Statins Side Effects

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

Part of cardiovascular side effects.

What is statins?

Statins 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:

• atorvastatin — LIPOGEN, Ranbaxy Pharmaceuticals (Pty) LTD (Film coated tablets)
• simvastatin — UNISIM, Unimed Healthcare (Pty) Ltd (Film-coated tablets.)
• rosuvastatin — COLEROS, iPharma (Pty) Ltd (Film-coated tablets)
• pravastatin — ASPEN PRAVASTATIN, PHARMACARE LIMITED (Tablets)

Common side effects of statins

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.

Atorvastatin (LIPOGEN)

• diarrhoea (loose stools), constipation, nausea (feeling sick), indigestion, winds
• headache
• muscle cramps, muscle and joint pains, back pain
• high sugar (glucose) levels in the blood with symptoms such as passing large amounts of urine, excessive thirst and having a dry mouth and skin
• swelling of hands, ankles or feet
• inflammation of muscles, muscle cramps/spasms
• sore throat, sinusitis, throat pain
• muscle tiredness
• nose bleed
• difficulty in sleeping
• vomiting (being sick), loss of appetite, abdominal pain
• weakness

The leaflet lists 32 more. Read the full leaflet.

Simvastatin (UNISIM)

• feeling sick (nausea), being sick (vomiting), wind, indigestion, stomach pain
• myalgia (soreness and achiness in the muscles that can range from mild to severe)
• muscle cramps
• tiredness, headaches, being short of breath when exercising, dizziness and looking pale (low number of red blood cells), frequent infections such as fever, severe chills, sore throat or mouth (low number of white blood cells)
• diabetes
• trouble sleeping
• headache, dizziness, tiredness, pins and needles (paraesthesia)
• poor memory, memory loss, confusion
• photosensitivity, blurred vision, impaired vision
• shortness of breath, hypersensitivity pneumonitis (inflamed lungs)
• constipation, diarrhoea
• skin rash, itching, loss of hair (alopecia), urticaria (hives)

The leaflet lists 17 more. Read the full leaflet.

Rosuvastatin (COLEROS)

• increased glucose levels, diabetes
• headache, dizziness
• constipation, nausea, stomach pain
• muscle pain
• feeling weak or a lack of energy
• abnormal bleeding or bruising
• memory loss
• numbness, tingling, loss of sensation in the arms and legs, burning feeling in the hands or feet (polyneuropathy)
• rash, itching or other skin reactions
• oedema (swelling under the skin)
• cough, shortness of breath¸ difficulty breathing
• lupus-like disease syndrome (including rash, joint disorders and effects on blood cells)

The leaflet lists 11 more. Read the full leaflet.

Pravastatin (ASPEN PRAVASTATIN)

• Headache, dizziness, abnormal sensation of the skin (paraesthesia)
• skin rash, hair loss (alopecia)
• muscle pains, muscle cramps
• fatigue
• Constipation, diarrhoea, nausea, vomiting, flatulence, indigestion (dyspepsia), abdominal pain, cramps
• abnormal urination (including dysuria, frequency, nocturia)
• sexual impotence in men. Side effects with an unknown frequency:
• High blood sugar (hyperglycaemia)
• weight gain
• trouble sleeping
• inflammation of blood vessels (vasculitis)

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.

Atorvastatin (LIPOGEN)

Do not use it at all if:

• you have previously had an allergic reaction to atorvastatin or to any of the tablet ingredients of LIPOGEN listed in section 6 (an allergic reaction may include rash, itching, swelling of face, lips, or hands/feet or breathing difficulties)
• you have a liver disease (symptoms may indicate fatigue, loss of appetite, right upper abdominal discomfort, dark urine, or jaundice – yellow discolouration of the skin)
• you have any unexplained abnormal blood test results for liver function
• you are pregnant, or planning to become pregnant
• you are breastfeeding
• you are taking rifampicin (used to treat tuberculosis), diltiazem (used to treat chest pain or high blood pressure) and grapefruit juice at the same time. Do not take LIPOGEN if any of the above applies to you. If you are not sure, please talk to your doctor or pharmacist before taking LIPOGEN

