Previous changes

August 2020 — minor update. Broken URL links updated.

October 2019 — reviewed. The topic has been updated to align with the National Institute for Health and Care Excellence (NICE) guideline Depression in children and young people: identification and management, which updates and replaces the NICE guideline Depression in Children and Young People: Identification and management in primary, community and secondary care. The topic has also been restructured for clarity.

• NICE reviewed the evidence and made new recommendations on the following:
  • Psychological therapies for children and young people with mild depression. 
  • Psychological therapies for children and young people with moderate to severe depression. 
• NICE also made one change without an evidence review:
  • The Mental Capacity Act has been added to the considerations when assessing and treating depression in young people.

February 2016 — reviewed. Interim update. The topic has been updated to align with the recommendations on psychological therapies and antidepressants included in the March 2015 update of the National Institute for Health and Care Excellence (NICE) guideline Depression in children and young people.

July 2013 — a literature search was conducted in July 2013 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs  published since the last revision of the topic. There are no changes to this topic.

February 2013 — minor update. The 2013 QIPP options for local implementation have been added to this topic.

October 2012 — minor update. The 2012 QIPP options for local implementation have been added to this topic.

March 2011 — minor update. Change of reference regarding prevalence estimates for depression in children. Issued in June 2011.

September 2008 to January 2009 — this is a new CKS topic. The evidence base has been reviewed in detail, and recommendations are clearly justified and transparently linked to the supporting evidence.

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 March 2025.

HTAs (Health Technology Assessments)

No new HTAs since 1 March 2025.

Economic appraisals

No new economic appraisals relevant to England since 1 March 2025.

Systematic reviews and meta-analyses

No new systematic reviews and meta-analyses since 1 March 2025.

Primary evidence

• Pillinger, T., Arumuham, A., McCutcheon, R.A., et al. (2025) The effects of antidepressants on cardiometabolic and other physiological parameters: a systematic review and network meta-analysis. The Lancet. https://www.thelancet.com [Free Full-text]

New policies

No new national policies or guidelines since 1 March 2025.

New safety alerts

No new safety alerts since 1 March 2025.

Changes in product availability

No changes in product availability since 1 March 2025.

Basis for recommendation

These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline Depression in children and young people: identification and management [NICE, 2024b].

Basis for recommendation

These recommendations are based largely on the National Institute for Health and Care Excellence (NICE) guideline Depression in children and young people: identification and management [NICE, 2024b], as well as on the British Medical Journal (BMJ) Best Practice Guide Depression in children [BMJ Best Practice, 2024], and the World Health Organization (WHO) International Classification of Diseases 11th revision (ICD-11) [WHO, 2025].

Basis for recommendation

These recommendations are based on the diagnostic criteria in the World Health Organization (WHO) International Classification of Diseases 11th revision (ICD-11) [WHO, 2025]. 

Note that the current version of the National Institute for Health and Care Excellence (NICE) guideline Depression in children and young people: identification and management [NICE, 2024b], upon which this topic is largely based, bases diagnosis and management advice on the now superseded ICD-10 criteria. Previously the demarcation of severity was based more precisely on symptom counts, however the NICE guideline does state that it is unlikely that severity can be understood in a single symptom count (or single consultation), and that family context, previous history, building trust, interviews with and without parents or carers, and the degree of associated impairment are all important in helping to assess severity. CKS therefore considers that severity may be assessed using a combination of thorough assessment, clinical judgement and the newer ICD-11 guidance, and that the current NICE management structure, based on severity, may continue to be used pending future updates.

Basis for recommendation

These recommendations are based on the National Institute for Health and Care Excellence (NICE) UK guideline Depression in children and young people: identification and management [NICE, 2024b].

CKS notes that in some other countries, more active screening for depression is recommended. For example, in the USA, the US Preventative Services Task Force recommends screening for major depression in all adolescents aged 12 to 18, but not screening in younger children based on a lack of evidence of net benefit [US Preventative Services Task Force, 2022]. No evidence was found on optimal screening intervals, and no specific recommendation was made as to the tool of screening, beyond noting that the most commonly used screening tool is the PHQ-9 questionnaire. A systematic review published in 2024 found a lack of available evidence relating to the potential benefits and harms of screening for depression in children and adolescents in primary care settings [Beck, 2024].

