Did you know this version of Internet Explorer is out of date?

To get the latest experience from our website, please upgrade your browser.

Have a drug or medical device concern?




The popular antidepressant Zoloft has brought in billions of dollars for its manufacturer, Pfizer. It is linked to serious side effects like autism and birth defects in babies when taken during pregnancy.

Zoloft (sertraline chloride) is an antidepressant developed and manufactured by Pfizer in 1990. It was originally developed for the U.K. market and was released under the brand name Lustral. Pfizer developed and marketed Zoloft as a safer alternative, with fewer side effects and withdrawal symptoms than competitor drugs such as Prozac, which was developed and manufactured by Eli Lilly.zoloft marketing

Nine years after its release in the U.K., the Food and Drug Administration (FDA) approved Zoloft for use in the United States.  By 2005, Zoloft was the most popularly prescribed antidepressant on the U.S. market, with nearly 30 million prescriptions being written. In that same year, it was the sixth most prescribed brand-name prescription medication, grossing nearly $ 2.6 billion.

Zoloft comes from a class of antidepressant drugs known as SSRIs (selective serotonin reuptake inhibitors). SSRIs have been used to control depression and other mental illnesses since the early 1980s. Today, they are the most prescribed class of antidepressant medication on the U.S. market. They are popular mainly due to the fact that they have fewer side effects than other types of antidepressants.

SSRIs work by controlling the brain’s level of serotonin, which is a neurotransmitter thought to affect mood, sleep and learning.

Generic-brand sertraline, which is now manufactured by Roxane, Roerig, Greenstone and others, became available in 2006. Zoloft and its generic forms come in both tablet and oral concentrate form. Typical dosage for treating depression is 50 mg once a day.

While SSRIs including, Zoloft, may have fewer side effects than other antidepressants, new studies also show they increase the risk of autism and birth defects in babies whose mothers took the drug while pregnant.

If you took Zoloft while pregnant, you may have legal options.

Zoloft and Autism

One of the most recent side effects linked to the use of Zoloft and other SSRIs during pregnancy is autism spectrum disorder, also referred to as ASD. ASD is a developmental disorder that impairs a person’s ability to communicate and interact.

A 2015 study published in JAMA Pediatrics showed that Zoloft and other SSRIs were associated with a 200 percent increased risk of having a child born with autism while antidepressants had an 87 percent overall increased risk.

Professor Anick Bérard of the University of Montreal, one of the authors of the study, wrote: “Our study has established that taking antidepressants during the second or third trimester of pregnancy almost doubles the risk that the child will be diagnosed with autism by age 7, especially if the mother takes selective serotonin reuptake inhibitors, often known by its acronym SSRIs.”

Boys are more likely to be diagnosed with autism than girls, and older mothers were also more likely to have autistic children.

A Johns Hopkins study from April 2014 published in Pediatrics, showed boys born to mothers who used SSRIs during pregnancy were three times more likely to be autistic.

Uses of Zoloft

Zoloft is primarily used to treat major depressive disorders (MDD). However, doctors also prescribe it for post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), obsessive-compulsive disorder (OCD), social anxiety disorder and panic disorder.

MDD affects nearly 7 percent of the U.S. adult population. If MDD goes untreated, the lifetime risk of suicide is 20 percent.

Diagnosis of MDD comes after some or all of the following symptoms occur for more than two weeks:
Sad or depressed mood. Loss of interest in most activities.
Changes in appetite and sleep. Feeling worthless/guilty/hopeless/helpless.
Mental and physical agitation. Difficulty concentrating.
Thoughts of suicide.

Common Side Effects of Zoloft

Zoloft  is well-tolerated by most patients and can be effective in treating depression or other disorders. Side effects vary in severity. Common side effects of Zoloft are milder than first-generation antidepressants. However, it is not ideal for pregnant women. Zoloft can cause serious birth defects when taken during pregnancy, as well as withdrawal symptoms in the baby following birth. The overall risk of birth defects is low.

Minor side effects of Zoloft that typically decrease after the first or second week of use include:

  • Nausea
  • Diarrhea
  • Weight loss or gain
  • Increased sweating
  • Dizziness
  • Sleepiness or insomnia
  • Tremor
  • Dry mouth
  • Headache
  • Restlessness
  • Suicidal Thoughts
  • Sexual Dysfunction

Zoloft causes some younger users of the drug to report being suicidal. The FDA requires Zoloft and all antidepressants to carry a black-box warning about the danger of suicide during the initial stages of treatment, especially in children. Clinical studies have shown that a small number of younger users of antidepressants, including sertraline, become suicidal. Some users experience sexual side effects, including problems with orgasm and ejaculatory delay. These do not typically decrease with use.

Zoloft and Pregnancy

If you are taking Zoloft, or have taken Zoloft and you are pregnant or are planning on becoming pregnant you should consult your doctor. The FDA uses “pregnancy categories” to communicate whether or not a drug is safe to take during pregnancy. Zoloft is in category “C,” which means that animal studies have shown some harm to the fetus, but there have been no adequate studies in humans. Research shows, however, that babies born to mothers who have taken Zoloft or another SSRI after the 20th week of pregnancy are more likely to suffer from persistent pulmonary hypertension of the newborn (PPHN), which is fatal in 10 percent of cases. In addition, one study showed that women taking sertraline had twice the risk of having a baby born with a heart defect.

Using SSRIs while pregnant — or even up to a month before conception — can lead to a fatal birth defect called anencephaly, in which a large portion of the brain and skull never develops. In addition, babies are more likely to suffer from facial malformations such as cleft lip and cleft palate if a mother took an SSRI during pregnancy. Taking an antidepressant while pregnant can also put babies at risk for withdrawal symptoms. The side effects can be serious, but the risk of a birth effect occurring is relatively low.

Other Precautions When Taking Zoloft

Patients with kidney disease or liver disease, or who suffer from seizures, mania or suicidal thoughts, should speak to their doctor before using Zoloft. In addition, Zoloft can cause interactions with other drugs or supplements.

Mixing SSRIs with monoamine oxidase inhibitors (MAOIs) or tryptamine-based drugs (used to treat migraines and headaches) can cause serotonin syndrome, a serious condition that can be recognized by the following symptoms:
Nausea or vomiting Diarrhea
Agitation Rapid heartbeat
Loss of coordination Hallucinations

Doctors typically will decrease the dosage of an SSRI before stopping treatment altogether. Otherwise, withdrawal symptoms can occur, including irritability, nausea, dizziness, vomiting, nightmares and headache.

Zoloft and Lawsuits

A number of parents have begun filing lawsuits against Pfizer after their babies were born with birth defects. The lawsuits claim Pfizer did not offer adequate warning about the risks of taking Zoloft. Federal lawsuits  against Pfizer are consolidated under multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania. More than 250 Zoloft birth defect cases are part of the MDL.