ALERT: Your health is top priority. We’re committed to providing reliable COVID-19 resources to keep you informed and safe.

Prozac

Prozac (fluoxetine) is one of the most popular selective serotonin reuptake inhibitors (SSRIs) in history. Suicidal thoughts and actions are a serious side effect of this drug. As of December 2019, the FDA had not issued any new warnings for this drug. But, a January 2018 article found the drug may affect attention span in children.

Prozac (fluoxetine) is an antidepressant. It was the first drug in the selective serotonin reuptake inhibitor (SSRI) class. Eli Lilly manufactures Prozac.

The U.S. Food and Drug Administration approved the drug in 1987. The FDA approved it to treat depression in adults, children and adolescents.

Over 4 million people reported using Prozac in 2013. It is the third most prescribed antidepressant in the U.S.

Prozac has earned the nickname “bottled sunshine.”

The drug also comes with some serious side effects. These include sexual dysfunction, suicidal thoughts, insomnia, anxiety, and anorexia.

Studies link it to birth defects and side effects in children.

As far back as the 1990s, people filed Prozac lawsuits over violent behavior or suicidal tendencies. More recently, people have filed lawsuits over birth defects they blamed on Prozac.

In January 2018, a study author Mari S. Golub said that healthy children who take Prozac may experience attention problems.

Dr. Golub and colleagues published their data in Developmental Cognitive Neuroscience in August 2017. They found Prozac had negative effects on attention span, impulsive behaviors and sleep in young monkeys.

As of March 2017, the FDA had not added new warnings to Prozac’s label.

Somatic Clinical Psychologist Andrew Bingham shares information he uncovered when studying the data on Prozac.

What does Prozac Treat?

The FDA approved Prozac to treat four psychiatric disorders and an additional two in combination with Zyprexa (olanzapine). In addition to the FDA-approved uses, doctors may also prescribe the drug off-label — for uses not approved by the FDA.

Generally, off-label use of a drug may be helpful for patients who have no other treatment for an illness or condition. But these uses may not have clinical trials that prove safety or effectiveness

FDA-Approved Prozac Uses
  • Major Depressive Disorder (MDD)
  • Obsessive-Compulsive Disorder (OCD)
  • Bulimia Nervosa
  • Panic Disorder with or without agoraphobia
  • Acute Depressive Episodes associated with Bipolar I Disorder (with Zyprexa)
  • Treatment-Resistant Depression (with Zyprexa)
Off-Label Prozac Uses:
  • Generalized anxiety disorder
  • Premature ejaculation
  • Migraine headaches
  • Diabetic neuropathy
  • Fibromyalgia
  • Neurocardiogenic syncope

Prozac Dosage

Prozac comes in a number of strengths. The typical dose is 20 mg a day taken in the morning. But depending on the psychiatric disorder treated, the frequency and dose may vary. The time of the day is also important in Prozac dosing. Some disorders call for patients to take Prozac and Zyprexa together. A combination drug containing Prozac and Zyprexa is sold under the brand Symbyax.

Disorders and Their Dosages
Major Depressive Disorder
Initial dose is 20 mg/day in the morning. After several weeks, the dose can increase to 20 mg twice a day (morning and noon). Maximum daily dose should not exceed 80 mg/day. It may take 4 weeks or longer to notice the full effect.
Major Depressive Disorder in Children
Initial dose of 10 mg or 20 mg/day. After 1 week at 10 mg, increase to 20 mg.
Obsessive Compulsive Disorder
Initial dose is 20 mg/day in the morning. After several weeks dose may increase to 20 mg twice daily. Maximum dose is 80 mg/day. It may take 5 weeks or longer to notice the full effect.
Bulimia Nervosa
Initial dose is 60 mg/day in the morning. There are no studies for higher doses in patients with Bulimia.
Panic Disorder
Initial dose of 10 mg/day and after one week, increase dose to 20 mg/day. Clinical trials did not study doses above 60 mg.
Depressive Episodes Associated with Bipolar I Disorder
Symbyax (a combination drug containing Prozac and Zyprexa) once a day in the evening. The starting dose is 5 mg Zyprexa and 20 mg Prozac. Doctors may adjust the dose for effectiveness with up to 12 mg of Zyprexa and 50 mg of Prozac.
Treatment Resistant Depression
Symbyax (a combination drug containing Prozac and Zyprexa) once a day in the evening. The starting dose is 5 mg Zyprexa and 20 mg Prozac. Doctors may adjust the dose for effectiveness with up to 12 mg of Zyprexa and 50 mg of Prozac.

