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Prescription oral capsulea selective serotonin reuptake inhibitor (SSRI), a type of antidepressant medicine

Fluoxetine

Fluoxetine hydrochloride · Say it: floo-OX-uh-teen

Fluoxetine is a prescription capsule taken by mouth. The label says it treats depression, obsessive-compulsive disorder, bulimia nervosa, and panic disorder.

Reading levelLanguage

⬛ Boxed warning (the FDA's strongest warning)

The boxed warning is about suicidal thoughts and behaviors. Antidepressants increased the risk of suicidal thoughts and behaviors in children, teenagers, and young adults in short-term studies. The studies did not show this increase in people over age 24, and there was a reduced risk in people aged 65 and older. Anyone starting antidepressant treatment should be watched closely for worsening mood and for new suicidal thoughts or behaviors. Families and caregivers should watch closely and stay in contact with the prescriber. The label says fluoxetine is not approved for use in children under 7 years of age. When fluoxetine is used with olanzapine, the boxed warning for Symbyax should also be read.

Used for

Major depressive disorder (depression), short-term and long-term treatment

Comes as

Capsules, 10 mg (white to off-white powder in a light blue and light orange capsule); Capsules, 20 mg (white to off-white powder in a light blue and light green capsule)

Common side effects

Abnormal dreams, Abnormal ejaculation, Decreased appetite

Key facts
Generic nameFluoxetine hydrochloride
Brand names—
Type of medicinea selective serotonin reuptake inhibitor (SSRI), a type of antidepressant medicine
How it is soldPrescription oral capsule
Comes asCapsules, 10 mg (white to off-white powder in a light blue and light orange capsule); Capsules, 20 mg (white to off-white powder in a light blue and light green capsule); Capsules, 40 mg (white to off-white powder in a light blue and white capsule)
Routeoral
Boxed warningYes, see below
Label date2026-06-19

💊 What is Fluoxetine used for?

  • Major depressive disorder (depression), short-term and long-term treatment
  • Obsessive-compulsive disorder (OCD), with obsessions and compulsions
  • Bulimia nervosa, to reduce binge-eating and vomiting behaviors (the label says it is not approved for use in children for this use)
  • Panic disorder, with or without agoraphobia (the label says it is not approved for use in children for this use)
  • Depressive episodes linked to bipolar I disorder, when taken together with olanzapine (the label says fluoxetine alone is not indicated for this)
  • Treatment-resistant depression, when taken together with olanzapine (the label says fluoxetine alone is not indicated for this)

How it works

The label describes fluoxetine as a selective serotonin reuptake inhibitor (SSRI). The label excerpt provided does not explain the mechanism in more detail.

How it is usually taken

  • The label says adult starting doses are taken in the morning. Higher doses may be taken once a day in the morning or split into morning and noon doses. The dose may be increased after several weeks if improvement is not enough. Doses are usually lower or given less often for people with liver problems, older adults, people with other illnesses, or people taking several other medicines. The label notes that changes in dose take several weeks to be fully reflected in the blood. Follow the instructions from your prescriber or pharmacist.

Comes as

  • Capsules, 10 mg (white to off-white powder in a light blue and light orange capsule)
  • Capsules, 20 mg (white to off-white powder in a light blue and light green capsule)
  • Capsules, 40 mg (white to off-white powder in a light blue and white capsule)

⚠️ Fluoxetine side effects

Common side effects

  • Abnormal dreams
  • Abnormal ejaculation
  • Decreased appetite
  • Anxiety
  • Weakness or tiredness (asthenia)
  • Diarrhea
  • Dry mouth
  • Indigestion (dyspepsia)
  • Flu-like symptoms
  • Erection problems (impotence)
  • Trouble sleeping (insomnia)
  • Decreased sex drive
  • Nausea
  • Nervousness
  • Sore throat (pharyngitis)
  • Rash

