Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Fluoxetine is not approved for use in pediatric patients except for patients with major depressive disorder or obsessive-compulsive disorder. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on fluoxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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fluoxetine
(floo OX e teen)

What is fluoxetine?
Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms. Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD). Fluoxetine may also be used for purposes other than those listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Fluoxetine HCl 10MG Capsules TEVA PHARMACEUTICALS USA30/$24.99 or 90/$48.97
Fluoxetine HCl 10MG Tablets PAR30/$13.99 or 90/$19.97
Fluoxetine HCl 20MG Capsules TEVA PHARMACEUTICALS USA30/$14.99 or 90/$26.99
Fluoxetine HCl 20MG/5ML Solution PAR120/$72.98 or 360/$199.91
Fluoxetine HCl 20MG Tablets PAR30/$25.99 or 90/$62.97
Fluoxetine HCl 40MG Capsules SANDOZ30/$40.99 or 90/$119.97
Prozac 10MG Capsules DISTA30/$166.26 or 90/$455.41
Prozac 10MG Tablets LILLY30/$122.17 or 90/$334.64
Prozac 20MG Capsules DISTA30/$151.93 or 90/$434.39
Prozac 20MG/5ML Solution DISTA120/$252.64 or 360/$712.8
Prozac 40MG Capsules DISTA30/$325.23 or 90/$943.63
Prozac Weekly 90MG CPDR LILLY4/$115.99 or 12/$315.95
Symbyax 12-25MG Capsules LILLY30/$466.3 or 90/$1398.9
Symbyax 12-50MG Capsules LILLY30/$441.86 or 90/$1262.39
Symbyax 6-25MG Capsules LILLY30/$291.4 or 90/$847.7

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What are the possible side effects of fluoxetine?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);

  • tremors, shivering, muscle stiffness or twitching;

  • a red, blistering, peeling skin rash;

  • problems with balance or coordination; or

  • agitation, confusion, sweating, fast heartbeat.

Less serious side effects may include:

  • drowsiness, dizziness, weakness;

  • runny nose, sore throat, headache, flu symptoms;

  • nausea, diarrhea, changes in appetite;

  • weight changes;

  • decreased sex drive, impotence, or difficulty having an orgasm; or

  • dry mouth, increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take fluoxetine?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from the medication. Do not break, chew, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

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What is the most important information I should know about fluoxetine?
Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Fluoxetine is the only antidepressant that is FDA-approved for use in children with depression. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose. If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed.Do not take extra medicine to make up the missed dose.

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What other drugs will affect fluoxetine?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine may cause you to bruise or bleed easily. Before taking fluoxetine, tell your doctor if you are using any of the following medicines: alprazolam (Xanax); clozapine (Clozaril, Fazaclo);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Fluoxetine has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. In a postmarketing report, outcome data were available for 723 pregnancies, 476 normal live births, 20 premature births, 105 therapeutic abortions, 81 spontaneous abortions, 14 twin pregnancies without malformations, three stillbirths, 14 perinatal major malformations, and 10 postperinatal malformations were reported. Fluoxetine is only recommended for use during pregnancy when benefits outweigh risk.

Neonates exposed to fluoxetine and other SSRIs or SNRIs late in the third trimester have developed complications requiring hospitalization, respiratory support, and tube feeding. The results of a cohort study indicate that 30% of neonates who had prolonged exposure to SSRIs in utero experience symptoms, in a dose-response manner, of a neonatal abstinence syndrome (e.g., tremor, gastrointestinal or sleep disturbances, hypertonicity, high-pitched cry) after birth. The authors suggest that infants exposed to SSRIs should be closely monitored for a minimum of 48 hours after birth. Based on the results of a retrospective case-controlled study, the manufacturer states that infants exposed to SSRIs after the 20th week of gestation may have a six-fold higher risk for developing persistent pulmonary hypertension of the newborn (PPHN) compared with infants who had not been exposed. It should be noted that PPHN is associated with significant neonatal morbidity and mortality. However, evidence from additional studies is warranted in order to confirm these findings. A prospective study compared the outcome of 228 pregnant women taking fluoxetine to 254 pregnant control women. The rates of spontaneous pregnancy loss were 10.5% and 9.1% respectively. The rates of major structural abnormalities were 5.5% and 4.0%. The incidence of three or more minor anomalies was significantly higher in exposed infants (15.5% vs. 6.5%). Infants exposed during the third trimester had high rates of premature delivery, admission to special care nurseries, and poor neonatal adaptation (including respiratory difficulty, cyanosis on feeding and jitteriness). Infants exposed late in gestation had shorter birth lengths and lower birth weights. One author has pointed out that he feels a problem with the above study was the absence of a relevant control group. Higher rates of perinatal complications, including lower birth weight, neonatal distress and prematurity, have been described in the offspring of mothers with mood and anxiety disorders who did not take any psychotropic drug during pregnancy. Furthermore, he points out that women who continued to take fluoxetine into the third trimester probably had more severe psychiatric illnesses. Another prospective study of 128 pregnant women exposed to a mean daily dose of 25.8 mg of fluoxetine during the first trimester reported no increase in the frequency of major malformations compared to two groups of control patients. (One control group received tricyclic antidepressants. The other control group received nonteratogens.) However, women exposed to fluoxetine and tricyclic antidepressants did demonstrate an increased frequency of miscarriage (13.5% and 12.2% compared to 6.8% in women exposed to nonteratogens.) One last prospective study compared rates of neonatal complications from 112 pregnant women taking fluoxetine and the 115 infants they delivered to the National Hospital Discharge Survey. The study concluded it was unlikely that maternal fluoxetine use during the third trimester results in significant postnatal complications.

Fluoxetine is excreted into human milk in small amounts. Fluoxetine is described by the American Academy of Pediatrics as a drug whose "effect on nursing infants is unknown but may be of concern".

A report of ten women nursing eleven infants found that less than 10% of the dose of fluoxetine (per kg of body weight) was delivered to the nursing infant during chronic maternal therapy. Other reports from two lactating women taking fluoxetine have described milk fluoxetine and norfluoxetine concentrations to be about one-fifth to one-quarter serum concentrations. No adverse effects were reported in any of the nursing infants above.

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Who should NOT use this medication?

  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor. MAO inhibitors and thioridazine are contraindicated within 5 weeks after discontinuance of fluoxetine. (See Drug Interactions under Warnings and see Interactions.)
  • Concurrent pimozide therapy. (See Specific Drugs under Interactions.)
  • Known hypersensitivity to fluoxetine or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a fluoxetine overdose may include nausea, vomiting, fever, sleepiness, rapid or uneven heartbeat, confusion, fainting, seizures, or coma.

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What should I discuss with my healthcare provider before taking fluoxetine?
Do not use fluoxetine if you are using any of the following drugs: pimozide (Orap); thioridazine (Mellaril); or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with fluoxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine (Mellaril) or an MAOI.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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