Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Prozac
  2. Prozac Weekly
  3. Rapiflux
  4. Sarafem
  5. Selfemra

Canadian Brand Name

  1. Phl-Fluoxetine

Descriptions


Fluoxetine is used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder. It is also used together with olanzapine to treat depression that is part of bipolar disorder.

Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). This medicine works by increasing the activity of a chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule
  • Capsule, Delayed Release
  • Tablet
  • Syrup
  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with depression. However, safety and efficacy have not been established in children younger than 8 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with obsessive-compulsive disorder. However, safety and efficacy have not been established in children younger than 7 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa or panic disorder. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluoxetine in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood) than younger adults, which may require caution and an adjustment in the dose for patients receiving fluoxetine.

Pregnancy

Information about this fluoxetine-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Clorgyline
  • Dronedarone
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Procarbazine
  • Rasagiline
  • Saquinavir
  • Selegiline
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Toloxatone
  • Tranylcypromine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Abiraterone Acetate
  • Acecainide
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Ajmaline
  • Alfuzosin
  • Almotriptan
  • Amineptine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amphetamine
  • Amtolmetin Guacil
  • Anagrelide
  • Ancrod
  • Anisindione
  • Antithrombin III Human
  • Apixaban
  • Apomorphine
  • Aprindine
  • Ardeparin
  • Argatroban
  • Arsenic Trioxide
  • Asenapine
  • Aspirin
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bivalirudin
  • Bretylium
  • Bromfenac
  • Brompheniramine
  • Bufexamac
  • Bupropion
  • Carbamazepine
  • Carvedilol
  • Celecoxib
  • Certoparin
  • Chloral Hydrate
  • Chloroquine
  • Chlorpheniramine
  • Chlorpromazine
  • Choline Salicylate
  • Cilostazol
  • Cinacalcet
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonixin
  • Clopidogrel
  • Clozapine
  • Cobicistat
  • Cocaine
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dalteparin
  • Danaparoid
  • Dasatinib
  • Defibrotide
  • Dermatan Sulfate
  • Desipramine
  • Desirudin
  • Desvenlafaxine
  • Dexfenfluramine
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Dextromethorphan
  • Dibenzepin
  • Diclofenac
  • Dicumarol
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Drotrecogin Alfa
  • Duloxetine
  • Ebastine
  • Eletriptan
  • Enflurane
  • Enoxaparin
  • Eptifibatide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Famotidine
  • Felbamate
  • Felbinac
  • Fenfluramine
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Fingolimod
  • Flecainide
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Fluphenazine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Frovatriptan
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Heparin
  • Hydroquinidine
  • Hydroxytryptophan
  • Ibuprofen
  • Ibuprofen Lysine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indomethacin
  • Iobenguane I 123
  • Isoflurane
  • Isradipine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lapatinib
  • Lepirudin
  • Levofloxacin
  • Levomilnacipran
  • Lidoflazine
  • Lofepramine
  • Lorcaserin
  • Lornoxicam
  • Loxoprofen
  • Lumefantrine
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Mefloquine
  • Melitracen
  • Meloxicam
  • Meperidine
  • Methadone
  • Mexiletine
  • Mifepristone
  • Milnacipran
  • Mirtazapine
  • Mizolastine
  • Morniflumate
  • Moxifloxacin
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Naratriptan
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Paliperidone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Pentosan Polysulfate Sodium
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Piketoprofen
  • Pirmenol
  • Piroxicam
  • Posaconazole
  • Prajmaline
  • Pranoprofen
  • Prasugrel
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Proglumetacin
  • Promethazine
  • Propafenone
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Protein C, Human
  • Protriptyline Hydrochloride
  • Quetiapine
  • Quinine
  • Ranolazine
  • Reviparin
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Rivaroxaban
  • Rizatriptan
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sematilide
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sibutramine
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sodium Salicylate
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • St John's Wort
  • Sulfamethoxazole
  • Sulfinpyrazone
  • Sulindac
  • Sultopride
  • Sumatriptan
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tenoxicam
  • Terbinafine
  • Tetrabenazine
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Timolol
  • Tinzaparin
  • Tirofiban
  • Tizanidine
  • Tolfenamic Acid
  • Tolmetin
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Treprostinil
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Tryptophan
  • Valdecoxib
  • Valproic Acid
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilazodone
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Vortioxetine
  • Warfarin
  • Zolmitriptan
  • Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alprazolam
  • Buspirone
  • Cyproheptadine
  • Delavirdine
  • Digoxin
  • Ginkgo
  • Lithium
  • Nebivolol
  • Phenytoin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bipolar disorder (mood disorder with mania and depression), or risk of or
  • Bleeding problems or
  • Diabetes or
  • Glaucoma, narrow-angle or
  • Hyponatremia (low sodium in the blood) or
  • Mania, history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Heart attack or stroke, recent or history of or
  • Heart failure or
  • Heart rhythm problems (eg, QT prolongation), or history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take the medicine with or without food.

For some conditions, it may take a month or longer before you begin to feel better.

