Antidepressants Side Effects

Home › Medicine Side Effects › antidepressants

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

Part of mental health medication side effects side effects.

What is antidepressants?

Antidepressants covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• fluoxetine — LORIEN, PHARMACARE LIMITED (Capsules)
• sertraline — SERTRALINE UNICORN, Camox Pharmaceuticals (Pty) Ltd (Film-coated tablets)
• citalopram — CILORAM 20 mg, Novagen Pharma (Pty) Ltd (Film-coated tablets)
• escitalopram — LEXAMIL, CIPLA MEDPRO (PTY) LTD (Tablets)
• paroxetine — SERRAPRESS 20, Pharma Dynamics (Pty) Ltd (Film coated tablets)
• venlafaxine — VENLOR XR, CIPLA MEDPRO (PTY) LTD. (Extended-release capsules)
• amitriptyline — AMDERIP 10/25/50, Strides Pharma SA (Pty) Ltd (Tablet)
• bupropion — CONTRAVE, Acino Pharma (Pty) Ltd (Prolonged-release tablet.)
• mirtazapine — MIRTAZAPINE 15 VIATRIS, MIRTAZAPINE 30 VIATRIS, Viatris South Africa (Pty) Ltd (Film-coated tablets.)
• trazodone — BIOTECH TRAZODONE, Biotech Laboratories (Capsules)
• duloxetine — Duloxetine XR 30 & 60 Biotech, Biotech Laboratories (Pty) Ltd (Gastro-resistant capsules)

Common side effects of antidepressants

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Fluoxetine (LORIEN)

• sleep problems
• headache
• feeling sick (nausea)
• diarrhoea
• tiredness
• not feeling hungry, weight loss
• nervousness, anxiety
• restlessness, poor concentration
• feeling tense
• decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)
• increased appetite, increase in weight
• unusual dreams

The leaflet lists 57 more. Read the full leaflet.

Sertraline (SERTRALINE UNICORN)

• chest cold, sore throat, runny nose
• decreased appetite, increased appetite
• difficulty sleeping, anxiety, depression, agitation, decreased sexual interest, nervousness, feeling strange, nightmare, teeth grinding
• dizziness, headache, sleepiness, lack of attention
• abnormal taste
• visual disturbance
• ringing in ears
• feeling like your heart is beating too hard or too fast, skipping a beat, or fluttering (palpitations)
• hot flush
• yawning
• nausea (feeling sick), upset stomach (diarrhoea), dry mouth, indigestion, constipation, abdominal pain, vomiting (being sick), gas
• increased sweating

The leaflet lists 46 more. Read the full leaflet.

Citalopram (CILORAM 20 mg)

• Sexual dysfunction such as decreased libido, problems with ejaculation, inability to orgasm
• Sleep disturbances including abnormal dreams and difficulty sleeping
• Agitation, anxiety, nervousness, and confusion
• Headache and migraine
• “Pins and needles” feeling through your body
• Shaking (‘tremors’)
• Dizziness
• Impaired concentration
• Forgetfulness
• Lack of enthusiasm
• Extreme tiredness, lack of energy (fatigue)
• Ringing in the ears

The leaflet lists 47 more. Read the full leaflet.

Escitalopram (LEXAMIL)

• Decreased or increased appetite, weight gain
• Anxiety, restlessness, abnormal dreams, decreased libido or inability to reach orgasm.
• Headache
• Inability to sleep or excessive sleepiness, dizziness, or tremor
• Pain over the sinuses with blocked or runny nose
• Nausea, runny stomach, constipation, vomiting or dry mouth
• Muscle or joint pain
• Ejaculation disorder or impotence
• Yawning
• Increased sweating
• Fatigue
• Heavy menstruation or more frequent menstruation

The leaflet lists 7 more. Read the full leaflet.