How should a child or young person with mild depression be managed?

For a child (aged 5–11 years) or young person (aged 12–18 years) with mild depression:

• Consider watchful waiting if:
  • The person and/or their family/carer do not want a formal intervention.
  • The person, in the opinion of the healthcare professional, may recover with no intervention. See the section on Referral criteria for more information.
• Arrange a follow up after 2 weeks to reassess the person. Contact children and young people who do not attend follow-up appointments. 
• For children and young people who have continuing mild depression after a period of watchful waiting, offer psychological intervention. Psychological interventions should be provided by therapists who are also trained in child and adolescent mental health in settings such as schools and colleges, primary care, social services, and the voluntary sector. 
  • The choice of psychological interventions should be discussed with the child or young person and/or their family/carers. They should be informed on:
    • What the different interventions involve.
    • The evidence for each age group (including the limited evidence for 5–11-year-olds). 
    • How the interventions could meet individual needs, preferences, and values.
  • The choice of psychological intervention should be based on:
    • A full assessment of needs, including:
      • The circumstances of the child or young person and their family/carers.
      • Their clinical and personal/social history and presentation.
      • Their maturity and developmental level.
      • The context in which treatment is to be provided.
      • The presence of comorbidities, neurodevelopmental disorders, communication needs (language and sensory impairment), and learning disabilities.
    • The preferences and values of the child or young person and/or their family/carers.
  • For children and young people with mild depression continuing after 2 weeks of watchful waiting and without significant comorbid problems or active suicidal ideas or plans: 
    • The following options should be considered (adapted to developmental level as needed in children):
      • Digital cognitive–behavioural therapy (CBT).
      • Group CBT group.
      • Group non-directive supportive therapy (NDST).
      • Group interpersonal psychotherapy (IPT).
    • If these options would not meet the child or young person's clinical needs or are unsuitable for their circumstances, the following should be considered (adapted to developmental level as needed in children):
      • Attachment-based family therapy or
      • Individual CBT. 
• If mild depression in a child or young person has not responded to psychological intervention after 2–3 months, the child or young person should be referred for review by a Child and Adolescent Mental Health Service (CAMHS) team.
  • Treatment options for moderate to severe depression should be followed for children and young people with persisting mild depression who are unresponsive to psychological interventions. 
• Antidepressants should not be used for the initial treatment of children and young people with mild depression.
• As part of the management of a child or young person with depression:
  • Provide appropriate information and advice on lifestyle and depression. See the section on Information and advice for more information.
  • Ensure that comorbid diagnoses (such as anxiety) and developmental, social, and educational problems are managed, either in sequence or in parallel, with the treatment for depression. 
    • If bullying is considered to be a factor in the child or young person's depression, CAMHS, primary care, and educational professionals should work collaboratively to prevent bullying and to develop effective anti-bullying strategies.
  • Be aware of the possible need for parents' own psychiatric problems (particularly depression) to be treated in parallel if the child or young person's mental health is to improve.
    • If such a need is identified, then a plan for obtaining such treatment should be made, bearing in mind the availability of adult mental health provision and other services.
  • Ensure that protocols with adult mental health services are in place to ensure the smooth transition of young people to adult services when they turn 18 years old. See the section on Transfer to adult services for more information.

How should a child or young person with moderate to severe depression be managed?

Children (aged 5–11 years) and young people (aged 12–18 years) presenting with moderate to severe depression should be reviewed by a Child and Adolescent Mental Health Service(CAMHS) team.

