Answer the side-effect intent for stresam 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 02/08/2022) and professional information (approved 02/08/2022) 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 Stresam?

Stresam contains the active ingredient Etifoxine hydrochloride.

Active ingredient — Etifoxine hydrochloride
Registration number — A39/2.6/0072
Registration holder — Adcock Ingram

It is approved for:

STRESAM is a tranquillizer used to oppose various emotional and bodily reactions, which accompany anxiety

Common side effects of Stresam

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.

Less frequent side effects

bleeding between the expected menstrual periods, in women taking oral contraceptive pill
slight drowsiness at the start of treatment and disappearing spontaneously with its continuation
skin rash or itchy skin
swelling of the face
intestinal disorder with watery diarrhoea
hepatitis (yellowing of the skin and eyes, belly pain, fever)
feeling of rapidly progressing obstruction in the throat (Quincke’s oedema)

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 Stresam from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.

Anything the approved information for Stresam 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 etifoxine hydrochloride or any of the other ingredients of STRESAM (listed in section 6)
if you are in a state of shock
if you have severely impaired liver and/or kidney function
if you suffer from myasthenia gravis (a disease which causes weak muscles)
if you have had severe liver problems, such as inflammation of the liver (hepatitis) or cytolytic hepatitis, during previous treatment with STRESAM
if you have had severe skin reactions during previous treatment with STRESAM
if you suffer from galactosaemia (a disorder of milk sugar digestion), glucose-galactose malabsorption (a rare condition which prevents the proper digestion of the sugars glucose and galactose) or lactase deficit (unable to digest lactose)

Use with care, and tell your doctor, if

If you are at risk of developing liver problems, your doctor will do some tests to check your liver function before starting STRESAM and around one month after you start treatment. You should stop taking the medicine and seek urgent medical attention if you experience the following events during treatment with STRESAM:
severe skin or allergic reactions
jaundice (yellowing of the skin and eyes), vomiting, tiredness, abdominal (belly) pain or swelling, swelling in the legs and ankles, dark urine colour, pale stool colour, or bloody or tar-coloured stool
these could be signs of severe liver problems
watery diarrhoea. Talk to your doctor or pharmacist if you experience bleeding from the uterus between menstrual periods (metrorrhagia) when on oral contraceptives during treatment with STRESAM. Caution is advised if you are using central nervous system depressants (medicines that slow down brain activity) such as sedatives and tranquilizers or alcohol- containing medicines together with STRESAM. If you are taking STRESAM and have any questions or concerns, speak to your doctor or pharmacist

Pregnancy and breastfeeding

STRESAM should not be used by pregnant or breastfeeding women
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 STRESAM
No data on male and female fertility are available

Interactions and medicines to check

The approved leaflet names these interactions.

medicines related to morphine (painkillers, cough mixtures)
antidepressants
hypnotic medicines (medicines used to help you sleep)
antihistamines (medicines used to relieve allergic symptoms)
medicines used in the treatment of high blood pressure
baclofen (a muscle relaxant)
thalidomide (a medicine used to treat a certain type of cancer). STRESAM with food and drink and alcohol Do not use alcohol or alcohol-containing medications together with STRESAM as alcohol increases the sedating effect of STRESAM. This may lead to decreased alertness and may make vehicle driving and machine operations dangerous

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.

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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-00089 · build rank 89 · 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.

Stresam Side Effects