Paroxetine (SERRAPRESS 20)

• increased or decreased appetite, weight gain, anorexia, increased risk of abdominal bleeding, increased or decreased blood sugar levels, increased cholesterol levels
• not sleeping well (insomnia) or feeling sleepy, agitation
• drowsiness, feeling dizzy or shaky (tremors), twitching, headache, fatigue
• blurred or abnormal vision
• yawning
• constipation, diarrhoea, dry mouth, nausea, vomiting, indigestion, abdominal pain, excessive gas (wind), heart burn, stomach pain, feeling bloated
• excessive sweating
• sexual dysfunction
• bruising
• feeling confused, having hallucinations (strange visions or sounds), memory loss, impaired concentration, feeling anxious (especially children), depersonalisation (a feeling where your thoughts and feelings seem unreal or not to belong to yourself), panic attacks, inability to sit still, manic reactions
• migraine (very severe headache), restlessness, nervousness, abnormal dreams, an abnormal sensation, typically tingly or prickly (“pins and needles”), overactive/over- responsive muscle reflexes, jerking of the muscles
• anisocria (characterised by unequal size of the eye pupil), mydriasis (dilation of the pupil of the eye)

The leaflet lists 10 more. Read the full leaflet.

Venlafaxine (VENLOR XR)

• increased cholesterol, loss of appetite, weight loss
• abnormal dreams, nervousness, unable to sleep, lower sex drive, anxiety, agitation, feeling like you are observing yourself from outside your body
• inability to change eye focus, dilated pupils, visual disturbances
• ringing in the ears
• irregular heartbeats you can feel, fast heartrate/pulse
• high blood pressure, hot flushes
• yawning
• decreased appetite, constipation, nausea, vomiting, loss of appetite, (diarrhoea) frequent loose watery stools, which can cause dehydration and may require hospitalisation and treatment with intravenous fluids, gas, upset stomach, abdominal pain, dry mouth
• joint pain, increased muscle tone/muscle stiffness, numbness/tingling in the hands or feet, muscle aches
• inability to pass urine, difficulties passing urine, more frequent urination
• abnormal ejaculation/orgasm (males), inability to achieve an orgasm, erectile dysfunction, sexual dysfunction
• excessive sweating (including night sweats)

The leaflet lists 22 more. Read the full leaflet.

Amitriptyline (AMDERIP 10/25/50)

• Drowsiness or sleepiness
• Blurred vision, increased pressure in the eye or difficulty focusing when looking at an object (accommodation disturbances)
• Constipation
• Dry mouth
• Body temperature rises above normal (hyperthermia)
• Skin rash that looks like pale red itchy bumps (urticaria)
• Reaction of skin to sunlight
• Inadequate secretion of ADH (antidiuretic hormone) causing you to urinate more often, changes in blood sugar level and blood sodium levels
• Dizziness, headache, weakness, numbness or pain in hands or feet, pins and needles, lack of coordination, unsteady body movement (ataxia), tremors (shaking), fits, stiff or jerky movements of your face and body that you can’t control
• Enlarged (dilated) pupil of the eyes
• Confusion, not knowing where you are (disorientation), agitation, feeling anxious, restlessness, difficulty sleeping, nightmares, unable to concentrate
• Suicidal thoughts or behavior, changes in behavior

The leaflet lists 9 more. Read the full leaflet.

Bupropion (CONTRAVE)

• 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

The leaflet lists 76 more. Read the full leaflet.

Mirtazapine (MIRTAZAPINE 15 VIATRIS, MIRTAZAPINE 30 VIATRIS)

• abnormal dreams
• confusion
• anxiety
• trouble falling or staying asleep (insomnia)
• nightmares
• drowsiness, sleepiness
• dizziness
• headache
• involuntary shaking (tremor)
• lack of energy and enthusiasm
• memory loss
• increase in appetite and weight gain

The leaflet lists 33 more. Read the full leaflet.

Trazodone (BIOTECH TRAZODONE)

• headache
• dizziness
• drowsiness
• nausea
• vomiting
• dry mouth, an unpleasant taste
• confusion
• unusual excitement
• low blood pressure
• tremors
• blurred vision
• constipation

The leaflet lists 43 more. Read the full leaflet.

Duloxetine (Duloxetine XR 30 & 60 Biotech)

• Lack of appetite
• Trouble sleeping, feeling agitated, feeling anxious, less sex drive and difficulty or failure to experience orgasm, unusual dreams
• Dizziness, headache, feeling sluggish, tremor, numbness, pricking or tingling of the skin
• Blurred eyesight
• Tinnitus (ringing or buzzing noise in one or both ears)
• Increase in blood pressure
• Flushing
• Yawning
• Constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind
• Increased sweating, (itchy) rash
• Muscle pain, muscle spasm
• Painful urination, frequent urination

The leaflet lists 27 more. Read the full leaflet.

