Answer the side-effect intent for keppra without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 11/01/2023) and professional information (approved 11/01/2023) 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 Keppra?
Which leaflet this comes from
There is no approved leaflet for Keppra in SAHPRA’s public repository. The information below is from the approved leaflet for DYNA LEVETIRACETAM, another South African product containing Levetiracetam. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Keppra contains the active ingredient Levetiracetam.
- Active ingredient — Levetiracetam
- Registration number — A44/2.5/0368; A44/2.5/0369; A44/2.5/0370
- Registration holder — Pharma Dynamics (Pty) Ltd
It is approved for:
- seizures in adults and children over the age of 16 years, when epilepsy is diagnosed for the first time DYNA LEVETIRACETAM can also be used as an additional medicine to treat:
- seizures in adults and children over the age of 16 years, when epilepsy is diagnosed
- myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
- primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 16 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause)
Common side effects of Keppra
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 as “Frequent” and “Less frequent” rather than the very common/common/uncommon scale used in some other markets.
Frequent side effects
- loss of appetite, anorexia
- irritability, anxiety, depression, hostility, problem getting to sleep, nervousness, aggression
- dizziness (sensation of spinning), headache, sleeping problems, convulsions, balance disorder, involuntary trembling, lack of energy or enthusiasm
- double vision, blurred vision
- vertigo (sensation of rotation)
- diarrhoea, indigestion, nausea, vomiting, abdominal pain
- runny nose, inflammation of nasal passages, sore throat, cough, common cold
- skin rash
- muscle pain, muscle weakness, loss of full control of bodily movement
- unusual weakness or tiredness
Less frequent side effects
- infection
- decreased number of red blood cells and/or white blood cells and /or platelets
- weight loss, weight gain, decreased blood sodium concentration
- destruction of striated muscle cells, muscle tissue damage
- inflammation of the liver, liver failure, abnormal liver test results
- burning and pricking sensation (pins and needles), memory loss, memory impairment, disturbance in attention, abnormal involuntary body movements, impairment of voluntary movement, increased muscular movement
- inflammation of the sinuses (sinusitis)
- eczema, itching, hair loss
- Injury
Serious side effects 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.
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 Keppra from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for Keppra 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
The approved leaflet identifies the following cautions and factors.
Do not use it at all if
- if you are hypersensitive (allergic) to levetiracetam, or to any of the ingredients of DYNA LEVETIRACETAM
- if you are pregnant, suspect you are pregnant or breastfeeding your baby
Use with care, and tell your doctor, if
- if you have thoughts of harming or killing yourself. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor immediately
- if you suffer from kidney problems, or receive dialysis, follow your doctor’s instructions. He/she may decide that your dose should be adjusted
- if you have a severe liver disease
- if you suffer from high fever or recurring infections, or bleeding disorders, as the doctor may want to do blood tests and monitor your condition
- if you have abnormal thoughts, feel irritable or react more aggressively than usual, or if you or your family and friends notice important changes in mood or behaviour
- if you stop taking DYNA LEVETIRACETAM suddenly, you may have increased seizures. Tell your doctor if you have new or worsening seizures. Do not stop taking DYNA LEVETIRACETAM without first talking to your doctor, even if you feel better. DYNA LEVETIRACETAM should not be given to infants and children under the age of 12 years
Pregnancy and breastfeeding
- If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist, or other health care professional for advice before taking this medicine
- Do not take DYNA LEVETIRACETAM if you are pregnant or suspect that you are pregnant
- Contact you doctor immediately
- Do not take DYNA LEVETIRACETAM if you are breastfeeding your baby
Interactions and medicines to check
The approved leaflet names these interactions.
- other anti-epileptic medicines (such as phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin, and primidone), as they may affect the way DYNA LEVETIRACETAM works
- probenecid (a medicine used to increase uric acid excretion by the kidneys in patients with gout), as this may affect the way DYNA LEVETIRACETAM works
- methotrexate (a medicine used to treat certain types of cancer), as the use of DYNA LEVETIRACETAM may increase your blood levels of methotrexate. Do not take macrogol (a medicine used as a laxative) for one hour before and one hour after taking DYNA LEVETIRACETAM, as this may result in a loss of its effect. DYNA LEVETIRACETAM with food and drink DYNA LEVETIRACETAM should be taken by mouth, swallowed with liquid and may be taken with or without food
Bring the actual products to the conversation
A pharmacist can check for interactions much faster from the packaging than from remembered names.
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-00320 · build rank 320 · 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.