ARV medicines Side Effects

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

Part of hiv & prep & arvs side effects.

What is ARV medicines?

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)
• emtricitabine — Prepetam, Austell Pharmaceuticals (Pty) Ltd (Tablet)
• zidovudine — ZOVILAM, Viatris Healthcare (Pty) Ltd (Tablets)
• nevirapine — MACLEODS NEVIRAPINE, MACLEODS PHARMACEUTICALS SA (PTY) LTD (Tablets)

Common side effects of ARV medicines

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.

Emtricitabine (Prepetam)

• Stomach pain
• Pain
• Abnormal physical weakness or lack of energy
• Diarrhoea
• Headache
• Nausea (feeling sick), vomiting
• Dizziness
• Difficulty sleeping, abnormal dreams
• Problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
• Rashes (including red spots or blotches sometimes with blistering and swelling of the skin which may be allergic reactions), itching, changes in skin colour including darkening of the skin in patches Blood tests may also show:
• Low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• Increased triglycerides (fatty acids), bile or sugar in the blood

The leaflet lists 12 more. Read the full leaflet.

Zidovudine (ZOVILAM)

• Decreased number of red blood cells, too few white blood cells
• Ear, nose and throat infections
• Too much lactate in the blood
• Loss of appetite
• Headache
• Difficulty to sleep
• Feeling dizzy
• Cough, irritated or runny nose
• Nausea, vomiting, abdominal pain or cramps, diarrhoea
• Rash
• Loss of hair
• Redness of the skin

The leaflet lists 28 more. Read the full leaflet.

Nevirapine (MACLEODS NEVIRAPINE)

• General ill-feeling or flu-like symptoms
• Tiredness
• Nausea
• Lack of appetite
• Yellowing of your skin or white of your eyes
• Dark urine (tea coloured)
• Pale stools
• Pain, ache, or sensitivity on your right side below your ribs These are all very serious side effects
• If you have them you may have had a serious allergic reaction to MACLEODS NEVIRAPINE 200 MG. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience any of the following:
• General ill-feeling or flu-like symptoms
• Fever
• Muscle or joint aches

The leaflet lists 6 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.

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

Emtricitabine (Prepetam)

Do not use it at all if:

• if you are hypersensitive (allergic) to tenofovir disoproxil, emtricitrabine or any of the other ingredients of PREPETAM (listed in section 6)
• If you are pregnant or breastfeeding
• If you have kidney problems or are on dialysis
• If you are already taking any other tenofovir or emtricitabine containing medicines or medicines containing lamivudine because these medicines contain the same or similar active ingredients
• If you are a female who is taking PREPETAM to prevent HIV infection and you become pregnant while taking PREPETAM
• If you are HIV positive or if your HIV status is not known, when using PREPETAM to prevent HIV infection

Use with care, and tell your doctor, if:

• If you have bone problems
• If you have liver problems including Hepatitis B Virus infection
• If you have had kidney problems in the past or take other medicines that can cause kidney problems
• If you are taking other medicines as PREPETAM may interact with these other medicines
• If you are also infected with the Hepatitis B Virus (HBV), you need close medical follow up for several months after stopping treatment with PREPETAM. Follow-up includes medical examinations and blood tests to check for HBV that could be getting worse
• Patients with Hepatitis B Virus who take PREPETAM and then stop it, may get “flare-ups” of their hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. PREPETAM is not approved for the treatment of Hepatitis B Virus infection. You should read the

Zidovudine (ZOVILAM)

Do not use it at all if:

• If you are hypersensitive (allergic) to lamivudine or zidovudine or any of the other ingredients of ZOVILAM tablets (listed in section 6)
• If you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia)
• If you are taking ZOVILAM tablets, you must not take it with stavudine, zalcitabine or ribavirin
• ZOVILAM should not be given to children of younger than 12 years
• ZOVILAM should not be taken with any other medicines containing lamivudine or medicines containing emtricitabine

Use with care, and tell your doctor, if:

• Not everyone responds to treatment with ZOVILAM in the same way. The doctor will monitor the effectiveness of your treatment and if necessary separate preparations of lamivudine and zidovudine will be given where dosage adjustment is needed
• You may develop very low red blood cell count, or a very low white blood cell count, especially if you have advanced HIV infection (AIDS), and because of this experience fever or chills when taking zidovudine and therefore, ZOVILAM
• Inflammation of the pancreas have occurred in patients treated with lamivudine and zidovudine, and therefore, ZOVILAM, and because of this experience stomach pain, nausea and vomiting when taking zidovudine and therefore, ZOVILAM
• ZOVILAM can cause a condition called lactic acidosis, together with an enlarged liver. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition while being treated with ZOVILAM. The doctor will monitor you for any signs of developing lactic acidosis. Possible signs of lactic acidosis are:
• Deep, rapid breathing
• Drowsiness

Nevirapine (MACLEODS NEVIRAPINE)

Do not use it at all if:

• if you are hypersensitive to (nevirapine) or to any of the ingredients or to any of the other ingredients of MACLEODS NEVIRAPINE 200 MG (listed in section 6)
• if you have liver disease
• if you have kidney failure
• If you had discontinued nevirapine containing medicines previously due to the development of severe rash or liver disease
• MACLEODS NEVIRAPINE 200 mg is not recommended if you are breast-feeding. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV from mother to child
• If you are not sure please ask your doctor

Use with care, and tell your doctor, if:

• MACLEODS NEVIRAPINE 200 mg decreases bone mineral density which could result in fractures. Your doctor may prescribe calcium and vitamin D supplements while taking MACLEODS NEVIRAPINE 200 mg
• Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms inform your doctor
• MACLEODS NEVIRAPINE 200 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)
• If you have advanced HIV infection (AIDS) and have any infection, you may develop acute symptoms of the infection or inflammation and a worsening of the symptoms of an existing infection once treatment with MACLEODS NEVIRAPINE 200 mg is started. If you notice signs of inflammation or infection, or deterioration thereof, tell your doctor at once
• You will need to take MACLEODS NEVIRAPINE 200 mg every day. MACLEODS NEVIRAPINE 200 mg helps to control your condition and delay disease progression, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor. Do not stop taking your medicine without first talking to your doctor
• Treatment with MACLEODS NEVIRAPINE 200 mg has not been shown to reduce the risk of passing HIV infection on to others by unprotected sexual contact or by blood transfer (for example, blood transfusions or sharing needles). You should continue to use appropriate precautions to prevent this

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.

Related pages

• HIV PrEP side effects

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