Does aripiprazole have a black box warning?
Yes. Aripiprazole (brand examples include Abilify and Abilify Maintena) carries a black box warning for increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults when starting antidepressant medicines. The warning applies to antidepressants used in that population, not to aripiprazole being an antidepressant by itself.
Aripiprazole does have other important safety warnings, but the “black box” language specifically concerns suicidality risk tied to antidepressant use in younger people. [1][2]
What age group does the black box warning cover?
The black box warning related to suicidal thoughts and behaviors applies to children, adolescents, and young adults (up to age 24) when treated with antidepressant medications. [1][2]
What about suicidal thoughts risk when taking aripiprazole?
Even when a specific black box warning isn’t the same as aripiprazole’s primary indication, treatment with psychiatric medicines can still require close monitoring. If someone develops worsening depression, suicidal thoughts, or unusual behavior changes, they should seek medical help right away. The key point for the black box warning is the suicidality risk that is monitored with antidepressant treatment in younger patients. [1][2]
Are there other FDA boxed warnings for aripiprazole?
No additional boxed warnings are listed for aripiprazole beyond the antidepressant suicidality warning context described above. [1][2]
Where can I find the official labeling text?
You can check the FDA-approved prescribing information for aripiprazole (including the specific product version, such as tablets vs. long-acting injection) for the black box section and related “Warnings” language. [1][2]
Sources
- https://www.accessdata.fda.gov/scripts/cder/daf/
- https://www.accessdata.fda.gov/drugsatfda/