Skip to main content
Find a Lawyer
Please enter a legal issue and/or a location
Begin typing to search, use arrow keys to navigate, use enter to select

Zoloft Side Effects and Lawsuits

Zoloft (sertraline hydrochloride) is an antidepressant doctors prescribe to treat depression, obsessive-compulsive disorder, posttraumatic stress disorder, and anxiety. Pfizer manufactures this selective serotonin reuptake inhibitor (SSRI).

The Food and Drug Administration (FDA) approved the drug in 1991. But the agency has issued numerous alerts about the side effects of Zoloft since then. Some patients have sued the drug manufacturer over Zoloft's serious side effects.

Here, we'll discuss the benefits and side effects of Zoloft. We'll also describe the history of Zoloft lawsuits, including the injuries plaintiffs claim they experienced while taking the drug.

Why Do Doctors Prescribe Zoloft?

Zoloft is one of the most popular SSRI antidepressants on the market. Doctors prescribe Zoloft to treat various conditions.

Specifically, patients take Zoloft to help with the following:

  • Depression
  • Major depressive disorder
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder
  • Posttraumatic stress disorder (PTSD)
  • Premenstrual dysphoric disorder
  • Social anxiety disorder (SAD)

Zoloft helps many people deal with depression and social anxiety. But some Zoloft side effects are severe. Some are so serious that patients have filed product liability lawsuits against Pfizer, Inc.

Zoloft Side Effects

Most prescription drugs have adverse side effects. Usually, these are minor. Most patients agree that the benefits of their medications outweigh the side effects.

With Zoloft, there are some minor side effects. But unfortunately, others can prove fatal. Minor side effects of Zoloft include the following:

  • Difficulty sleeping
  • Nausea
  • Dry mouth
  • Drowsiness

Most patients have no problem dealing with these side effects. Some of the others are more problematic. We discuss these in detail below.

Zoloft Health Risks

There are adverse health risks of taking Zoloft. This is in addition to the side effects discussed above.

The risks of using Zoloft include:

  • An increased risk of suicidal thoughts or actions
  • Bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding
  • Mania
  • Seizures
  • Weight loss
  • Sexual problems, including impotence

Seek immediate medical advice if you experience any of these health risks. You should never stop taking Zoloft suddenly. Doing so may result in harmful side effects. Your healthcare professional should slowly decrease your dose as necessary.

Zoloft and Pregnant Women

In 2006, the FDA also announced that taking antidepressants during pregnancy may cause a severe condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs. Babies born to women who took Zoloft during pregnancy were six times as likely to develop PPHN.

Studies also show that taking Zoloft during the first trimester can cause birth abnormalities. For example, a study in 2017 found that infants born to women who took Zoloft during pregnancy had an increased risk of developing cleft palate, club foot, cleft lip, and septal defects.

Clinical trials also show that Zoloft can cause heart defects that can be life-threatening for a baby. Always talk to your physician before taking any prescription medications during pregnancy.

Zoloft FDA Alert – Serotonin Syndrome

In July 2006, the FDA issued an alert. It stated that some patients taking Zoloft may suffer a life-threatening condition called serotonin syndrome. This condition can occur when patients take SSRIs (such as Zoloft) with medicines used to treat migraine headaches.

Signs and symptoms of serotonin syndrome include:

  • Restlessness
  • Hallucinations
  • Loss of coordination
  • Fast heartbeat
  • Increased body temperature
  • Rapid changes in blood pressure
  • Overactive reflexes
  • Diarrhea
  • Coma
  • Nausea
  • Vomiting

Serotonin syndrome may be more likely to occur when starting or increasing an SSRI or a triptan dose. If you take migraine headache medicines, ask your healthcare professional if your medication is a triptan.

Zoloft and an Increased Risk of Suicidality

In October 2004, the FDA directed all antidepressant drug manufacturers to change their labels to include boxed warnings regarding suicidal behavior in young people. Studies show that children and adolescents taking Zoloft are at a greater risk of having suicidal thoughts.

The FDA ordered drugmakers to alert healthcare providers about this increased risk of suicidality. Pfizer Pharmaceuticals added a black box warning to Zoloft's prescribing information in response to the FDA's advisory.

Other studies have shown that adults who take Zoloft are also at risk of worsening depression and increased suicidality. It's essential to monitor these patients, especially when treatment begins, and when their doctor increases their dosage.

Zoloft-Related Injuries

Patients who take Zoloft have reportedly suffered a wide array of side effects. When manufacturers fail to report these side effects, patients can sue for damages.

The three main side effects plaintiffs cite in Zoloft lawsuits are:

  • Suicidal thoughts and behavior
  • Congenital disabilities
  • False and misleading advertising

Some users claim that Zoloft provided no relief, despite the drug manufacturer's claims that the drug successfully treats depression. In many cases, patients experience the harmful side effects of the drug without the advertised benefits.

Liability for Zoloft Injuries

When a drugmaker fails to warn doctors and patients about their antidepressant medication's side effects, they open themselves up to liability. Patients who suffer an injury from taking a drug can sue the manufacturer.

Like all product manufacturers, drugmakers must warn consumers about the foreseeable risks of harm their products pose. This includes potential side effects and health risks. The court may hold them liable for damages if they fail to warn.

Zoloft Lawsuits

In April 2012, more than 40 plaintiffs filed suit against Pfizer. The plaintiffs alleged that Zoloft caused severe congenital disabilities in babies born to women who took the drug during pregnancy. The courts consolidated the lawsuits into a multi-district litigation case in the Eastern District of Pennsylvania.

In June 2017, the federal judge overseeing the multi-district litigation case dismissed the lawsuits. The court held that there wasn't sufficient evidence proving that Zoloft caused congenital disabilities in the plaintiffs' children. By July of that same year, the federal courts dismissed the remaining cases related to Zoloft and congenital disabilities.

California Resident Sues Pfizer for False Advertising

A woman filed a class action lawsuit against Pfizer. The plaintiffs' attorney filed the claim in the Northern District of California in San Jose. The plaintiffs alleged that Pfizer lied about Zoloft's effectiveness. The plaintiff's counsel argued that the drug worked no better than a placebo and that the drug company lied about it.

Pfizer denied the claims and asked the court to dismiss the complaint. The judge dismissed the complaint in September 2013.

Judge Dismisses Two Lawsuits Claiming Pfizer Withheld Information From the FDA

In 2016, two plaintiffs in West Virginia sued Pfizer, alleging that the drugmaker withheld information from the FDA regarding Zoloft's approval. The plaintiffs argued that the drug company knew the drug was dangerous and ineffective.

The judge found that the FDA thoroughly evaluated the drug for its safety and effectiveness. The court dismissed the two lawsuits in February 2017.

Talk to a Lawyer About Your Zoloft Lawsuit

If you or your child suffer an injury due to Zoloft use, contact an experienced drug and medical device attorney today. You must file your claim before the statute of limitations period expires. These statutes dictate how long a plaintiff has to file suit against a potential defendant.

It may take your product liability attorney several months to review and prepare your case. Don't wait until the last moment to speak with a lawyer near you.

Was this helpful?

You Don’t Have To Solve This on Your Own – Get a Lawyer’s Help

Meeting with a lawyer can help you understand your options and how to best protect your rights. Visit our attorney directory to find a lawyer near you who can help.

Or contact an attorney near you:

Next Steps

Contact a qualified product liability attorney to make sure your rights are protected.

Begin typing to search, use arrow keys to navigate, use enter to select

Help Me Find a Do-It-Yourself Solution

Copied to clipboard

Find a Lawyer

More Options