• For a child (aged 5–11 years) or young person (aged 12–18 years) with moderate to severe depression, psychological intervention should be offered for the initial management.
  • If moderate to severe depression in a child or young person is unresponsive to psychological intervention after 4–6 treatment sessions, a multidisciplinary review should be carried out after which further treatment should be considered. See the sections on Psychological intervention and Antidepressant treatment for more information.
  • For young people (aged 12–18 years), combination treatment with psychological intervention plus fluoxetine may be considered for the initial treatment of moderate to severe depression, as an alternative to psychological intervention followed by a multidisciplinary review and/or combination treatment. 
• As part of the management of a child or young person with depression:
  • Provide appropriate information and advice on lifestyle and depression. See the section on Information and advice for more information.
  • Ensure that comorbid diagnoses (such as anxiety) and developmental, social, and educational problems are managed, either in sequence or in parallel, with the treatment for depression. 
    • If bullying is considered to be a factor in the child or young person's depression, CAMHS, primary care, and educational professionals should work collaboratively to prevent bullying and to develop effective anti-bullying strategies.
  • Be aware of the possible need for parents' own psychiatric problems (particularly depression) to be treated in parallel if the child or young person's mental health is to improve.
    • If such a need is identified, then a plan for obtaining such treatment should be made, bearing in mind the availability of adult mental health provision and other services.
  • Once a child or young person is in remission (they have had fewer than two symptoms and full functioning for at least eight weeks), they should be reviewed regularly for a year by an experienced CAMHS professional before being discharged to primary care if remission is maintained. CAMHS should provide advice if ongoing monitoring in primary care is required. Those who have been successfully treated and discharged but then re-referred should be seen as soon as possible rather than placed on a routine waiting list.
  • Ensure that protocols with adult mental health services are in place to ensure the smooth transition of young people to adult services when they turn 18 years. See the section on Transfer to adult services for more information.

Which psychological interventions are recommended for children and young people with moderate to severe depression?

Children (aged 5–11 years) and young people (aged 12-18 years) presenting with moderate to severe depression should be reviewed by a Child and Adolescent Mental Health Service (CAMHS) team.

• The choice of psychological intervention should be discussed with the child or young people and/or their family/carers. They should be informed on:
  • What the different interventions involve.
  • The evidence for each age group (including the limited evidence for 5–11-year-olds). 
  • How the interventions could meet individual needs, preferences, and values.
• The choice of psychological intervention should be based on:
  • A full assessment of needs, including:
    • The circumstances of the child or young person and/or their family/carers.
    • Their clinical and personal/social history and presentation.
    • Their maturity and developmental level.
    • The context in which treatment is to be provided.
    • The presence of comorbidities, neurodevelopmental disorders, communication needs (language or sensory impairment), and learning disabilities.
  • The preferences and values of the child or young person and/or their family/carers.
• For a child (aged 5–11 years) with moderate to severe depression, the following psychological intervention should be considered, adapted to developmental level as needed:
  • Family-based interpersonal psychotherapy (IPT).
  • Family therapy (family-focused treatment for childhood depression and systems integrative family therapy).
  • Psychodynamic psychotherapy.
  • Individual cognitive–behavioural therapy (CBT).
• For a young person (aged 12–18 years) with moderate to severe depression, individual CBT should be offered for 3–6 months. If individual CBT would not meet the clinical needs of the young person or is unsuitable for their circumstances, the following options should be considered:
  • Psychodynamic psychotherapy. 
  • Brief psychosocial intervention.
  • Family therapy (attachment-based or systemic).
  • IPT for adolescents (IPT-A).
• If moderate to severe depression in a child (aged 5–11 years) or young person (aged 12–18 years) is unresponsive to psychological intervention after 4–6 treatment sessions, a multidisciplinary review should be carried out.
  • Following multidisciplinary review, if the child or young person's depression is not responding to psychological intervention as a result of other coexisting factors, such as the presence of comorbid conditions, persisting psychosocial risk factors (such as family discord), or the presence of parental mental ill-health, the following should be considered:
    • An alternative psychological intervention for the child or young person.
    • An alternative or additional psychological intervention for the parent or other family members.
  • Following multidisciplinary review, if moderate to severe depression is unresponsive to a specific psychological intervention after 4–6 sessions:
    • For children (aged 5–11 years), fluoxetine should be cautiously considered (in addition to psychological intervention), although the evidence for its effectiveness in this age group is not established. 
    • For young people (aged 12–18 years), fluoxetine can be offered (in addition to psychological intervention).
• Note that for young people (aged 12–18 years) with moderate to severe depression, combination treatment with psychological intervention plus fluoxetine can be considered for the initial treatment of moderate to severe depression, as an alternative to psychological intervention followed by a multidisciplinary review and/or combination treatment.
• If moderate to severe depression in a child (aged 5–11 years) or young person (aged 12–18 years) is unresponsive to combined treatment with a specific psychological intervention and fluoxetine after a further 6 sessions, or the person and/or their family/carers have declined the offer of fluoxetine:
  • The multidisciplinary team should make a full needs and risk assessment, which should include:
    • A review of the diagnosis.
    • Examination of the possibility of comorbid diagnoses.
    • Reassessment of the possible individual, family, and social causes of depression.
    • Consideration of whether there has been a fair trial of treatment.
    • Assessment for further psychological intervention for the person and/or additional help for the family. 
  • Following multidisciplinary review, the following should be considered:
    • An alternative psychological intervention that has not been tried previously (individual CBT, interpersonal therapy, or shorter‑term family therapy, of at least 3 months duration), or
    • Systemic family therapy (at least 15 fortnightly sessions), or
    • Psychodynamic psychotherapy (approximately 30 weekly sessions). 

