Zoloft is an SSRI antidepressant medication. It was one of the first and most popular antidepressant medications on the market and is approved to treat depression, obsessive-compulsive disorder, bipolar disorder, and anxiety disorders. Zoloft may cause a number of serious side effects. These severe side effects have been the basis of lawsuits filed against Zoloft’s manufacturer.

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What Is Zoloft?

Zoloft is the name brand for the generic medication sertraline and is a commonly prescribed SSRI antidepressant. It is approved to treat depression and other mental disorders. Zoloft is approved for use in children ages 6-17 years old to treat some conditions.

How Does Zoloft Work?

Zoloft is an SSRI antidepressant, so it works by increasing the activity of a chemical messenger, serotonin, in the mood centers of the brain. Serotonin is a neurotransmitter that acts to regulate sleep and mood and may help provide the satiety or “satisfaction” sensation. Zoloft increases the level of serotonin in the brain.

What Company Manufactures Zoloft?

Zoloft is manufactured by Pfizer. Since Zoloft was introduced in 1994, it has been prescribed to millions of people. Pfizer has faced multiple lawsuits for injuries caused by the medication and for improper marketing practices.

Is Zoloft FDA-Approved?

Zoloft received FDA approval in 1999. In 2001, it was the only medication approved to treat PTSD in the United States, and it was the most prescribed medication for the treatment of mood and anxiety disorders. Since 2004, the FDA has issued multiple warnings about the risks of Zoloft.

What Is Zoloft Prescribed To Treat?

Zoloft is prescribed to treat a number of conditions. It is approved to treat major depression, panic disorders, post-traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder in adults. It is also approved to treat obsessive-compulsive disorder in adults and children ages 6-17.

What Is Depression?

Depression, also known as Major Depressive Disorder (MDD), is a disorder that affects a person’s mood. Depression can cause a constant feeling of sadness and loss of interest.

Symptoms of depression include:

  • Loss of interest in normal activities
  • Feelings of guilt or worthlessness
  • Excessive crying
  • Lack of energy
  • Loss of concentration
  • Changes in appetite
  • Changes in sleep patterns
  • Suicidal thoughts and tendencies

What Is Obsessive-Compulsive Disorder?

Obsessive-compulsive disorder (OCD) causes persistent, unwanted obsessions that cause make people feel compelled to repeatedly do something. These obsessions can be thoughts, ideas, or sensations, and repeated actions can be a variety of behaviors which may include handwashing. This may considerably affect a person’s day-to-day life. 

What Are Anxiety and Panic Disorders?

Anxiety can cause feelings of nervousness and is a natural response to stress. In some situations, anxiety can be helpful, as it may alert to danger or help a person pay attention. Anxiety in general is not the same as anxiety disorders. Anxiety disorders are characterized by excessive worry, fear, or anxiety, and these feelings are not proportionate to the situation. These excessive feelings affect a person’s ability to function normally.

Panic disorders are one variety of anxiety disorders. They are characterized by unanticipated and recurrent episodes of heightened fear. These episodes are coupled with physical symptoms such as chest pain, shortness of breath, dizziness, heart palpitations, or abdominal discomfort or distress and are not induced by an obvious stressor. 

What Is Posttraumatic Stress Disorder?

Posttraumatic stress disorder (PTSD) refers to a psychiatric disorder that can occur in a person who was exposed to a traumatic event. Exposure to a traumatic event can mean that a person experienced the event, witnessed the traumatic event, or experienced the event secondhand. Secondhand experience can include learning about a loved one’s violent death or hearing details of someone else’s trauma. Examples of traumatic events include war, combat, natural disaster, major accident, terrorist attack, or rape. Threats of serious injury, death, or sexual assault are also considered to be traumatic events.

What Is Premenstrual Dysmorphic Disorder?

Premenstrual dysmorphic disorder (PMDD) is an extreme form of premenstrual syndrome (PMS) and is characterized by severe symptoms that occur before menstruation and end a few days after the start of a person’s period. Symptoms may include depression, tension, and irritability.

What Is Social Anxiety Disorder?

