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10 Sarafem Side Effects You Should Know About

Nabila Ismail, PharmDAustin Ulrich, PharmD, BCACP
Published on November 4, 2022

Key takeaways:

  • Sarafem is an antidepressant used to treat premenstrual dysphoric disorder. The brand name is no longer available in the U.S., so you may know it by its generic name — fluoxetine.

  • Some of Sarafem’s most common side effects are headache, trouble sleeping, and nausea. These tend to get better over time.

  • Most of Sarafem’s side effects are mild and manageable. But there have also been rare reports of serotonin syndrome and thoughts of self-harm.

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Sarafem, better known as fluoxetine, is an antidepressant medication that treats premenstrual dysphoric disorder (PMDD). A type of selective serotonin reuptake inhibitor (SSRI), it’s a sibling to Prozac — a medication that also uses fluoxetine as its key ingredient. 

While name-brand Sarafem has been discontinued in the U.S., its generic equivalent remains widely available. So if you live with PMDD, you may turn to medications like generic Sarafem for mood support during the weeks prior to your period. Sarafem is beneficial for this use, but it still has some side effects you should know about. Most Sarafem side effects are mild and lessen with time, but others are more serious in nature. 

Below, we’ll discuss 10 Sarafem side effects to consider before picking up your prescription.

1. Headache

Headaches are a common side effect of many medications. Unfortunately, it’s no different for Sarafem. In Sarafem’s initial clinical trials, about 13% to 15% of study participants reported this side effect. The good news is that for many people, this tends to improve after about a week of taking the medication.

If you have severe headaches or they last longer than a week, talk to your healthcare provider. They might suggest over-the-counter (OTC) medications, like acetaminophen (Tylenol) or ibuprofen (Advil, Motrin), for symptom management. They may also adjust your medication routine, if needed.

2. Changes in energy levels

If you’re living with PMDD, it’s common to experience symptoms of depression or anxiety before your menstrual cycle starts. Plus, more than two-thirds of people with depression also have symptoms of fatigue and low energy. Some of Sarafem’s potential benefits are helping improve mood, energy levels, and appetite. These effects can start to kick in within 1 to 2 weeks. 

However, it can be difficult to initially find the right balance. Since Sarafem can improve your mood and energy, it could lead to overactivity and overexcitement. This could mean the dosage needs to be adjusted or another medication may be recommended.

3. Trouble sleeping

Trouble sleeping (insomnia) is common with SSRIs like Sarafem. Up to 10% of people reported insomnia while taking Sarafem in clinical trials. As mentioned above, it may increase your energy levels — making it difficult to fall asleep. 

To avoid this, it’s generally recommended to take Sarafem in the morning. If you take it too close to bedtime, it may lead to a late night under the covers. But if you continue having trouble sleeping, notify your healthcare provider. They might suggest lowering your dose, changing your medication, or providing another medication to help you sleep.

4. Runny or stuffy nose

Some people taking Sarafem report feeling a runny or stuffy nose. Symptoms like sneezing and itching have been documented, too. About 16% to 23% of study participants experienced these side effects in clinical trials. It’s also possible to develop a runny nose if you suddenly stop taking Sarafem. 

If you develop a runny or stuffy nose that won’t go away, make sure to talk to your healthcare provider. They can offer tips to help control this side effect. And if they offer any dose adjustments, they may want you to gradually decrease your dose to avoid any withdrawal symptoms.

5. Flu-like symptoms

Flu-like symptoms — like chills, cough, and body aches — appeared in 3% to 7% of people taking Sarafem in clinical trials. The good news is that Sarafem is one of the SSRIs that runs a lower risk of causing flu-like symptoms. This is because of how long this medication stays in your body. These symptoms are also less likely to happen if you take Sarafem intermittently.

If you experience flu-like symptoms after starting Sarafem, talk to your healthcare provider. They can offer tips to help get your symptoms under control. In some cases, they may recommend an OTC medication for support.

6. Nausea

Experiencing nausea within the first few weeks of taking Sarafem is common. In clinical trials, up to 13% of people taking Sarafem reported nausea. While nausea can be frustrating, it should improve over time.

In general, you can take Sarafem with or without food. But if you experience nausea or an upset stomach after taking Sarafem, taking it with a snack or meal is a good idea. You can also try to find nausea relief by eating smaller meals more frequently throughout the day, staying hydrated, or taking an antacid, if needed.

7. Weight changes

Antidepressants are often associated with changes in your body weight. Many of them have weight gain as a side effect, but Sarafem is less likely to do this than other SSRIs.

In fact, some data shows that Sarafem actually leads to short-term weight loss — especially around the 1-month mark. However, after about a year, these changes largely went away.

8. Sexual changes

Another common side effect of SSRIs, like Sarafem, is sexual problems, especially for women. Lowered sex drive and orgasm changes are some common complaints.

For most people, sexual side effects aren’t permanent. They should start to go away after your body gets used to the medication. However, some people report long-term sexual side effects while taking Sarafem. If so, you should see a gradual return of sexual function after stopping the medication.

If you notice any bothersome sexual changes while taking Sarafem, let your healthcare provider know. They may switch your medication or medication dosage to help get your symptoms under control.

9. Thoughts of suicide or self-harm

While antidepressants like Sarafem help improve symptoms of depression, they have a boxed warning for thoughts of suicide or self-harm. This is the most serious warning the FDA can give to a medication. This risk appears to be highest in kids and adults ages 25 and younger.

If you start taking Sarafem, keep an eye out for new or worsening symptoms of depression. If you notice sudden changes in your mood, thoughts, or behaviors, contact your healthcare provider immediately. Suicide prevention hotlines are also a helpful resource. The National Suicide Prevention Lifeline is now the 988 Suicide and Crisis Lifeline that is available 24/7. All you have to do is dial 988.

10. Serotonin syndrome

Serotonin is a chemical in your body that’s well-known for its role in regulating your mood. Generally, if you’re diagnosed with anxiety or depression, you may have low levels of serotonin. But if your serotonin levels are too high, it’s also possible to develop serotonin syndrome. Most cases are mild, but they can also become life-threatening.

Serotonin syndrome is rare. But it can happen when you combine multiple medications that affect serotonin. This includes many other antidepressants, triptans, and more. 

There are a few subtle signs that may indicate you’re experiencing serotonin syndrome. Milder symptoms include agitation, dizziness, and high body temperature. More serious symptoms include tremors, muscle jerks, or hallucinations. Seek medical attention right away if you’re experiencing serious symptoms that you think may be related to serotonin syndrome.

When should I contact my healthcare provider about Sarafem side effects?

Many of Sarafem’s side effects are mild and manageable. In most cases, they should get better as your body gets used to the medication. But if any side effects become bothersome or excessive at any point, notify your healthcare provider as soon as you can. They can offer tips to help get your symptoms under control. 

Other situations require more immediate medical attention, such as signs of severe serotonin syndrome. You should also call 911 or 988 if you ever have thoughts of suicide or self harm.

The bottom line

Sarafem is an antidepressant used to treat PMDD. While it’s an effective medication, it has some side effects to keep in mind. Headache, nausea, and insomnia are some of the most common ones. These are usually mild or resolve over time. However, there are some side effects that can be more serious. Talk to your healthcare provider if you experience any severe side effects, such as signs of serotonin syndrome or thoughts of self harm.

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Why trust our experts?

Nabila Ismail, PharmD
Nabila Ismail, PharmD, is a pharmacist, freelance medical writer, and marketing strategist. She graduated with a doctorate in pharmacy from the University at Buffalo.
Joshua Murdock, PharmD, BCBBS
Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.
Austin Ulrich, PharmD, BCACP
Austin Ulrich, PharmD, BCACP, is a board-certified ambulatory care clinical pharmacist. In his early career, he provided direct patient care in a variety of settings, including hospital and community pharmacies, and in a primary care clinic as a clinical pharmacist.

References

Blumenthal, S., et al. (2014). An electronic health records study of long-term weight gain following antidepressant use. JAMA Psychiatry.

DailyMed. (2022). Fluoxetine

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Jacobsen, F. M. (1992). Fluoxetine-induced sexual dysfunction and an open trial of yohimbine. Journal of Clinical Psychiatry.

Jha, M. K, et al. (2018). When discontinuing SSRI antidepressants is a challenge: Management tips. American Journal of Psychiatry.

Judge, R., et al. (2000). Changes in energy during treatment of depression: an analysis of fluoxetine in double-blind, placebo-controlled trials. Journal of Clinical Psychopharmacology.

Michelson, D., et al. (1999). Changes in weight during a 1-year trial of fluoxetine. The American Journal of Psychiatry

National Alliance on Mental Illness. (2016). Fluoxetine (Prozac).

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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