Sertraline Side Effects

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Answer the side-effect intent for sertraline 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 sertraline?

Sertraline contains the active ingredient Sertraline hydrochloride.

• Active ingredient — Sertraline hydrochloride
• Registration number — A38/1.2/0618; A38/1.2/0619
• Registration holder — Camox Pharmaceuticals (Pty) Ltd

It is approved for:

• Depression and recurrence of depression in adults
• Obsessive-compulsive disorder (OCD) in adults and children aged 13 – 17 years
• Panic disorder with or without agoraphobia (fear of open places) in adults. Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to. OCD and panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions). Your doctor has decided that this medicine is suitable for treating your illness. You should ask your doctor if you are unsure why you have been given SERTRALINE UNICORN

Common side effects of sertraline

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

• 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
• skin rash
• back pain, joint pain, muscle pain
• tiredness and a feeling of overall discomfort, illness, or generally not feeling well, chest pain, weakness, fever
• weight increased
• injury

Less frequent side effects

• inflammation and irritation of your stomach and intestines (gastroenteritis)
• inflammation of the middle ear
• intestinal pain, due to inflammation of the intestine lining, which may be constant and persist for several days, usually in the lower left side of the abdomen, nausea, vomiting, fever, abdominal tenderness, constipation and less commonly, diarrhoea
• enlargement of one or more lymph nodes, the bean-shaped glands found in the neck, armpits, chest, groin and abdomen
• seasonal allergy
• thinking abnormal, lack of caring, sleep walking
• sexual problems in men and women (such as premature ejaculation and sexual dysfunction)
• a partial or total loss of memory (amnesia), decreased feeling, involuntary muscle contractions, passing out, moving a lot, migraine, dizziness while standing up, abnormal coordination, speech disorder
• excessive physical sensitivity, especially of the skin
• enlarged pupils, a partial loss of vision or blind spot in an otherwise normal visual field, double vision, light sensitivity, accumulation of blood in the space between the cornea (front clear surface of the eye) and iris (coloured part of the eye), problems with tear production and drainage
• ear pain
• high blood pressure, flushing, blood in urine
• deficient blood distribution to the limbs which may cause symptoms such as painful cramping in one or both of your hips, thighs or calf muscles after certain activities, leg numbness or weakness, coldness in your lower leg or foot, sores on your toes, feet or legs that won’t heal
• nose bleeds
• breathing fast, closing up of throat, a harsh vibrating noise when breathing, caused by obstruction of the windpipe, involuntary spasms in the muscles of the voice box causing the voice to break and have a tight, strained or strangled sound, difficulty talking, breathing slow, hiccups
• inflammation and/or sores (ulceration) of the mouth or tongue
• tooth disorder
• inflammation of the oesophagus (the part of the alimentary canal which connects the throat to the stomach)
• difficulty swallowing, increased saliva
• tongue disorder
• burping
• a swollen vein or group of veins in the region of the anus (haemorrhoids), rectal bleeding when blood passes from the rectum or anus. The bleeding may be noted on the stool or be seen as blood on toilet paper or in the toilet. The blood may be bright red
• swelling around the eyes, hair loss, itching, redness and swelling of the skin, dry skin, swelling of the face, cold sweat, skin sensitivity to sunlight, abnormal hair texture and skin odour, rash that occurs in the hair follicles
• frequent, abnormal urination during the day or night
• production of abnormally large volumes of dilute urine
• production of less urine than what is normal for you
• muscle cramps, twitching and weakness
• genital discharge
• swelling of your lower legs or hands
• chills
• thirst
• decreased medicine tolerance
• increased liver enzymes
• decreased weight
• abnormal semen
• increased blood cholesterol
• abnormal laboratory readings
• abnormal platelet function test
• relaxation of blood vessels procedure. Side effects with frequency unknown:
• lockjaw i.e., the uncontrolled inability to open the mouth or jaw
• bedwetting

