Formulary
Sertraline: Indications, Dosing, Side Effects and Interactions
For all selective serotonin re-uptake inhibitors Selectively inhibit the re-uptake of serotonin (5-hydroxytryptamine, 5-HT).
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Sertraline: Indications, Dosing, Side Effects and Interactions
For all selective serotonin re-uptake inhibitors Selectively inhibit the re-uptake of serotonin (5-hydroxytryptamine, 5-HT).
Drug action
For all selective serotonin re-uptake inhibitors Selectively inhibit the re-uptake of serotonin (5-hydroxytryptamine, 5-HT).
Indications and dose
**Depressive illness**
- **Adult** (By Mouth): Initially 50 mg once daily, then increased in steps of 50 mg at intervals of at least 1 week if required; maintenance 50 mg once daily; maximum 200 mg per day.
**Obsessive-compulsive disorder**
- **Adult** (By Mouth): Initially 50 mg once daily, then increased in steps of 50 mg at intervals of at least 1 week if required; maximum 200 mg per day.
**Panic disorder,Post-traumatic stress disorder,Social anxiety disorder**
- **Adult** (By Mouth): Initially 25 mg once daily for 1 week, then increased to 50 mg once daily, then increased in steps of 50 mg at intervals of at least 1 week if required, increase only if response is partial and if drug is tolerated; maximum 200 mg per day.
**Obsessive-compulsive disorder for sertraline**
- **Child 6-12 years** (By mouth): Initially 25 mg once daily for 1 week, then increased if necessary to 50 mg once daily, then increased in steps of 50 mg at intervals of at least 1 week if required; maximum 200 mg per day.
- **Child 13-17 years** (By mouth): Initially 50 mg once daily, then increased in steps of 50 mg at intervals of at least 1 week if required; maximum 200 mg per day.
**Major depression for sertraline**
- **Child 12-17 years** (By mouth): Initially 50 mg once daily, then increased in steps of 50 mg at intervals of at least 1 week if required; maximum 200 mg per day.
Cautions
For all selective serotonin re-uptake inhibitors Cardiac disease; concurrent electroconvulsive therapy; diabetes mellitus; epilepsy (discontinue if convulsions develop); history of bleeding disorders (especially gastro-intestinal bleeding); history of mania; susceptibility to angle-closure glaucoma Cautions, further information Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate with current or recent significant hyponatraemia i.e. serum sodium less than 130 mmol/L (risk of exacerbating or precipitating hyponatraemia).
Contraindications
For all selective serotonin re-uptake inhibitors Poorly controlled epilepsy; SSRIs should not be used if the patient enters a manic phase
Side effects
For all selective serotonin re-uptake inhibitors Common or very common Anxiety; appetite abnormal; arrhythmias; arthralgia; asthenia; concentration impaired; confusion; constipation; depersonalisation; diarrhoea; dizziness; drowsiness; dry mouth; fever; gastrointestinal discomfort; haemorrhage; headache; hyperhidrosis; malaise; memory loss; menstrual cycle irregularities; myalgia; mydriasis; nausea (dose-related); palpitations; paraesthesia; QT interval prolongation; sexual dysfunction; skin reactions; sleep disorders; taste altered; tinnitus; tremor; urinary disorders; visual impairment; vomiting; weight changes; yawning Uncommon Alopecia; angioedema; behaviour abnormal; hallucination; leucopenia; mania; movement disorders; photosensitivity reaction; postural hypotension; seizure; suicidal behaviours; syncope Rare or very rare Galactorrhoea; hepatitis; hyperprolactinaemia; hyponatraemia; serotonin syndrome; severe cutaneous adverse reactions (SCARs); SIADH; thrombocytopenia Frequency not known Increased risk of fracture; withdrawal syndrome Side-effects, further information Symptoms of sexual dysfunction may persist after treatment has stopped. Overdose Symptoms of poisoning by selective serotonin re-uptake inhibitors include nausea, vomiting, agitation, tremor, nystagmus, drowsiness, and sinus tachycardia; convulsions may occur. Rarely, severe poisoning results in the serotonin syndrome, with marked neuropsychiatric effects, neuromuscular hyperactivity, and autonomic instability; hyperthermia, rhabdomyolysis, renal failure, and coagulopathies may develop. For details on the management of poisoning, see Selective serotonin re-uptake inhibitors, under Emergency treatment of poisoning . Side-effects For sertraline Common or very common Chest pain; depression; gastrointestinal disorders; increased risk of infection; neuromuscular dysfunction; vasodilation Uncommon Back pain; burping; chills; cold sweat; dysphagia; dyspnoea; ear pain; euphoric mood; hypertension; hypothyroidism; migraine; muscle complaints; muscle weakness; oedema; oral disorders; osteoarthritis; periorbital oedema; respiratory disorders; sensation abnormal; speech disorder; thinking abnormal; thirst Rare or very rare Balanoposthitis; bone disorder; cardiac disorder; coma; conversion disorder; diabetes mellitus; drug dependence; dysphonia; eye disorders; gait abnormal; genital discharge; glaucoma; hair texture abnormal; hepatic disorders; hiccups; hypercholesterolaemia; hypoglycaemia; injury; lymphadenopathy; myocardial infarction; neoplasms; neuroleptic malignant syndrome; oliguria; peripheral ischaemia; psychotic disorder; rhabdomyolysis; vasodilation procedure; vision disorders; vulvovaginal atrophy Frequency not known Cerebrovascular insufficiency; gynaecomastia; hyperglycaemia; interstitial lung disease; pancreatitis
Interactions
**Severe interactions:**
- Severe adverse reactions have been reported in patients who have recently been discontinued from an MAOI (e.g.
