Prozac (fluoxetine) is the most popular selective serotonin reuptake inhibitor (SSRI) in history. The antidepressant’s side effects include birth defects and suicidal thoughts and actions. As of February 2018, the FDA had not warned of new side effects. But, a January 2018 article found the drug may affect attention span in children.

Prozac Pills
Prozac Facts
  1. Dosage 10 mg; 20 mg; 40 mg; 90 mg
  2. Used to Treat Depression, obsessive-compulsive disorder, Bulimia Nervosa, panic disorder
  3. Related Drugs Paxil (paroxetine), Zoloft (sertraline)
  4. Manufacturer Pfizer
  5. Black Box Warnings Suicidal thoughts in children and adolescents
  6. FDA Approval 1987

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.

People received 24.4 million prescriptions for generic fluoxetine in 2010. It is the third most prescribed antidepressant in the U.S.

Prozac earned the nickname “bottled sunshine.”

The drug also comes with some serious side effects. These include sexual dysfunction, suicidal thoughts 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, study author Edward Hackett said that healthy children who take Prozac may experience attention problems.

Hackett 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 February 2018, 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 Symbyax (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 uses may be helpful to 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 Symbyax)
  • Treatment Resistant Depression (with Symbyax)
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 and dosage indications. 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 indications call for patients to take Prozac and Symbyax together.

Disorders and Their Dosages
Major Depressive Disorder
Initial dose is 20 mg/day. After several weeks, the dose can increase to 20 mg twice a day (morning and noon). Maximum daily dose should not exceed 80 mg. 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 twice daily. Maximum dose is 80 mg/day. It may take 5 weeks for 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
5 mg Symbyax and 20 mg Prozac once a day in the evening. Doctors may adjust the dose for effectiveness with up to 12 mg of Symbyax and 50 mg of Prozac.
Treatment Resistant Depression
5 mg Symbyax and 20 mg Prozac once a day in the evening. Doctors may adjust the dose for effectiveness with up to 12 mg of Symbyax 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 safety insert 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
  • Headache
  • Diarrhea
  • Nervousness
  • Restlessness
  • Agitation and anxiety
  • Increased sweating
  • Weight gain or loss
  • Insomnia
  • Drowsiness
  • Fatigue
  • Tremor
  • Impotence
  • Abnormal dreams
Serious Side Effects Include:
  • Abnormal heart beat (OT prolongation)
  • Impaired judgement, thinking and motor skills
  • Abnormal bleeding
  • Allergic reactions, skin rash
  • Suicidal thoughts and behaviors
  • Serotonin syndrome
  • Activation of mania/hypomania
  • Vision problems (angle-closure glaucoma)
  • Seizures
  • Significant weight loss

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 dependency means that the body has adapted to a chemical to the point that it requires steady doses to normally function.

Prozac Generic
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 youths. Unfortunately, however, studies on 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.

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.

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 drug packaging 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 medication insert, pregnant women should only use Prozac if the benefit outweighs the risk to the fetus, and breast feeding is not recommended.

The FDA released a Safety Announcement in 2006 warning that SSRIs including Prozac can increase the risk of 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, “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.”

“FDA Will update the SSRI Drug Labels to reflect the new data and the conflicting results.”

The U.S. Food and Drug Administration

This condition 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 increased risk of heart wall defects, craniosynoctosis and heart defects.

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 heartbeats. 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 triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort)
These drugs increase the risk of serotonin syndrome.
Electroconvulsive Therapy (ECT)
ECT with Prozac may cause rare 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 and a decrease in dose 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.

Clinical Trial Controversy

Critics of the drug say there is no real proof the drug works. One of these critics is Dr. Alexander Bingham. He is a psychotherapist who spent years studying Prozac.

“Eli Lilly, the manufacturer of Prozac, conducted 20 clinical trials, 17 of which were so bad and so flawed . . . that they didn’t even submit them,” Bingham told Drugwatch. “They only submitted three to the FDA and were denied approval twice.”

Prozac has a controversial history filled with early failures.

Chemists Klaus Schmiegel and Bryan Molloy discovered the drug in 1971. The drug failed to treat blood pressure and obesity.

Then, the company tested the drug on hospitalized depressive patients. Not only did the drug not work, it made some patients worse.

The drug finally worked when Lilly tested it on five mildly depressed patients and all five improved.

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 seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) 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
Kevin Connolly
Kevin Connolly Managing Editor

9 Cited Research Articles

  1. National Institute of Health. (2009). Prozac. Retrieved from
  2. Moore, A. (2007). Eternal sunshine. Retrieved from
  3. Eli Lilly. (2016) Prozac Prescribing Information. Retrieved from
  4. FDA. (n.d.). Fluoxetine (marketed as Prozac) Information. Retrieved from
  5. 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
  6. Stone, K.J., Viera, A.J. & Parman C.L. (2003). Off-Label Applications for SSRIs. Retrieved from
  7. Reefhuis, J. et al. (2015). Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous reports. Retrieved from
  8. Golub, M.S. et al. (2017, August). Cognitive performance of juvenile monkeys after chronic fluoxetine treatment. Retrieved from
  9. Chen, J. (2018, January 29). Long-term mental effects of Prozac on primates. Retrieved from
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