Wellbutrin Side Effects

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Answer the side-effect intent for wellbutrin without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Wellbutrin?

Wellbutrin contains the active ingredient Bupropion hydrochloride.

• Active ingredient — Bupropion hydrochloride
• Registration number — 45/1.2/0826
• Registration holder — TRINITY PHARMA (PTY) LTD

It is approved for:

• DIRENTO SR 150 mg is used to treat mental depression
• After a satisfactory response, the continuation of treatment with DIRENTO SR 150 mg is effective in preventing relapse and preventing recurrence of further depression episodes

Common side effects of Wellbutrin

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.

Frequent side effects

• loss of appetite (anorexia), weight loss
• sleeplessness, restlessness or anxiety
• headache, feeling shaky (tremor), dizziness, changes in the taste of food
• visual disturbances
• ringing in the ears
• increase in blood pressure, flushing
• dry mouth, nausea, vomiting, stomach pain, constipation
• skin rash (sometimes due to an allergic reaction), itching, sweating
• fever, feeling weak, chest pain

Less frequent side effects

• pain in a joint, pain in a muscle or muscles, fever in association with rash
• changes in blood sugar levels
• feeling confused, depressed, aggressive, hostile, irritable, restless, strange dreams (including nightmares), feeling unreal or strange (depersonalisation); seeing or hearing things that are not there (hallucinations), sensing or believing things that are not true (delusions); severe suspiciousness (paranoia), thoughts of harming or killing one self while taking DIRENTO SR 150 mg or soon after stopping treatment, loss of contact with reality and unable to think or judge clearly (psychosis)
• difficulty with concentration, fits, dystonia, unsteadiness when walking or co-ordination (ataxia), uncontrolled movements, loss of memory, unpleasant tingling feeling in arms or legs (paraesthesia), fainting
• rapid/fast heartbeat
• feeling faint when you stand up suddenly, because your blood pressure falls
• increase in liver enzymes
• severe skin rashes that may affect the mouth and other parts of the body and can be life-threatening
• worsening of psoriasis (thickened patches of red skin)
• twitching
• urinating (passing water) more, or less than usual

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

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.

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 bupropion or any of the other ingredients in the DIRENTO SR 150 mg tablets
• If you have a condition that causes seizures (fits, such as epilepsy, or if you have a history of fits)
• If you are taking any other medicine containing bupropion
• If you are usually a heavy drinker and you have just stopped drinking alcohol or are going to stop while you are taking DIRENTO SR 150 mg tablets
• If you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines or similar medicines) or if you are going to stop them while you are taking DIRENTO SR 150 mg tablets
• If you have an eating disorder or had one in the past (for example bulimia or anorexia nervosa)
• If you are taking medicines for depression called monoamine oxidase inhibitors (MAOIs), or have taken them in the last 14 days
• If you have severe liver disorders, such as cirrhosis
• If you are under the age of 18 years
• If you are pregnant or breastfeeding. If any of these applies to you, talk to your doctor straight away, and do not take DIRENTO SR 150 mg tablets

Use with care, and tell your doctor, if

• Do not take more DIRENTO SR 150 mg tablets than recommended by your doctor as the active ingredient, bupropion, is associated with a dose-related risk of seizures (fits). Seizures (fits) are more likely:
• if you have or had a serious head injury or brain tumour
• if you have a history of seizures (fits)
• if you have taken other medicines that may make seizures more likely
• if you regularly drink a lot of alcohol
• if you use excessive tranquillisers
• if you have diabetes for which you use insulin or antidiabetic medicines
• if you are using brain stimulants or weight-loss products
• If you have a seizure (fit) during treatment: contact your doctor immediately who will advise you how to stop taking DIRENTO SR 150 mg tablets as your condition may have to be monitored. If you have kidney and liver problems, you might need a lower daily dosage. If you feel depressed or suicidal at any time when you are taking DIRENTO SR 150 mg tablets, contact your doctor or go to a hospital immediately. Also, if you feel anxious, have panic attacks, irritable, aggressive, suffer from sleeplessness, or have any other emotional problems, contact your doctor, as your treatment may have to be changed. Brugada syndrome
• if you have a condition called Brugada syndrome (a rare hereditary syndrome that affects the heart rhythm) or if cardiac arrest or sudden death occurred in your family

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 provider for advice before taking this medicine
• Safety in pregnancy and breastfeeding has not been established
• However, DIRENTO SR 150 mg is excreted in breast milk and you should not breastfeed your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• MAO inhibitors (medicines containing moclobemide)
• Orphenadrine, levodopa, amantadine (medicines for Parkinson’s disease)
• Cyclophosphamide, ifosfamide (medicines for treating cancer)
• Desipramine (medicine for depression)
• Carbamazepine, phenobarbitone, phenytoin (to treat epilepsy or some mental health disorders)
• Medicines for treating certain heart conditions
• Medicines called beta-blockers (such as metoprolol which is mainly used to treat high blood pressure)
• Citalopram; also selective serotonin re-uptake inhibitors and tricyclic antidepressants, as well as antipsychotics
• Alcohol
• Nicotine transdermal patches (this may result in your blood pressure going up) DIRENTO SR 150 mg with food and drink: See HOW TO TAKE DIRENTO SR 150 mg

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

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.

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

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

For a fuller walkthrough see how to report an adverse drug reaction.

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