Side Effects of Prozac

Even after three decades, researchers continue to study Prozac’s effects on the body, and new information about potential complications is still coming to light. The drug’s label lists a number of side effects discovered during clinical trials. In addition to common and mild side effects, Prozac may cause serious adverse events — some fatal.

Common Side Effects
  • Sexual dysfunction
  • Dry mouth
  • Nausea and vomiting
  • Headache
  • Diarrhea
  • Nervousness
  • Restlessness
  • Agitation and anxiety
  • Increased sweating
  • Weight gain or loss
  • Insomnia
  • Drowsiness
  • Fatigue
  • Tremor
  • Impotence
  • Abnormal dreams
  • Indigestion
  • Flu symptoms
  • Yawning
  • Sinusitis infection or sore throat
  • Hot flashes
Serious Side Effects Include:
  • Abnormal heart rhythm (QT prolongation)
  • Impaired judgment, thinking, and motor skills
  • Abnormal bleeding
  • Allergic reactions, skin rash
  • Suicidal thoughts and behaviors
  • Serotonin syndrome (a life-threatening condition with symptoms that include fever, agitation, increased reflexes, tremor, sweating, dilated pupils, and diarrhea)
  • Activation of mania/hypomania
  • Vision problems (angle-closure glaucoma)
  • Seizures
  • Changes in appetite or weight
  • Low sodium levels in the blood
  • Problems with blood sugar control

Prozac Withdrawal

Although most doctors don’t consider Prozac addictive — at least in the sense of inducing cravings in patients — doctors say it can make patients dependent. Drug dependence means that the body has adapted to a chemical to the point that it requires steady doses to normally function.

Prozac Generic
20 mg Prozac pills up close in their package

Because of this, patients who abruptly stop taking antidepressant drugs such as Prozac are likely to experience withdrawal symptoms such as nausea, headache, dizziness and lethargy. Patients must wean themselves off antidepressants slowly and under a doctor’s care.

Serotonin Syndrome

High doses of SSRIs often increase the severity of side effects, and one particular side effect—serotonin syndrome — can be fatal. Serotonin syndrome is a condition in which the body produces too much serotonin — a neurotransmitter that controls mood and behavior.

Symptoms can occur within minutes and include high blood pressure, hyperthermia, high body temperature and an increased heart rate that can lead to shock. Serotonin syndrome can arise when SSRIs act alone or in conjunction with other medications.

Prozac Black Box Suicide Warning

Prozac is one of the few antidepressants approved for the treatment of depression in children. However, studies in children have linked the drug to increased suicidal thoughts and behavior.

As a result, the FDA issued a public warning in October 2004, and two years later extended the advisory to include young adults as old as 24 years of age.

generic warning label on a Prozac bottle
Always consider reading the black box warning

In 2007, the FDA took an even stronger stance. The agency required antidepressant manufacturers to update existing black box warnings about the increased risks of suicidal thoughts and behavior during initial treatment in the first one to two months after starting treatment.

An FDA black box warning is the most stringent precaution a drug can carry before it is pulled from the shelves. It takes its name from the black border that surrounds the warning information on the drug’s packaging. The agency often requires pharmaceutical companies to include a bold warning on the drug’s label and patient instruction sheets if serious or life-threatening risks are associated with the drug’s use.

Prozac, Pregnancy & Birth Defects

In studies, most SSRIs can harm unborn animals in large doses, but there are no adequate studies in pregnant women. According to the Prozac label, pregnant women should only use Prozac if the benefit to the mother outweighs the risk to the fetus. Breastfeeding while taking Prozac is not recommended.

The FDA released a Safety Announcement in 2006 warning that SSRIs including Prozac can increase the risk of a rare heart and lung condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during the last half of pregnancy. The agency stated in its communication, “The FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.”

“The FDA will update the SSRI drug labels to reflect the new data and the conflicting results.”

The U.S. Food and Drug Administration

PPHN arises when a newborn’s circulatory system does not properly adapt to breathing outside of the womb. The FDA based the initial warning on one study. Then, the agency found more studies with conflicting findings and released another warning in 2011.