Get medical help right away if

  • Get medical help right away if you have new or sudden changes in mood, behavior, thoughts, or feelings, especially if severe. This includes attempts to commit suicide, thoughts about suicide or dying, acting on dangerous impulses, acting aggressive or violent, new or worse depression, new or worse anxiety or panic attacks, feeling agitated, restless, angry, or irritable, trouble sleeping, or unusual changes in behavior.
  • Get medical help right away, or call 911 in an emergency, if you have signs of serotonin syndrome. The label says this can be life-threatening. Signs include agitation, hallucinations, coma or other mental status changes, coordination problems or muscle twitching, racing heartbeat, high or low blood pressure, sweating or fever, nausea, vomiting, or diarrhea, muscle rigidity, dizziness, flushing, tremor, or seizures.
  • Get medical help right away if you have a severe allergic reaction. Signs include trouble breathing, swelling of the face, tongue, eyes, or mouth, and rash, itchy welts (hives), or blisters, alone or with fever or joint pain.
  • Get medical help right away if you have unusual bleeding or bruising. The label says the risk is higher if you take warfarin, an NSAID such as ibuprofen or naproxen, or aspirin.
  • Get medical help right away if you have eye pain, changes in vision, or swelling or redness in or around the eye.
  • Get medical help right away if you have a seizure or convulsion.
  • Get medical help right away if you have a manic episode. Signs include greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excessive happiness or irritability, or talking more or faster than usual.
  • Get medical help right away if you have signs of low sodium in the blood. Signs include headache, weakness or feeling unsteady, and confusion, problems concentrating, or memory problems. The label says older adults may be at greater risk.
  • Get medical help right away if you have a fast, slow, or irregular heartbeat, shortness of breath, or dizziness or fainting. The label says these can be signs of a life-threatening heart rhythm change.
  • Tell your healthcare provider about any unusual changes in appetite or weight. The label says children and teenagers should have their height and weight checked during treatment.
  • Talk with your healthcare provider if you have sexual side effects, such as delayed or no ejaculation, lower sex drive, trouble getting or keeping an erection, or delayed or no orgasm. The label says treatment options may be available.
  • Do not stop fluoxetine on your own. The label says stopping too quickly may cause anxiety, irritability, high or low mood, restlessness, sleep changes, headache, sweating, nausea, dizziness, electric shock-like feelings, shaking, or confusion.

🛑 Who should not take Fluoxetine, and who should be careful

The label says not to take it if

  • You are allergic to fluoxetine hydrochloride or any of its ingredients. The label excerpt is cut off at this point, so the full list of ingredients is not shown here.
  • You are taking an MAOI (monoamine oxidase inhibitor) intended to treat psychiatric disorders, or you took one within 5 weeks before stopping fluoxetine. The label says you should not take fluoxetine within 14 days of stopping an MAOI.
  • You are being treated with linezolid or intravenous methylene blue. The label says fluoxetine should not be started in this case.
  • You are taking pimozide. The label says it should not be used because of the risk of QT prolongation.
  • You are taking thioridazine, or you took it within 5 weeks before stopping fluoxetine. The label says it should not be used because of the risk of QT prolongation and higher thioridazine levels.

Tell your doctor before taking it if

  • The label says to talk with your healthcare provider about the risks of treating depression and the risks of not treating it.
  • Tell your provider if you take a blood thinner such as warfarin, an NSAID, or aspirin, because the risk of bleeding may increase.
  • Tell your provider if you have a history of seizures or conditions that may lower the seizure threshold.
  • Tell your provider if you have a risk of bipolar disorder. The label says the provider should screen for bipolar disorder and watch for mania or hypomania.
  • Tell your provider if you have a heart rhythm problem or other risk factors for QT prolongation.
  • Tell your provider if you have a narrow-angle eye condition, because the label says angle-closure glaucoma has occurred with antidepressants in people with narrow angles.
  • The label says fluoxetine may impair judgment, thinking, and motor skills, so use caution when operating machinery.
  • The label says that people with liver problems, older adults, and people with other illnesses or several medicines may need lower or less frequent doses.

🔀 Fluoxetine with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

  • MAOIs: Do not use with fluoxetine or within the time periods listed in the label.
  • Drugs broken down by the CYP2D6 enzyme pathway: The label says fluoxetine is a potent inhibitor of this pathway.
  • Tricyclic antidepressants (TCAs): The label says levels may need monitoring when given with fluoxetine or soon after stopping it.
  • Other medicines that act on the central nervous system: Use caution. The label says lower starting doses of these drugs and careful monitoring may be considered.
  • Benzodiazepines: The label mentions diazepam and alprazolam as examples with noted effects.
  • Antipsychotics: The label says fluoxetine may raise haloperidol and clozapine levels.
  • Anticonvulsants: The label says fluoxetine may raise phenytoin and carbamazepine levels, which may cause anticonvulsant toxicity.
  • Other serotonergic drugs: Other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort may increase the risk of serotonin syndrome.
  • Blood thinners and drugs that affect clotting, such as NSAIDs, aspirin, and warfarin: May increase the risk of bleeding.
  • Drugs that prolong the QT interval: Use with caution. Do not use with thioridazine or pimozide.
  • Olanzapine: When used together with fluoxetine, the label says to also read the drug interaction section of the Symbyax package insert.

Alcohol and food

The label does not say.

