TB treatment Side Effects

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

Part of vaccines & immunisation side effects.

What is TB treatment?

TB treatment 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:

• rifampicin — DUOPIC PAED, Adcock Ingram Limited (Tablets)
• isoniazid — ISONIAZID MYLAN, VIATRIS HEALTHCARE (PTY) LTD (Tablets)
• pyrazinamide — RISOPET, Pharma Dynamics (Pty) Limited (Film-coated tablets)

Common side effects of TB treatment

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.

Rifampicin (DUOPIC PAED)

• weakness, numbness and pain from nerve damage, usually in the hands and feet
• redness of eyes, discoloration of soft contact lenses
• diarrhoea, abdominal pain, nausea, loss of appetite, vomiting
• elevated liver activity blood test results
• disturbances of menstrual cycle
• flushing, reddish discoloration of body fluids like urine, tears, saliva and sweat, lower blood pressure, shock
• skin reactions which consist of redness and itching, with or without a rash
• muscle weakness and muscle disease
• constipation, dry mouth
• worsening of porphyria (a rare hereditary disease in which there is abnormal metabolism of the blood pigment haemoglobin)
• impaired memory
• medicine induces psychosis

The leaflet lists 33 more. Read the full leaflet.

Isoniazid (ISONIAZID MYLAN)

• sensations of tingling, pricking, or numbness of the skin, especially in the feet and hands (peripheral neuropathy)
• increases of liver enzymes as measured in blood samples. Usually, these enzyme increases return to normal within three months despite continued treatment. When the values rise above a certain level
• epileptic seizures
• inflammation of the brain
• personality changes
• memory impairment
• blood disorders which may make you more likely to get infections
• high blood sugar levels
• acidosis (upset of the acid balance in the body)
• low levels of vitamin B6 and nutrition problems
• mental disturbances including psychotic reactions such as hallucinations and delusions
• eye problems such as visual disturbances and eye pain

The leaflet lists 20 more. Read the full leaflet.

Pyrazinamide (RISOPET)

• headache, numbness, tiredness, drowsiness, light-headedness, dizziness, lack of co-ordination
• eye irritation, blurred vision, conjunctivitis
• nausea, vomiting, diarrhoea
• reddish-orange discoloration of urine, faeces, saliva, sputum, sweat and tears, fever, chills
• blood tests may show changes in the way your liver or kidneys are working
• tingling sensation in your hands, feet or lips (“pins and needles), feeling unwell
• limb weakness or numbness, loss of memory, vision, and/or intellect, uncontrollable obsessive and/or compulsive behaviours, delusions, headache, cognitive and behavioural problems and sexual dysfunction (symptoms of neurotoxicity)
• polyneuritis (paralysis and loss of reflexes, usually in the leg)
• constipation, dry mouth, stomach cramps, loss of weight, anorexia, metallic taste
• pain or inflammation in the large and small joints, bone pain, muscle pain, twitching or weakness 16 April 2024
• fever, a general feeling of discomfort, illness, or unease
• sore mouth or tongue (due to fungal infection such as thrush)

The leaflet lists 22 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.

Rifampicin (DUOPIC PAED)

Do not use it at all if:

• nevirapine (used to treat HIV infection)
• saquinavir/ritonavir combination (used to treat HIV infection)
• inhalation anaesthetics (used during surgery)
• ketoconazole (a medicine used to treat fungal infections)
• aluminium hydroxide (medicine used to treat diseases related to the gastric acid)
• disulfiram (medicine used for the treatment of chronic alcoholism). DUOPIC PAED may reduce the activity of the following medicines:

Use with care, and tell your doctor, if:

• Take special care with DUOPIC PAED: S4 If your child has kidney or liver problems, your child should not be given DUOPIC PAED
• If it is the only treatment option available, your doctor or healthcare provider will monitor your child’s liver function via blood tests every two to four weeks
• DUOPIC PAED may cause liver problems
• You should be attentive to symptoms of liver damage, such as unexplained loss of appetite, nausea, vomiting, dark urine, yellow discolouration of the skin (jaundice), persistent fatigue of greater than 3 days duration and abdominal pain and tenderness in your child
• If these occur, you should immediately report this to your child’s healthcare provider
• Your child’s urine, stool, saliva, sweat and tears may change colour, and soft contact lenses may be permanently stained as a result of being given DUOPIC PAED

Isoniazid (ISONIAZID MYLAN)

Do not use it at all if:

• if you are hypersensitive (allergic) to isoniazid or any of the other ingredients of ISONIAZID MYLAN 300 mg (listed in section 6)
• if you are hypersensitive to other chemically related medicines such as ethionamide, pyrazinamide and niacin
• if you have impairment of your liver function
• if you have an active liver disease irrespective of the cause
• if you have suffered liver problems with previous use of isoniazid
• if you suffered severe side effects when previously exposed to isoniazid

Use with care, and tell your doctor, if:

• if you drink a lot of alcohol regularly
• if you have, or have had, problems with your liver or kidneys
• if you suffer or have suffered from psychosis (mental disturbances with hallucinations or delusions)
• if you have diabetes mellitus (high blood sugar levels)
• if you are an elderly person
• if you have HIV infection (AIDS)

Pyrazinamide (RISOPET)

Do not use it at all if:

• if you are allergic (hypersensitive) to rifampicin, isoniazid, pyrazinamide, ethambutol, or to any of the ingredients of RISOPET
• if you have a liver disease (jaundice)
• if you have severe kidney disease
• If you have optic neuritis (inflammation of the nerves in your eye)
• if you are pregnant, planning to become pregnant or breast feeding your baby (see

Use with care, and tell your doctor, if:

• your doctor will need to check your blood before you take RISOPET. This will help your doctor to know if any changes happen to your blood after taking this medicine, as well as to check how your liver is working as each of the four components of RISOPET are known to affect the liver
• you experience any effects of hypersensitivity such as shock, kidney failure, anaemia, difficult or laboured breathing and asthma-like attacks, bleeding into the tissues, bruising, slow blood clotting after injury, fever, uncontrolled hay fever, develop eczema or if you develop any other form of rash after using RISOPET or rifampicin
• it is very important that you take RISOPET exactly as your doctor has told you. There is a chance of you developing a severe and dangerous reaction if you do not take your tablets every day. You must keep taking this medicine until your doctor tells you to stop
• if you have a liver disease, are an elderly patient, or suffer from or have suffered from alcoholism as RISOPET may cause liver damage. Do not use RISOPET if you experience the following symptoms: yellowing of the skin or eyes, rash, fever 16 April 2024
• if you have any of the following conditions: neuropathy (a disease that affects the nervous system), vitamin B6 deficiency, diabetes (high blood sugar), are malnourished, an alcoholic or infected with HIV virus (AIDS) as your doctor may prescribe pyridoxine (vitamin B6) to be taken during the course of your treatment
• if you have kidney problems as your dose of RISOPET may need to be adjusted

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

• COVID vaccine side effects

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