Serious side effects and warning signs

Effects the leaflets single out as needing prompt attention.

Escitalopram (LEXAMIL)

• Severe allergic reactions presenting with shortness of breath, hives or itching, swelling of the face, tongue, or whole body, tightness of the chest, nausea, vomiting or fever.
• Any combination of the following: rapidly developing changes in consciousness or alertness with confusion, elevated mood, agitation, hyperactive behaviour, shivering, fever, tremor, abnormal eye movements, severe muscle spasms, and inability to co-ordinate movements. These symptoms may be due to serotonin syndrome (see “Take special care with LEXAMIL”).
• Vomiting of blood or a substance that resembles coffee-grounds, or passing blood per rectum or passing black, tarry, foul-smelling stools.
• Confusion, aggression, personality changes or hallucinations (seeing or hearing things that are not real).
• Slow heart rate or palpitations
• Convulsions (seizures)
• Yellow discolouration of the skin or whites of the eyes accompanied by loss of appetite, nausea and/or vomiting with or without pain over the liver area.
• Pinpoint red spots on the skin, easy bruising, bleeding from the gums or blood in the urine, since any combination of these symptoms may be due to low platelet counts.

The leaflet lists 3 more. Read the full leaflet.

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

Cautions from each medicine’s approved leaflet.

Fluoxetine (LORIEN)

Do not use it at all if:

• if you are hypersensitive(allergic) to fluoxetine or any of the other ingredients of LORIEN (listed in section 6 )
• if you have severe kidney failure
• if you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately
• if you are taking other medicines used to treat depression, known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include medicines used to treat depression such as selegiline, moclobemide, phenelzine nialamide, iproniazid, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone and also linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood).or even fatal reactions can occur. Treatment with LORIEN should only be started 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). However, treatment with LORIEN can be started the following day after discontinuation of certain reversible non-selective MAOIs (for instance moclobemide). Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking LORIEN. If LORIEN has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor
• if you are taking thioridazine or have taken it in the past 5 weeks. Do not take thioridazine for at least 5 weeks after you stop taking LORIEN
• if you are under the age of 18 years

Use with care, and tell your doctor, if:

• if you have epilepsy or seizures or experience an increase in seizure frequency, contact your doctor immediately; LORIEN might need to be discontinued
• if you have an episode of excessively intense enthusiasm, interest, or desire (mania) now or in the past; if you have a manic episode, contact your doctor immediately because LORIEN might need to be discontinued
• if you have diabetes (your doctor may need to adjust your dose of insulin or another antidiabetic treatment)
• if you have liver problems (your doctor may need to adjust your dosage)
• if you have heart problems
• if you have a low resting heart rate and/or if you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)

Sertraline (SERTRALINE UNICORN)

Do not use it at all if:

• are hypersensitive (allergic) to sertraline or any of the other ingredients of SERTRALINE UNICORN (listed in section 6)
• are taking any medicines called monoamine oxidase inhibitors (MAOIs), including the antibiotic linezolid
• are taking any medicine called pimozide used to treat certain kinds of mental illness
• are under 18 years old and suffering from both a condition called obsessive- compulsive disorder along with depression
• suffer from liver or kidney impairment
• are pregnant or are breastfeeding

Use with care, and tell your doctor, if:

• have suffered from serotonin syndrome (SS) (life-threatening medicine reaction) or neuroleptic malignant syndrome (NMS) (neurological disorder) after taking certain medicines including amphetamines, triptans, fentanyl, tramadol, dextromethorphan, tapentadol, meperidine, methadone and pentazocine, MAOIs, antipsychotics and other dopamine antagonists The symptoms of SS and NMS can include mental status changes (e.g. agitation, confusion, hallucinations, coma), damage to the nervous system (e.g. a pounding headache, fast heartbeat, low blood pressure, excessive and dangerously high body temperature, flushing of the skin, profuse sweating), abnormal muscle movements (e.g. twitching, muscle spasms, stiffness, lack of coordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) and can be life-threatening. Your doctor may wish to stop your treatment
• are taking, or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs), like selegiline (to treat Parkinson’s disease), moclobemide (to treat depression), linezolid (an antibiotic) and methylene blue
• have or have had thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour
• have a history of bleeding disorders (this is usually seen in an increased tendency to develop bruises in illnesses like von Willebrand disease, haemophilia A, deficiency in F VIII, and haemophilia B) or if you have any of the following conditions along with a bleeding disorder (e.g. multiple pregnancy, gestational hypertension or preeclampsia), or if you are pregnant or have been taking medicines which thin the blood (e.g. acetylsalicylic acid (aspirin), or warfarin) which may increase the risk of bleeding
• have taken medicines such as amphetamines, tryptophan, fentanyl or St. John’s Wort (herbal medicine)
• have suffered from symptoms including fast heartbeat or loss of consciousness, or have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval, or experienced a specific type of abnormal heart rhythm that can lead to sudden cardiac death (Torsades de pointes)