How should antidepressants be prescribed to children and young people with moderate to severe depression?

Antidepressants should only be prescribed to children (5–11 years) and young people (12–18 years) with moderate to severe depression following an assessment and diagnosis by a child and adolescent psychiatrist.

• Antidepressants should not be offered to a child (5–11 years) or young person (12–18 years) with moderate to severe depression except in combination with concurrent psychological intervention. 
  • If psychological intervention is declined, antidepressants may still be given, but as the child or young person will not be reviewed at psychological intervention sessions, the prescribing doctor should closely monitor their progress on a regular basis and focus particularly on emergent adverse effects. 
• When starting antidepressant treatment:
  • The child or young person and/or their family/carers should be informed about:
    • The rationale for the drug treatment.
    • The delay in onset of effect.
    • The time course of treatment.
    • The possible adverse effects.
    • The need to take the medication as prescribed.
  • Discussion of these issues should be supplemented by written information appropriate to the child or young person's and family's or carers' needs and include patient information advice from the relevant regulatory authority. 
  • The child or young person should be closely monitored for the appearance of suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment, by the prescribing doctor and the person delivering the psychological therapy. Weekly review for the first four weeks of treatment is suggested.
• Fluoxetine is the preferred antidepressant for treating moderate and severe depression in children (5–11 years) and young people (12–18 years). It is the only antidepressant where the evidence shows that the benefits outweigh the risks. See the section on Prescribing information for detailed information on recommended doses, contraindications, cautions, adverse effects, drug interactions, monitoring requirements, how to discontinue treatment, and patient information.
  • If treatment with fluoxetine is unsuccessful or is not tolerated because of adverse effects, senior specialist advice should be sought, for example, from a consultant child and adolescent psychiatrist, regarding the use of sertraline or citalopram. Sertraline or citalopram should only be used when the following criteria have been met:
    • The child or young person and/or their family/carers have been fully involved in discussions about the likely benefits and risks of the new treatment and have been provided with appropriate written information. This information should cover the rationale for the drug treatment, the delay in onset of effect, the time course of treatment, the possible adverse effects, and the need to take the treatment as prescribed. It should also include the latest patient information advice from the relevant regulatory authority.
    • The child or young person's depression is severe and/or causing serious symptoms (such as weight loss or suicidal behaviour) to justify a trial of another antidepressant. 
    • There has been a fair trial of the combination of fluoxetine and a psychological intervention. In other words, that all efforts have been made to ensure adherence to the recommended treatment regimen. 
    • There has been a reassessment of the likely causes of the depression and of treatment resistance (for example, other diagnoses, such as bipolar disorder or substance misuse).
    • The child or young person and/or someone with parental responsibility for the child or young person (or the young person alone, if over 16 years or deemed competent) has signed an appropriate and valid consent form. 
  • Paroxetine, venlafaxine, tricyclic antidepressants, and St John's wort should not be used for the treatment of depression in children and young people.
    • A child or young person with depression who is taking St John's wort as an over-the-counter preparation should be informed of the risks and advised to discontinue treatment while being monitored for recurrence of depression and assessed for alternative treatments. 

