Contrave Side Effects

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

What is Contrave?

Contrave contains the active ingredient Bupropion hydrochloride.

• Active ingredient — Bupropion hydrochloride
• Registration number — 52/11.3/0478
• Registration holder — Acino Pharma (Pty) Ltd

It is approved for:

• Contrave contains 2 active ingredients: naltrexone hydrochloride and bupropion hydrochloride and is used in obese or overweight adults to manage weight together with a reduced calorie diet and physical exercise
• This medicine works on areas on the brain involved in the control of food intake and energy expenditure
• Obesity in adults over 18 years of age is defined as a body mass index of greater than or equal to 30 and overweight in adults over 18 years of age is defined as a body mass index greater than or equal to 27 and less than 30
• The body mass index is calculated as the measured body weight (kg) divided by the measured height squared (m2)

Common side effects of Contrave

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

• feeling sick (nausea), being sick (vomiting)
• pain in the abdomen
• constipation
• headache
• difficulty in sleeping (make sure you do not take Contrave close to bedtime)
• anxiety, agitation
• joint and muscle pain
• low amount of certain white blood cells (lymphocyte count decreased)
• dizziness, feeling of dizziness or “spinning” (vertigo)
• feeling shaky (tremor)
• increased energy, irritability
• feeling depressed, mood disorders
• chills, fever
• decreased appetite, diarrhoea
• changes in the taste of food (dysgeusia), dry mouth, toothache
• difficulty concentrating
• feeling of tiredness (fatigue) and sleepiness, drowsiness or lack of energy (lethargy)
• ringing in the ears (tinnitus)
• fast or irregular heartbeat
• hot flush
• watery eyes
• pain in the upper part of the abdomen
• delayed ejaculation
• chest pain, change to electrocardiogram (record of the electrical activity of the heart)
• excessive sweating (hyperhidrosis)
• hives, rash, itching (pruritus)
• hair loss (alopecia)

Less frequent side effects

• cold sores (oral herpes)
• itching, blisters, cracking, and scaling of the skin between the toes (athlete’s foot or tinea pedis)
• swollen glands in the neck, armpit or groin (lymphadenopathy)
• excessive loss of body water (dehydration)
• loss of appetite (anorexia)
• increased appetite, weight gain
• abnormal dreams, nightmares
• flushing
• feeling nervous, feeling spacey, tension, agitation, mood swings, hallucinations, confusion, severe suspiciousness (paranoia), disorientation
• loss of sexual desire
• tremor of the head or a limb which increases when trying to perform a particular function (intention tremor)
• balance disorder
• loss of memory (amnesia), mental impairment
• almost fainting (presyncope)
• motion sickness
• ear pain, ear discomfort
• visual disturbances, blurred vision, eye irritation, pain or swelling, increased sensitivity to light (photophobia)
• nasal discomfort, congestion, runny nose, sneezing, sinus disorder
• sore throat, increase in mucus that is coughed up, difficulty in breathing, disorder of the voice, cough, yawning
• fluctuating or increased blood pressure (sometimes severe)
• pain in the lower part of the abdomen
• burping
• swelling of the lips
• passage of fresh blood through the anus usually in or with stool (haematochezia)
• projection of an organ or the tissue encompassing an organ through the wall of the cavity that normally contains it (hernia)
• passing wind (flatulence), haemorrhoids, ulcer, cavities
• inflammation of the gallbladder (cholecystitis)
• a problem with the spine where supporting disc between two bones (vertebra) bulges out (intervertebral disc protrusion)
• jaw and groin pain
• a disorder characterised by a sudden compelling urge to urinate (micturition urgency), abnormally frequent urination, painful urination
• irregular menstrual cycle, vaginal bleeding, dryness of the female vulva and vagina
• difficulty in getting or keeping an erection
• feeling abnormal, weakness (asthenia)
• thirst, feeling hot
• coldness of extremities (hands, feet)
• increased creatinine levels in the blood (indicating loss of kidney function)
• increased liver enzymes and bilirubin levels, liver disorders, hepatitis
• decreased haematocrit (indicating loss of red blood cell volume)
• acne, oily skin
• unusual bleeding or bruising under the skin
• changes in blood sugar levels
• feeling irritable or hostile
• suicidal thoughts, suicide attempts, feeling of observing yourself from outside your body or sense of unreality of surroundings (depersonalisation)
• muscle stiffness, uncontrolled movements, problems with walking or coordination
• memory impairment
• fainting, loss of consciousness
• tingling or numbness of the hands or feet
• widening of blood vessels, low blood pressure when you stand up from sitting or lying down (postural hypotension)
• your skin or the whites of your eyes turning yellow (jaundice)
• erythema multiforme (a severe condition of the skin that may affect the mouth and other parts of the body, with red, often itchy spots starting on the limbs), Stevens Johnson Syndrome (a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals)
• worsening of psoriasis (thickened patches of red skin)
• muscle twitching
• urinary retention
• fixed, irrational ideas (delusions), aggression, abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis). Frequency cannot be estimated for the following side effects:
• psychosis
• abdominal discomfort
• indigestion
• rash
• an inflammatory disease caused when the immune system attacks its own tissues (lupus)
• increased blood pressure
• Feeling of acute and disabling anxiety (panic attack)