Social anxiety disorder, also known as social phobia, is characterized by intense anxiety, self-consciousness, and embarrassment because of the fear of being negatively judged by others. This leads to the avoidance of situations and may affect a person’s daily life in school, work, or in relationships.

Symptoms of social anxiety disorder include:

  • Blushing
  • Nausea
  • Sweating
  • Shaking
  • Difficulty talking

Is Zoloft Prescribed To Treat Other Conditions?

Zoloft is sometimes helpful when prescribed “off-label” to treat conditions that it does not have FDA approval to treat. This is allowed under Federal law, but pharmaceutical companies are not allowed to market the medications for the treatment of conditions for which they do not have the approval to treat.

These off-label uses may be provided for both children and adults Conditions for which Zoloft has been prescribed off-label include:

  • Binge-eating disorder
  • Bulimia nervosa
  • Generalized anxiety disorder
  • Bipolar disorder
  • Premature ejaculation
  • Headaches

Doctors should justify their reasoning for prescribing Zoloft off-label and should be very clear about other options if there are any.

Does Zoloft Cause Side Effects?

Like all medications, Zoloft may cause side effects in some people. The majority of these side effects are mild and will go away on their own over time. Some people, however, may experience serious side effects that require immediate medical attention. These side effects may become life-threatening in some cases and should be taken seriously.

Mild side effects linked to Zoloft include:

  • Nausea
  • Diarrhea or constipation
  • Weight loss or gain
  • Dizziness and drowsiness
  • Insomnia and agitation
  • Sweating
  • Dry mouth
  • Headache
  • Sexual dysfunction (males and females)

Bothersome or persistent side effects should be reported to a healthcare professional.

Can Zoloft Cause Severe Side Effects?

Zoloft may cause severe side effects. These could become life-threatening and should be taken seriously and reported to a doctor immediately.

Severe side effects linked to Zoloft include:

  • Birth Defects
  • Suidice Risk
  • Serotonin Syndrome
  • Withdrawal

These may require emergency medical treatment or intervention.

Is Zoloft Safe To Take When Pregnant?

Zoloft was the second of the SSRI medications and was thought to be fairly safe during pregnancy because it does not affect norepinephrine. It was used in millions of pregnant women, but it has been found to have an increased risk of miscarriage and birth defects.

Zoloft can have effects on newborns that are not birth defects. These nonteratogenic effects include the need for prolonged hospitalization, respiratory support, and the need for a feeding tube upon delivery.

Other serious effects in newborns linked to Zoloft may include:

  • Respiratory distress
  • Cyanosis
  • Apnea
  • Seizures
  • Temperature instability
  • Difficulty feeding
  • Constant crying
  • Irritability
  • Vomiting
  • Hypotonia
  • Hypoglycemia
  • Jitteriness
  • Tremor
  • Hypertonia
  • Hyperreflexia

Is Zoloft Linked to Birth Defects?

An FDA warning about Zoloft causing birth defects was issued in 2006, and Zoloft has since been listed as a Pregnancy Category C medication. These medications should not be taken by pregnant women unless absolutely necessary.

Birth defects linked to Zoloft use may include:

  • Persistent Pulmonary Hypertension (PPHN): fatal in 10% of infants
  • Hypoplastic Left/Right Heart Syndrome: may be fatal in infants
  • Anencephaly refers to an infant missing a portion of the brain, skull, and scalp. It is fatal shortly after birth.
  • Spina Bifida refers to the missing part of vertebrae with the spinal cord exposed. This requires surgery and is 15% fatal by age 4.
  • Cleft Palate or Lip is when the baby is missing a portion of the upper front jaw or roof of the mouth. This may require surgery.
  • Omphalocele is when the baby’s abdominal organs are on the outside of the body. This requires surgery and is sometimes fatal.
  • Scoliosis refers to a curved spine and may require surgery.
  • Club feet occur when the feet curl inwards. This may require surgery or extensive therapy.
  • Autism Spectrum Disorder/ASD or Delayed Development Disorder/DDD
  • Withdrawal symptoms in infants

Is It Safe To Take Zoloft While Breastfeeding?

