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SSRI (Selective Serotonin Reuptake Inhibitor) Pregnancy: §4.6: A substantial amount of data did not reveal evidence of induction of congenital malformations by sertraline. However, sertraline is NOT RECOMMENDED IN PREGNANCY unless the clinical condition of the woman is such that the benefit of treatment is expected to outweigh the potential risk. Use in later pregnancy has been reported to cause withdrawal-compatible symptoms in some neonates (respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence, difficulty sleeping), usually beginning within 24 hours of delivery — neonates should be observed. SSRI use in late pregnancy may increase the risk of persistent pulmonary hypertension of the newborn (approximately 5 cases per 1000 pregnancies). Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth.

Sertraline

Brand names: Lustral, Zoloft

Used in: Depression & Anxiety

Sertraline is a selective serotonin reuptake inhibitor (SSRI) used for depression, generalised anxiety disorder, panic disorder, social anxiety disorder, obsessive-compulsive disorder and post-traumatic stress disorder.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 50 mg daily (starting dose for depression and OCD)
Route: Oral
Frequency: Once daily, either in the morning or evening; with or without food
Max: 200 mg/day
Source: UK SPC (eMC) for Lustral 100mg film coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/2835/smpc). INITIAL TREATMENT — Depression and OCD: sertraline treatment should be started at a dose of 50 mg/day. Panic disorder, PTSD and social anxiety disorder: therapy should be initiated at 25 mg/day; after one week the dose should be increased to 50 mg once daily (this regimen has been shown to reduce the frequency of early treatment-emergent side effects characteristic of panic disorder). TITRATION (all of depression, OCD, panic disorder, social anxiety disorder and PTSD): patients not responding to a 50 mg dose may benefit from dose increases; dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half-life. Onset of therapeutic effect may be seen within 7 days, but longer periods are usually necessary, especially in OCD. MAINTENANCE: dosage during long-term therapy should be kept at the lowest effective level. Patients with depression should be treated for a sufficient period of at least 6 months to ensure they are free from symptoms; in prevention of recurrence of major depressive episodes the recommended dose is in most cases the same as that used during the current episode. Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders. ELDERLY: should be dosed carefully, as elderly may be more at risk for hyponatraemia. HEPATIC IMPAIRMENT: use should be approached with caution; a lower or less frequent dose should be used; sertraline should not be used in cases of severe hepatic impairment as no clinical data are available. PAEDIATRIC (fixed mg doses, not per-kg, so not expressed as a structured paedDose): children and adolescents with obsessive compulsive disorder — age 13-17 years initially 50 mg once daily; age 6-12 years initially 25 mg once daily, which may be increased to 50 mg once daily after one week; subsequent doses may be increased in 50 mg increments over a period of some weeks as needed, maximum dosage 200 mg daily, with dose changes not occurring at intervals of less than one week. The generally lower body weights of children compared to adults should be taken into consideration when increasing the dose from 50 mg. Efficacy is not shown in paediatric major depressive disorder, and no data is available for children under 6 years of age. Verify any under-18 use against a children's formulary. WITHDRAWAL: abrupt discontinuation should be avoided; when stopping treatment the dose should be gradually reduced over a period of at least one to two weeks to reduce the risk of withdrawal reactions; if intolerable symptoms occur following a decrease in dose or upon discontinuation, resuming the previously prescribed dose may be considered, then decreasing at a more gradual rate. Note: §4.5 was not retrieved in this bundle — the interactions listed below come from §4.3 of the UK SPC and from the US label; verify the full §4.5.

Dose adjustments

Renal

No dosage adjustment is necessary in patients with renal impairment (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

DOSAGE AND ADMINISTRATION Initial Treatment Dosage for Adults Major Depressive Disorder –Sertraline hydrochloride treatment should be administered at a dose of 50 mg once daily. While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of Sertraline hydrochloride for the treatment of this indication. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2019-11-01. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) — risk of serotonin syndrome with agitation, tremor and hyperthermia. Sertraline must not be initiated for at least 14 days after discontinuation of an irreversible MAOI, and must be discontinued for at least 7 days before starting an irreversible MAOI
  • Concomitant intake of pimozide

Side effects

  • Nausea — the most common undesirable effect
  • Sexual dysfunction: ejaculation failure in men occurred in 14% for sertraline vs 0% placebo in social anxiety disorder trials; libido decreased (common)
  • Insomnia (common); anxiety, depression, agitation, nervousness, nightmare, bruxism (common)
  • Dizziness, headache, somnolence (common); tremor and movement disorders including extrapyramidal symptoms (uncommon)
  • Decreased appetite and increased appetite (common)
  • Upper respiratory tract infection, pharyngitis, rhinitis (common)

Interactions

  • Irreversible MAOIs — contraindicated (§4.3); risk of serotonin syndrome
  • Pimozide — concomitant intake contraindicated (§4.3)
  • Drugs highly bound to plasma protein (e.g. warfarin, digitoxin) — because sertraline is tightly bound to plasma protein, coadministration may cause a shift in plasma concentrations potentially resulting in an adverse effect; in a study, sertraline 50-200 mg/day for 21 days gave a mean increase in prothrombin time of 8% relative to baseline with warfarin (US label §Drug Interactions)

Clinical monograph

How it works

It selectively inhibits the reuptake of serotonin (5-HT) at the presynaptic neuronal membrane, increasing serotonergic neurotransmission in the central nervous system.

Prescribing in practice

  • Monitor for suicidal thoughts and worsening mood, particularly in the early weeks of treatment and in patients under 25.
  • Anxiety, agitation, insomnia and gastrointestinal upset are common early and often settle; risk of hyponatraemia (especially in older patients) and increased gastrointestinal bleeding (consider gastroprotection with concurrent NSAID or anticoagulant).
  • Serotonin syndrome can occur with other serotonergic drugs; do not stop abruptly as discontinuation symptoms can occur.

Monitoring

Monitor mood, anxiety and emergence of suicidal ideation, especially early in treatment and in younger patients. Consider checking sodium in those at risk of hyponatraemia, and review for bleeding risk where co-prescribed with NSAIDs or anticoagulants.

Counselling the patient

  • It may take several weeks to feel the full benefit, and you may feel more anxious or restless at first.
  • Do not stop taking it suddenly; speak to your prescriber about reducing the dose gradually.
  • Seek urgent advice if your mood worsens or you have thoughts of harming yourself.

Evidence & guidelines

Guideline-recommended first-line SSRI for depression and anxiety disorders (NICE NG222/CG90).

Reference: NICE CG90 Depression; NICE NG116 PTSD; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.