Sarafem Warnings and Precautions

Some Sarafem warnings and precautions include being aware of possible drug interactions and the risk of seizures in some people who take the medicine. Before taking Sarafem, you should tell your healthcare provider about any medical conditions you have. You should not take Sarafem if you are allergic to any of the ingredients used to make Sarafem, have taken an MAOI within the past two weeks, or are taking pimozide or thioridazine.

Sarafem: What Should I Tell My Healthcare Provider?

You should talk to your healthcare provider prior to taking Sarafem® (fluoxetine hydrochloride) if you have:
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Some Sarafem Warnings and Precautions

Some warnings and precautions to be aware of with Sarafem include:
  • Even though Sarafem is not used to treat depression, it is classified as an antidepressant. Antidepressants (including Sarafem) may increase the risk of suicidal thoughts or behavior in children, teenagers, and adults (see Depression and Suicide for more information). Therefore, if you notice any changes in symptoms or develop new symptoms, talk to your healthcare provider immediately. Some of these symptoms may include anxiety, hostility, agitation, panic, restlessness, hallucinations, extreme hyperactivity, and suicidal thoughts or behavior (see Sarafem and Suicide for more information).
  • Before prescribing Sarafem, your healthcare provider should make sure that you do not have bipolar disorder. Sometimes, the symptoms of bipolar disorder and depression are very similar, and Sarafem can cause problems in people with bipolar disorder.
  • Sarafem can cause rashes or other allergic reactions. If you develop an unexplained rash or hives, talk to your healthcare provider.
  • Antidepressants can cause a group of dangerous symptoms known as serotonin syndrome. Taking Sarafem with other medications that affect serotonin can increase your risk of serotonin syndrome. These other medications include other antidepressants, triptans (migraine medications), and several other medications (see Sarafem Drug Interactions for more information).

Contact your healthcare provider immediately if you have any possible symptoms of serotonin syndrome, including:

    • Confusion
    • Seeing or hearing things that are not really there (hallucinations)
    • A fast heartbeat (tachycardia)
    • Feeling faint
    • Fever
    • Sweating
    • Muscle spasms
    • Difficulty walking
    • Diarrhea.


  • Sarafem can cause insomnia and anxiety. Talk to your healthcare provider if you are having problems sleeping or experiencing anxiety while taking Sarafem.
  • There is a possibility that Sarafem may cause unwanted weight loss or weight gain (see Sarafem and Weight Loss and Sarafem and Weight Gain).
  • If you have a seizure disorder, there is a possibility that taking Sarafem may cause seizures. Talk to your healthcare professional before taking Sarafem if you have seizures.
  • Sarafem may cause bleeding in the stomach or intestines. This risk is higher in people who take aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen. Symptoms of gastrointestinal bleeding may include:


    • Bright red blood coating the stool
    • Dark blood mixed with the stool
    • Black or tarry stool
    • Bright red blood in vomit
    • Vomit that has the appearance of coffee grounds. 
If you experience any of these symptoms, call your healthcare provider.
  • If you are elderly or taking a diuretic, Sarafem could cause low levels of salt in the blood (hyponatremia). This generally returns to "normal" when Sarafem is discontinued.
  • If you have liver problems, you may need a lower Sarafem dose, since the liver helps to remove Sarafem from the blood.
  • Sarafem stays in your system for a long time. This means that if you change your dose of Sarafem, you may not notice the effects of that change for several weeks. It also means that Sarafem will still be in your body for quite a while after you stop taking it.
  • Sarafem may affect your ability to perform complex tasks requiring mental and motor skills. Therefore, it is recommended that you become accustomed to its effects on you before becoming involved in activities requiring mental or motor concentration (such as driving a car or operating machinery).
  • Sarafem can interact with certain medications (see Sarafem Drug Interactions).
  • Sarafem is considered a pregnancy Category C medication. This means that Sarafem may not be safe to use during pregnancy. Talk to your healthcare provider about the risks and benefits of using Sarafem during pregnancy (see Sarafem and Pregnancy for more information).
  • Sarafem passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about using Sarafem (see Sarafem and Breastfeeding).
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