Citalopram (CILORAM 20 mg)

Do not use it at all if:

• if you are hypersensitive (allergic) to citalopram hydrobromide or any of the other ingredients of CILORAM
• if you have severely impaired kidney function (creatinine clearance of less than 30 ml/min)
• if you have an inborn heart condition where you may have irregular heartbeats (QT-prolongation)
• if you are taking a medicine called ‘pimozide’
• if you are taking medicines that fall into the class of monoamine oxidase inhibitors (MAOIs). MAOI include medicine such selegiline (used in the treatment of Parkinson’s disease) and moclobemide (used for treating depression). At least 14 days should pass between stopping the MAOI medicine and starting with CILORAM. MAOIs should not be taken for 7 days after you stop taking CILORAM
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if:

• if you have previously had thoughts about killing or harming yourself
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. Paradoxical anxiety If you suffer from panic disorder, you may experience increased anxiety symptoms at the start of the treatment with CILORAM. These symptoms will usually go away within the first two weeks of starting treatment. It may also be helpful to start with a low dose. Hyponatraemia (low sodium) Low sodium blood levels may develop if you are using CILORAM. Sodium levels will return to normal when CILORAM is stopped. Female patients are at a higher risk for developing low sodium. Akathisia/psychomotor restlessness (movement disorder) The use of CILORAM may lead to the development of a feeling of muscle quivering, restlessness and inability to sit still. The dose of CILORAM may not be increased if you develop any of these symptoms. Use in children and adolescents under 18 years of age CILORAM should not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side-effects such as suicide attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger) when they take this class of medicines. There are also no long-term safety data available to know what the effect CILORAM therapy will be on the growth and mental developing of children and adolescents. QT-Prolongation and torsades de pointes CILORAM causes dose-dependent QT prolongation (extended interval between the heart contracting and relaxing) and should not be used if you suffer from a heartbeat condition called ‘long QT syndrome’. CILORAM may also cause abnormal heart rhythm (torsades de pointes), mostly occurring in female patients with low potassium levels or a pre-existing QT-prolongation or other heart diseases. Caution if advised if you have a slow heart rate or if you recently had a heart attack or heart failure. If you suffer from a disease or condition which causes lower than normal potassium or magnesium levels in your blood it increases the risk of developing irregular heartbeats. Your potassium and magnesium levels must first be corrected before you start taking CILORAM. If you suffer from congestive heart failure, slow heartbeats or if you are taking any other medication that affects your heartbeat, you need to be monitored closely by your doctor and undergo regular ECG monitoring. Haemorrhage (bleeding inside the body) CILORAM may increase the risk of heavy vaginal bleeding shortly after birth (postpartum haemorrhage). There have been reports of bleeding tendencies. You should be careful if you use CILORAM together with other medication that affects bleeding or if you have a history of bleeding disorders. Withdrawal symptoms If you use CILORAM for a long period, sudden discontinuation of CILORAM may result in withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, agitation, anxiety nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability and visual disturbances. Treatment should be gradually tapered off over a period of several weeks or months to avoid withdrawal symptoms. Angle-Closure Glaucoma CILORAM may cause extended dilation of the pupil which may lead to blocked drainage canals in the eye, resulting in sudden rise in intra-eye pressure (‘narrow-angle glaucoma’). Take special care if you have or have previously had eye problems, such as certain kinds of glaucoma (increased pressure in the eye). St. John’s Wort Taking St. John’s Wort (a plant used for mental health conditions) together with CILORAM may result in undesirable effects. Sexual dysfunction Taking CILORAM may cause symptoms of sexual dysfunction. Special information relating to your disease Improvement is not achieved immediately. After the start of CILORAM treatment it may take several weeks before you experience any improvement. In the treatment of panic disorder it usually takes 3 months before any improvement is seen. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during the continued treatment. Therefore, it is very important that you follow exactly your doctor’s orders and do not stop the treatment or change the dose without consulting your doctor. Occasionally, the symptoms of depression or panic disorder may include thoughts of suicide or self-harm. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes apparent
• This is more likely to occur if you are a young adult, i.e., under 25 years of age and you have not used antidepressant medicines before. Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness, and excessive physical activity. If you experience this, contact your doctor. Symptoms such as restlessness or difficulty to sit or stand still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms. Sometimes you may be unaware of the above-mentioned symptoms and therefore you may find it helpful to ask a friend of relative to help you to observe the possible signs of change in your behaviour. Tell your doctor immediately or contact the nearest hospital if you have distressing thoughts or experiences or if any of the above-mentioned symptoms occurs during the treatment

