Answer the side-effect intent for hiv without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.
Sources
This page covers antiretroviral medicines — a group of products, not a single one. Each statement below is taken from the SAHPRA-approved patient information leaflet named beside it:
- MYLTEGA (dolutegravir, approved 05/04/2022)
- VIRLAM (tenofovir, approved 09/02/2021)
- ADCO-LAMIVUDINE 300 mg (lamivudine, approved 04/01/2022)
- MACLEODS EFAVIRENZ (efavirenz, approved 13/06/2023)
- ADCO ABACAVIR 20 mg/ml SOLUTION (abacavir, approved 30/01/2025)
Retrieved 2026-09-03. Your own medicine’s leaflet is the one that applies to you, and where it differs from this page the leaflet is correct.
What is HIV?
Antiretroviral medicines 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:
- dolutegravir — MYLTEGA, Mylan (Pty) Ltd (Film-coated tablet)
- tenofovir — VIRLAM, Pharma Dynamics (Pty) Ltd (Film-coated tablets)
- lamivudine — ADCO-LAMIVUDINE 300 mg, Adcock Ingram Limited (Tablet.)
- efavirenz — MACLEODS EFAVIRENZ, MACLEODS PHARMACEUTICALS SA (PTY) LTD (Tablets)
- abacavir — ADCO ABACAVIR 20 mg/ml SOLUTION, Adcock Ingram Limited (Oral Solution)
Check your own pack
Two medicines in the same group can differ in their approved uses, their cautions and their side effects. The leaflet inside your pack is the one that applies to you.
Common side effects of HIV
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.
Dolutegravir (MYLTEGA)
- insomnia (difficulty in sleeping)
- headache
- dizziness
- abnormal dreams
- nausea
- diarrhoea (frequent and watery bowel movements)
- vomiting
- flatulence (excessive gas/ wind)
- upper abdominal pain
- pruritus (an intense itching sensation)
- fatigue (temporary loss of strength and energy)
- depression
The leaflet lists 5 more. Read the full leaflet.
Tenofovir (VIRLAM)
- Blood test indicating raised liver enzyme levels
- Hives, itching, sweating
- Muscle pain
- Lack of energy, back or chest pain, pain
- Blood tests indicating abnormal levels for the following cholesterol or triglycerides, amylase (indication of pancreas infections), creatine kinase (indication of muscle damage), white blood cell count, glucose
- Blood in urine, glucose in urine as detected with urine analyses
- Low white- (symptoms include repeated fevers and infections) and red blood cell counts (symptoms include fatigue, dizziness, weakness and light-headedness, pale skin), low platelet count (symptoms include easy and excessive bruising, prolonged bleeding from cuts), abnormal organ or tissue development and function
- Exhaustion, muscle cramps body weakness due to a condition called lactic acidosis
- Inflammation of the pancreas (symptoms include upper abdominal pain, fever, nausea, vomiting)
- Inflammation of the liver (symptoms include discoloured urine and stools, diarrhoea, abdominal swelling, distention or bloating, loss of appetite)
- Kidney problems, kidney failure (swelling of your legs, ankles, and feet from retention of fluids, confusion, reduced amount of urine), nausea, drowsiness or fatigue)
- Tingling or prickling
The leaflet lists 7 more. Read the full leaflet.
Lamivudine (ADCO-LAMIVUDINE 300 mg)
- Nausea, vomiting, stomach pain or cramps, diarrhoea
- Unusual weakness or tiredness
- Fever, general feeling of illness
- Difficulty in sleeping
- Headache, sensation of pins and needles, tingling, burning, numbness
- Muscle pain or cramping
- Joint pain
- Cough, irritated or runny nose Side effects with frequency unknown:
- Loss of hair Side effects that may show up in your blood tests:
- A reduction in the number of white blood cells (neutropenia)
- A reduction in the number of platelets (cells that make the blood clot) (thrombocytopenia)
- A reduction in the number of red blood cells (anaemia)
The leaflet lists 3 more. Read the full leaflet.
Efavirenz (MACLEODS EFAVIRENZ)
- unusual dreams, feeling anxious, feeling depressed, difficulty falling asleep
- dizziness, difficulty concentrating, headache, drowsiness
- nausea, vomiting, diarrhoea, indigestion, stomach pain
- skin rash, itching, increased sweating
- fatigue, pain
- forgetfulness, confusion, abnormally happy mood, nervousness
- temporary loss of memory, disturbances of co-ordination and balance,tingling, pins and needles, tremor (shake)
- blurred vision
- ringing in the ears, vertigo (spinning sensation)
- feeling flushed, palpitations (rapid irregular action of heart), increased rate of heart beat
- asthma
- increased appetite, taste disturbances
The leaflet lists 15 more. Read the full leaflet.
