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Abilify MyCite

Last reviewed on RxList: 3/30/2020
Abilify MyCite Side Effects Center

What Is Abilify MyCite?

Abilify MyCite (aripiprazole tablets with sensor) a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the treatment of adults with schizophrenia; treatment of bipolar I disorder: acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate and maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate; and as adjunctive treatment of adults with major depressive disorder (MDD).

What Are Side Effects of Abilify MyCite?

Common side effects of Abilify MyCite include:

  • restlessness,
  • sedation,
  • tremors,
  • extrapyramidal disorder (muscle spasms, slowness of movement, and irregular/jerky movements),
  • insomnia,
  • constipation,
  • fatigue,
  • and blurred vision.

Dosage for Abilify MyCite

The recommended dose of Abilify MyCite depends on the condition being treated and ranges from 5 to 15 mg/day.

What Drugs, Substances, or Supplements Interact with Abilify MyCite?

Abilify MyCite may interact with:

Tell your doctor all medications and supplements you use.

Abilify MyCite During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Abilify MyCite. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Abilify MyCite during pregnancy. Abilify MyCite may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Abilify MyCite passes into breast milk but it is unknown how it would affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Abilify MyCite (aripiprazole tablets with sensor) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Schizophrenia is the most disabling mental illness. See Answer
Abilify MyCite Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Cerebrovascular Adverse Events, Including Stroke [see WARNINGS AND PRECAUTIONS]
  • Neuroleptic Malignant Syndrome (NMS) [see WARNINGS AND PRECAUTIONS]
  • Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Metabolic Changes [see WARNINGS AND PRECAUTIONS]
  • Pathological Gambling and Other Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
  • Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS] Falls [see WARNINGS AND PRECAUTIONS]
  • Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
  • Body Temperature Regulation [see WARNINGS AND PRECAUTIONS]
  • Dysphagia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ABILIFY MYCITE for the treatment of adults with schizophrenia, treatment of adults with manic and mixed episodes associated with bipolar I disorder, and adjunctive treatment of adults with major depressive disorder (MDD) has been established and is based on trials of aripiprazole including 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, and other disorders, and who had approximately 7619 patientyears of exposure to oral aripiprazole. A total of 3390 patients were treated with oral aripiprazole for at least 180 days and 1933 patients treated with oral aripiprazole had at least 1 year of exposure.

The conditions and duration of treatment with aripiprazole (monotherapy and adjunctive therapy with antidepressants or mood stabilizers) included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.

The most common adverse reactions of aripiprazole in adult patients in clinical trials (≥10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

Adverse Reactions In Adult Patients With Schizophrenia

The following findings are based on a pool of five placebo-controlled trials (four 4 week and one 6 week) in which oral aripiprazole was administered in doses ranging from 2 to 30 mg/day.

The commonly observed adverse reaction associated with the use of aripiprazole tablets in patients with schizophrenia (incidence of 5% or greater and aripiprazole tablets incidence at least twice that for placebo) was akathisia (aripiprazole tablets 8%; placebo 4%).

Adverse Reactions In Adult Patients With Bipolar Mania

Adult Patients Who Received Monotherapy

The following findings are based on a pool of 3 week, placebo-controlled, bipolar mania trials in which oral aripiprazole was administered at doses of 15 or 30 mg/day.

Commonly observed adverse reactions associated with the use of aripiprazole tablets in patients with bipolar mania (incidence of 5% or greater and aripiprazole tablets incidence at least twice that for placebo) are shown in Table 9.

Table 9: Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Adult Patients with Bipolar Mania Treated with Oral Aripiprazole Monotherapy

Preferred Term Percentage of Patients Reporting Reaction
Aripiprazole tablets
(n=917)
Placebo
(n=753)
Akathisia 13 4
Sedation 8 3
Restlessness 6 3
Tremor 6 3
Extrapyramidal
Disorder
5 2

Table 10 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks in schizophrenia and up to 3 weeks in bipolar mania), including only those reactions that occurred in 2% or more of patients treated with aripiprazole tablets (doses ≥2 mg/day) and for which the incidence in patients treated with aripiprazole tablets was greater than the incidence in patients treated with placebo in the combined dataset.

