
• prednisolone — Medrol, Pfizer Laboratories (Pty) Ltd (Tablets)
• methylprednisolone — DEPO-MEDROLTM, Pfizer Laboratories (Pty) Ltd (Suspension for injection)
• dexamethasone — DECASONE INJECTION, PHARMACARE LIMITED (INJECTION)
• hydrocortisone — MACLEODS HYDROCORTISONE INJECTION, MACLEODS PHARMACEUTICALS SA (PTY) LTD (INJECTION)
• betamethasone — BETANOID SYRUP, PHARMACARE LIMITED (Syrup)

Common side effects of steroids

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Prednisone (PANAFCORT)

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• These are all very serious side effects. If you have them, you may have had a serious reaction to PANAFCORT. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• a very sore throat, sudden onset of fever, low body temperature, shaking, chills, confusion or difficulty breathing. These may be signs that your body is fighting an infection, which may be serious and severe. You may also have difficulty in swallowing and the inside of your mouth may have white areas on the surface. Remember that your sensitivity to all kinds of infection may be increased and PANAFCORT may mask the signs and symptoms of infection
• coughing for a few weeks, coughing up blood or mucous, unintentional weight gain, tiredness, night sweats (tuberculosis)
• fits (convulsions). If you have epilepsy, you may notice you get fits (seizures) more often than usual or they are more severe
• you pass black tarry stools or notice fresh or clotted blood in your stools (faeces). You may also notice dark bits that look like coffee grounds in your vomit. These could be signs of a stomach ulcer with bleeding
• severe abdominal (stomach) pain, feeling cold (chills), fever, feeling sick (nausea) or being sick (vomiting). These could be signs of gastrointestinal perforation (also known as ruptured bowel) which is a hole in the wall of a part the gut
• severe upper stomach pain with nausea or vomiting. These may be signs of a problem with your pancreas (inflammation of the pancreas)
• ongoing pain in any joint, as this might be a sign of osteonecrosis (death of bone tissue). Initially, you may not have any symptoms due to osteonecrosis; however, as the condition worsens, affected joints might hurt only when putting weight on them. Eventually, you might feel the pain even when you’re lying down. The pain can be mild or severe
• sudden high blood pressure, kidney failure and decreased urine production, particularly if you have sclerosis (scleroderma renal crisis)

The leaflet lists 46 more. Read the full leaflet.

Prednisolone (Medrol)

• 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)
• 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

The leaflet lists 51 more. Read the full leaflet.

Methylprednisolone (DEPO-MEDROLTM)

• round or moon-shaped face (Cushingoid)
• fluid retention, which causes swelling that may be widespread, or confined to a limb or part of a limb
• sodium retention, which causes thirst due to dehydration
• low levels of potassium in the blood
• DEPO-MEDROL can cause serious mental health problems
• feeling depressed
• feeling high (mania)
• cataracts
• high blood pressure, symptoms of which are headaches, or generally feeling unwell
• ulcers, including perforated and bleeding ulcers
• thinning of skin
• acne

The leaflet lists 66 more. Read the full leaflet.

Dexamethasone (DECASONE INJECTION)

• stomach problems: having more of an appetite than usual
• moods that go up and down
• feeling high (mania)
• changing how you act (behavioural disturbances)
• having or showing a tendency to be easily annoyed (irritability)
• Infections: fungal and viral infections, tuberculosis
• impaired tissue repair and immune function can lead to delayed wound healing
• stomach problems: indigestion
• inflamed pancreas: this may cause severe pain in the back or stomach
• problems with salts in your blood such as too much sodium or low potassium or calcium. You may experience swelling of your limbs (water retention)
• heart and blood problems: high blood pressure
• bone problems: thinning of the bones (osteoporosis) with an increased risk of fractures, bone disease, damaged tendons

The leaflet lists 21 more. Read the full leaflet.

Hydrocortisone (MACLEODS HYDROCORTISONE INJECTION)

• Nausea (feeling sick)
• Abdominal cramps or stomach pains
• Headache
• Dizziness
• Tiredness
• Light-headedness
• Inability to sleep
• Nervousness
• Vomiting
• Increased appetite
• Indigestion – pain or discomfort in the stomach associated with difficulty in digesting food
• Purpura – A rash of purple spots due to small blood vessels leaking blood into the skin, joints, intestines or organs

The leaflet lists 28 more. Read the full leaflet.

Betamethasone (BETANOID SYRUP)

• feel depressed, feeling irritable, feeling anxious, having trouble sleeping or staying asleep
• having strange and frightening thoughts, changing how you act or having feelings of being alone. Side effects with an unknown frequency:
• Increased susceptibility and severity of infections, masking of infections, worsening of viral and fungal eye infections
• repeat of infections such as TB
• an increase in the number of white cells in the blood, especially during an infection with symptoms such as fever, bleeding, or bruising (leucocytosis)
• menstrual irregularities/ disturbances such as the absence of a menstrual period (amenorrhoea)
• salt and fluid retention with symptoms such as swelling, or inability of the small intestine to completely process the nutrient carbohydrate (a classification that includes sugars and starches) (decreased carbohydrate tolerance), high blood sugar levels (hyperglycaemia)
• high blood pressure with symptoms such as flushed face, headache, blurred vision, tiredness, confusion, and difficulty breathing (hypertension)
• swelling of the stomach (abdominal distention), hiccups, discomfort in the stomach, fungal infection (candidiasis)
• impaired wound healing, thinning of skin, increased bruising, spider veins (telangiectasia) stretch marks, acne
• muscle weakness (myopathy), thinning of bones (osteoporosis) bone fractures, tendon rupture
• excessive sweating (hyperhidrosis), a general sense of being unwell (malaise)

The leaflet lists 1 more. Read the full leaflet.

