Abilify: Side Effects, FDA Warnings and Patient Safety Information

Abilify (aripiprazole) is a type of medication called an atypical antipsychotic, similar to Risperdal (risperidone). Both help balance certain chemicals in your brain that affect mood and behavior.

Japanese drug company Otsuka Pharmaceutical developed Abilify. The U.S. Food and Drug Administration (FDA) approved the medication in 2002.

Abilify regulates your mood and thoughts by balancing dopamine and serotonin. These chemicals are essential for how you feel and act.

Abilify has a variety of side effects, like restlessness and nausea, but most are mild.

Side effects for children are not well-researched. Consequently, researchers writing in the Journal of the Canadian Academy of Adolescent Psychiatry recommend that Abilify be considered as a second-line treatment for children and adolescents with Bipolar Disorder and Schizophrenia.

Patients experiencing these side effects should understand that suddenly stopping Abilify may cause withdrawal. Abilify withdrawal symptoms include anxiety, panic attacks and sweating.

If you choose to stop taking Abilify, taper the medication according to your physician’s recommendations.

Serious Side Effects of Abilify

There are some serious risks associated with taking Abilify, including seizures, strokes and suicidal thoughts.

Neuroleptic Malignant Syndrome

A potentially fatal side effect of antipsychotic drugs like Abilify is neuroleptic malignant syndrome (NMS). Fever, muscle rigidity, altered mental state and instability are all visible signs of NMS.

Although rare, it is important to be aware of these signs of NMS if you take any antipsychotic drug.

Researchers have yet to fully understand its underlying mechanisms, but it’s possible that decreased levels of dopamine may cause NMS.

Tardive Dyskinesia

Tardive dyskinesia, or involuntary muscle movements, is a potentially irreversible side effect of Abilify. This condition primarily affects older patients, especially women.

The risk of permanent TD increases with long-term use and higher doses of Abilify.

Weight Gain

People taking Abilify may gain one to 10 pounds during treatment. However, significant weight gain, defined as a 7% or more increase in body weight, is uncommon. Some studies found that 13% of patients experienced clinically significant weight gain, while others found it occurred in less than 5% of patients.

While weight gain is possible in adults, it can also occur in adolescents who take aripiprazole, the active drug in Abilify. A 2022 review in Australasian Psychiatry examined various studies and found that adolescents with a mean age of 18 gained an average of 2.7 kg (six pounds) while taking aripiprazole. Those who took the drug longer gained more weight than those who took it for a shorter period.

As of October 21, 2025, the most reported adverse side effect in the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System was weight gain, followed by psychiatric disorders like anxiety, suicidal ideation and insomnia.

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

The FDA has received nearly 62,000 adverse reaction reports combined for five versions of Abilify. This information indicates that over half of all reported adverse reactions are serious. Death occurred in just over 4% of all reported cases.

FDA Black Box Warnings and Safety Communications

A boxed warning is the highest safety-related warning that the FDA can assign to medications. As of October 21, 2025, Abilify has two boxed warnings.

Older patients with dementia-related psychosis are at an increased risk of death when treated with antipsychotic medications such as Abilify. In clinical trials, older people who were diagnosed with dementia and treated with atypical antipsychotics like Abilify were 1.6 to 1.7 times more likely to die than those in the control group.

In children, adolescents and young adults, the use of Abilify with antidepressants increases the risk of suicidal thoughts and behaviors. In patients 24 and older, short-term studies of Abilify being used in combination with antidepressants did not show the same adverse effects. For patients aged 65 or older, there was a decrease in the risk of suicidal tendencies when using Abilify with antidepressants.

The FDA urges doctors and patients to closely monitor suicidal thoughts and actions when combining Abilify and antidepressants in young people. 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.

Health care providers should closely monitor patients who begin antidepressant therapy while on Abilify for emerging or worsening suicidal thoughts and behaviors. Likewise, if you use this combination of medications, you should communicate any side effects to your doctor.

These behaviors can lead to serious challenges in finances, legal matters and personal relationships, especially if they go unrecognized or misdiagnosed.

Side effects can arise quickly and usually resolve when you stop taking Abilify or reduce your dosage. However, due to these risks, the FDA added important warnings to Abilify’s medication guides and drug labels.

If you suffered injuries due to taking Abilify, you should report them to the FDA’s MedWatch program.

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.

Pathological gambling is the most commonly reported impulse control problem. 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, sexual behavior or other impulse-control issues.

As of March 31, 2025, the FAERS public dashboard showed a total of 2,289 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.

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.

Between 2016 and 2022, attorneys and patients filed over 2,800 Abilify lawsuits against the manufacturers and distributors of Abilify.

Plaintiffs alleged that Abilify caused serious impulse control issues, especially compulsive gambling. They also claim that Abilify’s developer, Otsuka Pharmaceutical, and Bristol-Myers Squibb, which owns the drug’s distribution rights in the U.S., failed to warn patients and doctors about this risk.

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.

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.

Drugwatch is unaware of any attorneys actively accepting Abilify lawsuits.