Fluoxetine

Important Safety Information — Fluoxetine

What is it approved for?

Fluoxetine is FDA-approved for the acute and maintenance treatment of major depressive disorder (MDD), the acute and maintenance treatment of obsessions and compulsions in obsessive-compulsive disorder (OCD), the acute and maintenance treatment of binge-eating and vomiting behaviors in moderate to severe bulimia nervosa, and the acute treatment of panic disorder with or without agoraphobia. Together with olanzapine it is approved for depressive episodes of bipolar I disorder and for treatment-resistant depression; fluoxetine alone is not indicated for those. Some uses also cover children and adolescents of specific ages listed on the label; it is not approved for children younger than 7.

Do not use if

• Taking an MAOI antidepressant, or having stopped one within the past 14 days (including linezolid or methylene blue given into a vein); an MAOI must not be started for at least 5 weeks after stopping fluoxetine
• Taking pimozide
• Taking thioridazine, or within 5 weeks of stopping fluoxetine
• Known allergy to fluoxetine or any ingredient in the capsules

Before starting, tell your provider if

• Personal or family history of bipolar disorder, mania or hypomania
• Seizures or conditions that lower the seizure threshold, glaucoma or narrow eye angles, congenital long QT syndrome or other heart rhythm risks, a recent heart attack or unstable heart disease, low sodium, diabetes, or liver disease such as cirrhosis
• Being underweight or having an eating disorder, because decreased appetite and weight changes can occur
• Bleeding problems, or use of aspirin, NSAIDs, warfarin or other medicines that affect clotting
• Medicines broken down by CYP2D6 or tightly bound to blood proteins: tricyclic antidepressants, haloperidol, clozapine, diazepam, alprazolam, phenytoin, carbamazepine, warfarin and others
• Other medicines that affect serotonin or the heart rhythm: triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, St. John's wort, or other QT-prolonging medicines
• Being older, taking diuretics, or being dehydrated, which raise the risk of low sodium
• Pregnancy, plans to become pregnant, or breastfeeding

Serious side effects — get medical help right away

• Serotonin syndrome. A potentially life-threatening reaction, more likely with other serotonin-affecting medicines but possible with fluoxetine alone. Get help right away for agitation, hallucinations, confusion, a fast heartbeat, high or low blood pressure, sweating or fever, flushing, tremor, muscle stiffness or twitching, loss of coordination, seizures, nausea, vomiting or diarrhea.
• Allergic reactions and rash. Rash and hives occurred in clinical trials, sometimes with fever, joint pain, swelling, breathing trouble or other body-wide symptoms. The label says to stop fluoxetine if a rash or allergic reaction appears; get emergency help for swelling of the face or throat or trouble breathing.
• Increased risk of bleeding. Bruising, nosebleeds and more serious bleeding, including in the digestive tract, can occur, especially with aspirin, NSAIDs, warfarin or other medicines that affect clotting.
• Manic episodes. In people with bipolar disorder an antidepressant may trigger a manic or mixed episode. Report greatly increased energy, racing thoughts, unusually grand ideas, severe trouble sleeping, reckless behavior, excessive happiness or irritability, or talking more or faster than usual.
• Angle-closure glaucoma. In people with untreated narrow eye angles, antidepressants can trigger an angle-closure attack. Get care right away for eye pain, changes in vision, or swelling or redness in or around the eye.
• Low sodium (hyponatremia). Often linked to a hormone imbalance (SIADH). Signs include headache, difficulty concentrating, memory problems, confusion, weakness and unsteadiness that can lead to falls; severe cases can cause hallucinations, fainting, seizures or coma.
• Seizures and heart rhythm changes. Fluoxetine is used cautiously in people with a history of seizures. QT prolongation and dangerous heart rhythms (Torsades de Pointes) have been reported, so it is used with caution in people with congenital long QT syndrome, other rhythm risks, or medicines that prolong the QT interval or raise fluoxetine levels.
• Changes in appetite and weight. Decreased appetite and weight changes have been reported and are listed by the label as an undesirable effect, especially in people who are underweight or have bulimia. Tell your provider about any change in appetite or weight.
• Discontinuation symptoms. Do not stop suddenly. Stopping abruptly can cause low mood, irritability, agitation, dizziness, electric shock-like sensations, anxiety, confusion, headache, tiredness, emotional ups and downs, trouble sleeping and hypomania; the label recommends lowering the dose gradually whenever possible.

Common side effects

Common side effects: abnormal dreams, ejaculation problems, decreased appetite, anxiety, weakness, diarrhea, dry mouth, indigestion, flu-like symptoms, erectile problems, trouble sleeping, decreased sexual desire, nausea, nervousness, sore throat, rash, sinus inflammation, sleepiness, sweating, tremor, flushing and yawning. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

Talk with your provider before starting, stopping or changing fluoxetine during pregnancy, because untreated depression also has risks. Published studies over several decades have not established an increased risk of major birth defects or miscarriage, although some reported more heart malformations without establishing a cause. SSRI exposure during pregnancy carries risks of persistent pulmonary hypertension of the newborn (PPHN) and poor adaptation in the newborn, and use in the month before delivery has been associated with a modest increase in the risk of heavy bleeding after birth. Fluoxetine and norfluoxetine pass into breast milk, and agitation, irritability, poor feeding and poor weight gain have been reported in breastfed infants, so tell your provider if you are breastfeeding.

If you are in crisis or thinking about suicide, call or text 988 (Suicide & Crisis Lifeline) or call 911.

Forever Health Rx does not provide crisis or emergency care.

Call your provider right away about new or worse depression, anxiety or panic attacks, agitation, restlessness, anger or irritability, acting aggressive or on dangerous impulses, trouble sleeping, or other unusual changes in mood or behavior.

Fluoxetine may impair judgment, thinking or motor skills; use caution with driving or machinery until you know how it affects you.

Prescription only. Fluoxetine is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.