Sarafem Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


1.1 Premenstrual Dysphoric Disorder (PMDD)

SARAFEM is indicated for the treatment of premenstrual dysphoric disorder (PMDD) [see Clinical Studies (14.1)].

The effectiveness of SARAFEM in long-term use (that is, for more than 6 months) has not been systematically evaluated in placebo-controlled trials. The use of SARAFEM for extended periods should be periodically re-evaluated for the individual patient [see Dosage and Administration (2.1)].


There is currently no drug history available for this drug.

Other Information

SARAFEM (fluoxetine hydrochloride tablets) is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79. The structural formula is:

Fluoxetine hydrochloride structural formula

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

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. Each tablet also contains microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Yellow No. 6 aluminum lake (10 mg and 20 mg tablets) and D&C Yellow No. 10 aluminum lake (10 mg and 20 mg tablets).

Sarafem Manufacturers

  • Warner Chilcott (Us), Llc
    Sarafem (Fluoxetine Hydrochloride) Tablet [Warner Chilcott (Us), Llc]

Login To Your Free Account