So far, the FDA has yet to make a final ruling.

A study published in the British Medical Journal (BMJ) in July 2015 by Jennita Reefhuis and colleagues linked Prozac to an increased risk of heart wall defects, craniosynoctosis, and heart defects. These risks were confirmed in a larger study by Gao Shan-Yan and colleagues in 2018.

Researchers from the CDC’s National Center on Birth Defects and Developmental Disabilities studied about 28,000 mothers with children born between 1997 and 2009. Of the 9,857 mothers of babies with birth defects, 659 reported taking an SSRI during pregnancy.

Drug Interactions

Prozac may interact with a variety of drugs and some complications may be severe. Side effects of drugs interaction include internal bleeding, seizures and abnormal heart rhythms. Patients should always check with their doctor before taking any medication with Prozac.

Some Serious Drugs Interactions Include:
Drugs that Interfere with Hemostasis (NSAIDS, aspirin, warfarin)
These drugs taken with Prozac may increase the risk of gastrointestinal bleeding.
Serotonergic Drugs (including monoamine oxidase inhibitors [MAOIs], triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort)
These drugs increase the risk of serotonin syndrome. Symptoms of serotonin syndrome include fever, agitation, increased reflexes, tremor, sweating, dilated pupils and diarrhea.
Electroconvulsive Therapy (ECT)
ECT with Prozac may result in prolonged seizures.
Drugs Metabolized by CYP2D6 (duloxetine, opioids, tricyclic antidepressants, haloperidol, etc.)
Taking Prozac with these drugs may cause too much medication to remain in the body. A decrease in dose of the medication metabolized by CYP2D6 is recommended.
Pimozide and Thioridazine
Taking these drugs with Prozac increases the risk of serious heart arrhythmias and sudden death.
Anticonvulsants (carbamazepine, phenytoin, topiramate, oxcarbazepine)
Taking these drugs with Prozac can cause anticonvulsant toxicity.
Prozac Pills
Prozac Facts
  1. Dosage 10 mg; 20 mg; 40 mg
  2. Used to Treat Depression, obsessive-compulsive disorder, Bulimia Nervosa, panic disorder. PROZAC and olanzapine in combination for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder (1) Treatment Resistant Depression (1)
  3. Related Drugs Paxil (paroxetine), Zoloft (sertraline)
  4. Manufacturer Pfizer
  5. Black Box Warnings Suicidal thoughts in children and adolescents and young adults
  6. FDA Approval 1987

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Medically Reviewed By

10 Cited Research Articles

Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. National Institute of Health. (2019). Prozac. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299
  2. Moore, A. (2007). Eternal sunshine. Retrieved from https://www.theguardian.com/society/2007/may/13/socialcare.medicineandhealth
  3. FDA. (n.d.). Fluoxetine (marketed as Prozac) Information. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fluoxetine-marketed-prozac-information
  4. FDA. (2011, December 14). FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-selective-serotonin-reuptake-inhibitor-ssri-antidepressant-use-during
  5. Stone, K.J., Viera, A.J. & Parman C.L. (2003). Off-Label Applications for SSRIs. Retrieved from https://www.aafp.org/afp/2003/0801/p498.html
  6. Reefhuis, J. et al. (2015). Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous reports. Retrieved from https://www.bmj.com/content/351/bmj.h3190
  7. Golub, M.S. et al. (2017, August). Cognitive performance of juvenile monkeys after chronic fluoxetine treatment. Retrieved from https://www.sciencedirect.com/science/article/pii/S1878929316302444?via%3Dihub
  8. Chen, J. (2018, January 29). Long-term mental effects of Prozac on primates. Retrieved from https://theaggie.org/2018/01/29/long-term-mental-effects-prozac-primates/
  9. Gao SY. et al. (2018). Selective serotonin reuptake inhibitor use during early pregnancy and congenital malformations: a systematic review and meta-analysis of cohort studies of more than 9 million births. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231277/
  10. Moore TJ. et al. (2017, February). Adult utilization of psychiatric drugs and differences by sex, age, and race. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/27942726
View All Sources
Who Am I Calling?

Calling this number connects you with a Drugwatch representative. We will direct you to one of our trusted legal partners for a free case review.

Drugwatch's sponsors support the organization's mission to keep people safe from dangerous drugs and medical devices. For more information, visit our sponsors page.

(888) 645-1617