Abilify Side Effects

As of March 31, 2024, the most reported adverse side effect in the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System was weight gain, followed by 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 over 59,000 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.

Boxed Warnings for Abilify Updated

A boxed warning is the highest safety-related warning that the Food and Drug Administration can assign to medications. As of June 5, 2024, 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 Alzheimer’s disease 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.

Health care providers should closely monitor patients who begin antidepressant therapy while on Abilify for emerging or worsening suicidal thoughts and behaviors. Likewise, patients using this combination of medications should communicate their symptoms with a health care provider.

Abilify FDA Warnings

On May 3, 2016, the FDA released a warning of potential impulse control problems coinciding with the use of Abilify. Such compulsions include gambling, binge eating, shopping and sex. These uncontrollable urges are rare, and patients have reported that the urges stopped within days to weeks of discontinuation of the medication.

As of March 31, 2024, there are 1,832 reports of gambling or gambling disorder, according to the FDA.

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

The side effects on children are not well-researched. Because of this, researchers writing in the Journal of the Canadian Academy of Adolescent Psychiatry recommend that people should consider Abilify as a second-line treatment for children and adolescents with Bipolar Disorder and Schizophrenia.

Patients experiencing disruption from these side effects should be aware that suddenly stopping Abilify may cause withdrawal. Abilify withdrawal symptoms include anxiety, panic attacks and sweating. If you choose to stop Abilify, taper the medication by following your physician’s recommendations.

While rare, some Abilify side effects can greatly impact a patient’s quality of life or lead to death.

Neuroleptic Malignant Syndrome

A potentially fatal side effect of antipsychotic drugs, including Abilify, is neuroleptic malignant syndrome. Fever, muscle rigidity, altered mental state and instability are all visible signs of NMS. Although rare, affecting less than .05% of patients according to WebMD, 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 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 1 to 10 pounds during treatment, and weight gain accounted for about 8% of all reported Abilify side effects. 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, this side effect primarily affects adolescents who take aripiprazole, the active drug in Abilify. A 2022 review in Australasian Psychiatry examined 11 studies and found that adolescents, with a mean age of 18, gained an average of 2.7 kg (6 pounds) while on aripiprazole. Those who took the drug for over 12 weeks gained more weight than those who took it for a shorter period.

Impulse Control

In 2022, researchers conducted a review of FAERS reports relating to impulse control, including pathological gambling, compulsive shopping, increased appetite and hypersexuality, dating back to December 2020. This review in the International Journal of Neuropsychopharmacology concluded that aripiprazole was involved in 94% of all the adverse drug reaction reports of impulse control disorders.

Hundreds of people have filed Abilify lawsuits against Bristol-Myers Squibb and Otsuka America Pharmaceutical, the companies behind Abilify. Plaintiffs claim that the impulsive side effects they experienced when taking the drug irreparably altered their lives. In 2016, the FDA warned consumers about a connection between aripiprazole and new and worsening impulse control issues.

Impulse control problems related to Abilify often go away with the reduction or elimination of the medication. If you take Abilify and struggle with impulse control, talk to your doctor about adjusting the dose or stopping the medication. Do not lower your dosage or quit taking your medication without consulting your care provider, as this could lead to withdrawal.

Because Abilify is used to treat several conditions, it has many alternatives depending on your needs.

Regulators and public health agencies stress the importance of careful monitoring and individualized treatment plans, particularly in vulnerable populations such as older adults and those with pre-existing conditions.

If Abilify does not seem to decrease your symptoms or you experience side effects, speak with your care provider about changing your dosage or switching to a different medication.

Editor Lindsay Donaldson contributed to this article.