Abilify: Side Effects, FDA Warnings and Patient Safety Information
Abilify (aripiprazole) is a prescription medication that treats several mental health conditions. However, it has links to serious side effects like compulsive gambling and behavioral problems, which led to thousands of lawsuits and a legal settlement over injuries and inadequate warnings.
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- Last update: August 7, 2025
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What Is Abilify and How Does It Work?
Abilify (aripiprazole) is a type of medication called an atypical antipsychotic, similar to Risperdal (risperidone). Both help balance certain chemicals in the brain that affect mood and behavior. However, more than 2,000 lawsuits claimed Abilify caused compulsive gambling and other impulse control problems.
The Japanese drug company Otsuka Pharmaceutical developed Abilify. The U.S. Food and Drug Administration (FDA) approved the drug in 2002.
- Autism spectrum disorder
- Bipolar I disorder
- Depression (when used alongside antidepressant medications)
- Schizophrenia
- Tourette disorder
Abilify regulates mood and thoughts by balancing two chemicals in the brain: dopamine and serotonin. These chemicals are essential for how we feel and act.
Serious Abilify Side Effects and FDA Warnings
Abilify side effects range from common, minor side effects to severe issues. People often report experiencing headaches, nervousness, anxiety, nausea, insomnia and weight gain as common side effects. However, there are also more serious risks associated with this medication.
- Increased risk of death in elderly patients with dementia
- Neuroleptic malignant syndrome, a rare but life-threatening neurological disorder
- Pathological gambling and other compulsive behaviors
- Seizures or convulsions
- Strokes and mini-strokes, including fatalities
- Suicidal thoughts and behaviors, especially in younger patients who take antidepressants
- Tardive dyskinesia, a condition that causes involuntary movements
FDA Black Box Warnings and Safety Communications
The FDA requires two black box warnings — the agency’s most serious alerts — for Abilify. One of these warnings highlights an increased risk of suicidal thinking and behavior in young people who take antidepressants. The FDA urges doctors and patients to closely monitor suicidal thoughts and actions when combining Abilify and antidepressants among young populations.
The other Abilify black box warning is about a heightened risk of death for elderly patients with dementia. The FDA has not approved Abilify for people with “dementia-related” psychoses.
In 2016, the FDA issued an additional safety warning that Abilify may lead to problems with impulse control, especially regarding gambling.
- Compulsive gambling
- Excessive shopping
- Increased sexual activity
- Overeating
These behaviors can lead to serious challenges in finances, legal matters and personal relationships, especially if they go unrecognized or misdiagnosed.
These issues can arise quickly and usually resolve when people stop taking Abilify or reduce their dosage. However, due to these risks, the FDA added important warnings to Abilify’s medication guides and drug labels.
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January 22, 2025:
The FDA updated the label for Abilify, stating that using it during pregnancy can affect a new mother’s ability to produce milk after giving birth.
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August 7, 2019:
The FDA changed the Abilify label, adding that the drug can pass into breast milk at levels ranging from 0.7% to 8.3% of the mother’s dose. Some infants may have weight gain issues, and mothers might experience low milk supply while taking it.
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February 23, 2017:
Abilify’s label changed to reflect FDA warnings that taking the drug could lead to falls and fractures.
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August 18, 2016:
The FDA added a warning for impulse control and compulsive behavior risks to Abilify’s label. The agency indicated that the risk of gambling urges was especially prevalent, noting that compulsive urges regarding sexual activity, shopping and binge eating were also possible.
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January 15, 2016:
The FDA added two potential adverse reactions to Abilify’s label based on postmarketing monitoring: pathological gambling and hiccups.
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November 15, 2002:
Abilify received its initial FDA approval.
If you suffered injuries as a result of taking Abilify, you should report them to the FDA’s MedWatch program.
Impulse Control Disorders and Behavioral Risks
Abilify’s impulse control issues can occur in anyone taking the medication, even if they haven’t experienced similar urges before. While these behaviors are rare, they can be harmful if not addressed promptly.
Pathological gambling is the most commonly reported impulse control issue. The FDA noted 164 cases of pathological gambling linked to aripiprazole when it added the warning in 2016, along with 20 other cases involving compulsive eating, shopping or sexual behavior. As of March 31, 2025, the FDA Adverse Events Reporting System (FAERS) public dashboard showed a total of 2,229 reports of gambling-related side effects associated with Abilify use.
The FDA mandated warnings about these impulse control risks on Abilify’s label, urging patients and caregivers to monitor for any unusual behaviors. Consult your doctor before stopping the medication.
A 2018 study in International Clinical Psychopharmacology provided further evidence supporting the FDA’s 2016 warning about behavioral risks. Researchers identified a strong link between Abilify and impulse control disorders. Their study of the European Medicines Agency’s EudraVigilance dashboard revealed that Abilify users reported impulse control issues more frequently than expected, with a particularly high risk associated with the long-acting injection form.
Legal Action Over Abilify Injuries
Between 2016 and 2022, attorneys and patients filed over 2,800 Abilify lawsuits against the manufacturers and distributors of Abilify, alleging that the drug caused serious impulse control issues, especially compulsive gambling. The U.S. Judicial Panel on Multidistrict Litigation grouped these cases into multidistrict litigation (MDL) in Florida. MDLs allow the panel to combine multiple similar lawsuits into a single litigation to make the legal process more efficient.
The lawsuits claimed that Otsuka Pharmaceutical (Abilify’s developer) and Bristol-Myers Squibb (which owns the rights to distribute Abilify in the U.S.) failed to warn patients and doctors about the risk of compulsive gambling.
In 2019, the U.S. District Court for the Northern District of Florida approved a settlement, creating a fund to compensate those affected and appointing a claims administrator to manage claims and payouts. The process officially ended when the court closed the fund in 2022 after the completion of all payments.
At this time, Drugwatch is unaware of any attorneys actively accepting Abilify lawsuits.
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