Escitalopram (LEXAMIL)

Do not use it at all if:

• If you are allergic (hypersensitive) to escitalopram oxalate or to any of the inactive ingredients of LEXAMIL. Please discuss this with your doctor or pharmacist if you are unsure
• If you are younger than 18 years of age, as safety and efficacy in children have not been proven
• If you are also taking monoamine oxidase inhibitors (MAOIs) for the treatment of depression or other mood disorders. Please speak to your doctor or pharmacist if you are unsure
• If you are taking linezolid, an antibiotic
• If you have been diagnosed with an abnormal heart rhythm or heart block or if you have previously been told that the medicines you are using may slow your heart rate

Use with care, and tell your doctor, if:

• Previously been diagnosed with mania or manic episodes
• Seizures (convulsions) or epilepsy
• Diabetes mellitus
• You think about suicide
• Previously been diagnosed with a bleeding disorder. Please inform your doctor immediately if you develop bruising, blood in the urine, bleeding from the gums, or pinpoint red spots on the skin while taking LEXAMIL
• You are scheduled to undergo electroconvulsive therapy (ECT)

Paroxetine (SERRAPRESS 20)

Do not use it at all if:

• if you are hypersensitive (allergic) to paroxetine, or to any of the ingredients of SERRAPRESS 20
• if you are taking other medicines for depression called monoamine oxidase inhibitors (MAOls, including moclobemide and linezolid), or have taken them at any time within the last two weeks. Your doctor will advise you how you should begin taking SERRAPRESS 20 once you have stopped taking the MAOI. You should also not start taking MAO inhibitors for two weeks after SERRAPRESS 20 treatment is terminated
• SERRAPRESS 20 should not be used for children and adolescents under the age of 18 years
• if you have epilepsy or a history of seizures / fits
• if you are taking a medicine containing pimozide or thioridazine (to treat a mental disorder), as SERRAPRESS 20 may cause a serious irregular heart beat which can be fatal when taken in combination with these medicines
• if you have porphyria (an enzyme disorder with symptoms such as severe abdominal pain, pain in your chest, back or legs, vomiting or a rapid heartbeat

Use with care, and tell your doctor, if:

• if you are an adolescent or young adult aged less than 18 years
• if you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines take time to work (usually about two weeks but sometimes longer)
• if you have previously had thoughts about killing or harming yourself
• your doctor will monitor your treatment and your progress carefully for the first few weeks. If you have any thoughts of harming or killing yourself at any time, contact your doctor immediately or go to a hospital straight away
• do not stop taking SERRAPRESS 20 without telling your doctor. If you stop taking your SERRAPRESS 20 film coated tablets suddenly, you may experience withdrawal effects
• if you suffer from epilepsy or seizures (fits)

Venlafaxine (VENLOR XR)

Do not use it at all if:

• if you are hypersensitive (allergic) to venlafaxine hydrochloride or any of the other ingredients of VENLOR XR TABLET (listed in section 6)
• if you are currently being treated with medicines which fall under a class called monoamine oxidase inhibitors (such as moclobemide)
• if you have stopped taking a medicine which falls under the class of monoamine oxidase inhibitors in less than 14 days
• if you are less than 18 years of age
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if:

• if you have been diagnosed with major depressive disorder
• if you have been diagnosed with an eye condition called glaucoma
• if you have a heart condition
• if you have high blood pressure
• if you have a history of seizures (fits)
• if you have a history or family history of a mood disorder