🤰 Fluoxetine in pregnancy and breastfeeding

Pregnancy

The label says there is a pregnancy exposure registry for people taking antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling 1-844-405-6185. The label says exposure to SSRIs, especially in the month before delivery, has been linked to less than a 2-fold increase in the risk of postpartum bleeding. Available studies have not shown an increased risk of major birth defects or miscarriage. Some studies reported heart-related birth defects, but the label says these studies do not prove cause. The label also notes risks from untreated depression in pregnancy, a newborn lung condition called persistent pulmonary hypertension of the newborn (PPHN), and poor newborn adaptation after SSRI exposure. Talk with your healthcare provider about these risks and benefits.

Breastfeeding

The label does not say.

🗓️ Storage, missed doses and taking too much

Storage

Store at 20 to 25 °C (68 to 77 °F). Short excursions to 15 to 30 °C (59 to 86 °F) are allowed, according to the label.

If a dose is missed

The label does not say.

If too much is taken

The label lists these effects from fluoxetine overdose: seizures, which may be delayed; altered mental status, including coma; heart problems, which may be delayed, such as abnormal heart rhythms and cardiac arrest; high blood pressure, which is the most common blood pressure change, though low blood pressure can occur rarely, including with alcohol; and serotonin syndrome, which may be more likely when other serotonin-raising drugs are involved. The label says activated charcoal may be considered for people who arrive early after an overdose. It also suggests contacting a Poison Center at 1-800-221-2222 or a medical toxicologist. If you think someone has overdosed, get emergency medical help right away.

🗒️ Questions to ask about Fluoxetine

🎯 Check what you understood

1. According to the label, what can happen when fluoxetine is combined with an MAOI?

2. What does the label say about changing a dose of fluoxetine?

3. Which of these is listed in the label as a reason to get medical help right away?

❓ Fluoxetine: frequently asked questions

What is fluoxetine used for?

The label says fluoxetine is used to treat major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, and panic disorder. It is also used with olanzapine for bipolar depression and treatment-resistant depression.

What is the most important warning about fluoxetine?

The boxed warning says antidepressants can increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults. The label says people of all ages starting treatment should be watched closely for worsening mood or new suicidal thoughts.

Can I stop taking fluoxetine suddenly?

The label says not to stop fluoxetine without first talking to your healthcare provider. It notes that stopping too quickly may cause serious symptoms.

Does fluoxetine increase bleeding risk?

The label says fluoxetine may increase the risk of bleeding or bruising, especially when taken with warfarin, NSAIDs such as ibuprofen or naproxen, or aspirin.

What should I do if I think someone has taken too much fluoxetine?

The label says to get emergency medical help right away. It also suggests contacting a Poison Center at 1-800-221-2222 or a medical toxicologist.

🧪 Tests and reports linked to Fluoxetine

The label text mentions these. If you have one of these reports, get every line of it explained.

📖 Medical words used on this page

  • Allergic reaction

    An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.

  • Anaphylaxis

    Anaphylaxis is a severe, whole-body allergic reaction that comes on fast and is a medical emergency needing urgent help.

  • Angle-closure glaucoma

    Angle-closure glaucoma is a sudden rise in eye pressure when fluid cannot drain from the eye. A sudden attack is an emergency.

  • Anticoagulant

    An anticoagulant is a medicine that slows blood clotting, used to prevent or treat harmful clots. It raises the risk of bleeding.

  • Anticonvulsant

    An anticonvulsant is a medicine that helps prevent or control seizures. Some are also used for nerve pain, migraine or mood conditions.

  • Antidepressant

    An antidepressant is a medicine used to treat depression, and often anxiety, pain and other conditions, by acting on chemical messengers in the brain.

  • Antiplatelet

    An antiplatelet is a medicine, such as aspirin or clopidogrel, that stops platelets clumping together to form clots in arteries.

  • Antipsychotic

    An antipsychotic is a medicine used for psychosis, schizophrenia and bipolar disorder, and sometimes for other conditions.

  • Arrhythmia

    An arrhythmia is a heartbeat that is too fast, too slow or irregular, because the heart's electrical signals are not working in their usual pattern.

  • Benzodiazepine

    A benzodiazepine is a type of calming medicine used for anxiety, sleep problems, seizures or muscle spasm. It can cause drowsiness and dependence.

  • Bipolar I disorder

    Bipolar I disorder is a long-term mood condition in which a person has had at least one episode of mania, often with periods of depression too.

  • Boxed warning

    A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.

  • Concomitant

    Concomitant means 'at the same time'; on a medicine label, concomitant use means taking two medicines during the same period.

  • Congenital malformations

    Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.

📖 Medical words on this page

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Source: official FDA drug label (label updated 2026-06-19). Read the full label on DailyMed

MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.