Abacavir (ADCO ABACAVIR 20 mg/ml SOLUTION)
- Eating disorder (anorexia)
- High temperature
- Loss of appetite
- Fatigue
- Inflammation of the pancreas (pancreatitis)
- Serious skin reactions, skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
- 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 skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
- Excess lactic acid in the blood (lactic acidosis)
- Severe allergy
- Increase in blood sugar
- Increase fat in the blood Other possible side effects of combination therapy for HIV Combination therapy including ADCO ABACAVIR SOLUTION may cause other conditions to develop during HIV treatment. Cases of a condition called lactic acidosis, which is a build-up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking antiretroviral therapies. Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not known at this time. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin. Symptoms of infection and inflammation Old infections may flare up People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections. Symptoms usually include fever, plus some of the following:
- headache
The leaflet lists 13 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
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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.
Evidence required before publish — source the following for HIV from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for HIV says about how long specific effects last
- Whether the source describes any effect as usually temporary, or as needing review if it persists
- Whether any effect is described as continuing after the product is stopped
Factors that may affect side effects
Cautions from each medicine’s approved leaflet.
Dolutegravir (MYLTEGA)
Do not use it at all if:
- if you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of MYLTEGA (listed in section 6)
- if you have liver disease or if your liver is not functioning normally
- if you are taking a medicine called metformin (this medicine is used for diabetes – lowering of sugar levels in the body)
- if you are taking medicines called dofetilide and pilsicainide (these medicines are used to treat abnormal rate of muscle contractions in the heart)
- if you are pregnant or breastfeeding your baby
Use with care, and tell your doctor, if:
- If you get any rash as it may be an indication that you are having an allergic reaction. You should stop taking MYLTEGA and contact your doctor immediately if you get other symptoms of an allergic reaction such as fever, fatigue, muscle or joint aches, blisters, sores in your mouth, swelling of your feet or face
- If you get any other symptoms of other serious infections, usually due to your already weakened immune system. When you start treatment you may find that old, hidden infections (such as tuberculosis) flares up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight against these infections
- If you notice that there is a change in the distribution of fat throughout your body e.g. a hump forming on your back, loss of fat from your face, collection of fat around your abdomen
- If you experience joint aches and pains, stiffness in your joints or any difficulty with movement, it may be an indication that your bones are being damaged
- If you are taking any other medicines even if they are non-prescription. However do not stop taking MYLTEGA without your doctor’s advice
- MYLTEGA is not a cure HIV infection, it only reduces the amount of virus in your blood therefore HIV can still be transmitted while you are taking MYLTEGA. You should therefore use condoms during intercourse
Tenofovir (VIRLAM)
Do not use it at all if:
- if you are allergic (hypersensitive) to lamivudine or tenofovir, or any of the other ingredients in VIRLAM
- if you have moderate to severe impairment of kidney function
- if you are pregnant or breastfeeding
- if you are younger than 18 years of age
- if you Are taking zalcitabine
Use with care, and tell your doctor, if:
- you have symptoms such as deep, rapid breathing, drowsiness, and non-specific symptoms, such as nausea, vomiting and stomach pain
- This is a serious, life- threatening side-effect known as lactic acidosis (excess of lactic acid in your blood). Lactic acidosis occurs more often in women, particularly if they are very overweight. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with VIRLAM, please report any of these symptoms to your doctor as a matter of urgency
- you have hepatitis B virus (HBV) infection
- you have a kidney disorder. Please report to your doctor immediately if you develop swelling of the lower limbs, hands, body or face, are short of breath and if you pass very little or no urine. You may have to go for regular blood tests to monitor your kidney function
- you develop excess fat on your abdomen (stomach), behind your neck, or your breasts may enlarge, while your legs and arms become thinner. Contact your doctor as soon as possible if you notice changes in body fat distribution. You may require blood tests to monitor your cholesterol and blood sugar (glucose) levels
- you develop severe stomach pain or cramps accompanied by fever, chills, and severe nausea and vomiting
Lamivudine (ADCO-LAMIVUDINE 300 mg)
Do not use it at all if:
- If you are hypersensitive (allergic) to lamivudine or any of the other ingredients in ADCO- LAMIVUDINE 300 mg TABLETS (listed in section 6.1)
Use with care, and tell your doctor, if:
- If you are pregnant or breastfeeding
- If you have, or previously have had, a hepatitis B infection of the liver. ADCO-LAMIVUDINE 300 mg TABLETS may make the infection worse
- If you develop stomach pain, nausea or vomiting. Check with your doctor, as these could be signs of an inflamed pancreas
- It may result in a condition called lactic acidosis. If you are feeling unwell, consult your doctor
- Liver disease has been known to occur
- If you have kidney disease
Efavirenz (MACLEODS EFAVIRENZ)
Do not use it at all if:
- if you are hypersensitive to MACLEODS EFAVIRENZ 600 mg (efavirenz) or to any of the ingredients or to any of the other ingredients of MACLEODS EFAVIRENZ 600 mg (listed in section 6)
