Fluoxetine is used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This medication may improve your mood, sleep, appetite, and energy level and may.
This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease ), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
l the doctor right away if you notice worsening depression /other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts /attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech).
SARAFEM (fluoxetine hydrochloride tablets) is a selective serotonin reuptake inhibitor (SSRI) for oral administration.
Table 6 enumerates the most common treatment-emergent adverse reactions associated with the use of fluoxetine up to 80 mg (incidence of at least 2% for fluoxetine and greater than placebo) in female patients ages 18 to 45 years from US placebo-controlled clinical trials in the treatment of depression, OCD, and bulimia.
6 aluminum lake (10 mg and 20 mg tablets) and D&C Yellow No. 10 aluminum lake (10 mg and 20 mg tablets). Each SARAFEM tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 15 mg (48.5 μmol) or 20 mg (64.7 μmol) of fluoxetine.
Sarafem (fluoxetine hydrochloride) Tablets is a selective serotonin reuptake inhibitor (SSRI) used to treat premenstrual dysphoric disorder (PMDD). Sarafem is available in generic form.
capsule, green/yellow, imprinted with DISTA 3105, PROZAC 20 mg.
Skin and Appendages - Infrequent : acne, alopecia, contact dermatitis, eczema, maculopapular rash, skin discoloration, skin ulcer; Rare : furunculosis, herpes zoster, hirsutism, psoriasis, purpuric rash, seborrhea.
capsule, blue/orange, imprinted with TEVA, 7198.
†Thinking abnormal is the COSTART term that captures concentration difficulties. Table 6: Treatment-Emergent Adverse Reactions : Incidence in Female Patients Ages 18 to 45 Years in Depress ion, OCD, and Bulimia Placebo-Controlled US Clinical Trials Body System/Adverse Reaction* Percentage of Patients Reporting Adverse Reaction Fluoxetine (N = 1145) Placebo (N = 553) Body as a Whole Headache 24 21 Asthenia 14 6 Flu syndrome 7 3 Abdominal pain 6 5 Accidental injury 4 3 Fever 3 2 Cardiovascular System Palpitation 3 2 Vasodilatation 3 1 Digestive System Nausea 27 11 Anorexia 11 4 Dry mouth 11 8 Diarrhea 10 7 Dyspepsia 7 5 Constipation 5 3 Vomiting 3 2 Metabolic and Nutritional Disorders Weight loss 3 1 Nervous System Insomnia 24 11 Nervousness 14 10 Anxiety 13 9 Somnolence 13 6 Tremor 12 1 Dizziness 11 5 Libido decreased 4 1 Abnormal dreams 3 2 Thinking abnormal 3 2 Respiratory System Pharyngitis 6 5 Yawn 5 -- Skin and Appendages Skin and Subcutaneous Tissue Disorders Sweating 8 3 Rash 5 3 Special Senses Abnormal vision 3 1 Urogenital System Urinary frequency 2 1 *Included are reactions reported by at least 2% of patients taking fluoxetine, except the following adverse reactions, which had an incidence on placebo greater than fluoxetine (depression, OCD, and bulimia combined): back pain, cough increased, depression (includes suicidal thoughts), dysmenorrhea, flatulence, infection, myalgia, pain, pruritus, rhinitis, sinusitis.
Pictures of Sarafem (Fluoxetine Hydrochloride), drug imprint information, side effects for the patient.
To make sure fluoxetine is safe for you, l your doctor if you have:
Take the PMDD Quiz!
However, you may have a relapse of depression if you stop taking your antidepressant. Do not start or stop taking this medicine during pregnancy without your doctor's advice. l your doctor right away if you become pregnant. Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby.
If you also take olanzapine (Zyprexa), read the Zyprexa medication guide and all patient warnings and instructions provided with that medication.
Stay alert to changes in your mood or symptoms.
Sarafem is a selective serotonin reuptake inhibitors (SSRI) antidepressant. This medicine affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms.
Report any new or worsening symptoms to your doctor, 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:
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
narcotic pain medicine-- fentanyl, tramadol.
if you are being treated with electroconvulsive therapy (ECT).
You may report side effects to FDA at 1-800-FDA-1088.