Answer the side-effect intent for ritalin without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.
Part of mental health medication side effects side effects.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 13/01/2025) and professional information (approved 13/01/2025) 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 Ritalin?
Which leaflet this comes from
There is no approved leaflet for Ritalin in SAHPRA’s public repository. The information below is from the approved leaflet for RADD, another South African product containing Methylphenidate. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Ritalin contains the active ingredient Methylphenidate.
- Active ingredient — Methylphenidate
- Registration number — 22/1.2/0052; 22/1.2/0053; 22/1.2/0054; 22/1.2/0055
- Registration holder — Pharma Dynamics (Pty) Ltd
It is approved for:
- in children over the age of 6 years and adults in the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
- only after trying treatments which do not involve medicines, such as counselling and behavioural therapy. RADD improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention (attention span), concentration and reduce impulsive behaviour
Common side effects of Ritalin
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
- if you are at risk of any condition that may affect the blood vessels of the brain (stroke or mini-stroke, are taking medicine to increase your blood pressure) your doctor will request to see you on a frequent basis for a check-up
- if you have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words as RADD may make these conditions worse
- if you currently suffer from depression or fatigue (extreme tiredness/weakness) as RADD may worsen these conditions
- if you have a mental health problem as RADD may increase the symptoms
- if you suffer from any of the following whilst taking RADD as your dosage may need to be adjusted or discontinued: mood swings (from being manic to being depressed – called bipolar disorder); starting to be aggressive or hostile, or your aggression gets worse – seeing, hearing or feeling things that are not there (hallucinations); believing things that are not true (delusions); feeling unusually suspicious (paranoia); feeling agitated, anxious or tense; feeling depressed or guilty
- if you have ever abused or been dependent on alcohol, prescription medicines or street drugs as this could result in serious heart adverse effects
- if you have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs) as RADD may make these conditions worse
- if you have thoughts about killing yourself or harming yourself whilst taking RADD it is imperative you contact your doctor immediately
- if you experience problems with your vision (blurred vision, distortion)
- if you have open-angle glaucoma or are at risk for acute angle-closure glaucoma (an eye disease)
- if you are taking antidepressants or medicines for anxiety as they may affect the way RADD works
- if you have a problem with swallowing in general, or swallowing whole tablets as RADD tablets have to be swallowed whole
- if you have a narrowing or blockage of your gut or food-pipe
- if you need to have blood screening tests for drug use, as RADD may give a positive result
- When taking RADD, adolescent and adult males may unexpectedly experience prolonged erections. This may be painful and can occur at any time, contact your doctor if this occurs. Your doctor will request tests before and during your treatment with RADD, this is to monitor how RADD affects you. RADD should be taken in the morning, before or after a meal. Children and adolescents
- if your child is not growing or gaining height or weight as expected RADD treatment may need to be interrupted Children and adolescents on long-term treatment (longer than 12 months) will have their weight and growth monitored by the doctor. Other medicines and RADD Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)
- medicines used to reduce or increase blood pressure, as RADD may affect the way these medicines work
- medicines to thin the blood (warfarin), as RADD may affect the way these medicines work
- alcohol or medicines containing alcohol, as this may affect the way RADD works and result in unwanted side effects
- certain types of anaesthetic – you should not take RADD on the day of your surgery if a certain type of anaesthetic is used
- This is because there is a chance of a sudden rise in blood pressure during the operation
- clonidine (used to treat high blood pressure, ADHD, anxiety and pain), as this may result in serious side effects
- medicines for depression (such as chlorpromazine, haloperidol and lithium), as these medicines may affect the way RADD works and could result in unwanted side effects
- disulfiram (used in the treatment of alcoholism) may affect the way RADD works
- medicines for severe mental health problems, as this may result in serious side effects
- medicines for epilepsy (such as ethosuximide, phenobarbital, phenytoin, primidone), as RADD may affect the way these medicines work
- edicines used to control the acidity of the urine, as they may affect the way RADD works
- medicines to increase blood pressure may affect the way these medicines work
- medicines for diarrhoea that contain furazolidone, procarbazine (used together with other chemotherapy medicines), selegiline (used in the treatment of Parkinson’s disease)
- medicines for depression or anxiety called a serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor’ (SNRI). Taking RADD with these type of medicines could cause a life threatening increase of serotonin in the brain (serotonin syndrome), which may lead to feeling confused or restless, sweating, shivering, muscle jerks or fast heartbeat. If you develop these side effects, see a doctor straight away. RADD with food, drink and alcohol RADD should be taken in the morning, and can be taken with or without food. Do not drink alcohol while taking RADD. Alcohol may make the side effects of this medicine worse. Remember that some foods and medicines contain alcohol. Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking RADD. Do not take RADD if you are pregnant or breastfeeding your baby as it is not known if RADD will harm your baby. Driving and using machines RADD may have a moderate influence on the ability to drive and use machines. Since RADD may cause vision changes including blurred vision, drowsiness and dizziness you should use caution before driving or operating machinery until you know how RADD affects you. It is not always possible to predict to what extent RADD may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which RADD affects them. RADD contains lactose monohydrate RADD contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking RADD. RADD contains lactose which may have an effect on the control of your blood sugar if you have diabetes mellitus
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 Ritalin from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for Ritalin 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 methylphenidate hydrochloride or any of the other ingredients of RADD
- if you currently suffer from anxiety, tension and agitation as RADD may make these symptoms worse
- if you have poorly controlled open-angle or angle-closure glaucoma (increased pressure in your eye)
- if you have a tumour of your adrenal gland (phaeochromocytoma)
- if you are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) –
- if you or anyone in your family has been diagnosed with Tourette’s syndrome (sudden, brief, intermittent movements or sounds that you have no control over)
- if you have a thyroid problem
- if you have an eating problem where you do not feel hungry or want to eat – such as anorexia nervosa
- if you have mental health problems such as a psychopathic or borderline personality problem, abnormal thoughts or visions or an illness called schizophrenia, signs of a severe mood problem such as feeling like killing yourself, severe depression, where you feel very sad, worthless and hopeless or mania, where you feel unusually excitable, over-active, and uninhibited
- if you have been diagnosed with Bipolar disorder and the symptoms are not properly controlled
- if you have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
- if you have ever had heart problems – such as a heart attack, uneven heartbeat, pain and discomfort in the chest, heart failure, heart disease or were born with a heart problem
- you have had a problem with the blood vessels in your brain – such as a stroke, swelling and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood vessels (vasculitis)
- if you are pregnant or breastfeeding your baby
Use with care, and tell your doctor, if
- RADD treatment is not indicated in all children with ADHD. Your doctor will decide if your child should use this medicine, based on a very thorough assessment of the severity and how long your child has been experiencing these symptoms in relation to their age
- RADD is not for use in children under 6 years of age and in elderly patients (over 65 years)
- RADD does not have to be taken forever. Treatment will generally stop after puberty Take special care with RADD:
- if you have high blood pressure as RADD could worsen this condition
- if you have a heart problem as RADD could worsen the condition and result in unwanted
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-00055 · build rank 55 · Phase 1 · Tier 1. 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 1,500–2,200 words.