Depo-Provera: Risks, FDA Warnings and Legal Concerns

Depo-Provera is a prescription birth control injection containing a progestin hormone called medroxyprogesterone acetate. The FDA approved the drug for pregnancy prevention in 1992.

Women typically get the shot from a medical provider every three months, but a lower-dose version called Depo-SubQ Provera 104 can be self-administered.

Depo-Provera is most commonly used by younger women who want an effective, maintenance-free birth control method. It can also be used by those who cannot use estrogen or who have had difficulty with other birth control methods.

However, Depo-Provera’s link to meningioma brain tumors has given rise to lawsuits against Pfizer, Pharmacia & Upjohn Company, and authorized generic manufacturers. These cases claim the companies failed to warn the public of the risk.

Depo-Provera contains the active ingredient medroxyprogesterone acetate (a type of progestin hormone). It works by stopping the ovaries from releasing an egg. It also thickens mucus in the cervix and thins the lining of the uterus, making it more difficult for the egg to be fertilized.

The shot is a prescription-only medication, and patients can get the shot at their doctor’s office. Alternatively, Depo-SubQ Provera 104 can be administered at home. Your medical provider can show you how to give yourself the shot.

The Depo shot lasts up to 14 weeks, though you need to get a new shot every 12 weeks to keep it effective. You don’t have to do anything else for Depo to work except get the shot on time.

In December 2025, the FDA added a meningioma warning to Depo-Provera’s label. The new label states that meningioma cases have been reported following Depo use. It instructs doctors to monitor long-term users for any neurological changes or symptoms of brain tumors.

The label change followed a 2024 study published in the BMJ. This research found that extended Depo-Provera use was associated with a significantly increased risk of meningioma. Previously, the FDA had required a black box warning for loss of bone mineral density, but it had not addressed meningioma risk until the update.

The change in the U.S. also lagged behind international warnings. In September 2024, the European Medicines Agency issued a direct communication warning healthcare providers about Depo-Provera’s link to meningiomas. Canada’s Depo label had also already included warnings that meningiomas have been reported with long-term use.

It’s important to note that the FDA warning doesn’t mean everyone will develop meningioma, and the absolute risk is still low. But the label does recommend monitoring for symptoms of meningioma. Symptoms can include vision problems, hearing loss, confusion, memory problems and numbness or tingling in the face.

Despite concerns about meningioma, Depo-Provera hasn’t been recalled. It’s still available in the U.S. for use.

Studies have connected long-term use of Depo-Provera with meningioma brain tumors. Meningioma can grow in the tissues that cover the brain and spine. Depo is a synthetic progesterone, and scientists have linked progesterone to the development of intracranial and cerebral meningiomas.

“Meningioma is the most common type of primary brain tumor, accounting for approximately 30% of all brain tumors,” clinical pharmacist Dazhi Liu told Drugwatch. “These tumors originate in the meninges, which are the outer three layers of tissue between the skull and the brain that cover and protect the brain just under the skull.”

A March 2024 French study published in BMJ found that Depo-Provera may be linked to a higher risk of meningioma. According to researchers, Depo-Provera users had a 5.6-fold increase in the risk of developing a meningioma after using it for more than a year.

An American study published in Cancers in September 2024 confirmed the meningioma risk found in the BMJ study. Researchers found that Depo-Provera use was associated with a 53% increase in odds of developing a meningioma, and the risk went up with duration of use.

Meningioma Symptoms

Meningioma symptoms may include vision or hearing changes and weakness in the arms or legs. Meningiomas may also cause headaches that are worse in the morning. New-onset seizures and cognitive changes, including memory loss and confusion, have also been reported.

If you experience the onset of seizures or sudden changes in vision or memory, seek emergency care.

Patient Experiences With Depo-Provera and Meningiomas

Drugwatch has spoken to a few women who have experienced meningiomas after long-term Depo-Provera use, and they shared their stories with us.

One of these women, T.C., has chosen to use initials to protect her privacy.

Tina Thomas

Tina Thomas’ first meningioma symptom was hearing loss. Her meningioma treatment required doctors to remove the tumor to prevent it from getting worse. But it came back and affected her vocal cords. She had another surgery. Now, Thomas has permanent hearing loss and a raspy voice.

“That meningioma has really scarred my life,” Thomas told Drugwatch.

She didn’t realize that Depo-Provera was linked to meningioma until she saw a commercial on TV.

“You mean to tell me that they knew about this and they’re still giving these shots to women?” Thomas said. “They just did not value our lives at all.”

T.C.

T.C. cared for two young children — one with special needs — while managing a full-time job at a hospital. At the same time, she dealt with extreme fatigue and constant headaches that she didn’t know were signs of a meningioma.

She told Drugwatch that her life has become overwhelming.

“Since my meningioma diagnosis, I’ve been on medication and have to undergo regular MRIs to monitor the tumor,” T.C. said. “At first, it was every six months, but now it’s once a year. It’s a constant worry that the tumor might grow, and the appointments feel never-ending.”

Other serious Depo-Provera side effects listed on its prescription label include bone density loss, increased risk of breast cancer and allergic reactions.

Depo-Provera and DepoSubQ-Provera have black box warnings for bone mineral density loss. A black box warning is the FDA’s strongest warning.

If you take Depo-Provera for more than two years, you may face an increased risk of bone loss. The drug’s black box warning discourages using Depo long-term unless there are no alternatives.

Make sure you tell your medical provider about any side effects you experience. Depending on the severity of the side effects, your provider may switch you to another method of birth control.

Thousands of women diagnosed with meningioma after long-term Depo-Provera use have filed lawsuits against Pfizer, Pharmacia & Upjohn and other generic manufacturers. Lawsuits allege the manufacturer failed to warn patients and providers about these risks.

These lawsuits are consolidated in federal court under MDL 3140. As of June 2026, there are 3,769 active lawsuits.

According to lawsuits, Pfizer and Upjohn knew or should have known for years that Depo-Provera can cause or contribute to meningiomas. Even if they knew about the risk, they failed to warn patients and medical providers.

Women who used the shot and were later diagnosed with meningioma may be eligible to file a Depo-Provera lawsuit.