What information and advice should I give to a child or young person with depression and/or their family/carers?

• Provide verbal and written information on depression. Patient information can be found on:
  • The NHS website : 
    • Depression in children and young people.
  • The Royal College of Psychiatrists website: 
    • Depression in children and young people.
    • Depression: for parents and carers.
  • The YoungMinds website.
  • The Mind website:
    • Information for young people aged 11-18.
  • The Anna Freud Centre website:
    • Children and young people's wellbeing.
  • The Stem4 website.
  • The Papyrus website for prevention of young suicide.
• Give appropriate lifestyle advice.
  • Encourage regular exercise, and suggest they consider following a structured and supervised exercise programme (typically up to three times a week for 45 minutes to an hour for 10 to 12 weeks).
  • Give advice about a healthy diet, and good sleep hygiene. See the CKS topics on Obesity and Insomnia for more information.
  • Encourage positive coping strategies to help the young person feel better, such as involvement in a hobby or activity, and discourage or address those that may be exacerbating the problem, such as alcohol or recreational drug use. 

What are the four tiers of CAMHS?

• The Child and Adolescent Mental Health Service (CAMHS) usually provides coordinated care involving professionals in both a primary and secondary care setting. Four tiers exist within CAMHS, offering different areas of specialism in a 'stepped‑care' approach:
  • Tier 1: A primary care service provided by professionals working in universal services.
    • Professionals providing the service include GPs, health visitors, school nurses, social workers, teachers, juvenile justice workers, voluntary agencies, and social services.
    • Function/services include identifying mental health problems early in their development, offering general advice, and pursuing opportunities for mental health promotion and prevention.
  • Tier 2: A service provided by professionals relating to workers in primary care.
    • Professionals providing the service include child and adolescent mental health workers, clinical child psychologists, paediatricians (particularly community paediatricians or those with specialist training in mental health), educational psychologists, child and adolescent psychiatrists, child and adolescent psychotherapists, counsellors, community nurses or nurse specialists, and family therapists.
    • Function/services include training and consultation to other professionals (who might be within tier 1), consultation to families, outreach, and assessment.
  • Tier 3: Specialized services for more severe, complex, or persistent disorders.
    • Professionals providing the service include child and adolescent psychiatrists, clinical child psychologists, and nurses (community- or hospital-based).
    • Function/services include assessment and treatment, assessment for referrals to tier 4, and contributions to the services, consultation, and training at tier 1 and tier 2.
  • Tier 4: Essential tertiary-level services, such as day units, highly specialized outpatient teams and inpatient units. The availability of services will vary depending on locality, but all children should be seen by a specialist with experience in child and adolescent mental health.
    • Professionals providing the service include child psychotherapists; occupational therapists; speech and language therapists; art, music, and drama therapists; and family therapists.
    • Function/services include child and adolescent inpatient units, secure forensic units, eating disorders units, specialist teams (for example, for sexual abuse), and specialist teams for neuro-psychiatric problems.
• The stepped‑care model of depression draws attention to the different needs of children and young people with depression, depending on the characteristics of their depression and their personal and social circumstances, and the responses that are required from services. However, because the lower tiers (1 and 2) vary geographically in terms of the services provided and the types of professionals and interventions available in some areas, interventions delivered at tier 2 will be delivered by tier 3, or even tier 1, in another area. This has been accommodated in the care pathway developed for the National Institute for Health and Care (NICE) guideline Depression in Children and Young People: Identification and management in primary, community and secondary care (See Table 1).  

Table 1: The stepped-care model.

What are the referral criteria for a child or young person with depression?

The Child and Adolescent Mental Health Service (CAMHS) usually provides coordinated care involving primary and secondary care professionals. Four tiers (1–4) exist within CAMHS, offering different areas of specialism in a 'stepped‑care' approach.