Use with care, and tell your doctor, if:

• you have kidney problems or a history of kidney problems
• you have or have had repeated or unexplained muscle pains or cramps, muscle tenderness, weakness particularly if accompanied by fever
• you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. simvastatin, fenofibrate classes of medicines)
• you consume substantial quantities of alcohol and/or have a history of liver disease. Your doctor may perform some blood tests called liver function tests
• you are an elderly patient
• you have severe acute infection, low blood pressure, major surgery, trauma, diseases of metabolism (e.g. diabetes) or hormonal diseases or electrolytes disorders (abnormalities in the blood levels of sodium, potassium), or uncontrolled seizures (fits)

Simvastatin (UNISIM)

Do not use it at all if:

• if you are hypersensitive (allergic) to simvastatin or other statin or any of the other ingredients of UNISIM
• if you currently have liver problems
• if you have unexplained persistent elevation of serum transaminase (liver enzymes)
• if you are pregnant or breastfeeding
• if you are taking one or more of the following medicines at the same time:
• itraconazole, voriconazole, ketoconazole, or posaconazole (medicines for fungal infections)

Use with care, and tell your doctor, if:

• Tell your doctor if you drink large amounts of alcohol
• Tell your doctor if you have ever had liver disease. UNISIM may not be right for you
• Tell your doctor if you develop kidney failure resulting from muscle breakdown (rhabdomyolysis). Other factors which can lead to kidney failure include severe infection, low blood pressure, severe problems with your metabolism (a process by which your body uses to get or make energy from the food you eat), problems with your hormonal system, imbalance of electrolyte (such as potassium, sodium), uncontrolled fits, operation or injury
• Tell your doctor if you are due to have an operation
• You may need to stop taking UNISIM for a short time
• Your doctor should do a blood test before you start taking UNISIM

Rosuvastatin (COLEROS)

Do not use it at all if:

• if you are hypersensitive (allergic) to rosuvastatin or any of the other ingredients of COLEROS (as listed in section 6)
• if you currently have a liver disease
• if you have severe kidney problems
• if you have been diagnosed with myopathy (a muscle disease)
• if you take a medicine called ciclosporin (used, for example, after organ transplants)
• if you are pregnant or breastfeeding or if you are a woman of childbearing potential not using appropriate contraceptive measures. In addition, do not take COLEROS 40 (the highest dose) if you are at risk of muscle disorders. The following conditions may increase the risk of muscle disorders:

Use with care, and tell your doctor, if:

• if you have problems with your kidneys
• if you have unexplained muscle aches and pains, muscle weakness, cramps and especially if you feel unwell or have a fever, tell your doctor immediately
• if your thyroid gland is not working properly (hypothyroidism)
• if you have a personal or family history of hereditary muscular disorders
• if you have a previous history of muscle problems when using cholesterol lowering medicines
• if you regularly consume large amounts of alcohol

Pravastatin (ASPEN PRAVASTATIN)

Do not use it at all if:

• If you are hypersensitive (allergic) to pravastatin sodium or any of the other ingredients of ASPEN PRAVASTATIN (listed in section 6)
• if you have acute or chronic liver disease
• if you are pregnant or breastfeeding your baby
• if you have a history of unexplained persistent increased blood levels of liver enzymes, called serum transaminases
• If you have porphyria

Use with care, and tell your doctor, if:

• If you have a rare condition marked by increased levels of high density lipoprotein cholesterol (HDL-C)
• if you regularly drink large amounts of alcohol
• if you have liver disease
• if you have any diseases of skeletal muscles or muscle tissue, or if you have muscle pain, tenderness or weakness of your muscles. Please consult your doctor. He/she will decide whether you should keep taking your tablets or not
• if you have kidney problems
• if you are taking ciclosporin (an immunosuppressant drug) at the same time as ASPEN PRAVASTATIN, your doctor will advise you to stop taking ASPEN PRAVASTATIN

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.

Related pages

• Aspavor side effects

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