Sertraline and 27 other antidepressants get clearer UK safety warnings

Sertraline, fluoxetine, citalopram and the other antidepressants licensed in the UK will carry clearer and more prominent safety warnings, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced on Thursday, 15 October 2026. After a review by the Commission on Human Medicines of how risks are explained for all 28 antidepressants authorised in the UK, the regulator said patient information leaflets will get a new boxed warning pointing to information on suicidal thoughts and behaviours, leaflets for certain medicines will name a condition called Post SSRI Sexual Dysfunction (PSSD), and references to a "chemical imbalance" will be removed. The regulator stressed that the changes are not meant to put people off treatment that works for them.

Antidepressants such as sertraline are among the most commonly prescribed medicines for depression and anxiety, and many people, women included, take them for months or years while juggling work, family and caring roles. For someone in that position, the small folded leaflet inside the box is often the only written information they read about their medicine. The review was prompted by patients and families who said the existing leaflets did not explain some side effects clearly enough, and the regulator has noted that four prevention of future deaths reports linked to antidepressant prescribing or safety information have been sent to it since 2020.

The changes do not add new risks that were unknown before. The warning about suicidal thoughts already existed, especially for younger people and in the early weeks of treatment or after a dose change. What changes is where it sits and how easy it is to find. A boxed warning near the top of the leaflet, plus a card on the pack that tells people where to get help, is meant to make sure the message reaches patients and the people who live with them, at the moments when it matters most.

The naming of PSSD is a notable shift. People who reported lasting sexual side effects after stopping SSRIs have long said they felt unheard. The regulator's own evidence review found substantial uncertainty about how often PSSD happens and how long it lasts, so the leaflet change is about honest disclosure rather than a firm estimate of risk. Dropping the "chemical imbalance" phrase follows years of debate among researchers, who now describe the effects of antidepressants as likely involving several biological processes rather than a simple shortage of one brain chemical.

Dr Alison Cave, the MHRA's Chief Safety Officer, said that when antidepressants are used appropriately and under clinical supervision, the benefits outweigh the risks for the vast majority of people. She said the aim is not to discourage use but to improve the prominence and clarity of the existing warnings.

Short-term: People collecting antidepressants in the UK may see the new wording online first and in packs over the coming months. Pharmacists and doctors are likely to field questions from patients who notice the stronger language, and the clear advice from the regulator is not to stop a medicine suddenly without speaking to a prescriber.

Long-term: The review sets a model for how a regulator can respond when patients say safety information is hard to read. Other regulators, including those whose leaflets still use older language, may face pressure to follow, and the 2027 supporting leaflet could change how the first conversation about antidepressants happens in a clinic.

Who is affected: Everyone in the UK prescribed one of the 28 authorised antidepressants, their families and carers, and the doctors, nurses and pharmacists who prescribe and dispense them. Readers elsewhere who take the same medicines may also find the clearer UK wording a useful prompt to ask their own doctor about side effects.

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