• The child or young person can be managed in tier 1 (primary care services) in the following cases:
  • Exposure to a single undesirable event in the absence of other risk factors for depression.
  • Exposure to a recent undesirable life event in the presence of 2 or more other risk factors with no evidence of depression and/or self‑harm.
  • Exposure to a recent undesirable life event, where 1 or more family members (parents or children) have multiple‑risk histories for depression, providing that there is no evidence of depression and/or self‑harm in the child or young person.
  • Mild depression without comorbidity. 
• Referral to tier 2 or 3 is indicated:
  • For any child or young person with mild depression:
    • And two or more risk factors for depression.
    • And one or more family members (parents or children) with multiple-risk histories for depression.
    • Who has not responded to interventions in tier 1 after 2–3 months.
  • For any child or young person with:
    • Moderate or severe depression (including psychotic depression).
    • Signs of a recurrence of depression in those who have recovered from previous moderate or severe depression.
    • Unexplained self‑neglect of at least 1 month's duration that could be harmful to their physical health.
    • Active suicidal ideas or plans.
  • If referral is requested by a young person and/or their family/carers.  
• Referral to tier 4 CAMHS is indicated for any child or young person:
  • At a high recurrent risk of acts of self-harm or suicide. See the CKS topic on Self-harm for more information.
  • With significant ongoing self-neglect (such as poor personal hygiene or significant reduction in eating that could be harmful to their physical health).
  • Who requires a level of intensity of assessment/treatment and/or level of supervision that is not available in tier 2 or 3.
• Refer to local pathways for information about the method of, and criteria for, urgent referrals to CAMHS (for example concern about high risk of suicide or psychotic symptoms). For further information relating to those at risk of self-harm, or who have self-harmed, see the CKS topic Self-harm.

What do I need to know about fluoxetine treatment for children with depression?

• Fluoxetine should only be prescribed to children and young people with moderate to severe depression following an assessment and diagnosis by a child and adolescent psychiatrist.
  • It should not be offered except in combination with a concurrent psychological intervention. If psychological intervention is declined, antidepressants may still be given, but as the child or young person will not be reviewed at psychological intervention sessions, the prescribing doctor should closely monitor their progress on a regular basis and focus particularly on emergent adverse effects. 
• The starting dose of fluoxetine for a child (5–11 years) or young person (12–18 years) with depression should be 10 mg daily.
  • This can be increased to 20 mg daily after 1 week if clinically necessary, although lower doses should be considered in children of lower body weight.
  • There is little evidence regarding the effectiveness of doses higher than 20 mg daily; however, higher doses may be considered in older children of higher body weight and/or when, in severe illness, an early clinical response is considered a priority.
  • Fluoxetine may be used in children between the ages of 5 and 7, but is not licensed in this age group.
• Specific arrangements must be made, by the prescribing doctor and the healthcare professional delivering the psychological intervention, for careful monitoring of adverse effects, as well as for reviewing the mental state and general progress of the child or young person. 
  • Weekly contact is recommended for the first 4 weeks of treatment. The precise frequency should be decided on an individual basis and recorded in the notes.
  • The child or young person should be closely monitored for the appearance of suicidal behaviour, self‑harm, or hostility, particularly at the beginning of treatment.
  • Unless it is felt that the treatment needs to be started immediately, symptoms that might be subsequently interpreted as adverse effects should be monitored for 7 days before prescribing.
    • Once treatment is started, the child or young person and/or their family/carers should be informed that if there is any sign of new symptoms of these kinds, urgent contact should be made with the prescribing doctor. 
• If a child or young person is responding to fluoxetine, treatment should be continued for at least 6 months after remission (defined as no symptoms and full functioning for at least 8 weeks). Treatment should continue for 6 months beyond this 8-week period.
• Where fluoxetine is to be discontinued, it should be phased out over a period of 6–12 weeks with the exact dose being titrated against the level of discontinuation/withdrawal symptoms.

[NICE, 2024b; BNFC, 2025]

Contraindications and cautions

• Do not prescribe fluoxetine for children or young people:
  • With poorly controlled epilepsy
  • With symptoms of mania.
  • Without assessment, diagnosis and prescribing advice from a child and adolescent psychiatrist.
• Prescribe fluoxetine with caution to children or young people with:
  • 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.

