Amlodipine Side Effects

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

Part of cardiovascular side effects.

What is amlodipine?

Amlodipine contains the active ingredient Amlodipine.

• Active ingredient — Amlodipine
• Registration number — 41/7.1/0812; 41/7.1/0813
• Registration holder — Gulf Drug Company (Pty) Ltd

It is approved for:

• AMLODIPINE GDC contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists
• AMLODIPINE GDC is used to treat high blood pressure (hypertension) and a type of chest pain called angina pectoris, a rare form of which is Prinzmetal’s or variant angina
• AMLODIPINE GDC is also used to reduce the risk of fatal and non-fatal heart disease or stroke
• AMLODIPINE GDC can be used alone or in combination with other medicines to treat these conditions

Common side effects of amlodipine

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

• dizziness, headache, sleepiness
• a sudden turning red or darker colour in the face, neck, and upper chest (flushing)
• swelling commonly affecting the extremities (arms and legs)
• stomach pain, nausea (feeling sick), discomfort or pain in the upper abdomen, often after eating or drinking (indigestion/dyspepsia), change in bowel habits (including diarrhoea and constipation)
• ankle swelling
• swelling in any part of the body
• tiredness
• physical weakness or a lack of energy

Less frequent side effects

• sleeplessness, mood changes (including anxiety)
• persistent feeling of sadness and changes in how you think, sleep, eat and act (depression)
• trembling, distorted sense of taste, decrease in normal sensations or feeling of pins and needles and tingling, weakness, numbness and pain
• visual disturbances including double vision
• ringing or other noises in one or both of your ears (tinnitus)
• cough, shortness of breath, runny nose, sneezing, and stuffiness (rhinitis)
• vomiting, dry mouth, swelling of the gums
• increase in liver enzymes
• hair loss, skin discoloration
• excessive sweating
• itching and rash (red or pink spots, bumps, or blotches on the skin)
• raised red, itchy skin rash that can sting or burn (hives/urticaria)
• increased sensitivity of skin to sun (photosensitivity)
• back pain, muscle cramps and pain, joint stiffness, physical weakness
• frequent urination especially during the night
• enlargement of male breasts
• weight increase/decrease. Side effects occurring with frequency unknown
• If you have a condition where the adrenal glands produce too much of the hormone aldosterone (hyperaldosteronism), laboratory tests may incorrectly diagnose this condition as high blood pressure where the underlying cause is unknown (essential hypertension)

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 sensitive (allergic) or ever had a harmful reaction to amlodipine, dihydropyridine (used to lower blood pressure), or any of the other ingredients of AMLODIPINE GDC
• if you suffer from severe hypotension (severe low blood pressure, symptoms include light headedness or dizziness)
• if you have previously experienced shock which could include cardiogenic shock (this is the term used when blood pressure becomes so low that your heart stops working properly and medical treatment is required)
• if you recently (within the past 28 days) suffered a heart attack
• if the blood flow from the left side of your heart is obstructed (e.g. aortic valve narrowing)
• if you have unstable angina (chest pain which may occur when you are resting)
• in combination with grapefruit juice
• if you are pregnant or breastfeeding your baby
• if you are younger than 6 years of age

Use with care, and tell your doctor, if

• If you have heart failure
• If you have severe increase in blood pressure (hypertensive crisis)
• If you suffer from aortic stenosis (a heart condition where the aortic valve, located between the heart’s left ventricle and the aorta, narrows or thickens, restricting blood flow) with symptoms such as fatigue, feeling faint or fainting when exercising and shortness of breath
• If you are taking anti-fungal medicine or certain HIV medicines as these may increase the blood pressure lowering effects of AMLODIPINE GDC
• If you suffer from diabetes
• If you need to undergo blood tests, as the use of AMLODIPINE GDC may interfere with the results
• If you are an elderly patient
• If you suffer from severe kidney problems
• If you suffer from liver problems
• If you have low blood pressure or other heart conditions
• If you suffer from porphyria
• If you are about to have a procedure where you would need general anaesthesia, you must tell the doctor that you are taking AMLODIPINE GDC. Children and adolescents AMLODIPINE GDC has not been studied in children under the age of 6 years. AMLODIPINE GDC should only be used for hypertension in children and adolescents from 6 years to 17 years of age

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 healthcare professional for advice before taking this medicine
• If you are pregnant, or become pregnant whilst taking AMLODIPINE GDC, stop taking AMLODIPINE GDC and talk to your doctor as soon as possible
• You should not take AMLODIPINE GDC when breastfeeding your baby
• If you are a female of childbearing potential, you should ensure that you and your partner take adequate contraceptive cover to avoid pregnancy

Interactions and medicines to check

The approved leaflet names these interactions.

