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Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications FDA SIDE EFFECTS UPDATE: Antipsychotic Drugs and Breast Cancer Risk
Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language
February 28, 2025
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Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning Erzofri, Fanapt, Geodon, Haldol, Invega, Lybalvi, Molindone, Risperidone, Saphris, Secuado, Seroquel, Symbax and Zyprexa.
How to Read This Report
This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.
Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.
Additional Details for This Update: FDA Mandates New Safety Labeling for Many Antipsychotics
The FDA now mandates that updated safety information regarding the link between hyperprolactinemia (elevated prolactin levels) and breast cancer be added to the labeling of many antipsychotic medications.
Hyperprolactinemia is a recognized side effect of many antipsychotics and can lead to various health issues, including fertility problems, reduced libido, and breast tissue growth. Prolonged use has also been linked to an increased risk of osteoporosis.
Some studies have found that prolonged periods of antipsychotic-induced elevated prolactin may result in the development of breast cancer, while other studies have not found a link. However, the FDA has determined that the evidence is sufficient to warrant a label warning on antipsychotic drugs known to increase prolactin levels.
For each drug listed in this update, its propensity to elevate prolactin levels has been categorized as high, medium, or low, using information from a recent study. Newer antipsychotics, known as “atypical” or second-generation, generally have a lower risk of causing hyperprolactinemia compared to older antipsychotic medications.
Erzofri (active ingredient: paliperidone palmitate) extended release injection
Initial FDA Approval: 2006
Side Effect Update Date: January 22, 2025
Medication Description: Treats schizophrenia and schizoaffective disorder in adults.
Updated Side Effects/Safety Information: A section describing this medication’s risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer, adding that “published studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer.”
Essential Extras: Paliperidone has a “high” propensity for prolactin elevation.
FDA Safety Announcement: Erzofri FDA Safety Label Change and Revised Drug Label
Fanapt (active ingredient: iloperidone)
Initial FDA Approval: 2009
Side Effect Update Date: January 22, 2025
Medication Description: Treats schizophrenia and bipolar 1 in adults.
Updated Side Effects/Safety Information: A section describing this medication’s risk of of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Essential Extras: Iloperidone has a “medium” propensity for prolactin elevation.
FDA Safety Announcement: Fanapt FDA Safety Label Change and Revised Label
Geodon (ziprasidone) capsules or intramuscular injection
Initial FDA Approval: 2001
Side Effect Update Date: January 22, 2025
Medication Description: Treats schizophrenia and bipolar 1 disorder in adults. Injection is used for acute treatment of agitation or manic episodes in adults with schizophrenia or bipolar 1 disorder.
Updated Side Effects/Safety Information: A section describing this medication’s risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Sleepwalking (or somnambulism) was added as an adverse reaction in the postmarketing experience section.
A new warning section was added on the risk of serotonin syndrome, which is a potentially life-threatening condition. The risk is increased with the concomitant use of other drugs, such as MAOIs (linezolid), SSRIs, SNRIs, triptans, amphetamines, St. John’s Wort and more. See revised label for complete details.
Essential Extras: Ziprasidone has a “low” propensity for prolactin elevation.
FDA Safety Announcement: Geodon FDA Safety Label Change and Revised Drug Label
Haldol (active ingredient: haloperidol decanoate) intramuscular injection
Initial FDA Approval: 1986
Side Effect Update Date: January 22, 2025
Medication Description: Treats individuals with schizophrenia who require prolonged parenteral (bypassing the digestive system) antipsychotic therapy.
Updated Side Effects/Safety Information: A section describing this medication’s risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Essential Extras: Haloperidol has a “high” propensity for prolactin elevation.
FDA Safety Announcement: Haldol FDA Safety Label Change and Revised Drug Label
Invega extended release tablets, Invega Sustena, Invega Trinza, Invega Hafyera (active ingredient: paliperidone palmitate) intramuscular injection
Initial FDA Approval: 2009 (injection) 2006 (tablets)
Side Effect Update Date: January 23, 2025
Medication Description: Treats schizophrenia or schizoaffective disorder in adults. Tablets are approved as treatment for schizophrenia or schizoaffective disorder in adults or adolescents.
Updated Side Effects/Safety Information: A section describing this medication’s risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Essential Extras: Paliperidone has a “high” propensity for prolactin elevation
FDA Safety Announcement: Invega FDA Safety Label Change and Revised Drug Label
Lybalvi (active ingredient: olanzapine; samidorphan l-malate) tablets
Initial FDA Approval: 2021
Side Effect Update Date: January 27, 2025
Medication Description: Treats schizophrenia and bipolar disorder in adults.
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Also, sleepwalking (or somnambulism) and fecal incontinence were added as adverse reactions in the postmarketing experience section.
