FDA's 2016 aripiprazole warning: compulsive gambling, eating, shopping and sex, and the label change it required
On 3 May 2016 the FDA warned that uncontrollable urges to gamble, binge eat, shop and have sex were reported with aripiprazole, 184 cases in 13 years. Urges stopped when the dose was cut or the drug stopped. Labels changed that August.
We have not finished checking this source. No judgement either way. how we score evidence
Caveat on this rating: Spontaneous case reports without a rate; the FDA called the problems rare and said not to stop the drug suddenly.
The FDA safety communication on aripiprazole and impulse-control problems, now offline at fda.gov, and the August 2016 label approval that followed it.
Significant findings
On 3 May 2016 the FDA warned "that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced." A search of FDA's adverse event database and the literature over 13 years "identified a total of 184 case reports"; 167 were US cases, including adults and children, and pathological gambling was the most common (164 cases). The agency said the existing label's mention of pathological gambling "does not entirely reflect the nature of the impulse-control risk" and that it was adding new warnings to the labels and Medication Guides for all aripiprazole products. Prescribers were told to ask specifically about new or increasing urges, and to watch closely in people with a personal or family history of OCD, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse or other addictive behaviours.
This row's anchor is the follow-through: FDA's 18 August 2016 approval of revisions to the Highlights, Warnings and Precautions (5), Patient Counseling Information and Medication Guide for Abilify and Abilify Maintena, "consistent with our May 3, 2016 letter" about "the risk of impulse-control problems".
The other direction
The FDA called these problems "rare" and set them against scale: about 1.6 million patients received a dispensed prescription for oral aripiprazole from US outpatient retail pharmacies in 2015. Case reports cannot give a rate or prove cause, and FAERS captures only what is reported. The FDA also said, in the same notice: "Patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional."
What this does not show
It does not mean everyone on aripiprazole is at risk of these urges, or that the drug should be stopped. It is a reason to name new urges early.
Worth asking
If I notice new urges to gamble, spend, eat or have sex, who do I tell, and how quickly?
Source
Supplement approval letter, NDA 021436/S-041 and related (Abilify, Abilify Maintena): labeling for the risk of impulse-control problems — US Food and Drug Administration, Center for Drug Evaluation and Research (2016)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- not recorded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
We have not finished checking this source, so there is no scoring to show yet. “We have not checked this yet” and “this is disputed” are different statements, so no scored band is shown rather than a low one.
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "not yet assessed". We have not finished checking this source. No judgement either way. One caveat travels with that badge: Spontaneous case reports without a rate; the FDA called the problems rare and said not to stop the drug suddenly. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Supplement approval letter, NDA 021436/S-041 and related (Abilify, Abilify Maintena): labeling for the risk of impulse-control problems — US Food and Drug Administration, Center for Drug Evaluation and Research (2016). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: not recorded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.