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

• 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)
• you have heart disease, low potassium levels or low magnesium levels, family history of QT prolongation, low heart rate and concomitant use of medications which prolong QT interval
• unexpected and abnormal bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or a rash of purple spots on the skin caused by internal bleeding from small blood vessels (purpura) to life-threatening bleeding from ruptured blood vessels in big organs (e.g. in your brain, stomach, intestines etc) where massive blood loss can lead to death
• are switching from another antidepressant medicine or anti-obsessional medicine (used to treat OCD)
• have suffered from a manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately
• have epileptic fits or a history of seizures. If you have a fit (seizure), contact your doctor immediately
• experience symptoms of sexual dysfunction. In some cases, these symptoms have continued after stopping treatment
• have low sodium level in your blood, since this can occur as a result of treatment with SERTRALINE UNICORN. You should also tell your doctor if you are taking certain medicines for hypertension, since these medicines may also alter the sodium level in your blood
• are elderly as you may be more at risk of having low sodium level in your blood
• experience side-effects when stopping treatment (withdrawal reactions). These side-effects are common, particularly if the treatment is stopped suddenly. The risk of withdrawal symptoms depends on the length of treatment, dosage, and the rate at which the dose is reduced. Generally, such symptoms are mild to moderate. However, they can be serious in some patients. They normally occur within the first few days after stopping treatment. In general, such symptoms disappear on their own and wear off within 2 weeks. In some patients they may last longer (2 – 3 months or more). When stopping treatment with SERTRALINE UNICORN, it is recommended to reduce the dose gradually over a period of several weeks or months, and you should always discuss the best way of stopping treatment with your doctor
• have any movement disorders or develop a distressing restlessness and need to move, are often unable to sit or stand still (akathisia)
• This is most likely to occur during the first few weeks of treatment. Increasing the dose may be harmful so if you develop such symptoms you should talk to your doctor
• suffer from a condition called osteoporosis (weak bones which are easily broken) or if you are taking medicines called corticosteroids (which can increase the risk of osteoporosis). Taking a SERTRALINE UNICORN, may increase your risk of fracture in bones such as the hip, wrist or spine
• have any diseases or conditions that affect your metabolism or your blood responses such as having had a heart attack or have a condition in which your heart doesn’t get enough blood flow and oxygen (unstable angina)
• have problems with your liver or kidneys
• have diabetes (high blood sugar); your blood glucose levels may be altered due to SERTRALINE UNICORN and your diabetes medicines may need to be adjusted
• are having electro-convulsive therapy (ECT)
• have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
• have a laboratory reading for benzodiazepines (e.g., diazepam, alprazolam), as a false-positive reading can result if taking SERTRALINE UNICORN
• have problems in your blood clotting (e.g., bruising easily, blood taking long to clot when you have an injury). Children and adolescents SERTRALINE UNICORN should not usually be used in children and adolescents less than 18 years old, except for patients with obsessive-compulsive disorder (OCD). Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, thoughts of harming or killing themselves (suicidal thoughts) and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines. Nevertheless, it is possible that your doctor decides to prescribe SERTRALINE UNICORN to a patient under 18 if it is in the patient’s interest. If your doctor has prescribed SERTRALINE UNICORN to you and you are less than 18 years old and you want to discuss this, please contact him/her. Furthermore, if any of the symptoms listed above appear or worsen while you are taking SERTRALINE UNICORN, you should inform your doctor. Also, the long-term safety of SERTRALINE UNICORN in regard to growth, maturation and learning (cognitive) and behavioural development in this age group has not yet been demonstrated

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
• You should not take SERTRALINE UNICORN while you are pregnant
• Women of childbearing potential should use adequate methods of contraception if taking SERTRALINE UNICORN
• Please inform your doctor before taking SSRI such as SERTRALINE UNICORN if you have 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., when you are carrying more than one baby at a time (multiple pregnancy), when you have high blood pressure in pregnancy (gestational hypertension) or if you have preeclampsia (a pregnancy complication characterised by mild to severe high blood pressure, protein in your urine, damage to another organ system, most often the liver and kidneys and swelling in your legs, feet, and hands which usually happens late in pregnancy, this can lead to seizures in the mom and be life-threatening to the mom and the baby)
• If you take SERTRALINE UNICORN near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders
• Your doctor or midwife should be aware that you are taking SERTRALINE UNICORN so they can advise you