Essential Extras: Olanzapine has a “medium” propensity for prolactin elevation
FDA Safety Announcement: Lybalvi FDA Safety Label Change and Revised Drug Label
Molindone hydrochloride tablets (formerly brand name Moban, which has been discontinued)
Initial FDA Approval: 1974
Side Effect Update Date: January 22, 2025
Medication Description: Treats schizophrenia.
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Essential Extras: Molindone has a “high” propensity for prolactin elevation.
FDA Safety Announcement: Moban FDA Safety Label Change and Revised Drug Label
Risperidone (brand names Perseris kit subcutaneous injection, Uzedy subcutaneous injection Rykindo, Risvan Intramuscular extended release, Risperdal tablets and oral solution)
Initial FDA Approval: 1993
Side Effect Update Date: January 25, 2025
Medication Description: Treats schizophrenia. Some of the products also treat bipolar disorder in adults. Risperdal is also approved to treat irritability associated with autistic disorder.
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Essential Extras: Risperidone has a “high” propensity for prolactin elevation.
FDA Safety Announcement:
Perseris FDA Safety Label Change and Revised Drug Label
Rykindo FDA Safety Label Change and Revised Drug Label
Risvan FDA Safety Label Change and Revised Drug Label
Risperdal FDA Safety Label Change and Revised Drug Label
Uzedy FDA Safety Label Change and Revised Drug Label
Saphris (active ingredient: asenapine maleate) sublingual tablets
Initial FDA Approval: 2009
Side Effect Update Date: January 22, 2025
Medication Description: Treats schizophrenia in adults and bipolar I disorder in adults and adolescents.
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Essential Extras: Asenapine has a “low” propensity for prolactin elevation.
FDA Safety Announcement: Saphris FDA Safety Label Change and Revised Drug Label
Secuado (active ingredient: asenapine) transdermal patch
Initial FDA Approval: 2019
Side Effect Update Date: January 22, 2025
Medication Description: Treats adults with schizophrenia.
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Essential Extras: Asenapine has a “low” propensity for prolactin elevation.
FDA Safety Announcement: Secuado FDA Safety Label Change and Revised Drug Label
Seroquel (active ingredient: quetiapine) tablets and Seroquel XR (active ingredient: quetiapine) extended release tablets
Initial FDA Approval: 1997
Side Effect Update Date: January 22, 2025
Medication Description: Treats schizophrenia and bipolar disorder in adults and adolescents. Treats major depressive disorder in adults (with adjunct antidepressant medications).
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Also, fecal incontinence was added as an adverse reaction in the postmarketing experience section.
Essential Extras: Quetiapine has a “low” propensity for prolactin elevation.
FDA Safety Announcement: Seroquel FDA Safety Label Change and Revised Drug Label
Symbax (active ingredients: fluoxetine hydrochloride; olanzapine)
Initial FDA Approval: 2003
Side Effect Update Date: January 22, 2025
Medication Description: Treats bipolar disorder and treatment-resistant depression in adults and children age 10 and up.
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Sleepwalking (or somnambulism) and fecal incontinence were added as adverse reactions in the postmarketing experience section.
Essential Extras: Olanzapine has a “medium” propensity for prolactin elevation
FDA Safety Announcement: Symbax FDA Safety Label Change and Revised Drug Label
Zyprexa (active ingredient: olanzapine) pills, orally disintegrating tablets, short-acting intramuscular injection; Zyprexa Relprevv (active ingredient: olanzapine pamoate) extended release intramuscular injection
Initial FDA Approval: 1996
Side Effect Update Date: January 22, 2025
Medication Description: Zyprexa treats schizophrenia and bipolar disorder in adults and adolescents and treats major depression in adults in conjunction with fluoxetine. Zyprexa Relprevv (extended release intramuscular injection) is used only to treat schizophrenia.
Updated Side Effects/Safety Information: The section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer.
Sleepwalking (or somnambulism) and fecal incontinence were also added as adverse reactions in the postmarketing experience section.
Essential Extras: Olanzapine has a “medium” propensity for prolactin elevation
FDA Safety Announcement: Zyprexa FDA Safety Label Change Change and Revised Drug Label
Zyprexa Relprevv FDA Safety Label Change and Revised Drug Label
Want to Share Your Story?
If you’ve experienced side effects or medication issues related to this topic, we want to hear from you.
Submit Your Story- DRUG SAFETY-RELATED LABELING CHANGES (SRLC)
- DRUGS@FDA: FDA APPROVED DRUGS
- ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
- NATIONAL LIBRARY OF MEDICINE’S DAILYMED DRUG LABEL DATABASE
- MERRIAM-WEBSTER MEDICAL DICTIONARY
- Serotonin syndrome: MedlinePlus Medical Encyclopedia. (n.d.)
- Hyperprolactinemia. (2023, February 10). Yale Medicine
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