Prozac Lawsuit – Side Effects & Warnings

Prozac (fluoxetine) is an SSRI antidepressant which is used to treat depression and other mental disorders such as OCD and panic disorders. Prozac’s manufacturer, Eli Lilly has faced thousands of Prozac lawsuits for suicidal behaviors, birth defects and injuries caused by the medication.

Prozac Lawsuit

Prozac is the best-known and oldest member of the SSRI antidepressant medication class and has a long history of problems associated with its use. Eli Lilly, manufacturer of Prozac, has faced thousands of lawsuits, beginning in the 1990s, in federal, state and local courts throughout the U.S. for injuries caused by the drug. Lilly has paid $millions in settlements and awards for damages in cases involving birth defects, suicide and other serious side effects or injuries.

Drug Warning: Prozac

Brand Name Prozac
Generic Name fluoxetine
Classification serotonin-specific reuptake inhibitor (SSRI) antidepressant
Manufacturer Eli Lilly & Co.
Dosage form(s) 10mg capsule

20mg capsule

40mg capsule

90mg XL capsule (weekly)

20mg/5ml oral solution

Alternative dosage forms In combination with olanzepine as “Symbyax” capsules

Under brand name “Sarafem” for Premenstrual Dysphoric Disorder

Normal dosage 10 to 80mg daily

Equivalent amount weekly as XL capsules

Prozac is a selective serotonin reuptake inhibitor (SSRI) which treats depression and other mental disorders. It works by increasing neurotransmitter, serotonin, levels in mood centers and certain areas of the brain.

Prozac is approved to treat:

  • Major depressive disorder (MDD) in adults and children
  • Obsessive-compulsive disorder (OCD) in adults and children
  • Bulimia nervosa
  • Panic disorder (PD)
  • Premenstrual dysphoric disorder (PMDD)

When combined with the atypical antipsychotic medication Zyprexa (olanzepine), Prozac is approved to treat:

  • Bipolar I disorder or Manic depression in adults and children over 10 years of age
  • Recurrent or refractory Major depressive disorder

Prozac Side Effects

Like all medications, Prozac may cause side effects. Most side effects are mild to moderate and will go away over time. Other Prozac side effects are more severe, may be more persistent, serious or even life-threatening.

Common side effects of Prozac:

  • Nausea
  • Anorexia
  • Sleepiness
  • Insomnia
  • Anxiety
  • Decreased libido
  • Tremor
  • Dizziness
  • Dry mouth
  • Sweating
  • Weakness

More severe side effects of Prozac:

  • Suicidal thoughts and behaviors
  • Increased risk of bleeding
  • Seizures
  • Serotonin syndrome
  • Discontinuation syndrome
  • Glaucoma
  • Birth defects
  • Hypersensitivity reactions
  • Heart rhythm changes
  • Low sodium levels

Prozac Warnings

Prozac was the first of the “newer” antidepressants, now called SSRIs. It was designed to be effective with fewer side effects than older types of antidepressants and while it represented a huge improvement in treatment of depression, the drug has had a significant history of troubles and has been the subject of numerous warnings by the U.S. Food and Drug Administration (FDA).

Prozac Suicide and Violence

In May of 1990, the FDA issued safety alerts regarding unreported side effects of Prozac including suicidal and violent behavior, episodes of bulimia, strokes, and hemolytic anemia in children, adolescents and young adults (under 24). Some of these events were the subject of widespread media coverage and controversy.

Prozac Black Box Warning

In 2004, the FDA began requiring that all SSRI and other antidepressants include a “black box” warning on all package labeling and prescribing information. A black box warning is the highest level of alert that can be issued by the FDA. Prozac’s black box or boxed statement warns of the potential for increased suicidal behavior and increased risk of suicide, particularly in children, adolescents and young adults. In 2007, the FDA required that the Prozac black box warning be updated to state that the risk of suicidal thoughts and behaviors was most prevalent in the initial treatment period but longer that previously thought, lasting for one to two months after the drug was started.

Prozac Birth Defects

In 2006, prescribing information was changed to include information about the risk of birth defects and autism which may affect unborn fetus when Prozac is used during pregnancy.

When taken during pregnancy, Prozac may cause:

  • Coarction of aorta
  • Septal defect
  • Hypoplastic Left Heart Syndrome (HLHS)
  • Pulmonary stenosis
  • Transposition of great arteri
  • Tetralogy of fallot
  • Autism Spectrum Disorder
  • Persistent pulmonary hypertension of the newborn (PPHN)

Prozac Serotonin Syndrome

In 2013, Prozac labeling was updated to include more information about Serotonin Syndrome and its risks, including the use of Monoamine Oxidase Inhibitor (MAOIs) and other medications which could increase the effects of serotonin.

  • Confusion
  • Agitation and restlessness
  • Muscle rigidity
  • Muscle twitching
  • High fever
  • Shivering
  • Heavy sweating
  • Irregular heartbeat
  • Seizures
  • Loss of consciousness

Serotonin syndrome may be serious or life-threatening. Sudden or rapidly worsening symptoms should be treated as a medical emergency.

Prozac Settlements

The first Prozac lawsuits were filed as early as the 1990s and since then, Eli Lilly has faced thousands of lawsuits and paid $millions in awards, settlements and fines for injuries caused by Prozac. Most lawsuits have already been settled and there are no new Prozac lawsuits on the horizon but Prozac or other forms of fluoxetine may continue to pose potential risks to patients who take the medication. As such, Prozac attorneys and lawyers will remain watchful.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.


Since its establishment in 1999, Seeger Weiss has led some of the most complex and high-profile litigations in the U.S.