Depo-Provera Side Effects and Safety: What the FDA Record Shows

Depo-Provera Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Depo-Provera: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.

What Depo-Provera Is Prescribed For, and Where Depo-Provera Side Effects Come From

According to the FDA label, epo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy. Depo-Provera CI is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use: The use of Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. […]

Two separate official sources describe depo-provera side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.

The FDA has revised this label recently. The label’s own record of recent major changes reads: Warnings and Precautions, Meningioma ( 5.4 ) 12/2025 A recent revision usually means new safety information was added.

The FDA Boxed Warning on Depo-Provera

A boxed warning is the most serious warning the FDA requires on a prescription label. It does not mean the medicine should not be used. It means there is a specific risk serious enough that the FDA requires it to appear at the very top of the prescribing information, so that prescribers weigh it deliberately for each patient.

Prescribers see this warning every time they consult the label. If it concerns you, it is a reasonable thing to raise at your next appointment and ask how it applies to your own situation.

Warnings Beyond the Common Depo-Provera Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Depo-Provera it covers: Thromboembolic Disorders: Discontinue Depo-Provera CI in patients who develop thrombosis. ( 5.2 ) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) Meningioma: Discontinue Depo-Provera CI if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. ( 5.4 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Depo-Provera CI becomes pregnant or complains of severe abdominal pain.

( 5.5 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.6 ) Liver Function: Discontinue Depo-Provera CI if jaundice or disturbances of liver function develop. ( 5.8 ) Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.13 ) 5.1 Loss of Bone Mineral Density Use of Depo-Provera CI reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine depo-provera side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.

Depo-Provera Side Effects Listed on the FDA Label

The label’s adverse reactions section records what was observed in clinical trials: he following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the Warnings and Precautions section ( 5 ): Loss of Bone Mineral Density [see Warnings and Precautions (5.1) ] Thromboembolic disease [see Warnings and Precautions (5.2) ] Breast Cancer [see Warnings and Precautions (5.3) ] Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.6) ] Bleeding Irregularities [see Warnings and Precautions (5.11) ] Weight Gain [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence >5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lb at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. […]

Trial data is the most reliable source for how common depo-provera side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.

Reported Depo-Provera Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Depo-Provera should not be used in certain situations: he use of Depo-Provera CI is contraindicated in the following conditions: Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2) ] . Known or suspected malignancy of breast [see Warnings and Precautions (5.3) ] . Known hypersensitivity to Depo-Provera CI (medroxyprogesterone acetate) or any of its other ingredients [see Warnings and Precautions (5.6) ] . […]

Interactions with other medicines. rugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Depo-Provera CI. […]

Older adults. 8.5 Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.

Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.

Depo-Provera Recall History

The FDA enforcement database records 2 recall entries involving Depo-Provera products (2 Class II). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.

The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.

If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.

Is There Litigation Involving Depo-Provera?

Lawsuits involving Depo-Provera have been filed in the United States. A lawsuit is an allegation: it means claimants assert that a manufacturer failed to warn adequately or that a product was defective. It is not a finding that the medicine caused any particular person’s illness, and courts have not necessarily reached any conclusion.

Whether any individual claim has merit depends on medical records, timing and the law in that person’s state. Our case pages track the current status of the litigation itself.

Read the current case status and filing information →

Litigation Timeline

If You Are Worried About Depo-Provera Side Effects

Concern about depo-provera side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.

Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its depo-provera side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.

You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.

Frequently Asked Questions

What are the most commonly reported depo-provera side effects?

In FDA reports, the most frequently mentioned are breast cancer, breast cancer female, meningioma. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.

Has Depo-Provera been recalled?

There are 2 recall records for Depo-Provera products, the most recent dated 2025-01-15. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.

Does Depo-Provera have a boxed warning?

Yes. The boxed warning is reproduced above. It is the most serious warning the FDA requires, and it exists so that prescribers weigh a specific risk for each patient rather than overlooking it.

Do the FDA report numbers tell me how common these depo-provera side effects are?

No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.

Where can I check depo-provera side effects for the exact product I have?

DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.

Official Sources

• DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
• FDA Adverse Event Reporting System dashboard — the public report data summarised above
• FDA recalls and safety alerts — current recall notices
• FDA MedWatch — how to report a side effect yourself

Related Guides

• All Drug Safety Profiles
• Drug Safety Explainers
• Product Recalls
• Active Case Pages

Medical and legal disclaimer. This page summarises publicly available FDA data about Depo-Provera and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Depo-Provera caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.

FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.