What are the side effects of Abilify (aripiprazole)?

Side Effects of Abilify (Aripiprazole)

Abilify causes a wide range of side effects, with the most common being nausea, vomiting, constipation, headache, dizziness, akathisia (inner restlessness), insomnia, anxiety, and blurred vision in adults, while children more frequently experience sedation, weight gain, and extrapyramidal symptoms. 1

Common Side Effects

Adults

The FDA-approved labeling identifies the following most common adverse effects: 1

• Gastrointestinal: Nausea, vomiting, constipation
• Neurological: Headache, dizziness, insomnia
• Psychiatric: Anxiety, restlessness, akathisia (inner sense of restlessness/need to move)
• Other: Blurred vision, upper respiratory illness

Pediatric Patients

Children experience a somewhat different side effect profile: 1

• Sedation and fatigue (feeling sleepy)
• Weight gain and appetite changes (increased or decreased)
• Extrapyramidal symptoms: Uncontrolled movements, restlessness, tremor, muscle stiffness
• Increased salivation or drooling
• Gastrointestinal: Nausea, vomiting
• Other: Headache, insomnia, stuffy nose

Serious and Life-Threatening Side Effects

Neuroleptic Malignant Syndrome (NMS)

This rare but potentially fatal condition requires immediate medical attention and presents with: 1

• High fever
• Muscle rigidity (stiff muscles)
• Confusion
• Sweating
• Changes in pulse, heart rate, and blood pressure

Tardive Dyskinesia

Aripiprazole can cause uncontrolled body movements in the face, tongue, or other body parts that may be irreversible, even after discontinuation. 1 This risk increases with duration of treatment and total cumulative dose.

Cerebrovascular Events

Stroke and cerebrovascular problems can occur in elderly patients, potentially leading to death. 1 This is particularly concerning in elderly patients with dementia-related psychosis.

Metabolic Complications

The FDA label warns of several metabolic disturbances: 1

• Hyperglycemia and diabetes: Can lead to diabetic ketoacidosis, coma, or death. Symptoms include excessive thirst, frequent urination, extreme hunger, weakness, confusion, and fruity-smelling breath.
• Dyslipidemia: Increased cholesterol and triglyceride levels
• Weight gain: Should be monitored regularly throughout treatment

Cardiovascular and Neurological Side Effects

Orthostatic Hypotension

Lightheadedness or fainting may occur when rising from sitting or lying positions due to decreased blood pressure. 1 This increases fall risk, particularly in elderly patients.

Falls

The combination of sedation, dizziness, decreased blood pressure, and slowed motor function significantly increases fall risk, potentially causing fractures or other injuries. 1

Seizures

Convulsions can occur, particularly in patients with a history of seizures or conditions that lower the seizure threshold. 1

Hematologic and Other Serious Effects

• Low white blood cell count (leukopenia/neutropenia), which increases infection risk 1
• Difficulty swallowing (dysphagia), which can lead to aspiration pneumonia 1
• Temperature dysregulation: Impaired ability to regulate body temperature, especially during exercise or heat exposure 1

Behavioral and Psychiatric Side Effects

Emotional Blunting

The European Society for Medical Oncology (ESMO) reports that aripiprazole can cause emotional blunting manifesting as anxiety, agitation, and changes in emotional responsiveness. 2 Headache and insomnia may contribute to emotional dysregulation. 2

Impulse Control Disorders

Unusual and compulsive urges may develop, including: 1

• Pathological gambling
• Compulsive eating or binge eating
• Compulsive shopping
• Hypersexuality

Patients and family members should be counseled to report these behaviors immediately.

Depression and Suicidality

Depression occurs in approximately 1% of patients, and appropriate counseling is recommended before initiating therapy to prevent worsening of pre-existing depression or emergence of suicidal ideation. 3

Extrapyramidal Symptoms

While aripiprazole has a lower risk of extrapyramidal symptoms compared to first-generation antipsychotics, these effects still occur: 4, 5

• Akathisia (motor restlessness) is among the most commonly reported side effects 5
• Tremor, muscle stiffness, and other movement disorders
• Risk increases at higher doses 4

Special Population Considerations

Elderly Patients

Older patients are more sensitive to medication effects, requiring: 4, 6

• Lower starting doses
• Increased monitoring for falls, sedation, and difficulty swallowing
• Assessment every 2-4 weeks after medication changes 6

Poor CYP2D6 Metabolizers

Patients with poor cytochrome P450 2D6 metabolism may experience more frequent and severe side effects, requiring dose adjustments. 2

Clinical Pearls and Monitoring

Common pitfall: The FDA label emphasizes that many gastrointestinal side effects occur early in treatment—70-80% within the first 2 weeks—with 75-80% being mild and 60-65% resolving within the first month. 3 This temporal pattern should guide patient counseling and management decisions.

Weight monitoring: Approximately 12% of patients experience 5-10% body weight loss, compared to 5% on placebo. 3 For patients losing more than 5% of baseline body weight, discontinuation should be considered. 3

Drug interactions: Monitor for interactions with strong CYP450 inducers (rifampin, phenobarbital, carbamazepine, phenytoin), which may decrease efficacy, and CYP2D6/3A4 inhibitors, which may increase aripiprazole levels and side effects. 2, 4