If you are using the oral liquid, shake the bottle well before measuring each dose. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup. A regular household teaspoon will not measure the proper amount of medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (delayed-release capsules, pulvules, or solution):
    • For bulimia nervosa:
      • Adults—60 milligrams (mg) per day as a single dose in the morning.
      • Children—Use and dose must be determined by your doctor.
    • For depression:
      • Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day. After a few weeks, your doctor may change you to a weekly dose of 90 mg, taken as a single dose one day per week.
      • Children 8 years of age and older—At first, 10 to 20 mg per day as a single dose in the morning. Your doctor may adjust your dose as needed.
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.
    • For obsessive-compulsive disorder:
      • Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.
      • Children 7 years of age and older—At first, 10 mg per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 7 years of age—Use and dose must be determined by your doctor.
    • For panic disorder:
      • Adults—At first, 10 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For premenstrual dysphoric disorder:
      • Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may have you take 20 mg every day of your menstrual cycle or for only 15 days of your cycle. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits, to allow changes in your dose and help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take fluoxetine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking fluoxetine during the 2 weeks after you stop a MAO inhibitor and wait 5 weeks after stopping fluoxetine before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not take thioridazine (Mellaril®) with fluoxetine and wait 5 weeks after stopping fluoxetine before you start taking thioridazine. Do not use pimozide (Orap®) with fluoxetine. Using these medicines together can cause very serious heart problems.

Fluoxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use fluoxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St. John's wort, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with fluoxetine.

Fluoxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Tell your doctor right away if you develop a rash or hives, swelling of the face, eyes, or mouth, or trouble breathing after taking this medicine.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Contact your doctor right away if you have dizziness, fainting, or a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have ever had a heart rhythm problem, such as QT prolongation, or if you or a family member has had a heart attack, heart failure, low blood pressure, or a stroke.

The use of alcohol is not recommended in patients who are taking fluoxetine.

For diabetic patients:

  • This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may cause some people to become drowsy or less able to think clearly, or to have poor muscle control. Make sure you know how you react to fluoxetine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well able to control your movements.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Hives
  2. inability to sit still
  3. itching
  4. restlessness
  5. skin rash

Less common

  1. Chills or fever
  2. joint or muscle pain

Rare

  1. Anxiety
  2. cold sweats
  3. confusion
  4. convulsions (seizures)
  5. cool pale skin
  6. diarrhea
  7. difficulty with concentration
  8. drowsiness
  9. dryness of the mouth
  10. excessive hunger
  11. fast or irregular heartbeat
  12. headache
  13. increased sweating
  14. increased thirst
  15. lack of energy
  16. mood or behavior changes
  17. overactive reflexes
  18. purple or red spots on the skin
  19. racing heartbeat
  20. shakiness or unsteady walk
  21. shivering or shaking
  22. talking, feeling, and acting with excitement and activity you cannot control
  23. trouble with breathing
  24. unusual or incomplete body or facial movements
  25. unusual tiredness or weakness

Incidence not known

  1. Abdominal or stomach pain
  2. agitation
  3. back or leg pains
  4. bleeding gums
  5. blindness
  6. blistering, peeling, or loosening of the skin
  7. bloating
  8. blood in the urine or stools
  9. bloody, black, or tarry stools
  10. blue-yellow color blindness
  11. blurred vision
  12. chest pain or discomfort
  13. clay-colored stools
  14. constipation
  15. continuing vomiting
  16. cough or dry cough
  17. dark urine
  18. decreased urine output
  19. decreased vision
  20. depression
  21. difficulty with breathing
  22. difficulty with swallowing
  23. dizziness or lightheadedness
  24. eye pain
  25. fainting
  26. fast, pounding, or irregular heartbeat or pulse
  27. general body swelling
  28. high fever
  29. hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  30. hostility
  31. indigestion
  32. irregular or slow heart rate
  33. irritability
  34. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  35. light-colored stools
  36. loss of appetite
  37. loss of bladder control
  38. muscle twitching
  39. nausea
  40. nightmares
  41. no blood pressure or pulse
  42. noisy breathing
  43. nosebleeds
  44. pain in the ankles or knees
  45. painful, red lumps under the skin, mostly on the legs
  46. pains in the stomach, side, or abdomen, possibly radiating to the back
  47. pinpoint red spots on the skin
  48. rapid weight gain
  49. red or irritated eyes
  50. red skin lesions, often with a purple center
  51. redness, tenderness, itching, burning, or peeling of the skin
  52. severe muscle stiffness
  53. severe sleepiness
  54. slurred speech
  55. sore throat
  56. sores, ulcers, or white spots on the lips or in the mouth
  57. stopping of heart
  58. sudden shortness of breath or troubled breathing
  59. sudden weakness in the arms or legs
  60. sudden, severe chest pain
  61. swelling of the face, ankles, or hands
  62. swollen or painful glands
  63. thoughts of killing oneself
  64. tightness in the chest
  65. tiredness
  66. twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  67. unconsciousness
  68. unpleasant breath odor
  69. unusual bleeding or bruising
  70. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  71. unusually pale skin
  72. use of extreme physical or emotional force
  73. vomiting of blood
  74. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Decreased appetite

Less common or rare

  1. Abnormal dreams
  2. breast enlargement or pain
  3. change in sense of taste
  4. changes in vision
  5. feeling of warmth or heat
  6. flushing or redness of the skin, especially on face and neck
  7. frequent urination
  8. hair loss
  9. increased appetite
  10. increased sensitivity of the skin to sunlight
  11. menstrual pain
  12. stomach cramps, gas, or pain
  13. unusual secretion of milk, in females
  14. weight loss
  15. yawning

Incidence not known

  1. Cracks in the skin
  2. loss of heat from the body
  3. painful or prolonged erections of the penis
  4. scaly skin
  5. swelling of the breasts or breast soreness in both females and males
  6. unusual milk production

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.