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

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

Cautions from each medicine’s approved leaflet.

Prednisone (PANAFCORT)

Do not use it at all if:

• if you are hypersensitive (allergic) to prednisone or any of the other ingredients of PANAFCORT (listed in section 6)
• if you have a stomach ulcer or an ulcer of the small intestines (gut)
• if you have osteoporosis (bones become less dense over time, weaker, more brittle and more likely to break)
• if you have mental health problems for example severe anxiety or nervousness, or if you suffer from psychosis (where you have lost some degree of contact with reality and / or is seeing). hearing, and /or believing things that aren’t real)
• if you currently have a fungal, bacterial, or viral infection or you get an infection while being treated with PANFACORT, unless advised by your doctor
• if you recently had a vaccination, like for example against smallpox

Use with care, and tell your doctor, if:

• if you need to be vaccinated, as certain vaccines should not be administered during certain treatments with PANAFCORT, you should wait 3 months after stopping treatment with PANAFCORT before being vaccinated
• if you have heart failure
• if you have diabetes or if you are diabetic and taking insulin to control your blood sugar levels
• if you have kidney disease (chronic renal failure or uraemia)
• if you are elderly
• if you are taking diuretics (water tablets), that can cause low potassium levels (diuretics can be used in the treatment of high blood pressure or heart failure)

Prednisolone (Medrol)

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)

Methylprednisolone (DEPO-MEDROLTM)

Do not use it at all if:

• if you are hypersensitive (allergic) to methylprednisolone acetate, or any of the other ingredients of DEPO-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 recently had, or are about to have any vaccination
• if you have suffered from tuberculosis in the past, stomach ulcer, severe mental disorder, Cushing’s syndrome (high cortisol hormone levels causing effects such as round or moon-shaped face), herpes eye infection, smallpox or chickenpox Speak to your doctor or health care provider immediately if any of the above applies to you. DEPO-MEDROL should not be injected directly into a vein (intravenous), the spinal cord (intrathecal) or spinal column (epidural route)

Use with care, and tell your doctor, if:

• if you have chickenpox, measles, shingles or herpes eye infection. 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 if you have suffered tuberculosis in the past
• 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)

Dexamethasone (DECASONE INJECTION)

Do not use it at all if:

• if you suffer from migraine headaches
• if you have any type of infection. DECASONE INJECTION 4 mg/ml may mask the symptoms of an infection. Consult your doctor as soon as possible
• if you suffer from stunted growth
• if you have Cushing’s Syndrome
• if you are elderly
• if you are planning to receive any vaccinations

Use with care, and tell your doctor, if:

• if you receive large doses of DECASONE INJECTION 4 mg/ml for a long period
• if you have thinning of the bones (osteoporosis), particularly if you are a female who has been through menopause
• if you have high blood pressure or heart disease
• if you have diabetes (high blood sugar) or there is a family history of diabetes
• if you have a history of tuberculosis (TB)
• if you have ever experienced muscle weakness during treatment with steroid medicines such as DECASONE INJECTION 4 mg/ml

Hydrocortisone (MACLEODS HYDROCORTISONE INJECTION)

Do not use it at all if:

• If you had an allergic reaction such as skin rash, swelling, or wheezing, or breathing problems after being given MACLEODS HYDROCORTISONE INJECTION, or another corticosteroid, tell your doctor or health care professional
• It is important to tell your doctor if you are pregnant and your doctor will give the appropriate medicine
• It is important to tell your doctor if you are breastfeeding and your doctor will give the appropriate medicine. High doses may cause your baby’s adrenal glands not to work properly
• MACLEODS HYDROCORTISONE INJECTION suppresses growth in infants, children and adolescents and therefore treatment will be limited to the lowest possible dose for the shortest possible time. You should not be administered MACLEODS HYDROCORTISONE INJECTION: It is important that you tell your doctor or healthcare professional if you suffer from any of the conditions mentioned below, if you are receiving MACLEODS HYDROCORTISONE INJECTION or have been prescribed MACLEODS HYDROCORTISONE INJECTION:
• If you had an allergic reaction such as skin rash, swelling, or wheezing, or breathing problems after being given MACLEODS HYDROCORTISONE INJECTION, or another corticosteroid, tell your doctor or health care professional
• Any infection that is not being treated with antibiotics or antivirals or if you had a widespread (systemic) fungal infection

Use with care, and tell your doctor, if:

• Gut problems, such as ulcers in your stomach, diverticulitis (inflamed pockets in the bowel wall causing left-sided abdominal pain, constipation or diarrhoea
• Kidney problems
• High blood pressure
• Diabetes mellitus
• Osteoporosis (brittle bones)
• If you have chicken pox, measles, shingles or a herpes eye infection. 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

Betamethasone (BETANOID SYRUP)

Use with care, and tell your doctor, if:

• If you have recently had a heart attack
• if you have an underactive thyroid gland (hypothyroidism)
• if you have myasthenia gravis (a disease which causes muscle weakness)
• If you have, or suspect that you may have, an infection or any infective diseases
• If you have recently been in contact with someone who has chickenpox, shingles, or measles, or recently had, or have chickenpox, shingles, or measles, yourself. You should consult your doctor if you suspect any of these
• If you have been taking this medicine or any other corticosteroids repeatedly for a long period of time

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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