- Lithium In a placebo-controlled trial in normal volunteers, the co-administration of sertraline with lithium did not significantly alter lithium pharmacokinetics, but did result in an increase in...
- Warfarin Co-administration of sertraline 200 mg daily with warfarin resulted in a small but statistically significant increase in prothrombin time, which may in some rare cases unbalance the INR...
- Sertraline does not act as an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP1A2 to a clinically significant degree.
**Other interactions (36):**
- Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see section 4.3).
- Reversible, selective MAO-A inhibitor (moclobemide) Due to the risk of serotonin syndrome, the combination of sertraline with a reversible and selective MAOI, such as moclobemide, should not be given.
- Following treatment with a reversible MAO-inhibitor, a shorter withdrawal period than 14 days may be used before initiation of sertraline treatment.
- It is recommended that sertraline should be discontinued for at least 7 days before starting treatment with a reversible MAOI (see section 4.3).
- Reversible, non-selective MAOI (linezolid) The antibiotic linezolid is a weak reversible and non-selective MAOI and should not be given to patients treated with sertraline (see section 4.3).
- Pimozide Increased pimozide levels of approximately 35% have been demonstrated in a study of a single low dose pimozide (2 mg).
Pregnancy
For all selective serotonin re-uptake inhibitors Specialist sources indicate SSRIs may be suitable for use in pregnancy, but the risks and benefits of use must be considered, and the lowest effective dose should be used. The available data regarding malformation risk for all SSRIs are conflicting and confounded, and a causal association between the use of SSRIs in pregnancy, and spontaneous miscarriage, preterm delivery, low birth weight, and adverse effects on infant neurodevelopment remains unconfirmed. Published data on first trimester use of fluoxetine and paroxetine are contradictory. Some studies suggest a small increased risk of cardiovascular malformations with the use of fluoxetine, and congenital malformations (particularly cardiovascular) with the use of paroxetine, however other studies do not support an association. There may be a small increased risk of persistent pulmonary hypertension in the newborn with the use of SSRIs beyond 20 weeks' gestation, and use in the later stages of pregnancy may result in neonatal withdrawal syndrome-neonates should be monitored for associated central nervous system, motor, respiratory, and gastro-intestinal symptoms. There may also be a small increased risk of postpartum haemorrhage when used in the month before delivery (see Important safety information ).
Breast feeding
For all selective serotonin re-uptake inhibitors Specialist sources indicate that sertraline and paroxetine are the SSRIs of choice in breast-feeding based on passage into milk, half-life, and published evidence of safety. However, all SSRIs can be used in breast-feeding with caution, and since there are risks with switching an SSRI, it may be more clinically appropriate to continue treatment with an SSRI that has been effective, or restart treatment with an SSRI that has previously been effective. With all SSRIs, infants should be monitored for drowsiness, poor feeding, adequate weight gain, gastro-intestinal disturbances, irritability, and restlessness. Breast feeding For sertraline Specialist sources indicate can be used. Present in milk in small amounts; long half-life increases risk of accumulation in the infant.
Hepatic impairment
For all selective serotonin re-uptake inhibitors In general, manufacturers advise caution (prolonged half-life). Hepatic impairment For sertraline Manufacturer advises avoid in severe impairment (no information available). Dose adjustments Manufacturer advises dose reduction or increasing dose interval in mild to moderate impairment.
Medicinal forms
Tablet,Tablet,Suspension,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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