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SafetyScorer

Is Sertraline safe?

Sertraline

Sertraline (Zoloft, Lustral) is one of the most prescribed antidepressants and one of the better tolerated. Nausea and sexual side effects are common, under-25s need close watching early on, and it interacts with other serotonin drugs and blood thinners.

High confidence#30 of 65 medicationsUpdated
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Brands
Zoloft (US); Lustral (UK); generic sertraline worldwide
Dose range
25 or 50 mg to a maximum of 200 mg once a day
Boxed warning
Suicidal thoughts and behaviours in children and young adults
Extra cases of suicidal thoughts or behaviour
14 per 1,000 under 18; 5 per 1,000 aged 18 to 24 (all antidepressants, short trials)
Controlled substance
No
Sexual side effects (men, trials)
Ejaculation failure 8% vs 1% on placebo
On the market
US since 1991

How the score breaks down

The overall score is the weighted average of these factors. Scoring rules

  • Serious side effects30% of score

    68 out of 100, Fair

    Common side effects include nausea (26% vs 12% on placebo), insomnia and sexual problems. Serious risks are less common but real, including suicidal thoughts in young people, Serotonin syndromeA reaction caused by too much serotonin in the body, usually from combining medicines that raise it. Symptoms range from shivering to high fever.More in the glossary, bleeding and low sodium in older adults.

  • Overdose margin20% of score

    82 out of 100, Good

    Much safer in overdose than older tricyclic antidepressants. Among 634 overdoses of sertraline alone, the label lists 8 deaths, though most outcomes were unknown. One person survived 13.5 g. Mixed overdoses are more dangerous.

  • Interactions15% of score

    60 out of 100, Fair

    MAOIs, linezolid, methylene blue and pimozide are ContraindicationA situation in which a medicine should not be used, because the risk clearly outweighs any benefit, such as a known allergy to it.More in the glossary. Tramadol, triptans, other antidepressants and St John's wort raise Serotonin syndromeA reaction caused by too much serotonin in the body, usually from combining medicines that raise it. Symptoms range from shivering to high fever.More in the glossary risk. NSAIDs, aspirin and warfarin raise bleeding risk.

  • Dependence and misuse15% of score

    80 out of 100, Good

    Not addictive and not a Controlled substanceA medicine or drug that the law restricts because it can be misused or cause dependence. Countries group them into schedules or classes.More in the glossary, with no craving or dose escalation. Stopping suddenly can cause discontinuation symptoms such as dizziness, irritability and "brain zaps", so it is tapered under medical advice.

  • Regulatory warnings10% of score

    50 out of 100, Weak

    Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary on suicidal thoughts and behaviours in children, teenagers and young adults, added to all antidepressants in 2004 and extended to under-25s in 2007. No other major restrictions.

  • Track record10% of score

    92 out of 100, Excellent

    Approved in the US in 1991 and one of the most prescribed psychiatric drugs worldwide, with three decades of trial and real-world data, including in pregnancy.

Is sertraline safe?

For most adults, yes. Sertraline, sold as Zoloft in the US and Lustral in the UK, is a selective serotonin reuptake inhibitor (SSRI) and one of the most prescribed antidepressants in the world. It is far less dangerous in overdose than the older tricyclics it largely replaced, and it is not addictive.

It is not a trivial medicine, though. Side effects are common in the first weeks, it carries a Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary for suicidal thoughts in young people, and it interacts with a range of other drugs. We score it 72: good, with specific risks that are manageable with the right monitoring.

The boxed warning, in numbers

Since 2004 every antidepressant in the US has carried a Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary about suicidal thoughts and behaviour in children and teenagers, extended to young adults under 25 in 2007. It is based on pooled short-term trials of about 77,000 adults and more than 4,400 children. Compared with placebo, antidepressants led to:

AgeChange in suicidal thoughts or behaviour per 1,000 treated
Under 1814 more
18 to 245 more
25 to 641 fewer
65 and over6 fewer

No suicides occurred in the children's trials. The warning is about watching closely in the first months and after dose changes, not about avoiding treatment: depression itself is the biggest risk factor for suicide. Families should report new agitation, worsening mood or talk of self-harm to the prescriber straight away.

