Prozac Information
Prozac, an antidepressant marketed by Eli Lilly & Co., is one of the most popular SSRIs (selective serotonin reuptake inhibitors) on the market. Its potential side effects include serotonin syndrome, suicidality, and birth defects.

What is Prozac?

Prozac was launched by Eli Lilly & Co. in 1987, and was the first SSRI approved for use in the U.S. By the time the drug lost patent protection in 2001, Prozac was being used by 40 million people. The prior year, it had accounted for a quarter of Lilly’s $10.8 billion in sales and more than a third of its $3 billion profit.

What is Prozac Used For?

Prozac is used to treat:

  • Major depressive disorder
  • Bulimia nervosa
  • Obsessive-compulsive disorder
  • Panic disorder
  • Depression associated with bipolar disorder (in conjunction with Zyprexa)

Prozac Side Effects

Common Prozac side effects include:

  • Nausea
  • Nervousness
  • Insomnia
  • Weakness
  • Anxiety
  • Drowsiness
  • Tremor
  • Diarrhea
  • Dyspepsia
  • Headache
  • Decreased libido
  • Anorexia
  • Xerostomia
  • Decreased appetite.

Other potential side effects include bulimia nervosa, dizziness, skin rash, and diaphoresis.

Prozac and Birth Defects

In 2006, the U.S. Food & Drug Administration issued a warning regarding a possible association between SSRI antidepressants like Prozac and persistent pulmonary hypertension of the newborn (PPHN). However, a few years later, the agency backtracked, stating that due to conlicting studies, it was unclear whether or not the drugs actually cause this potentially-deadly birth defect.

A number of studies have also suggested that antidepressants like Prozac can increase the risk of certain birth defects when used during pregnancy. Heart defects, specifically atrial septal defects or ventricular septal defects, where among the most common abnormalities found. The drugs have also been associated with an abdominal wall birth defect called Omphalocele, as well as a skull defect called Craniosynostosis.

A recent study also found that children exposed to SSRIs during the last two trimesters of pregnancy were 117% more likely to be diagnosed with autism spectrum disorder.

Prozac and Suicide

The labels for Prozac and other SSRI antidepressants include a Black Box Warning regarding a potential association with suicidal thoughts in children, adolescents and young adults. A Black Box is the strongest warning possible for prescription drugs in the U.S.

Prozac and Serotonin Syndrome

In 2006, the FDA warned that use of Prozac and other SSRI antidepressants in conjunction with certain migraine medications called Triptans may result in a dangerous increase in the brain’s serotonin levels, known as serotonin syndrome.

  1. FDA “Prozac Prescribing Information”
  2. FDA (2006) “FDA Public Health Advisory: Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns.”
  3. NCBI (2006) “SSRI Antidepressants and Birth Defects”
  4. BMJ (2009) “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study”
  5. MedPage Today (2011) “More Evidence SSRIs in Pregnancy Boost Birth Defect Risk”
  6. NEJM (2007) “Use of Selective Serotonin-Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects”
  7. JAMA Pediatrics (2016) “Antidepressant Use During Pregnancy and the Risk of Autism Spectrum Disorder in Children”
  8. FDA (2007) “FDA Drug Safety Communication: Antidepressant Use in Children, Adolescents, and Adults.”
Last Modified: February 23, 2016

Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.


Follow Us on Google+ on Facebook on LinkedIn on Twitter on YouTube on Pinterest

Skip to content