[NICE, 2024b; BNFC, 2025; EMC, 2025]

Adverse effects

• The most common adverse effects are headache, nausea, insomnia, fatigue and diarrhoea. These side effects may improve with continued treatment and do not generally require the treatment to be stopped.
• Suicidal behaviour has been linked with the use of antidepressants, particularly in children and young people. 
  • Children and young people should be monitored for suicidal behaviour and risk of self-harm, particularly at the beginning of treatment or if the dose is changed. 
• Other adverse effects of fluoxetine include:
  • Common — reduced appetite, anxiety, restlessness, abnormal dreams, reduced libido, dizziness, tremor, palpitations, QT interval prolongation, flushing, yawning, dyspepsia, vomiting, dry mouth, blurred vision, rash, pruritus, hyperhidrosis, arthralgia, frequent urination, menstrual cycle irregularities.
  • Uncommon — depersonalisation, abnormal thinking, hyperactivity, dyskinesia, ataxia, myoclonus, memory impairment, mydriasis, tinnitus, hypotension, dyspnoea, epistaxis, dysphagia, gastrointestinal haemorrhage, alopecia, increased bruising, cold sweat, dysuria, muscle twitching, sexual dysfunction.
  • Rare or very rare — leucopenia, neutropenia, thrombocytopaenia, hyponatraemia, hypomania, mania, hallucinations, panic attacks, confusion, aggression, convulsions, akathisia, buccoglossal syndrome, serotonin syndrome, ventricular arrythmia, vasculitis, pharyngitis, oesophageal pain, pancreatitis, hepatitis, purpura, myalgia, urinary retention, galactorrhoea, hyperprolactinaemia, priapism, mucosal haemorrhage
  • Frequency not known — postpartum haemorrhage.

[BNFC, 2025; EMC, 2025]

Drug interactions

• Drug interactions with fluoxetine include:
  • Antiepileptics — fluoxetine is predicted to increase the concentration of fosphenytoin and phenytoin.
    • Manufacturer advises monitor and adjust dose.
  • Aspirin and nonsteroidal anti-inflammatory drugs (such as ibuprofen) — increased risk of bleeding. In addition, both fluoxetine and ibuprofen can increase the risk of hyponatraemia.
  • Irreversible, non-selective monoamine oxidase inhibitors (MAOI) (e.g. iproniazid)  — concurrent use contraindicated. Risk of serotonin syndrome with MAOI-A such as linezolid and methylene blue.
  • Medications which prolong the QT interval  — potential for additive effect although no studies. For example, antipsychotics, tricyclic antidepressants, certain antibiotics and antihistamines. Manufacturer advises use with caution.
  • Metoprolol  — risk of excessive bradycardia - concurrent use contraindicated.
  • Omega-3-acid ethyl esters — predicted to increase the risk of bleeding events when given with fluoxetine.
  • Tramadol — fluoxetine is predicted to decrease the efficacy of tramadol.
    • Manufacturer makes no recommendation.
  • Warfarin and other anticoagulants — predicted to increase the risk of bleeding events when given with fluoxetine.
    • Manufacturer advises use with caution or avoid.
• For a complete list of possible drug interactions with fluoxetine, see the electronic Medicines Compendium (eMC) or the British National Formulary (BNF).

[BNFC, 2025; EMC, 2025]

Pregnancy and breastfeeding

Pregnancy

• Data on the use of fluoxetine in pregnancy are conflicting.
• Fluoxetine may cause an increased risk of cardiovascular defects if used in the first trimester and may increase the risk of persistent pulmonary hypertension in the newborn when used in late pregnancy.
• There may be a small overall increased risk of postpartum haemorrhage associated with use of fluoxetine in the month prior to delivery.
• The manufacturer advises that fluoxetine should not be used during pregnancy unless the benefit outweighs the possible risk to the foetus.
• The manufacturer advises that abrupt discontinuation should be avoided during pregnancy.
• Infants born to mothers who have been taking fluoxetine should be monitored for drowsiness, poor feeding, weight gain, irritability, restlessness and gastro-intestinal disturbances.

Breastfeeding

• Fluoxetine is excreted in breast milk and may cause adverse effects in breastfeeding infants. 
• The manufacturer advises that if treatment with fluoxetine is necessary, discontinuation of breastfeeding should be considered. If continued, the lowest effective dose of fluoxetine should be used.

[BNFC, 2025; EMC, 2025]