Side effects most people notice

In the Zoloft label's pooled trials, the most common effects were:

  • nausea (26% vs 12% on placebo) and diarrhoea (20% vs 10%)
  • insomnia (20% vs 13%), tremor and sweating
  • sexual side effects, including ejaculation failure in 8% of men vs 1%, and lower libido

Stomach effects usually settle within a few weeks. Sexual side effects often persist and are a common reason people stop. They are worth raising with a doctor, as there are options.

Interactions to know about

The dangerous combination is with MAOI antidepressants, the antibiotic linezolid or intravenous methylene blue, which can cause Serotonin syndromeA reaction caused by too much serotonin in the body, usually from combining medicines that raise it. Symptoms range from shivering to high fever.More in the glossary: agitation, fever, sweating, muscle twitching and a fast heartbeat. The label contraindicates these and pimozide. Tramadol, triptans for migraine, other antidepressants, lithium and St John's wort also add serotonin effects. Our 5-HTP page covers the same risk with that supplement.

SSRIs reduce the ability of platelets to clump, so bleeding risk rises with ibuprofen, aspirin and warfarin. Older adults are also more prone to low blood sodium on SSRIs, which shows up as confusion, headache or unsteadiness.

Stopping sertraline

Sertraline is not habit-forming in the way alprazolam is. There is no high and no craving. But stopping abruptly can cause discontinuation symptoms: dizziness, electric-shock sensations, irritability, flu-like feelings and vivid dreams. For some people they last weeks. The label advises a gradual reduction, and current UK guidance recognises that some people need a slow taper over months. Plan any change with your prescriber.

Doses

The usual starting dose for depression is 50 mg once a day, and 25 mg for panic disorder, PTSD and social anxiety. Doctors raise it in steps no more often than weekly, up to a maximum of 200 mg a day. Overdose of sertraline alone is rarely fatal, but any overdose needs urgent assessment, especially if alcohol or other drugs are involved.

Who should be careful

Talk to your doctor or pharmacist before starting sertraline, or before adding anything new to it, if you:

  • are under 25, or have had thoughts of suicide or self-harm
  • have bipolar disorder or a past episode of mania, which an SSRI can trigger
  • take a blood thinner, regular NSAIDs, tramadol, a triptan or another antidepressant
  • are over 65, take diuretics or have had low sodium before
  • have epilepsy, glaucoma or a heart rhythm problem
  • are pregnant, planning a pregnancy or breastfeeding

How we scored it

Track record (92) and Overdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (82) are strong for a psychiatric medicine. Regulatory warnings (50) reflect the Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary for under-25s, interactions (60) the serotonin and bleeding risks, and dependence (80) the discontinuation symptoms rather than addiction.

Questions people ask

How long does sertraline take to work?

Some people notice better sleep or less anxiety in the first two weeks, but the full effect on mood usually takes four to six weeks or longer. Side effects such as nausea often appear first and fade. Keep in touch with your prescriber during this time, especially if you are under 25.

Is sertraline addictive?

No. It does not cause cravings, a high or a need for ever-higher doses, and it is not a Controlled substanceA medicine or drug that the law restricts because it can be misused or cause dependence. Countries group them into schedules or classes.More in the glossary. But the body adapts to it, so stopping suddenly can cause discontinuation symptoms. Your doctor can plan a gradual taper when the time comes.

Can I drink alcohol on sertraline?

The label advises against alcohol. Drinking can worsen depression and anxiety and add to drowsiness. If you choose to drink, keep it light and see how you feel, and talk to your doctor if you are unsure.

Can I take ibuprofen or tramadol with sertraline?

Ask a pharmacist first. NSAIDs such as ibuprofen and aspirin add to the bleeding risk of SSRIs, especially in older people. Tramadol and some migraine triptans add to serotonin effects. Acetaminophen is usually a simpler choice for pain.

Is sertraline safe in pregnancy?

It is one of the antidepressants used most in pregnancy and breastfeeding, and untreated depression also carries risks. There are small risks to discuss, such as temporary symptoms in the newborn. Do not stop it on your own if you become pregnant; talk to your doctor or midwife.

Sources

  1. 1.ZOLOFT (sertraline) label (opens in a new tab) · DailyMed / Viatris, 2023
  2. 2.Sertraline hydrochloride tablets label (overdose data) (opens in a new tab) · DailyMed, 2019
  3. 3.Sertraline (opens in a new tab) · NHS, 2025
  4. 4.Sertraline drug information (opens in a new tab) · MedlinePlus, 2025
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