Although studies suggest that an infant will not get a large amount of Zoloft and its metabolite through breast milk, women who are taking Zoloft should exercise caution when breastfeeding. Doctors should be cautious when prescribing Zoloft to nursing mothers. 

Does Taking Zoloft Increase the Risk of Suicide?

Zoloft has been shown to increase the risk of suicide in those with depression, especially in those who are under 25, have a history of suicide, or are bipolar. The FDA issued a “black box warning” in 2004 that required that information about the risk of suicide be printed at the top of prescribing information, enclosed in a black box.

Does Taking Zoloft Cause Serotonin Syndrome?

Zoloft may cause serotonin to build up in the brain, resulting in “serotonin syndrome.” This is most common when Zoloft is taken with other serotonin medications including cough suppressants, migraine treatments, and some herbal supplements.

Serotonin syndrome symptoms may include:

  • Unexpected high fever
  • Increased heart rate, abnormal heartbeat
  • Loss of balance or coordination
  • Confusion or hallucinations
  • Seizures

Severe cases of serotonin syndrome may be life-threatening. To reduce the risk, all medication use should be discussed with a doctor.

Does Stopping Zoloft Cause Withdrawal or Discontinuation Syndrome?

Patients who take SSRIs for a long period of time may become physically dependent. When Zoloft is suddenly discontinued, serotonin withdrawal symptoms can occur. Some withdrawal symptoms may last for a long time.

Symptoms of SSRI discontinuation syndrome may include:

  • Dizziness
  • Nausea/Diarrhea
  • Headache
  • Chills or shivers
  • Brain “zaps”
  • Electric sensations in the skin

Many physicians recommend tapering off Zoloft rather than sudden discontinuation. This may help minimize the withdrawal symptoms.

Have Lawsuits Been Filed Because of Zoloft?

Pfizer is facing a number of lawsuits related to Zoloft. Patients or loved ones of those harmed by Zoloft may be eligible for compensation for medical costs, lost wages, and pain and suffering.

Though over 700 federal Zoloft and class action lawsuits were filed, Pfizer was successful at getting many of the lawsuits dismissed or withdrawn after courts ruled against the plaintiffs. Other lawsuits filed in state courts in West Virginia, Missouri, New York, and other states were also dismissed or resulted in a decision for Pfizer.

Though a few Zoloft lawsuits may remain in federal, state, or local courts, most lawsuits have resulted in withdrawal or dismissal.  People who feel they suffered an injury due to the use of Zoloft should seek legal advice.

What Types of Lawsuits Have Been Filed Regarding Zoloft?

At least 250 Zoloft lawsuits were filed by plaintiffs in Pennsylvania litigation. In these Zoloft lawsuits, plaintiffs alleged that the use of the antidepressant during pregnancy causes birth defects. Other Zoloft lawsuit cases have claimed violent behaviors as a result of the medication. Suicides and homicides have occurred in several patients who were prescribed Zoloft before committing the acts and still, others claimed that the medication’s effectiveness was overstated.

A class action Zoloft lawsuit case in California accused the company of promoting ineffective medication. Some experts claimed that Zoloft’s effectiveness was equivalent to a placebo or no treatment at all. The Zoloft lawsuit charged that Pfizer knew the drug’s benefits were overestimated but was dismissed in September 2014.

More than 250 Zoloft lawsuits alleged that birth defects were caused by the drug. These Zoloft lawsuits were filed, seeking compensation to help parents manage healthcare costs from the associated conditions. Federal lawsuits which had been consolidated into multidistrict litigation in Pennsylvania were all withdrawn or dismissed by November 2017.

Other Zoloft users have filed Zoloft lawsuits due to distressing physical and psychological effects. As a selective serotonin reuptake inhibitor (SSRI), Zoloft has commonly been noted to cause a number of side effects, some of which are severe, may be serious, or result in permanent injury or death.

What Zoloft Lawsuit Settlements Have There Been?

In 2010, Pfizer paid $98,000 to settle a lawsuit involving allegations of failure to warn about the risks associated with Zoloft. Over the years, Pfizer has paid millions of dollars to settle claims related to the marketing of its products.

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


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