October is Breast Cancer Awareness Month, an opportunity to review breast cancer screening needs and individual risk factors with a healthcare provider. For patients taking Risperdal, Invega, and Zyprexa, that discussion may include research examining an association between certain prolactin-elevating medications and breast cancer risk.
Studies have shown that certain antipsychotic drugs, including Risperdal (risperidone), Invega (paliperidone), and Zyprexa (olanzapine), can raise levels of the hormone prolactin. Some research has found that elevated prolactin may be associated with breast cancer risk.
These medications treat serious conditions, and any decisions about them should be made with a treating physician. Do not stop taking any of these medications or change your dose without first talking to your doctor.
Research Linking Elevated Prolactin to Breast Cancer Risk
A 2022 observational study published in the Journal of Clinical Psychopharmacology examined breast cancer risk among more than 540,000 commercially insured US women ages 18 to 64 who started antipsychotics, anticonvulsants, or lithium between 2007 and 2016. It found that certain prolactin-elevating antipsychotics were associated with an increased breast cancer risk compared with anticonvulsants and/or lithium.
After adjusting for age and other measured risk factors, researchers found a 62% higher relative hazard of invasive breast cancer for certain antipsychotics with high prolactin-elevating potential and a 54% higher relative hazard for those with moderate potential.
These are relative figures measured across a large population. They do not describe any one patient’s chance of developing breast cancer.
Conditions These Antipsychotics Are Prescribed to Treat
This information applies to patients taking Risperdal (risperidone), Invega (paliperidone), or Zyprexa (olanzapine), including generic versions. Their use extends beyond schizophrenia and often depends on the medication, formulation, and patient population. Approved indications include bipolar I disorder, schizoaffective disorder, and irritability associated with autism. Clinicians may also prescribe these medications for off-label uses.
Examples of FDA-approved indications for these medications include:
- Risperdal (risperidone): Schizophrenia, acute manic or mixed episodes associated with bipolar I disorder, and irritability associated with autism in pediatric patients.
- Invega (paliperidone): Schizophrenia and schizoaffective disorder.
- Zyprexa (olanzapine): Schizophrenia, acute manic or mixed episodes associated with bipolar I disorder, and maintenance treatment of bipolar I disorder.
FDA-approved generic versions of these medications contain the same active ingredients as their corresponding brand-name products. Patients taking generic versions may face the same potential side effects and risks as those taking brand-name medications.
Signs of Elevated Prolactin to Discuss With a Doctor
There are several potential signs of elevated prolactin levels or hyperprolactinemia that should be addressed with a healthcare provider.
Signs of elevated prolactin may include:
- Reduced libido in both sexes
- Infertility
- Changes in menstruation (irregular or missed periods)
- Unexpected milky discharge from the nipple
- Breast tenderness or swelling
- Enlarged breast tissue in men
Be sure to ask your healthcare provider whether you are up to date on screening. Discuss your medication history, personal and family history, and any new breast changes so your provider can assess your individual needs.
For additional background, read Wisner Baum’s “Prolactin & Breast Cancer: What Patients Taking Risperdal, Invega, or Zyprexa Need to Know.”
Current Status of the Antipsychotic Breast Cancer Litigation
In April 2025, Wisner Baum filed a lawsuit on behalf of California resident Bridgett Brown, who developed breast cancer after taking Risperdal and Zyprexa. The lawsuit names Johnson & Johnson, Janssen entities, and Eli Lilly among the defendants. It alleges that the manufacturers failed to adequately warn patients and prescribers about potential breast cancer risks. These allegations have not been established as findings of liability.
In a statement about Brown’s lawsuit, Monique Alarcon, an attorney at Wisner Baum, said: “Had our client or her prescribing physicians been properly informed by the drug makers about breast cancer risk, she would not have taken these medications or would have sought safer alternatives.”
In January 2025, the prescribing information for Risperdal, Invega, and Zyprexa was updated to revise how it addresses the potential association between elevated prolactin and breast cancer. The lawsuit alleges that, prior to that update, the labels denied any breast cancer risk.
The updated labels now state: “Published epidemiologic studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer.” The lawsuit alleges that this description of the research is itself misleading.
On November 24, 2025, a federal judge granted the motion to return Brown v. Johnson & Johnson to California state court. That ruling addressed where the case would proceed, not whether the medications caused breast cancer or whether the defendants were liable.
Current antipsychotic litigation includes:
Speak With Wisner Baum About Your Legal Options
Wisner Baum offers free, confidential case reviews for individuals diagnosed with breast cancer after taking Risperdal, Invega, or Zyprexa, including generic versions. Eligibility depends on the prescription history, product manufacturer, medical records, and applicable filing deadlines.
Contact Wisner Baum online or call (310) 207-3233 to discuss your legal options.