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 naltrexone, to bupropion or to any of the other ingredients Contrave (listed in section 6)
• if you have an abnormally high blood pressure (hypertension) that is not controlled using a medicinal product
• if you have a condition that causes fits (seizures) or if you have a history of fits
• if you have a brain tumour
• if you are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you are taking Contrave
• if you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines), or if you are going to stop them while you are taking Contrave
• if you have a bipolar disorder (extreme mood swings)
• if you are using any other medicines which contain bupropion or naltrexone
• if you have an eating disorder or had one in the past (for example, bulimia or anorexia nervosa)
• if you are currently dependent on chronic opiates or opiate agonists (for example methadone), or you are going through acute withdrawal (cold turkey)
• if you are taking medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days
• if you have severe liver disease
• if you have end stage kidney disease
• if you are under 18 years of age

Use with care, and tell your doctor, if

• if you feel depressed, consider suicide, have a history of attempting suicide, panic attacks or any other mental health problems, you should inform your doctor before taking this medicine
• if you have seizures (fits). Contrave has been shown to cause fits in up to 1 in 1000 patients. If you have a fit (seizure), you should stop taking Contrave and consult your doctor immediately
• if you have had a serious head injury or head trauma
• if you regularly drink alcohol
• if you regularly use medicines to help you to sleep (sedatives)
• if you are currently dependent on or addicted to cocaine or other stimulating products
• if you have diabetes and use insulin or oral medicines that may lower sugar levels in your blood (hypoglycaemia)
• if you have a heart condition and are currently taking medicines such as digoxin
• if you are taking medicines that may increase the risk of fits. You should stop taking Contrave immediately and consult your doctor if you are experiencing any symptoms of an allergic reaction such as swelling of the throat, tongue, lips, or face, difficulty swallowing or breathing, dizziness, fever, rash, pain in the joints or in the muscles, itching or hives after taking this medicine. You should talk to your doctor if:
• you have high blood pressure before taking Contrave, because it can become worse. You will have your blood pressure and heart rate measured before you start taking Contrave and while you are taking it. If your blood pressure or heart rate increases significantly, you may need to stop taking Contrave
• you have uncontrolled coronary artery disease (a heart disease caused by poor blood flow in the blood vessels of the heart) with symptoms such as angina (characterised by chest pain) or a recent heart attack
• you already have or have had a condition affecting the circulation of blood in the brain (cerebrovascular disease)
• you have any liver problems before you start Contrave
• you have any kidney problems before you start Contrave
• you have a history of mania (feeling elated or over-excited, which causes unusual behaviour)
• If you are taking medicines for depression, the use of these medicines together with CONTRAVE can lead to serotonin syndrome, a potentially life-threatening condition 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. Older People Use caution when taking Contrave, if you are 65 years or older. Contrave is not recommended if you are over 75 years. Children and adolescents No studies have been conducted in children and adolescents under the age of 18. Therefore Contrave should not be used in children and adolescents below 18 years

