Explain possible side effects and interaction/safety considerations for pyridoxine without overstating causality or efficacy.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 07/02/2023) and professional information (approved 07/02/2023) for this product: patient information leaflet, professional information. Retrieved 2026-09-03. Where this page and the approved leaflet differ, the leaflet is correct.
What is pyridoxine?
Which leaflet this comes from
There is no approved leaflet for Pyridoxine in SAHPRA’s public repository. The information below is from the approved leaflet for NEUROBION AMPOULES, another South African product containing Thiamine hydrochloride, Pyridoxine hydrochloride, Cyanocobalamin. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Pyridoxine contains the active ingredient Thiamine hydrochloride, Pyridoxine hydrochloride, Cyanocobalamin.
- Active ingredient — Thiamine hydrochloride, Pyridoxine hydrochloride, Cyanocobalamin
- Registration holder — P&G South African Trading (Pty) Ltd
It is approved for:
- Restoring Vitamin B1, B6 and/or B12 levels
- The prevention and treatment of deficiencies in vitamin B1, B6 and B12. S3 NEUROBION AMPOULES assist with the management of neuropathies. (Symptoms of neuropathies include: tingling, numbness, loss of sensation, burning sensation, loss of balance and co-ordination.)
Possible side effects of pyridoxine
Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.
About these frequency terms
This leaflet groups effects on the very common/common/uncommon scale.
Reported side effects
- difficulty in breathing
- dizziness These are all serious side effects
- If you have them, you may have had a serious reaction to NEUROBION AMPOULES. You may need urgent medical attention or hospitalisation Tell your doctor if you notice any of the following:
- sweating
- fast heartbeat
- skin reactions with itching and urticaria (skin rash with red, raised, itchy bumps)
- nausea
- vomiting
- diarrhea
- stomach ache
- acne
- eczema
- injection site reaction (Pain, stinging, tingling, burning, redness and swelling at site of injection)
- Chromaturia (“reddish urine”, appearing during the first 8 hours after been given NEUROBION AMPOULES and typically resolves within 48 hours)
Interactions and medicines to check
The approved leaflet names these interactions.
- isoniazide and cycloserine (medicines used for the treatment of tuberculosis)
- penicillamine (a medicine used to treat rheumatoid arthritis)
- hydralazine (a medicine used to treat high blood pressure and heart failure) Long-term use of medicines called loop diuretics (water pills) such as furosemide, may reduce the levels of Vitamin B1 in your blood. Furosemide is used to reduce extra fluid in the body caused by conditions such as heart failure, liver disease, and kidney disease. Long term use of acid-lowering medicines agents (such as omeprazole, lansoprazole, pantoprazole, cimetidine and ranitidine) may lead to vitamin B12 deficiency
Bring the actual products to the conversation
A pharmacist can check for interactions much faster from the packaging than from remembered names.
Who should use extra caution?
The approved leaflet identifies the following cautions and factors.
Do not use it at all if
- If you are hypersensitive to Vitamin B1, Vitamin B6, Vitamin B12, or any of the other ingredients of NEUROBION AMPOULES
- If you are taking a medicine containing Levodopa which is used for treating Parkinson’s disease
- If you are below the age 14 years
Use with care, and tell your doctor, if
- Special care should be taken with NEUROBION AMPOULES: You should not use NEUROBION AMPOULES before you have been diagnosed as it may mask neurological symptoms (symptoms that affect your nervous systems such as numbness or tingling in your hands and feet, stiff limbs and may become irritable, drowsy and confused) caused by a deficiency of Vitamin B12
- If a Vitamin B12 deficiency is not detected and treated, it could affect your nervous system
- Neurological symptoms are described in the literature following long term intake (6 – 12 months) of more than 50 mg average daily dose of Vitamin B6
- You should therefore have regular check ups if you are taking NEUROBION AMPOULES over longer periods of time
- Tell your doctor or healthcare professional before being given the injection if you are taking or have recently taken levodopa (for Parkinson’s disease)
Pregnancy and breastfeeding
- If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking NEUROBION AMPOULES
- If you use NEUROBION AMPOULES, you should not breast feed your baby
Dose, timing and other factors that can affect side effects
The approved leaflet identifies the following cautions and factors.
Do not use it at all if
- If you are hypersensitive to Vitamin B1, Vitamin B6, Vitamin B12, or any of the other ingredients of NEUROBION AMPOULES
- If you are taking a medicine containing Levodopa which is used for treating Parkinson’s disease
- If you are below the age 14 years
Use with care, and tell your doctor, if
- Special care should be taken with NEUROBION AMPOULES: You should not use NEUROBION AMPOULES before you have been diagnosed as it may mask neurological symptoms (symptoms that affect your nervous systems such as numbness or tingling in your hands and feet, stiff limbs and may become irritable, drowsy and confused) caused by a deficiency of Vitamin B12
- If a Vitamin B12 deficiency is not detected and treated, it could affect your nervous system
- Neurological symptoms are described in the literature following long term intake (6 – 12 months) of more than 50 mg average daily dose of Vitamin B6
- You should therefore have regular check ups if you are taking NEUROBION AMPOULES over longer periods of time
- Tell your doctor or healthcare professional before being given the injection if you are taking or have recently taken levodopa (for Parkinson’s disease)
Pregnancy and breastfeeding
- If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking NEUROBION AMPOULES
- If you use NEUROBION AMPOULES, you should not breast feed your baby
Serious symptoms and warning signs
This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.
General warning signs that apply to any medicine
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.
What to do if side effects occur
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.
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 supplement side effects.
← 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-00217 · build rank 217 · 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.