- if you have a rash or other skin condition
- if you are pregnant or planning to become pregnant, or breastfeeding
- If you have a liver disorder or liver failure
- If you are taking any of the following medicines: o Ergot derivatives such as ergotamine tablets used to treat migraines o Terfenadine or astemizole – used for treatment of allergies. o Cisapride – used for treatment of digestive problems. o Midazolam or triazolam – used as tranquilizers/sedatives o Bepridil – used to treat heart disease. o Pimozide – used to treat certain mental conditions. Do not give MACLEODS EFAVIRENZ 600 mg to children and adults weighing less than 40 kg
Use with care, and tell your doctor, if:
- if you have ever had liver disease (including hepatitis B or C)
- if you ever had mental illness or are using drugs or alcohol
- if you ever had seizures or are taking medicines for seizures
- if you have high cholesterol or triglycerides. Tell to your doctor if any of these applies to you
- You may need extra check-ups, including blood tests, while you’re taking your medication
- MACLEODS EFAVIRENZ 600 mg may change your body shape, by changing the way body fat is distributed. You may lose fat from your legs, arms and face and/or gain fat around the abdomen (tummy) and internal organs; get larger breasts or fatty lumps on the back of the neck (buffalo hump)
Abacavir (ADCO ABACAVIR 20 mg/ml SOLUTION)
Do not use it at all if:
- If you have had an allergic reaction (hypersensitive) to abacavir or any of the other ingredients of this medicine (listed in Section 6)
- If you have liver disease, you should not take ADCO ABACAVIR SOLUTION
- If you are pregnant or breastfeeding your baby. ADCO ABACAVIR SOLUTION is not a cure for HIV infection or AIDS. Patients taking ADCO ABACAVIR SOLUTION may still develop infections or other illnesses associated with HIV disease and AIDS. It is therefore important that you remain under the supervision of your doctor while taking this medicine. ADCO ABACAVIR SOLUTION does not reduce the risk of passing HIV to others through sexual contact or blood contamination. You should use appropriate precautions
Use with care, and tell your doctor, if:
- fever
- shortness of breath, sore throat or cough
- nausea or vomiting or diarrhoea or abdominal pain
- severe tiredness or achiness or generally feeling ill If you have discontinued ADCO ABACAVIR SOLUTION due to a hypersensitivity reaction, YOU MUST NEVER TAKE ADCO ABACAVIR SOLUTION or any other medicine containing abacavir again, as within hours you may experience a life-threatening lowering of your blood pressure or death. If you have stopped taking ADCO ABACAVIR SOLUTION for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting. Your doctor will check whether any symptoms you had may be related to this hypersensitivity reaction. If your doctor thinks there is a possibility that they were related, you will be instructed never to take ADCO ABACAVIR SOLUTION or any other medicine containing abacavir again. It is important that you follow this advice. Occasionally life-threatening hypersensitivity reactions have occurred when ADCO ABACAVIR SOLUTION was restarted in patients who reported only one of the symptoms on the Alert Card before stopping. On rare occasions hypersensitivity has been reported when ADCO ABACAVIR SOLUTION was restarted in patients who had no symptoms of hypersensitivity before stopping. Since stopping and restarting ADCO ABACAVIR SOLUTION may increase the risk of hypersensitivity occurring, it is important that you use ADCO ABACAVIR SOLUTION exactly as directed by your doctor and pharmacist and do not stop taking ADCO ABACAVIR SOLUTION without first consulting your doctor. Please keep the special Alert Card attached to the
- ADCO ABACAVIR SOLUTION can cause a life-threatening and fatal allergic reaction. If you experience any symptoms, contact your doctor immediately. If an allergic reaction is confirmed, you must never take ADCO ABACAVIR SOLUTION again. Please note that not taking your medicine regularly may increase the risk of you having an allergic reaction. You must take ADCO ABACAVIR SOLUTION regularly
- If you have liver disease, including hepatitis B or C avoid using ADCO ABACAVIR SOLUTION as it may make it worse
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
Do not stop a prescribed treatment on your own
Stopping some treatments suddenly causes its own problems, and the condition being treated may get worse. If you want to stop, ask a pharmacist or doctor how to do it safely — they can usually offer an alternative.
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.
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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
If you are having thoughts of harming yourself
Help is available in South Africa. The SADAG helpline is 0800 567 567, or you can go to your nearest emergency department. You do not have to wait until it feels like an emergency.
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
Reporting is not a substitute for medical care
If someone is unwell now, get medical help first and report afterwards. Urgent symptoms always take precedence over paperwork.
For a fuller walkthrough see how to report an adverse drug reaction.
Related pages
← Back to more medicine side effects.
Report a side effect
If you think you have had a side effect, you can report a suspected side effect in South Africa. Report a suspected side effect through the appropriate SAHPRA pathway where relevant.
Information only
This page gives general medicine-safety information for people in South Africa. It is not a diagnosis and not personalised medical advice. It cannot tell you whether a symptom you are having is caused by a particular product. Speak to a pharmacist or doctor about your own situation, and do not stop or change a prescribed treatment on the basis of a web page.
Editorial status: draft — not for publication
Brief SE-00526 · build rank 526 · Phase 2 · Tier 2. Every evidence slot on this page must be completed from the SAHPRA-approved source and the page signed off by a qualified clinical or pharmacy reviewer before it is published. Target length 1,300–2,000 words.