Side effects linked to Abilify (aripiprazole) range from weight gain and insomnia to compulsive behaviors and suicidal thoughts. Some side effects of the antipsychotic drug can cause permanent damage.
Patients have reported developing impulse control problems. These irresistible urges include gambling, sex and shopping. They have disrupted patients’ daily lives. Patients feel the effects in finances, relationships and their well-being.
The drug is also associated with problems involving metabolism. This can lead to weight gain and dangerously high blood sugar levels. It can also cause abnormally low blood pressure, seizures and difficulty swallowing.
The medication carries two black box warnings. One describes life-threatening risks to elderly patients with dementia. The other advises patients that drugs like Abilify can lead to thoughts of suicide.
Common Adverse Reactions in Clinical Trials
The most common adverse reactions in adult patients in Abilify clinical trials were nausea, vomiting, constipation, headache, dizziness, movement disorder, anxiety, insomnia and restlessness.
In clinical trials involving children, the most common adverse reactions were sleepiness, headache, vomiting, muscle or movement issues, fatigue, increased appetite, insomnia, nausea, common cold and weight gain.
The clinical trials involved 13,543 adults and 1,686 children ages 6 to 18 years. The most common side effects occurred in 10 percent or more of the patients.
Impulse Control Issues
A study published in JAMA Internal Medicine in December 2014 found dopamine receptor agonist drugs like Abilify “are associated with serious impulse control disorders; the associations were significant [and] the magnitude of the effects was large.”
The study by Thomas J. Moore and colleagues analyzed 2.7 million serious adverse drug event reports submitted to the FDA Adverse Event Reporting System from 2003 to 2012.
The researchers identified 710 events indicating impulse control disorders with dopamine receptor agonist drugs. Gambling was the most frequent behavior reported — followed by hypersexuality, compulsive shopping and poriomania, which is an impulsive tendency to wander away.
“Our findings confirm and extend the evidence that dopamine receptor agonist drugs are associated with these specific impulse control disorders,” the study’s authors wrote. “At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings.”
In 2016, the U.S. Food and Drug Administration added new warnings about the behaviors to the drug labels and the patient medication guides. The agency published a safety announcement warning the public about reports of “compulsive or uncontrollable urges to gamble, binge eat, shop and have sex” associated with Abilify.
“These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.”
The FDA reviewed its database for reports submitted from the time it approved the first aripiprazole product in November 2002 to January 2016. The agency identified 184 case reports in which there was an association between impulse control problems and aripiprazole use.
The majority of cases involved patients who had no prior history of such behaviors and only began experiencing the urges after starting treatment. The side effect stopped within days to weeks of reducing the dose or stopping the drug completely, according to the FDA.
The FDA instructed doctors to inform patients and caregivers of the risk, and it urged patients and caregivers to talk with a doctor right away if a patient experiences new impulses after starting treatment.
“These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized,” the agency said.
Pathological gambling was the most common impulse control problem identified during the FDA review. The agency said it found 164 cases of compulsive gambling associated with Abilify over the roughly 13-year period. The compulsive gambling reportedly stopped when the medicine was discontinued or the dose was reduced.
In addition, studies going back to 2011 uncovered patients who previously did not have gambling problems and developed them when taking the drug.
“The drug triggers a pathological urge to gamble constantly, sometimes among persons with no previous interest,” Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices, told The Daily Beast in 2016. “It might be people starting to spend $300 a week on lottery tickets, and in other cases people will gamble away tens of thousands of dollars.”
“The drug triggers a pathological urge to gamble constantly, sometimes among persons with no previous interest. It might be people starting to spend $300 a week on lottery tickets, and in other cases people will gamble away tens of thousands of dollars.”
Sexual Side Effects
Hypersexual activity is another compulsive behavior associated with Abilify. The sexual side effects of Abilify don’t appear as common as compulsive gambling, however.
The same FDA review that found 164 gambling cases found nine patients exhibiting compulsive sexual behavior.
Four patients described in medical literature who experienced hypersexual behavior noticed the behavior when they first started aripiprazole, according to the FDA.
The behavior resolved after the patients stopped taking the drug. But the behavior started again when the patients started taking the drug again.
A 2016 article in The Daily Beast quoted a letter from a woman who said her life was turned upside down when she started taking Abilify. She exchanged sexual messages and photographs with men.
It all ended when her husband caught her. But that wasn’t before the pictures made their way to her workplace, and she was publicly shamed.
Abilify carries an increased risk of suicidal thinking and behavior in children, adults and young adults. The FDA requires a black box warning that details this side effect. This warning applies to antidepressants in general.
The label advises patients to monitor for the emergence or worsening of suicidal thoughts and behaviors. Patients should not to stop taking any medication without first talking to their doctor.
Other Potential Risks
Abilify has also been linked to several other potential risks such as deadly strokes in elderly patients, withdrawal, weight gain and involuntary movement disorders.
The drug may increase the risk of seizures, so patients with a history of seizures or epilepsy should talk to their doctor before starting treatment. The medication can also make it difficult to swallow, which can lead to pneumonia if patients inhale food. The drug may also increase levels in blood sugar and the risk of developing diabetes.
Black Box Warning for Elderly Patients with Dementia
The FDA requires Abilify’s label to include a black box warning about elderly people and the drug. According to the warning, elderly people with dementia who are treated with antipsychotics are more likely to die than those who don’t take antipsychotics. The label says the drug may increase the risk of stroke in elderly people that can lead to death.
Neuroleptic Malignant Syndrome
Neuroleptic malignant syndrome (NMS) is a rare, life-threatening reaction to antipsychotic drugs, such as Abilify, according to a review written by The Neurohospitalist and published by the National Institutes of Health. NMS has been associated with virtually all neuroleptics.
The condition is characterized by fever, altered mental status, muscle rigidity and instability of the autonomic nervous system, which controls involuntary or unconscious functions such as heart rate, digestion, respiratory rate, urination and sexual arousal.
Tardive Dyskinesia (Uncontrolled Body Movements)
Tardive dyskinesia (TD) is a serious side effect of Abilify characterized by involuntary movements that most often affect the lower face. Tardive means delayed and dyskinesia means abnormal movement.
If TD occurs, it is often after long-term use (months or years) of these medications, but in some instances, it can result after just six weeks of drug use. Once it happens, the condition may not be reversible even after the medication is discontinued.
Researchers in 2009 studied second-generation antipsychotic medications, including Abilify, and their association with “rapid and significant” weight gain in youth. Their study published in JAMA found first-time use of the medications was associated with significant weight gain.
Study participants who took aripiprazole gained 9.7 pounds after an average of about 11 weeks of treatment. A group of participants who didn’t take the drug gained less than half a pound.
Researchers wrote that previous studies also found weight gain in adults taking the drug, but it was not as rapid and as significant as in youth. In general, the drug’s effects on weight are thought to be less than other antipsychotics.
Because Abilify affects how your brain works, suddenly stopping the drug may lead to withdrawal symptoms. This is especially the case if you have taken it over an extended time or if you take a higher dose.
- Appetite changes
- Concentration problems
- Joint pain
- Panic attacks
Medical professionals recommend gradually tapering off the drug. This should always be done in consultation with your doctor.
Please seek the advice of a medical professional before making health care decisions.