Azithromycin Side Effects

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

What is azithromycin?

Azithromycin contains the active ingredient Azithromycin.

• Active ingredient — Azithromycin
• Registration number — 45/20.1.1/1076
• Registration holder — Unicorn Pharmaceuticals (Pty) Ltd

It is approved for:

• AZITHROMYCIN UNICORN 500 is an antibiotic that belongs to a group of antibiotics called macrolides
• It is used to treat infections caused by bacteria and other microorganisms
• AZITHROMYCIN UNICORN 500 is used to treat lower respiratory tract infection including bronchitis, S4 pneumonia (infection in the lungs), skin infections and infections in the genital area in adults
• In children, AZITHROMYCIN UNICORN 500 is prescribed in the treatment of ear and tonsil infections

Common side effects of azithromycin

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.

Reported side effects

• Hives; difficulty in swallowing or breathing; swelling of your hands, feet, ankles, face, lips, tongue, or throat, hoarseness
• Rash or itching
• Fainting
• These are all very serious side effects. If you have them, you may have had a serious allergic reaction to AZITHROMYCIN UNICORN 500. 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: Less frequently occurring side effects:
• Fast or irregular heartbeats (palpitations). Side effects occurring with frequency unknown:
• Convulsions (fits/seizures)
• Changes of the heart rhythm seen on an electrocardiogram (QT prolongation and torsade de pointes)
• These are all serious side effects. You may need urgent medical attention. Tell your doctor as soon as possible if you notice any of the following: Frequently occurring side effects:
• Lack of appetite (anorexia)
• Dizziness, headache, sensation of pins and needles or numbness (paraesthesia), changes in your sense of taste
• Visual impairment
• Deafness
• Diarrhoea (loose stools), stomach pain, feeling sick (nausea), wind, being sick (vomiting), indigestion, constipation
• Joint pain (arthralgia)
• Unusual tiredness
• Change in the quantity of white blood cells and the concentration of bicarbonate in the blood. Less frequently occurring side effects:
• Reduction in the number of white blood cells
• Thrush (candidiasis), oral thrush, vaginal infection, pneumonia, fungal infection, bacterial infection, inflammation of the throat (pharyngitis), stomach flu (gastroenteritis), breathlessness, chest pain, wheezing and cough (respiratory disorder), inflammation of the mucous membrane inside the nose (rhinitis)
• Build-up of fluid in tissues that line the lungs and the chest
• Nervousness, feeling agitated or restless
• Reduced sense of touch (hypaesthesia)
• Hearing loss or ringing in your ears, ear disorder, ‘spinning’ sensation (vertigo)
• Hot flushes
• Nosebleed (epistaxis)
• Inflammation of the stomach lining (gastritis), difficulty swallowing, swollen abdomen, dry mouth, belching, mouth ulcer, increased salivary flow
• Inflammation of the liver (hepatitis) causing yellowing of the skin or eyes or tiredness
• Stevens-Johnson syndrome (more severe form of erythema multiforme), sensitivity to sunlight, itchy skin rash, pale or red irregular raised patches with severe itching (urticaria), inflammation of the skin (dermatitis), dry skin, excessive sweating
• Swelling and reduced motion in your joints (osteoarthritis), muscle pain, back pain, neck pain
• Painful urination, pain in your kidneys
• Spotting, testicular disorder
• Face swelling, chest pain, fever, nerve pain, swelling (oedema), general feeling of being unwell, weakness
• Change in liver enzyme levels and blood levels, post procedural complications. Side effects occurring with frequency unknown:
• Reduction of red blood cells due to destruction (haemolytic anaemia), reduction in number of platelets (thrombocytopenia)
• Dark tarry stool with or without visible blood
• Aggression, anxiety, sleepiness (somnolence), sleeplessness (insomnia), confusion, hallucinations
• Difficulty chewing or swallowing and slurred speech (myasthenia gravis), fainting (syncope), muscle spasms, changes in smell and taste
• Low blood pressure (hypotension)
• Inflammation of the lining of the large intestine (pseudomembranous colitis, you might get diarrhoea, stomach cramps, fever, blood in the stools), taste disturbances, inflammation of the pancreas causing pain and tenderness in the abdomen and back, discolouration of the tongue
• Liver not functioning normally, cholestatic jaundice (a complication of cholestasis, in which bile is unable to flow through the liver normally)
• Toxic epidermal necrolysis (red painful rash that looks like a scald and may cause peeling of the skin), erythema multiforme (raised red patches on the skin which may blister)

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 azithromycin, erythromycin, any of the macrolide or ketolide antibiotics or any other ingredient of AZITHROMYCIN UNICORN 500
• If you are taking medication containing ergotamine (usually in migraine medication)
• If you suffer from any liver disease
• If you are pregnant, trying to become pregnant or breastfeeding your baby

Use with care, and tell your doctor, if

• If you develop a severe allergic reaction (hives, difficulty breathing, swelling of your face, lips, tongue, or throat) to AZITHROMYCIN UNICORN 500, this reaction can reoccur even after you have stopped the treatment
• If you have syphilis
• have known or suspected bacteremia (bacterial infection in the blood)
• If your liver is not functioning normally (which is characterised by yellowing of the skin and eyes, dark urine, bleeding easily) contact your doctor immediately and stop taking AZITHROMYCIN UNICORN 500
• If you have any heart disorders (QT prolongation, currently receiving any medicines to treat an irregular heartbeat)
• If you have any electrolyte disturbance (low levels of potassium or magnesium in your blood)
• If you have a slow, irregular heartbeat (bradycardia) or severe heart failure in which your heart is unable to pump enough blood throughout your body
• If you have any signs or symptoms of secondary infection (including a fungal infection)
• If you develop diarrhoea during the treatment with AZITHROMYCIN UNICORN 500, please inform your doctor immediately
• If you suffer from myasthenia gravis (muscle weakness)
• If you have a kidney disorder. Children and adolescents AZITHROMYCIN UNICORN 500 should not be given to children under 1 year of age or weighing less than 45 kg

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking AZITHROMYCIN UNICORN 500
• It is not yet known if AZITHROMYCIN UNICORN 500 is safe for your baby or unborn child
• The safety and efficacy of AZITHROMYCIN UNICORN 500 in breastfeeding has not been established
• The effect of AZITHROMYCIN UNICORN 500 on fertility is not yet available

Interactions and medicines to check

The approved leaflet names these interactions.

• Nelfinavir (treats HIV)
• Hay fever tablets (non-sedating)
• Phenytoin (for seizures)
• Cimetidine (used for ulcers of the stomach and intestines)
• Ciclosporin (immunosuppressant medication)
• Digoxin (heart medication)
• Aluminium or magnesium containing antacids (used for heartburn)
• Migraine medication containing ergotamine
• Blood thinning tablets (e.g. warfarin)
• Oral contraceptive tablets (used to prevent unwanted pregnancies). AZITHROMYCIN UNICORN 500 with food and drink AZITHROMYCIN UNICORN 500 can be taken, orally with or without food

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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