Answer the side-effect intent for olanzapine 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 01/02/2022) and professional information (approved 01/02/2022) 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 olanzapine?
Which leaflet this comes from
There is no approved leaflet for Olanzapine in SAHPRA’s public repository. The information below is from the approved leaflet for ZYPREXA IM, another South African product containing Olanzapine. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Olanzapine contains the active ingredient Olanzapine.
- Active ingredient — Olanzapine
- Registration number — 35/2.6.5/0307
- Registration holder — Equity Pharmaceuticals (Pty) Ltd
It is approved for:
- Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious and tense
- Acute mania, a condition with symptoms of excitement or euphoria, in patients with Bipolar I disorder. ZYPREXA IM injection is given when rapid control of agitation and distressing behaviour is needed and treatment with ZYPREXA tablets is not appropriate. Your doctor will change your treatment to ZYPREXA tablets, as soon as appropriate
Common side effects of olanzapine
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 strength
- weight gain
- extreme tiredness
- some people may feel dizzy or faint (with a slow heart rate), especially when getting up from lying or sitting position. This will usually pass on its own but if it does not, tell your doctor
- constipation
- dry mouth
- feeling more hungry
- increases or decreases of level of certain types of white blood cells
- water retention leading to swelling of the hands, ankles or feet
- joint pain
- restlessness
- dizziness
- sleepiness
- increases in liver enzymes
- increases in the levels of circulating fats
- increases in the levels of sugars in the blood and urine
- increases of level of prolactin in the blood
- increases in levels of uric acid in the blood
- sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males
Less frequent side effects
- hypersensitivity (e.g. swelling in the mouth and throat, itching, rash)
- sensitivity to sunlight
- slow heart rate
- inflammation of the pancreas causing severe stomach pain, fever and sickness
- decreases of level of blood platelets
- liver inflammation
- liver disease appearing as yellowing of the skin and white parts of the eyes
- diabetes and worsening of diabetes occasionally associated with ketoacidosis (ketones in the blood and urine) or coma
- muscle disease presenting as unexplained aches and pains
- restless leg syndrome
- seizures, usually associated with a history of seizures (epilepsy)
- problems with speech (stuttering)
- prolonged and/or painful erection
- bleeding from nose
- hair loss
- rash
- increases in the levels of creatine phosphokinase in the blood
- allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia). While receiving ZYPREXA IM, elderly patients with dementia of the Alzheimer’s type may suffer from stroke, pneumonia, urinary incontinence, lack of ability to urinate, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients. In patients with Parkinson’s disease ZYPREXA IM may worsen the symptoms. Patients with bipolar mania receiving ZYPREXA IM in combination with lithium or valproate may get the following side effects: weight gain, fever, abdominal distension, dry mouth, feel more hungry, memory loss or forgetfulness, problems with speech, tremor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or nurse
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 olanzapine from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for olanzapine 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 allergic (hypersensitive) to olanzapine or any of the ingredients of ZYPREXA IM injection (listed in section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor
- If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure of the eye). Safety and efficacy of ZYPREXA IM injection in children below 18 years of age have not been established
Use with care, and tell your doctor, if
- Tell the doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. The doctor or nurse may also want to measure your blood pressure and pulse
- The use of ZYPREXA IM injection in elderly patients with dementia is not recommended as it may have serious side effects
- ZYPREXA IM injection may cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once
- ZYPREXA IM injection may cause unusual movements mainly of the face or tongue. If this happens after you have been given ZYPREXA IM injection, tell your doctor
- ZYPREXA IM injection may cause allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia). If this happens, tell your doctor
- ZYPREXA IM injection may cause high blood sugar and high level of fat (triglycerides and cholesterol) have been seen in patients taking this medicine. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPREXA IM injection and regularly during treatment
- ZYPREXA IM injection may cause elevations of liver enzymes, tell your doctor if this happens, if you suffer from a liver disease or if you are treated with medicines that can potentially damage the liver
- ZYPREXA IM injection may cause dysphagia. Tell your doctor if you are at risk for aspiration pneumonia (lung infection due to the inhalation of stomach content and/or secretion of oropharynx)
- Tell the doctor if you or someone else in your family has a history of blood clots, as ZYPREXA IM has been associated with formation of blood clots
- If you suffer from any of the following illnesses tell your doctor as soon as possible: o stroke or “mini” stroke (temporary symptoms of stroke) o Parkinson’s disease o prostate problems o a blocked intestine (paralytic ileus) o increased pressure in the eye (glaucoma) o liver or kidney disease o blood disorders o heart disease o diabetes o seizures
- If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke
- As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor
Pregnancy and breastfeeding
- 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 this medicine
- • Usage in pregnancy: The safety of ZYPREXA IM injection in pregnancy has not been established
- The following symptoms may occur in newborn babies, of mothers that have used ZYPREXA in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding
- If your baby develops any of these symptoms you may need to contact your doctor
- • Usage during breastfeeding: The safety of ZYPREXA IM injection has not been established in breastfeeding women
- Driving and using machinery: ZYPREXA IM injection may make you feel drowsy
Interactions and medicines to check
The approved leaflet names these interactions.
- Always tell your healthcare provider if you are taking any other medicines (this includes complementary or traditional medicines)
- Especially tell your doctor if you are taking medicines for Parkinson’s disease
- A combination of ZYPREXA IM injection with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquilisers, including benzodiazepines) and antidepressants
- Only take other medicines while you are on ZYPREXA IM injection if your doctor tells you that you can
- If you receive ZYPREXA IM injection, a benzodiazepine injection is not recommended at the same time as this may result in excessive sleepiness, may have serious effects on your heart rate or your breathing, and, in very rare cases, may result in death
- If your doctor has to give a benzodiazepine injection to treat your condition, there should be at least a one hour time period after the ZYPREXA IM injection and you are to be monitored closely after the benzodiazepine injection is given
- Receiving ZYPREXA IM with food and drink: Do not drink any alcohol if you have been given ZYPREXA IM injection as together with alcohol it may make you feel drowsy
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-00343 · build rank 343 · 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.