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemide (to treat depression) and selegiline (to treat Parkinson’s disease), the antibiotic linezolid and methylene blue (to treat high levels of methaemoglobin in the blood). Do not use SERTRALINE UNICORN together with these medicines
• Medicines to treat mental disorders such as psychosis (pimozide). Do not use SERTRALINE UNICORN together with pimozide. SERTRALINE UNICORN may cause very serious side effects and death due to Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) when taken with some medicines. SERTRALINE UNICORN should not be taken together with the following medicines:
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD) (e.g., methylphenidate), narcolepsy, and obesity (e.g., fenfluramine))
• medicines to treat migraines (e.g., sumatriptan)
• medicines used in anaesthesia (fentanyl, mivacurium and suxamethonium) or to treat chronic pain
• medicines to treat severe pain (e.g., tramadol, dextromethorphan, tapentadol, meperidine, methadone and pentazocine)
• medicines called 5-HT antagonists that are used for the prevention and treatment of nausea and vomiting, (particularly that caused by chemotherapy, radiation therapy, or postoperatively)
• products containing the amino acid tryptophan (used to for problems such as sleep and depression)
• St. John’s Wort (Hypericum perforatum) (a natural herbal product used to treat mild depression)
• medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, olanzapine and risperidone). SERTRALINE UNICORN may have effects on other medicine SERTRALINE UNICORN may strengthen the effect or side effects of the following medicines
• medicines known to increase the risk of changes in the electrical activity of the heart (QTc prolongation and/or ventricular dysrhythmias) e.g., some antipsychotics and antibiotics. This can lead to sudden cardiac arrest (abrupt loss of heart function, breathing and consciousness) and death within minutes without emergency care
• medicines to treat mania and depression (lithium). You may experience more frequent side-effects of involuntary trembling and shaking
• medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine). Your doctor may need to monitor your blood levels of the epilepsy medicine and adjust the dose thereof to prevent unwanted side-effects
• medicines to treat diabetes (tolbutamide, glibenclamide)
• sedatives (diazepam)
• blood thinning medicine like warfarin or medicines acting on platelet function (e.g., medicines used to treat pain/arthritis (Non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin) or ticlopidine) or other medicines that might increase bleeding, there can be an increased bleeding risk
• medicines used in anaesthesia (fentanyl, mivacurium and suxamethonium) or to treat chronic pain – their effects may be prolonged
• other medicines to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine), their side-effects may become worse
• medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine), their side-effects may become worse
• medicines used to treat high blood pressure, chest pain or regulate the rate and rhythm of the heart (such as verapamil, diltiazem, flecainide, propafenone), their blood levels may become too high and you may have too low blood pressure or too slow heart beat or worsening of side-effects. Other medicines may interact with SERTRALINE UNICORN The following medicines may increase the blood levels of sertraline and strengthen the effect of SERTRALINE UNICORN or lead to more unwanted side effects
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole) and bacterial infections (such as clarithromycin, telithromycin, erythromycin)
• medicines used to treat HIV/AIDS and Hepatitis C (protease inhibitors such as ritonavir, telaprevir)
• some antidepressants (nefazodone, fluoxetine, fluvoxamine))
• medicines used to prevent nausea and vomiting after an operation or chemotherapy (aprepitant)
• medicines to treat excessive stomach acid, ulcers and heartburn (omeprazole, lansoprazole, pantoprazole, rabeprazole). The following medicines may decrease the blood levels of sertraline and weaken the effect of SERTRALINE UNICORN
• medicines to treat excessive stomach acid, ulcers and heartburn (cimetidine)
• medicines used to treat tuberculosis (TB) and other bacterial infections (rifampicin)
• medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine). SERTRALINE UNICORN with food, drink and alcohol SERTRALINE UNICORN tablets can be taken with or without food. Alcohol should be avoided whilst taking SERTRALINE UNICORN. SERTRALINE UNICORN should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body and lead to unwanted side- effects

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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