Table 10: Adverse Reactions in Short-Term, Placebo- Controlled Trials in Adult Patients Treated with Oral Aripiprazole

System Organ Class
Preferred Term
Percentage of Patients Reporting Reaction*
Aripiprazole tablets
(n=1843)
Placebo
(n=1166)
Eye Disorders
  Blurred Vision 3 1
Gastrointestinal Disorders
  Nausea 15 11
  Constipation 11 7
  Vomiting 11 6
  Dyspepsia 9 7
  Dry Mouth 5 4
  Toothache 4 3
  Abdominal Discomfort 3 2
  Stomach Discomfort 3 2
General Disorders and Administration Site Conditions
  Fatigue 6 4
  Pain 3 2
Musculoskeletal and Connective Tissue Disorders
  Musculoskeletal Stiffness 4 3
  Pain in Extremity 4 2
  Myalgia 2 1
  Muscle Spasms 2 1
Nervous System Disorders
  Headache 27 23
  Dizziness 10 7
  Akathisia 10 4
  Sedation 7 4
  Extrapyramidal Disorder 5 3
  Tremor 5 3
  Somnolence 5 3
Psychiatric Disorders
  Agitation 19 17
  Insomnia 18 13
  Anxiety 17 13
  Restlessness 5 3
Respiratory, Thoracic, and Mediastinal Disorders
  Pharyngolaryngeal Pain 3 2
  Cough 3 2
*Adverse reactions reported by at least 2% of patients treated with oral aripiprazole, except adverse reactions which had an incidence equal to or less than placebo.

An examination of population subgroups did not reveal any clear evidence of differential adverse reaction incidence on the basis of age, gender, or race.

Adult Patients with Adjunctive Therapy with Bipolar Mania

The following findings are based on a placebo-controlled trial of adult patients with bipolar disorder in which aripiprazole tablets was administered at doses of 15 or 30 mg/day as adjunctive therapy with lithium or valproate.

In a study of patients who were already tolerating either lithium or valproate as monotherapy, discontinuation rates due to adverse reactions were 12% for patients treated with adjunctive aripiprazole tablets compared to 6% for patients treated with adjunctive placebo. The most common adverse drug reactions associated with discontinuation in the adjunctive aripiprazole-treated compared to placebotreated patients were akathisia (5% and 1%, respectively) and tremor (2% and 1%, respectively).

The commonly observed adverse reactions associated with adjunctive aripiprazole tablets and lithium or valproate in patients with bipolar mania (incidence of 5% or greater and incidence at least twice that for adjunctive placebo) were: akathisia, insomnia, and extrapyramidal disorder.

Table 11 enumerates the incidence, rounded to the nearest percent, of adverse reactions that occurred during acute treatment (up to 6 weeks), including only those reactions that occurred in 2% or more of patients treated with adjunctive aripiprazole tablets (doses of 15 or 30 mg/day) and lithium or valproate and for which the incidence in patients treated with this combination was greater than the incidence in patients treated with placebo plus lithium or valproate.

Table 11: Adverse Reactions in a Short-Term, Placebo- Controlled Trial of Adjunctive Therapy in Patients with Bipolar Disorder

System Organ
Class
Percentage of Patients Reporting Reaction*
Aripiprazole tablets + Li or Val Placebo + Li or Val
Preferred Term (n=253) (n=130)
Gastrointestinal Disorders
  Nausea 8 5
  Vomiting 4 0
  Salivary Hypersecretion 4 2
  Dry Mouth 2 1
Infections and Infestations  
  Nasopharyngitis 3 2
  Inves tigations    
  Weight Increased 2 1
Nervous System Disorders
  Akathisia 19 5
  Tremor 9 6
  Extrapyramidal Disorder 5 1
  Dizziness 4 1
  Sedation 4 2
Psychiatric Disorders
  Insomnia 8 4
  Anxiety 4 1
  Restlessness 2 1
* Adverse reactions reported by at least 2% of patients treated with oral aripiprazole, except adverse reactions which had an incidence equal to or less than placebo. Lithium or Valproate

Adult Patients Receiving Aripiprazole Tablets As Adjunctive Treatment Of Major Depressive Disorder

The following findings are based on a pool of two placebo-controlled trials of patients with major depressive disorder in which aripiprazole tablets were administered at doses of 2 mg to 20 mg as adjunctive treatment to continued antidepressant therapy.

The incidence of discontinuation due to adverse reactions was 6% for adjunctive aripiprazole-treated patients and 2% for adjunctive placebo-treated patients.

The commonly observed adverse reactions associated with the use of adjunctive aripiprazole tablets in patients with major depressive disorder (incidence of 5% or greater and aripiprazole tablets incidence at least twice that for placebo) were: akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision.