Pregnancy and breastfeeding

• Contrave should not be used during pregnancy, or while breast-feeding
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Interactions and medicines to check

The approved leaflet names these interactions.

• Monoamine oxidase inhibitors (medicines to treat depression or Parkinson’s disease) such as phenelzine, selegiline, or rasagiline. You must stop taking these medicines for at least 14 days before starting Contrave
• Opiates and opiate-containing medicines for example to treat cough and cold (such as mixtures containing dextromethorphan or codeine), opiate addiction (such as methadone), pain (for example, morphine and codeine), diarrhoea (for example, peregoric). You must have stopped taking any opiate medicines at least 7-10 days before starting Contrave. Your doctor may carry out a blood test to ensure that your body has cleared these medicines before starting your treatment. Naltrexone blocks the effects of opiates; if you take higher doses of opiates to overcome these effects of naltrexone, you may suffer from an acute opiate intoxication which may be life threatening. After you stop treatment with Contrave you may be more sensitive to low doses of opiates. Tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects:
• Medicines that may, when used alone or in combination with naltrexone/bupropion, increase the risk of fits such as:
• medicines for depression and other mental health problems
• steroids (except drops, creams, or lotions for eye and skin conditions or inhalers for breathing disorders such as asthma)
• medicines used to prevent malaria
• quinolones (antibiotics such as ciprofloxacin to treat infections)
• tramadol (a painkiller belonging to the class of opiates)
• theophylline (used in the treatment of asthma)
• antihistamines (medicines to treat hayfever, itch, and other allergic reactions) that cause sleepiness (such as chlorphenamine)
• medicines to lower sugar levels in your blood (such as insulin, sulphonylureas such as glyburide or glibenclamide, and meglitinides such as nateglinide or repaglinide)
• medicines to help you to sleep (sedatives such as diazepam)
• Medicines to treat depression (such as amitriptyline, desipramine, imipramine, venlafaxine, paroxetine, fluoxetine, citalopram, escitalopram) or other mental health problems (such as risperidone, haloperidol, thioridazine). CONTRAVE may interact with some medicines used for treatment of depression and you may experience a so-called serotonin syndrome. Symptoms are mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea)
• Some medicines used to treat high blood pressure (beta-blockers such as metoprolol, and clonidine, a centrally acting antihypertensive)
• Some medicines used to treat irregular heart rhythm (such as propafenone, flecainide)
• Some medicines used to treat cancer (such as cyclophospamide, ifosphamide, tamoxifen)
• Some medicines for Parkinson’s disease (such as levodopa, amantadine or orphenadrine)
• Ticlopidine or clopidogrel, mainly used in the treatment of heart disease or stroke
• Medicines used in the treatment of HIV infection and AIDS, such as efavirenz and ritonavir
• Medicines used to treat epilepsy such as valproate, carbamazepine, phenytoin or phenobarbital. Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicines or CONTRAVE. CONTRAVE may make other medicines less effective when taken at the same time:
• If you take digoxin for your heart If this applies to you, tell your doctor. Your doctor may consider adjusting the dose of digoxin. Contrave with alcohol Excessive use of alcohol while being treated with Contrave might increase the risk for fits (seizures), mental disorder events or might reduce alcohol tolerance. Your doctor may suggest you do not drink alcohol while you are taking Contrave, or try to drink as little as possible. If you do drink a lot now, do not just stop suddenly, because that may put you at risk of having a fit

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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