Antibiotics Side Effects

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

What is antibiotics?

Antibiotics 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:

• amoxicillin — Mymox 250 / 500, Unichem SA (Pty) Ltd (Capsules, hard.)
• azithromycin — MYZAT, AUROGEN SOUTH AFRICA (PTY) LTD (Powder for oral suspension)
• ciprofloxacin — CIPRO UNIMED, Unimed Healthcare (Pty) Ltd (Film-coated tablets)
• doxycycline — DOXYCYCLINE BIOTECH 100, Biotech Laboratories (Pty) Ltd. (Film-coated tablets.)
• cefalexin — Ranceph Suspension, Ranbaxy Pharmaceuticals (Pty) Ltd (Suspension)
• cephalexin — CERLAZ Oral Suspension 125 mg/5 ml & 250 mg/5ml, Aurogen South Africa (Pty) Ltd (Powder for Oral Suspension)
• metronidazole — Bemetrazole 200. Bemetrazole 400, Ranbaxy Pharmaceutical (Pty) Ltd (Tablets)
• flucloxacillin — MACROPEN, Viatris South Africa (Pty) Ltd (Capsules and Macropen powder for suspension)
• erythromycin — PURMYCIN-125 SUSPENSION, PURMYCIN-250 SUSPENSION, PHARMACARE LIMITED (Suspension)
• trimethoprim — ILVITRIM SUSPENSION, Shanur Healthcare (Pty) Ltd (A white opaque viscous suspension.)

Common side effects of antibiotics

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.

Amoxicillin (Mymox 250 / 500)

• Inflammation of the vagina, causing itching, burning, pain and discharge
• Abnormal taste, headache, dizziness
• Hot flushes
• Feeling tired
• Diarrhoea, nausea (feeling sick), vomiting (being sick), indigestion, stomach pain, black ‘hairy’ tongue
• Gastritis (pain, nausea, vomiting, vomiting blood, blood in the stool), inflammation of the mouth or tongue
• Anaemia (fatigue, loss of energy, pale skin, cramps in your legs, difficulty with concentration)
• Low number of cells involved with blood clotting; blood may take longer to clot than it normally would
• Convulsions (fits)
• Hyperactivity. Side effects with an unknown frequency:
• Thrush (a yeast infection of the vagina, mouth or skin folds)

Azithromycin (MYZAT)

• headache
• Diarrhoea, vomiting, abdominal pain, nausea
• Lymphocyte count decreased, Eosinophil count increased, Blood bicarbonate decreased, Basophils increased, Monocytes increased, Neutrophils increased (which are detectable through laboratory tests)
• yeast infections of the mouth and vagina (thrush)
• Hypersensitivity and anaphylactic reaction (a severe, potentially life-threatening allergic reaction)
• Anorexia (An eating disorder causing people to obsess about weight and what they eat)
• Nervousness, Insomnia, Agitation
• Aggression, Anxiety
• Delirium (serious disturbance in mental abilities that results in confused thinking and reduced awareness of surroundings), Hallucination
• Dizziness, Somnolence (Strong desire for sleep and feeling of drowsiness
• Dysgeusia (an altered or impaired sense of taste)
• Paraesthesia (tingling or prickling, “pins-and-needles” sensation)

The leaflet lists 30 more. Read the full leaflet.

Ciprofloxacin (CIPRO UNIMED)

• nausea
• diarrhoea (running stomach)
• vomiting (throwing up)
• dyspepsia (indigestion)
• stomach pain
• flatulence (wind)
• changes to the blood count (haemolytic anaemia, leukopenia, leukocytosis, neutropenia, anaemia), a drop in a type of white blood cells (agranulocytosis), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone-marrow depression which may also be fatal
• allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) and allergic reaction called serum sickness-like reaction
• general feeling of weakness and myalgia (muscle pain in back, chest, body), muscle cramps, inflammation of the tendons
• decreased appetite, increased blood sugar (hyperglycaemia) which can cause you feeling thirsty and passing water more often than usual or decreased blood sugar (hypoglycaemia) which can cause you feeling weak or irritable, sweating and/or trembling
• hyperactivity, feeling of being agitated, confusion, anxiety, abnormal dreams, depression (feeling of sadness or thinking of suicide), psychotic reactions, feeling of happiness and sadness
• headache, dizziness, sleep disorders, taste disorders

The leaflet lists 26 more. Read the full leaflet.

Doxycycline (DOXYCYCLINE BIOTECH 100)

• headache
• feeling or being sick
• eat disorder
• reddish-purple spots on the lower extremities, swollen and sore joints, abdominal pain or bloody urine
• hives
• swelling of the legs and arms
• vaginal infection, vaginitis
• thrush of the vagina or mouth
• blood disorders, these are due to changes in numbers of different cell types in the blood. Symptoms may include tiredness, easy bruising or infections
• discolouration of thyroid tissue (does not affect thyroid function)
• inherited blood disorder (porphyria) and urine discolouration is a symptom
• eating disorder (loss of appetite)

The leaflet lists 21 more. Read the full leaflet.

Cefalexin (Ranceph Suspension)

• changes to blood counts which may show up as bruising or a very tired feeling. You will need a blood test to confirm this
• headache
• feeling sick (nausea), being sick (vomiting), diarrhoea
• dizziness, drowsiness and tiredness (fatigue)
• damage to your kidneys or liver which can be detected by a blood and/or urine test
• loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine. (These may be manifestation of inflammation of the liver caused by RANCEPH SUSPENSION.)
• fits, seizures and confusion particularly in patients with damaged kidney
• vaginal itching or irritation (thrush)
• stomach cramps or spasms
• Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome) There may be changes in the results of certain laboratory tests:
• abnormal liver function tests. Increase in levels of liver enzymes
• positive results of a type of blood test called Coombs’ test

The leaflet lists 1 more. Read the full leaflet.

Cephalexin (CERLAZ Oral Suspension 125 mg/5 ml & 250 mg/5ml)

• Hypersensitivity reactions including anaphylaxis (an allergic reaction to which the body has become hypersensitive.)
• Anaphylaxis – a severe, life-threatening allergic reaction
• Rash or itching
• Reactions resembling serum sickness-like reactions – immune response that’s similar to an allergic reaction. It happens when certain medication cause the immune system to react. Date: 2021.07.06 CERLAZ ORAL SUSPENSION 125 mg/5 mL and These are all very serious side effects
• If you have them, you may have had a serious reaction to CERLAZ ORAL SUSPENSION. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following: The following side effects occur frequently:
• Eosinophilia – increased number of disease-fighting white blood cell
• Headache
• Nausea
• Vomiting
• Diarrhoea The following side effects rarely occur:
• Haemolytic anaemia – a disorder in which red blood cells are destroyed faster than they can be made
• Drug induced neutropenia – decrease in absolute neutrophil counts due to exposure to a medicine

The leaflet lists 14 more. Read the full leaflet.

Metronidazole (Bemetrazole 200. Bemetrazole 400)

• gastrointestinal disturbances, especially nausea (feeling sick) and taste disorders; nausea is sometimes accompanied by headache, and vomiting (being sick)
• diarrhoea
• dry mouth
• a furred tongue
• oral mucositis (sore/red mouth)
• stomatitis (sore mouth, mouth ulcers and cold sores)
• mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations)
• problems with your eyesight such as blurred or double vision
• weakness
• dizziness
• drowsiness
• skin rash

The leaflet lists 23 more. Read the full leaflet.

Flucloxacillin (MACROPEN)

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Fainting
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• These are all very serious side effects. If you have them, you may have had a serious reaction to MACROPEN. 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 widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30 % of the body surface – toxic epidermal necrolysis)
• Widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)
• A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis)
• Flu-like symptoms with a rash, fever, swollen glands and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS))
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme)
• Chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome
• Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)

The leaflet lists 28 more. Read the full leaflet.

Erythromycin (PURMYCIN-125 SUSPENSION, PURMYCIN-250 SUSPENSION)

• fever, reinfection or a second infection with a bacteria, fungus or virus (super infection)
• skin eruptions
• a higher than normal level if disease fighting white blood cells(eosinophilia)
• reversible deafness
• seeing or hearing things that are not real (hallucinations)
• confusion, a feeling of spinning even when you’re not moving(vertigo)
• low blood pressure (hypotension)
• nausea, vomiting, diarrhoea, upper abdominal discomfort, an eating disorder (anorexia)
• a condition in which the opening between the stomach and small intestine thickens (infantile hypertrophic pyloric stenosis)
• enlarged liver (hepatomegaly)
• chest pain, a general sense of being unwell (malaise)
• increase in liver enzymes

Trimethoprim (ILVITRIM SUSPENSION)

• a fungal infection called thrush or candidiasis which can affect your child’s mouth or vagina
• high levels of potassium in your blood, which can cause abnormal heart beats (palpitations)
• headache
• feeling sick (nausea)
• diarrhoea
• skin rashes
• pseudomembranous colitis (infection of the colon resulting in watery and sometimes bloody stools)
• changes in the blood cells, resulting in feeling weak, tired or listless, pale skin, and more frequent infections
• cyanosis (bluish or greyish colour of the skin, nails, lips or around the eyes)
• hypothyroidism where the thyroid doesn’t create and release enough thyroid hormone into your bloodstream. This makes you feel tired, gain weight and unable to tolerate cold temperatures
• low blood sugar
• low sodium concentration in your blood

The leaflet lists 30 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.

Amoxicillin (Mymox 250 / 500)

Do not use it at all if:

• If you are hypersensitive (allergic) to amoxicillin trihydrate, penicillins, cephalosporins or any of the other ingredients of MYMOX (listed in section 6)
• If you have ever had an allergic reaction to any antibiotic, which can include a skin rash or swelling of the face or throat

Use with care, and tell your doctor, if:

• If you have epilepsy or meningeal disorders (inflammation of the membranes and fluid surrounding the brain and spinal cord), as MYMOX may increase the risk of convulsions (fits) when taken at high doses
• If you have kidney problems or are not urinating frequently
• If you have liver problems
• If you have been diagnosed with infectious mononucleosis, also called glandular fever (fever, sore throat, swollen glands and extreme tiredness)
• If you have been diagnosed with lymphatic leukaemia
• If you develop diarrhoea and stomach cramps, which may happen while you are taking MYMOX or a few months after you have stopped taking MYMOX

Azithromycin (MYZAT)

Do not use it at all if:

• If you are allergic to azithromycin, erythromycin or any of MYZAT’s ingredients
• If you are allergic to any group of macrolide derivative medicines
• If you are already taking medicines called ergot derivatives this may leads to ergotism (physiological state produced by a poison due to concurrent administration of MYZAT with ergot derivatives)
• If you have any liver problems

Use with care, and tell your doctor, if:

• If you develop any skin or allergic reactions
• If you develop severe diarrhoea
• If you have any problems with your kidney. You doctor will tell about cautions for how to take MYZAT
• If you have any liver problem (like jaundice – yellowing of the skin and the eyes)
• If your baby is below 12 months of age
• If you face cardiac dysrhythmia (an abnormal rate of muscle contractions in the heart) and torsade de pointes

Ciprofloxacin (CIPRO UNIMED)

Do not use it at all if:

• If you are hypersensitive (allergic) to ciprofloxacin, fluoroquinolones or any of the other ingredients of CIPRO UNIMED (listed in section 6)
• If you are pregnant or breastfeeding your baby
• CIPRO UNIMED should not be used in children under the age of 18 years
• If you are also taking a muscle relaxing medicine called tizanidine
• If you are also taking methotrexate, a medicine used to reduce your bodies immune response
• If you are deficient in glucose-6-phosphate dehydrogenase due to an inherited illness

Use with care, and tell your doctor, if:

• if you have a history of seizures, convulsive disorders or suffer from other neurological conditions, you might experience side effects associated with the central nervous system. If this happens, stop taking CIPRO UNIMED immediately, and contact your doctor
• if you are using medicines that will cause your urine to become alkaline
• if you have impaired liver or kidney function
• if you have a history of tendon problems during previous treatment with antibiotics such as CIPRO UNIMED
• if you have QT interval prolongation or congenital long QT syndrome which is an abnormality of the heart leading to a very fast heart beating which may lead to sudden loss of consciousness
• if you have heart disorders such as heart failure, myocardial infarction or bradycardia

Doxycycline (DOXYCYCLINE BIOTECH 100)

Do not use it at all if:

• if you are hypersensitive (allergic) to doxycycline hyclate, other tetracyclines or any of the other ingredients of DOXYCYCLINE BIOTECH 100 (listed in section 6)
• if you have some form of kidney (renal) disease
• if you are pregnant or breastfeeding your baby
• if you are pregnant, you are more susceptible to severe doxycycline-induced liver damage
• if you are younger than 12 years of age as permanent discoloration of teeth may occur
• if you have an inflammatory disease of connective tissue (systemic lupus erythematosus)

Use with care, and tell your doctor, if:

• if you are likely to be exposed to direct sunlight or ultraviolet light, or if you are already sunburned
• if you have any liver disease or are taking medicine which affect your liver
• if you have severe kidney problems
• if you experience severe skin reactions such as erythema multiforme (circular, irregular red patches), Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers), toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns)
• if you have diarrhoea or usually get diarrhoea when you take antibiotics or have suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using DOXYCYCLINE BIOTECH 100 tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics
• if you suffer from porphyria (a deficiency of specific enzymes within the body causing an increase of substances called porphyrins)

Cefalexin (Ranceph Suspension)

Do not use it at all if:

• if you are allergic (hypersensitive) to cefalosporins (similar group of antibiotics)
• If you are hypersensitive to any of the other ingredients of RANCEPH SUSPENSION
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if:

• if you have had allergic reaction (hypersensitivity reactions) to cefalosporins, penicillins or other medicines in the past
• if you are allergic to penicillin
• if you have a serious allergic reaction that could lead to heart problems
• if you develop diarrhoea. Inflammation of the colon (pseudomembranous colitis). Such condition may be life-threatening; care should be taken. Your doctor may discontinue RANCEPH SUSPENSION
• if you have kidney problems
• if you need a laboratory investigation such as blood test or urine test, do inform your doctor about the medicine you are taking

Cephalexin (CERLAZ Oral Suspension 125 mg/5 ml & 250 mg/5ml)

Do not use it at all if:

• If you are allergic or sensitive to CERLAZ ORAL SUSPENSION or any of the ingredients of CERLAZ ORAL SUSPENSION
• If you are allergic to a group of antibiotics called cephalosporins
• If you are pregnant or breastfeeding Tell your doctor or healthcare professional before taking CERLAZ ORAL SUSPENSION:
• If you are a penicillin-sensitive patient (an allergy or sensitive to the antibiotic used to treat or prevent various infections)
• If you have impaired renal function (when your kidneys are not working as well as they should), a dosage reduction may be necessary. Especially in Elderly patient’s, who are more likely to have decreased renal function, care should be taken in dose selection
• If you observe any diarrhoea while taking CERLAZ ORAL SUSPENSION. Stop treatment immediately and discuss with your doctor

Metronidazole (Bemetrazole 200. Bemetrazole 400)

Do not use it at all if:

• If you are hypersensitive (allergic) to metronidazole or any of the other ingredients of BEMETRAZOLE (listed in section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• If you have a disease or disorder ,especially of the blood
• If you are taking the medicine, busulfan (treatment for cancer of blood cells). Do not take BEMETRAZOLE if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before receiving BEMETRAZOLE. Do this even if they have applied in the past

Use with care, and tell your doctor, if:

• If you have hepatic encephalopathy (worsening of brain function that occurs when the liver is no longer able to remove toxic substances in the blood)
• If you have severe liver toxicity/acute liver failure with Cockayne syndrome (neuro degenerative disorder characterised by growth failure, no development of the nervous system, abnormal sensitivity to sunlight, eye disorders and premature aging)have been reported with systemic use Patients with Cockayne syndrome should report any symptoms of potential liver injury to their physician and stop taking metronidazole
• If a liver function test must be performed throughout treatment until liver function is within normal range
• If liver function is elevated during treatment , metronidazole should be discontinued
• Metronidazole has anti- treponemal activity and may mask the immune response seen in untreated syphilis
• Contacts of syphilis receiving metronidazole should be probably be screened for an additional 4 to 8 weeks

Flucloxacillin (MACROPEN)

Do not use it at all if:

• If you or your child are hypersensitive (allergic) to amoxicillin, flucloxacillin, any other penicillins or any of the other ingredients of MACROPEN (listed in section 6)
• If you or your child have had a serious allergic reaction to any antibiotics. Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, skin rash, itching or hives
• If you or your child previously had jaundice (a medical condition with yellowing of the skin or whites of the eyes)
• Do not give MACROPEN to neonates

Use with care, and tell your doctor, if:

• If you or your child have a known allergy to penicillins as this could lead to an allergic reaction with collapse and sometimes death
• If you or your child have kidney problems
• If you or your child have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
• If you or your child are not urinating regularly
• If you are breastfeeding or intend to breastfeed
• MACROPEN passes into breast milk and can be used only with caution during breastfeeding. However, breastfeeding must be stopped if gastrointestinal disorders (diarrhoea, candidiasis or skin rash) occur in the newborn

Erythromycin (PURMYCIN-125 SUSPENSION, PURMYCIN-250 SUSPENSION)

Do not use it at all if:

• If you or your child are hypersensitive (allergic) to erythromycin, or to any of the other ingredients of PURMYCIN SUSPENSION (listed in section 6)
• If you or your child have liver function problems
• If you or your child have developed jaundice (yellowing of the skin and eyes) during previous treatment with erythromycin
• If you or your child are taking the following medicines:
• simvastatin (used to lower cholesterol and triglycerides (types of fat) in the blood)
• tolterodine (used for treating overactive bladder with symptoms of urinary frequency, urgency, and leakage)

Use with care, and tell your doctor, if:

• if you are pregnant or breastfeeding your baby
• if you have heart problems
• if you are taking other medicines which are known to cause serious disturbances in heart rhythm
• if you have previously experienced diarrhoea following the use of antibiotics
• rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP)have been reported. If an allergic reaction occurs, stop using PURMYCIN SUSENSION and tell you healthcare provider
• If you are pregnant and have been told that you have a sexually transmitted disease called syphilis. In this case erythromycin, as contained in PURMYCIN SUSPENSION, may not be effective for preventing the transfer of this infection to your baby. Consult your doctor before receiving PURMYCIN SUSPENSION

Trimethoprim (ILVITRIM SUSPENSION)

Do not use it at all if:

• if you or your child are hypersensitive (allergic) to sulphamethoxazole, sulphonamide or trimethoprim or any of the other ingredients of ILVITRIM SUSPENSION (listed in section 6)
• if you/your child have been told that you have or are at risk for a rare blood disorder called porphyria
• if you/your child have severe liver or severe kidney problems
• if you/your child have been told that you have an anaemia due to not having enough folic acid or vitamin B12
• if you are pregnant or breastfeeding
• ILVITRIM SUSPENSION should not be given to infants during the first 6 weeks of life

Use with care, and tell your doctor, if:

• If you/your child has skin rashes, often accompanied by flu-like symptoms after taking ILVITRIM SUSPENSION. The rash may progress to widespread blistering or peeling of the skin. This can be a serious skin reaction to ILVITRIM SUSPENSION
• Stop taking ILVITRIM SUSPENSION and seek urgent advice from your doctor
• There have been very rare reports about excessive immune reactions due to a dysregulated activation of white blood cells resulting in inflammations (haemophagocytic lymphohistiocytosis), which can be life-threatening if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, feeling weak, lightheaded, shortness of breath, bruising, or skin rash simultaneously or with a slight delay, contact your doctor immediately
• If you develop an unexpected worsening of cough and shortness of breath, inform your doctor immediately
• If you are elderly you may have more severe side effects, e.g. problem with your blood causing bruises or bleeding (thrombocytopenia). This can happen more frequently if you are also taking water tablets, e.g. thiazides
• If you/your child have kidney problems. You/your child should take enough fluids, especially if you are underweight or malnourished

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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