Table 12 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks), including only those adverse reactions that occurred in 2% or more of patients treated with adjunctive aripiprazole tablets (doses ≥2 mg/day) and for which the incidence in patients treated with adjunctive aripiprazole tablets was greater than the incidence in patients treated with adjunctive placebo in the combined dataset.

Table 12: Adverse Reactions in Short-Term, Placebo- Controlled Adjunctive Trials in Patients with Major Depressive Disorder

System Organ Class Percentage of Patients Reporting Reaction*
Aripiprazole tablets + ADT Placebo + ADT
Preferred Term (n=371) (n=366)
Eye Disorders    
  Blurred Vision 6 1
Gastrointestinal Disorders    
  Constipation 5 2
General Disorders and Administration Site Conditions
  Fatigue 8 4
  Feeling Jittery 3 1
Infections and Infestations    
  Upper Respiratory Tract Infection 6 4
Investigations    
  Weight Increased 3 2
Metabolism and Nutrition Disorders
  Increased Appetite 3 2
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 4 3
  Myalgia 3 1
Nervous System Disorders    
  Akathisia 25 4
  Somnolence 6 4
  Tremor 5 4
  Sedation 4 2
  Dizziness 4 2
  Disturbance in Attention 3 1
  Extrapyramidal Disorder 2 0
Psychiatric Disorders    
  Restlessness 12 2
  Insomnia 8 2
* Adverse reactions reported by at least 2% of patients treated with adjunctive aripiprazole tablets, except adverse reactions which had an incidence equal to or less than placebo.
Antidepressant Therapy

Dose-Related Adverse Reactions In Patients With Schizophrenia

Dose response relationships for the incidence of treatment-emergent adverse events were evaluated from four trials in adult patients with schizophrenia comparing various fixed doses (2, 5, 10, 15, 20, and 30 mg/day) of oral aripiprazole to placebo. This analysis, stratified by study, indicated that the only adverse reaction to have a possible dose response relationship, and then most prominent only with 30 mg, was somnolence [including sedation]; (incidences were placebo, 7.1%; 10 mg, 8.5%; 15 mg, 8.7%; 20 mg, 7.5%; 30 mg, 12.6%).

Extrapyramidal Symptoms

Schizophrenia

In short-term, placebo-controlled trials in schizophrenia in adults, the incidence of reported EPS-related events, excluding events related to akathisia, for aripiprazole-treated patients was 13% vs. 12% for placebo; and the incidence of akathisia-related events for aripiprazole-treated patients was 8% vs. 4% for placebo.

Objectively collected data from those trials was collected on the Simpson Angus Rating Scale (for EPS), the Barnes Akathisia Scale (for akathisia), and the Assessments of Involuntary Movement Scales (for dyskinesias). In the adult schizophrenia trials, the objectively collected data did not show a difference between aripiprazole tablets and placebo, with the exception of the Barnes Akathisia Scale (aripiprazole tablets, 0.08; placebo, –0.05).

Similarly, in a long-term (26 week), placebo-controlled trial of schizophrenia in adults, objectively collected data on the Simpson Angus Rating Scale (for EPS), the Barnes Akathisia Scale (for akathisia), and the Assessments of Involuntary Movement Scales (for dyskinesias) did not show a difference between aripiprazole tablets and placebo.

Bipolar Mania

In the short-term, placebo-controlled trials in bipolar mania in adults, the incidence of reported EPSrelated events, excluding events related to akathisia, for monotherapy aripiprazole-treated patients was 16% vs. 8% for placebo and the incidence of akathisia-related events for monotherapy aripiprazoletreated patients was 13% vs. 4% for placebo. In the 6 week, placebo-controlled trial in bipolar mania for adjunctive therapy with lithium or valproate, the incidence of reported EPS-related events, excluding events related to akathisia for adjunctive aripiprazole-treated patients was 15% vs. 8% for adjunctive placebo and the incidence of akathisia-related events for adjunctive aripiprazole-treated patients was 19% vs. 5% for adjunctive placebo.

In the adult bipolar mania trials with monotherapy aripiprazole tablets, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between aripiprazole tablets and placebo (aripiprazole tablets, 0.50; placebo, –0.01 and aripiprazole tablets, 0.21; placebo, –0.05). Changes in the Assessments of Involuntary Movement Scales were similar for the aripiprazole tablets and placebo groups. In the bipolar mania trials with aripiprazole tablets as adjunctive therapy with either lithium or valproate, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive aripiprazole tablets and adjunctive placebo (aripiprazole tablets, 0.73; placebo, 0.07 and aripiprazole tablets, 0.30; placebo, 0.11). