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Fluoxetine: Side Effects, Use, and Benefits

Last Updated on March 5, 2024 by Diane Ridaeus

One needs information in order to make informed decisions. We offer here a body of facts taken from researchers around the world, that you may or may not have been told before beginning to take an SSRI like fluoxetine. Knowledge is empowerment, so read on!

Learn more about Fluoxetine and its side effects as well as the problems one may encounter when stopping the drug, so you can accurately weigh the benefits against the risks for yourself.


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What Is Fluoxetine?

Fluoxetine is an SSRI (selective serotonin reuptake inhibitor) antidepressant drug. Since its first approval in 1987, fluoxetine (Prozac) has become one of the most widely-prescribed antidepressant medications in the world. Fluoxetine has the longest half-life of all SSRI medications, 4-6 days.9 While fluoxetine shares a considerable list of potential downsides with all other SSRIs, a longer half-life can make it easier to wean off than most other drugs in the same class. Fluoxetine is sold as a capsule, a delayed-release capsule, and a tablet version.1,10,11

Fluoxetine was first marketed under the brand name Prozac and later, Sarafem. Sarafem is exactly the same as Prozac, but is marketed specifically to women to address premenstrual issues (PMDD).

All versions of fluoxetine carry the black box warnings for suicide as do all other SSRI medications.

What Does Fluoxetine Treat?

The FDA approved the use of fluoxetine for many conditions according to the drug’s label.

Fluoxetine is FDA-approved for:

  • Acute and maintenance treatment of MDD (major depressive disorder)
  • Acute and maintenance treatment of OCD (obsessive-compulsive disorder)
  • Acute and maintenance treatment for Bulimia Nervosa (eating disorder)
  • Acute and maintenance treatment for PD (panic disorder) with or without agoraphobia
  • Treatment-resistant depression, when combined with olanzapine
  • PMDD (premenstrual dysphoric disorder)
  • Treatment resistant depression & acute depression episodes in bipolar, if combined with a prescription of olanzapine

Off-label Uses of SSRIs

Fluoxetine is commonly prescribed “off-label” even where no evidence exists of efficacy.12

Off-label uses of SSRIs like fluoxetine are extremely common and wide-ranging, including:
  • Social phobias
  • Anxiety disorders
  • Insomnia
  • PTSD (trauma-related stress disorder)
  • Raynaud’s phenomena (blood-flow restriction during cold temperatures and/or stress)13
  • Migraines
  • Diabetic neuropathy (nerve-associated pain in diabetic patients)
  • Borderline personality disorder (chronic emotional instability or antisocial behaviors)
  • Selective mutism (anxiety-related speech disorder)
  • Dysthymia (mild but persisting depression)
  • Body dysmorphic disorder (preoccupation with physical defects often accompanied with self-harm, repetitive skin picking, etc.)14
  • Premature ejaculation
  • Fibromyalgia

How Does Fluoxetine Work?

SSRIs restrict or suspend the normal flow of a natural chemical called serotonin, causing an artificial build-up. Serotonin is mostly produced in the gut. It is a neurotransmitter meaning it transports messages between nerve cells within the body, brain and all throughout the CNS. Once the serotonin has transmitted its neural message, it is meant to be reabsorbed into the body to be used again. However, a drug like fluoxetine suspends this molecule outside the synapse where it eventually degrades and is lost. Moncrieff’s research showed a lessened serotonin plasma concentration after antidepressant use.15 Therefore, it is reasonable to propose that a serotonergic drug such as fluoxetine can actually create a serotonin deficiency.

Serotonin’s roles in the body are incalculably vast — including the regulation of physical and psychological functions such as mood, sleep, sexual desire, bone health, and wound healing. Researchers still do not have an answer as to why SSRIs cause suicidal thinking or behavior in persons who never experienced such thoughts or behaviors before taking Prozac.

Some studies have even questioned how much of the effectiveness attributed to SSRIs like fluoxetine should instead be attributed to the placebo effect.2

The mechanics of SSRIs are not completely understood, even after being marketed for more than 3 decades.

Fluoxetine Side Effects

The benefit to risk ratio for medications is different for each person. One person may find fluoxetine allows them to get a better sleep, while another may find it keeps them awake all night long. Some fluoxetine side effects may persist and even worsen, and some may diminish over time. The most important thing to know about risks and benefits is that yours are unique to you.1

Moderate Side Effects

Some side effects are considered mild or moderate, and include:
  • Decreased appetite
  • Weight loss
  • Altered sense of taste
  • Changes in vision
  • Hair loss
  • Breast pain or enlargement
  • Redness or flushing of the skin
  • Increased menstrual pain
  • Stomach pain, cramps, constipation, gas
  • Frequent urination

Serious Side Effects

Alternatively, some side effects should be immediately discussed with your doctor if they arise.
  • Suicidal thoughts or behaviors
  • Serotonin syndrome (see below for detailed explanation)
  • Blindness
  • Agitation
  • Continued vomiting or vomiting blood
  • Difficulty swallowing
  • Restlessness
  • Inability to sit still
  • Itching, hives, or skin rash
  • Muscle or joint pain
  • Chills or fever
  • Anxiety
  • Confusion
  • Diarrhea
  • Headache
  • Cold sweats
  • Lack of energy
  • Racing heartbeat
  • Difficulty breathing
  • Overactive reflexes
  • Unusual body or facial movements

Though the above side effects are likely to arise shortly after beginning the medication, there are also long-term implications of taking SSRIs like fluoxetine. Research has shown that antidepressant users are at a 33% higher risk of death and a 14% higher risk of heart attack and stroke than non-users. Serotonin syndrome and addiction are also concerns for those taking fluoxetine.3

As some of the side effects can be particularly concerning, such as suicidal thoughts or impulses, you should quickly reach out to the prescribing doctor if you experience these phenomena. An informed physician can help you evaluate your symptoms and create a plan for managing them, or help you to determine whether you should step down from the medication. Even if you are seeking therapeutic effects from fluoxetine, there may be a better option that does not cause as many deleterious side effects. Ask your prescriber about these options in your discussions.

Never stop SSRIs abruptly.

Fluoxetine and Serotonin Syndrome

Fluoxetine has the potential to cause a potentially life-threatening side effect known as serotonin syndrome. Serotonin syndrome is a serious drug reaction caused by medications that overload the levels of serotonin in the body. Though serotonin is naturally produced within the body, too much can be fatal.

Signs and symptoms of serotonin syndrome include:
  • Restlessness or agitation
  • Confusion
  • Insomnia
  • Muscle rigidity
  • Headache
  • Heavy sweating
  • High blood pressure or rapid heart rate
More serious symptoms include:
  • Tremors
  • High fever
  • Irregular heartbeat
  • Seizures
  • Unconsciousness

Serotonin syndrome is most frequently caused by combining medications that increase the plasma levels of serotonin, such as taking multiple SSRIs, migraine medications, or taking additional serotonergic agents simultaneously with fluoxetine. Presentations of serotonin syndrome require immediate transport and treatment in an ICU to prevent fatality. If you suspect you are experiencing serotonin syndrome, it is vital that you get treatment without delay.4

Fluoxetine and Pregnancy, Fertility

For a long time, fluoxetine was considered safe while trying to get pregnant and during pregnancy. However, newer studies show some cause for concern.

If taking fluoxetine while attempting to get pregnant, there may be some issues with lower sexual desire for both men and women. Some men that are taking fluoxetine may also experience lowered sperm count.5 Fertility in women did not seem similarly impacted.

pregnancy risk while taking fluoxetineDuring pregnancy, research reveals concerns for the fetus. Some studies have suggested an increased chance of cardiovascular defects, reducing oxygen delivery, increasing cortisol levels, and other complications to the unborn child. Fluoxetine passes the placenta and can also decrease uterine blood flow. It has been determined that fluoxetine is passed to the infant during breastfeeding.6,8

There have also been pregnancy-related complications tied to taking fluoxetine throughout the third trimester. There has been some evidence to suggest a higher chance for preterm delivery (delivery prior to 37 weeks of pregnancy) and a higher likelihood of the infant having a low birth weight, especially at higher doses of fluoxetine.

Once the child is born, they may also experience some symptoms of withdrawal, including tight muscles, difficulty breathing, tremors, unusual sleep patterns, being irritable, and/or trouble eating. These symptoms appear to be more likely when fluoxetine is used throughout the third trimester or combined with other psychiatric medications during the pregnancy.

Some patients breastfeeding an infant while taking fluoxetine have reported vomiting, irritability, diarrhea, and reduced sleep in their babies. These instances are more likely to occur when the infant is less than two months of age. The product labels for fluoxetine recommend that those who breastfeed should not use the medication.6-8

Is Fluoxetine Addictive?

The terms “addiction” and “dependence” are, medically speaking, not dissimilar. The criteria that define substance use disorder are characterized by continuing to take a substance despite any negative consequences.

Defining criteria include:
  • A desire to cut back or quit but being unable to do so.
  • Spending an excessive amount of time and effort to acquire the substance.
  • Urges or cravings to use the substance.
  • Withdrawals occur when the substance is stopped or delayed.

In terms of drug regulation, fluoxetine and other SSRIs are not controlled substances.

However, this does not mean that one cannot develop a dependency on fluoxetine. This dependency occurs when the body and brain become accustomed to functioning in the presence of the drug and cannot return to normal function without it. Withdrawal effects are the main driver in drug dependency, including SSRIs. This dependency is more likely to arise when fluoxetine has been taken long-term, but can also occur in the short term.

Common fluoxetine withdrawal symptoms include:
  • Electric shock sensations
  • Sensory disturbances
  • Dysphoric mood
  • Anxiety
  • Lethargy
  • Hypomania
  • Headache
  • Confusion
  • Dizziness
  • Insomnia
  • Emotional lability, crying spells, irritation, rage, and agitation

Because fluoxetine has a long half-life, withdrawal symptoms may not arise until days or even potentially weeks after the medication is stopped. They may last weeks, or longer, even years. For some, these may be mild, and for others quite severe. In the past, antidepressant withdrawal was quite likely diagnosed as a “relapse” but today, medical consensus is to recommend gradual tapering to avoid fluoxetine withdrawal syndrome.16

Like so many commercial products out of the pharma industry, the risks of fluoxetine addiction and dependency were not studied before its approval. In fact, it has yet to be a priority, even as the number of prescriptions rises. 30-plus years later, the label states no studies have been done on fluoxetine dependency as a potential outcome of using the medication.10

Suggested Reading: Fluoxetine Tapering

Alternative Treatments to Avoid Fluoxetine Side Effects

It is possible to find alternatives to drug-based therapy that eliminate the risk of side effects, and that can provide the benefits one hoped for but didn’t receive with prescription drugs. There are safe and holistic methods that can provide relief as effectively, if not more so, than fluoxetine. Some of these methods include:

These and other strategies are used at ATMC to help clients eliminate unwanted symptoms that prescription drugs could not.

Long-Term Recovery With ATMC

Whether your goal is tapering off an existing fluoxetine prescription or looking for a solution before attempting an SSRI, Alternative To Meds Center can help you on your journey. With a skilled medical team in place and decades of experience supporting patients as they reduce and eliminate medications, we can help you avoid complications throughout the process.

Our alternative mental health and addiction treatment in Arizona is combined with a welcoming, therapeutic environment in order to support a transition to a symptom-free and healthier life. We will formulate a unique plan that focuses on whole-body wellness, as being successful in your path requires a detailed treatment plan that uniquely addresses you.

Sources:


1. Edinoff, A. N., Akuly, H. A., Hanna, T. A., Ochoa, C. O., Patti, S. J., Ghaffar, Y. A., Kaye, A. D., et al. (2021). Selective Serotonin Reuptake Inhibitors and Adverse Effects: A Narrative Review. Neurology International, 13(3), 387–401. MDPI AG. {cited 2024 Feb 7]

2. Khan, A., & Brown, W. A. (2015). Antidepressants versus placebo in major depression: an overview. World psychiatry : official journal of the World Psychiatric Association (WPA), 14(3), 294–300. [cited 2024 Feb 7]

3. Maslej, M. M., Bolker, B. M., Russell, M. J., Eaton, K., Durisko, Z., Hollon, S. D., Swanson, G. M., Thomson, J. A., Jr, Mulsant, B. H., & Andrews, P. W. (2017). The Mortality and Myocardial Effects of Antidepressants Are Moderated by Preexisting Cardiovascular Disease: A Meta-Analysis. Psychotherapy and psychosomatics, 86(5), 268–282. https://doi.org/10.1159/000477940

4. Scotton, W. J., Hill, L. J., Williams, A. C., & Barnes, N. M. (2019). Serotonin syndrome: pathophysiology, clinical features, management, and potential future directions. International Journal of Tryptophan Research, 12, 1178646919873925. [cited 2024 Feb 7]

5. Korshunov, M. N., Korshunova, E. S., Kastrikin, Y. V., & Darenkov, S. P. (2021). Selective serotonin reuptake inhibitors and spermatogenesis. Urology Herald, 9(2), 74-79. [cited 2024 Feb 7]

6. Gao, S. Y., Wu, Q. J., Zhang, T. N., Shen, Z. Q., Liu, C. X., Xu, X., Ji, C., & Zhao, Y. H. (2017). Fluoxetine and congenital malformations: a systematic review and meta-analysis of cohort studies. British journal of clinical pharmacology, 83(10), 2134–2147. [cited 2024 Feb 7]

7. Mother To Baby | Fact Sheets [Internet]. Brentwood (TN): Organization of Teratology Information Specialists (OTIS); 1994-. Fluoxetine (Prozac®) 2022 Oct. Available from: https://www.ncbi.nlm.nih.gov/books/NBK582711/  [cited 2024 Feb 7]

8. Morrison JL, Riggs KW, Rurak DW. Fluoxetine during pregnancy: impact on fetal development. Reprod Fertil Dev. 2005;17(6):641-50. doi: 10.1071/rd05030. PMID: 16263070. [cited 2024 Feb 7]

9. Marken PA, Munro JS. Selecting a Selective Serotonin Reuptake Inhibitor: Clinically Important Distinguishing Features. Prim Care Companion J Clin Psychiatry. 2000 Dec;2(6):205-210. doi: 10.4088/pcc.v02n0602. PMID: 15014630; PMCID: PMC181142. [cited 2024 Feb 7]

10. FDA label Prozac (fluoxetine capsules, delayed- release capsules for oral use) approval 1987 [cited 2024 Feb 7]

11. FDA label Sarafem (fluoxetine hydrochloride tablets) approval revised 2009 [cited 2024 Feb 7]

12. Stone KJ, Viera AJ, Parman CL. Off-label applications for SSRIs. Am Fam Physician. 2003 Aug 1;68(3):498-504. PMID: 12924832. [cited 2024 Feb 7]

13. Musa R, Qurie A. Raynaud Disease. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK499833/  [cited 2024 Feb 7]

14. Danborg PB, Valdersdorf M, Gøtzsche PC. Long-term harms from previous use of selective serotonin reuptake inhibitors: A systematic review. Int J Risk Saf Med. 2019;30(2):59-71. doi: 10.3233/JRS-180046. PMID: 30714974; PMCID: PMC6839490. [cited 2024 Feb 7]

15. Moncrieff J, Cooper RE, Stockmann T, Amendola S, Hengartner MP, Horowitz MA. The serotonin theory of depression: a systematic umbrella review of the evidence. Mol Psychiatry. 2023 Aug;28(8):3243-3256. doi: 10.1038/s41380-022-01661-0. Epub 2022 Jul 20. PMID: 35854107; PMCID: PMC10618090. [cited 2024 Feb 7]

16. Gabriel M, Sharma V. Antidepressant discontinuation syndrome. CMAJ. 2017 May 29;189(21):E747. doi: 10.1503/cmaj.160991. PMID: 28554948; PMCID: PMC5449237. [cited 2024 Feb 7]



This content has been reviewed and approved by a licensed physician.

Dr. Samuel Lee

Dr. Samuel Lee is a board-certified psychiatrist, specializing in a spiritually-based mental health discipline and integrative approaches. He graduated with an MD at Loma Linda University School of Medicine and did a residency in psychiatry at Cedars-Sinai Medical Center and University of Washington School of Medicine in Seattle. He has also been an inpatient adult psychiatrist at Kaweah Delta Mental Health Hospital and the primary attending geriatric psychiatrist at the Auerbach Inpatient Psychiatric Jewish Home Hospital. In addition, he served as the general adult outpatient psychiatrist at Kaiser Permanente.  He is board-certified in psychiatry and neurology and has a B.A. Magna Cum Laude in Religion from Pacific Union College. His specialty is in natural healing techniques that promote the body’s innate ability to heal itself.

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