Atorvastatin Side Effects

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

Part of cardiovascular side effects.

What is atorvastatin?

Atorvastatin contains the active ingredient Atorvastatin.

• Active ingredient — Atorvastatin
• Registration number — 45/7.5/0447; 45/7.5/0448
• Registration holder — LHC Pharmaceuticals (Pty) Ltd

It is approved for:

• What you need to know before you take Atorvastatin LHC tablets 3
• How to take Atorvastatin LHC tablets 4
• Possible side effects 5
• How to store Atorvastatin LHC tablets 6

Common side effects of atorvastatin

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

• Nausea
• Abdominal pain
• Constipation
• Wind
• Indigestion
• Diarrhoea
• Headache
• Muscle pain
• Weakness
• Insomnia
• Dizziness
• Numbness or tingling in the fingers and toes
• Reductions in sensation to pain or touch
• Joint pain
• Back pain
• Depression
• Allergic reactions
• Abnormal liver function test
• Increase in blood creatine kinase (enzyme in skeletal muscles)

Less frequent side effects

• Loss of appetite
• Visual disturbance
• Hearing loss
• Sleep disturbances including nightmares
• Ringing in the ears and/or head
• Change in the sense of taste
• Hyperglycaemia (high blood sugar)
• Hypoglycaemia (low blood sugar)
• Weight gain
• Numbness or tingling in the fingers and toes
• Loss of memory
• Vomiting
• Belching
• Pancreatitis (inflammation of the pancreas leading to stomach pain)
• Hepatitis (liver inflammation)
• Liver failure
• Alopecia (hair loss)
• Urticaria (skin rash and itching)
• Bullous rashes
• Muscle cramps
• Neck pain
• Muscle fatigue
• Muscle rupture
• Tendinopathy (tendon condition that causes pain and swelling), sometimes complicated by rupture
• Sexual difficulties
• Gynaecomastia (breast enlargement in men and women)
• Malaise (feeling tired or weak)
• Peripheral oedema (swelling, especially in the ankles)
• Pyrexia (fever)
• Tendon rapture
• Blurred vision
• urine tests that are positive for white blood cells Unknown frequency side effects:
• Myasthenia gravis (a disease with general muscle weakness including in some cases muscles used when breathing)
• Ocular myasthenia (a disease-causing eye muscle weakness)

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 atorvastatin or any of the ingredients of Atorvastatin LHC tablets (listed in section 6)
• If you suffer from active liver disease such as liver cirrhosis
• If you have any unexplained persistent elevation of serum trasaminases (enzymes that catalyses transfer of amino group) or any abnormal blood tests for liver function
• If you are on treatment with rifampicin or diltiazem
• With grapefruit juice
• If you are pregnant or breastfeeding your baby
• if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C

Use with care, and tell your doctor, if

• If you have active liver disease or elevated liver enzymes during treatment with Atorvastatin LHC tablets, your doctor should immediately discontinue your treatment with Atorvastatin LHC tablets. Therefore, it is recommended to perform liver function test before treatment is initiated and continued to be performed periodically thereafter
• If you experience repeated or unexplained muscle tenderness, weakness, aches or pains particularly if accompanied by general feeling of being unwell and fever, you should report these warning signs immediately to your healthcare professional as you may have had rhabdomyolysis (breaking down of skeletal muscle cells). Your doctor will need to carry out a blood test to check for levels of creatinine phosphokinase (CPK), if the levels are too high treatment should be discontinued
• If you are taking a medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and Atorvastatin LHC tablets can lead to serious muscle problems
• If you have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease-causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia
• Tell your doctor if you have ever had any type of stroke; your doctor will need to consider this in deciding the best treatment and dose for you

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
• Atorvastatin LHC tablets should not be used in pregnancy, breastfeeding mothers and in women of childbearing potential not using adequate contraceptive measures as there is a possibility that it could interfere with foetal sterol synthesis
• There have been a number of reports of congenital abnormalities associated with the use of Atorvastatin LHC tablets
• An interval of one month should be allowed from stopping Atorvastatin LHC treatment to conception in the event of planning a pregnancy

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines used to alter the way your immune system works, e.g. ciclosporin
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, ketoconazole, itraconazole and rifampicin
• Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol and ezetimibe
• Some calcium channel blockers used for angina or high blood pressure, e.g. diltiazem, medicines that regulate your heart rhythm, e.g. digoxin, amiodarone
• Protease inhibitors used in the treatment of HIV
• Other medicines known to interact with Atorvastatin LHC include warfarin (which reduces blood clotting), oral contraceptives, phenytoin (an anti-convulsant for epilepsy), antacids (indigestion products containing aluminium or magnesium) and colchicine (used to treat gout)
• Some medicines used in the treatment of hepatitis C (e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir) Atorvastatin LHC tablets with food and drink and alcohol: Grapefruit juice Patients are advised not to drink grapefruit juice when they are on treatment with Atorvastatin LHC tablets as it may increase blood levels of Atorvastatin LHC. Alcohol Avoid excessive consumption of alcohol while taking Atorvastatin LHC tablets

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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