• Other medicines for hypertension (high blood pressure). AMLODIPINE GDC may lower your blood pressure even more if you are already taking other hypertension medicines which can lead to dizziness, blurred vision and fainting
• Medicines used to treat diabetes, as the doses of these medicines may need to be adjusted
• Lithium (used to treat mania (mental state characterised by an unusually elevated, unrestrained, excessive emotionally expressive or irritable mood, as well as increased energy, activity, and productivity) that is part of bipolar disorder (manic-depressive illness), as you may develop toxic blood concentrations of lithium if used in combination with AMLODIPINE GDC
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to change the way your immune system works). AMLODIPINE GDC may increase the levels of these medicines in your blood. You doctor may monitor the blood levels of these medicines and change their dose if required
• Ciclosporin (an immunosuppressive medicine used to treat organ rejection post-transplant). If you have had a renal transplant your doctor will monitor your ciclosporin levels and may reduce your dose if necessary
• Simvastatin (used to lower cholesterol), as simultaneous use of AMLODIPINE GDC may result in increased levels of simvastatin in the blood. Your doctor may reduce your simvastatin dose
• Quinidine or procainamide (used to treat and prevent abnormal heart rhythms, or dysrhythmias). AMLODIPINE GDC may increase the activities these medicines, potentially leading to or worsening of irregular heartbeats. Some medicines can interact with AMLODIPINE GDC to make its effect and risk of adverse effects stronger. If you are taking the medicines below, your doctor might monitor you more closely:
• Medicines used to treat viral, fungal and bacterial infections (such as clarithromycin, erythromycin, ketoconazole, itraconazole or rifampicin), as these may lead to increased levels of the active ingredient amlodipine in the blood. Your doctor may want to monitor you more closely and adjust your dose of AMLODIPINE GDC if required
• Protease inhibitors used to treat HIV (such as ritonavir, saquinavir, indinavir, nelfinavir, amprenavir, lopinavir and atazanavir). This may cause increased levels of the active ingredient amlodipine in your blood. Your doctor may want to monitor you more closely and adjust your dose of AMLODIPINE GDC if required
• Grapefruit or grapefruit juice must not be taken AMLODIPINE GDC as the levels of the active ingredient amlodipine in the blood may be increased resulting in increased blood pressure lowering effects
• Dantrolene (a muscle relaxant and sometimes used as infusion for severe body temperature abnormalities) may affect potassium levels in the blood when taken with AMLODIPINE GDC
• Medicines for angina (chest pains), such as nitro-glycerine tablets administered under the tongue, long acting nitrates or other medicines for hypertension (high blood pressure) such as beta-blockers or calcium channel blockers (such as verapamil, diltiazem), as this may increase the blood pressure lowering effects of AMLODIPINE GDC
• Aldesleukin used in the treatment of kidney cancer and skin melanoma or medicines used to treat mental conditions (antipsychotics), as this may cause a strengthening of the blood pressure lowering effects
• Sodium valproate (used for epilepsy), as this may increase blood levels of the active ingredient amlodipine with an increase the blood pressure lowering effects of AMLODIPINE GDC (Discuss with your doctor if you are unsure). Some medicines can interact with AMLODIPINE GDC to make its effect weaker. You should avoid taking AMLODIPINE GDC together these medicines:
• St John’s Wort (an herbal medicine used to treat anxiety), as this may lead to decreased levels of the active ingredient amlodipine in the blood and lead to a reduced blood pressure lowering effect of AMLODIPINE GDC
• Certain medicines used to treat fits (carbamazepine, phenobarbital, phenytoin), as these may reduce the effect of AMLODIPINE GDC. AMLODIPINE GDC with food and drink AMLODIPINE GDC can be taken with or without food. Grapefruit and grapefruit juice must not be taken with AMLODIPINE GDC

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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