Amitriptyline (AMDERIP 10/25/50)

Do not use it at all if:

• If you are allergic (hypersensitive) to amitriptyline hydrochloride or any of the other ingredients of AMDERIP (listed in section 6)
• if you recently had a heart attack
• if you have heart disease, heart failure or irregular heartbeats
• if you are taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within the last 14 days, such as selegiline
• if you are taking linezolid which is an antibiotic
• if you are taking medicines for the treatment high blood pressure, such as amlodipine, nifedipine

Use with care, and tell your doctor, if:

• If you experience dry mouth, constipation, difficulty urinating and blurred vision or vision problems, you should consult your doctor
• If you have drowsiness, agitation, restlessness, difficulty sleeping (insomnia) and restlessness
• If you have high blood pressure (hypertension) or a heart condition/disorder
• If you have high blood sugar levels (diabetes)
• If you experience changes in your sex drive (libido), interference with sexual function, swelling of breasts in women, breast swelling in men (gynaecomastia) and flow of milk from breast when not breastfeeding (galactorrhoea)
• If you have a psychiatric disorder (depression or mania)

Bupropion (CONTRAVE)

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

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

Mirtazapine (MIRTAZAPINE 15 VIATRIS, MIRTAZAPINE 30 VIATRIS)

Do not use it at all if:

• If you are hypersensitive (allergic) to mirtazapine or any of the other ingredients of MIRTAZAPINE VIATRIS (listed in section 6)
• If you are pregnant or breastfeeding
• If you are a child and under 18 years old
• If you are taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAOIs)

Use with care, and tell your doctor, if:

• if you have previously had thoughts about killing or harming yourself
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour. Also take special care with MIRTAZAPINE VIATRIS If you have, or have ever had one of the following conditions:
• seizures (epilepsy). If you develop seizures or your seizures become more frequent, stop taking MIRTAZAPINE VIATRIS and contact your doctor immediately
• serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of MIRTAZAPINE VIATRIS
• Stop taking MIRTAZAPINE VIATRIS and seek medical attention immediately if you notice any of the symptoms described in section 4 in relation to these skin reactions. If you ever developed any severe skin reactions, treatment with MIRTAZAPINE VIATRIS should not be restarted
• liver disease, including jaundice. If jaundice occurs, stop taking MIRTAZAPINE VIATRIS and contact your doctor immediately

Trazodone (BIOTECH TRAZODONE)

Do not use it at all if:

• if you are hypersensitive (allergic) to trazodone hydrochloride or any of the other ingredients of BIOTECH TRAZODONE (listed in section 6)
• if you are recovering from a myocardial infarction (heart attack)
• if you are a heavy drinker or are taking any other antidepressants or sleeping tablets
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if:

• If you have thoughts of harming or killing yourself. These thoughts may be increased when first starting treatment, since BIOTECH TRAZODONE takes time to work, usually about two weeks but sometimes longer. You may be more likely to think like this
• If you have previously had thoughts about killing or harming yourself
• If you are a young adult. There is an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. Also tell your doctor:
• If you have heart problems such as coronary artery disease (condition that affects the supply of blood to the heart) and problems with the heart rhythm
• If you suffer from epilepsy (fits or seizures)
• If you have severe kidney or liver problems

Duloxetine (Duloxetine XR 30 & 60 Biotech)

Do not use it at all if:

• Are hypersensitive (allergic) to duloxetine hydrochloride or any of the other ingredients of DULOXETINE XR BIOTECH (listed in section 6 of this leaflet)
• Are pregnant or breastfeeding
• Have severe liver disease
• Have severe kidney disease
• Are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI). DULOXETINE XR BIOTECH should not be used in children under 18 years of age as safety has not been established

Use with care, and tell your doctor, if:

• Have had seizures (fits)
• Have had mania or suffer from bipolar disorder
• Have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
• Suffer from hypertension or cardiac disease. Your doctor will tell you how to take DULOXETINE XR BIOTECH. Your doctor may also recommend you to monitor your blood pressure more frequently, while taking DULOXETINE XR BIOTECH
• Have liver or kidney disease
• Are taking St John’s wort (Hypericum perforatum), a herbal medicine used to treat depression

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.

Related pages

• Lexamil side effects
• minoxidil side effects

← Back to more medicine side effects.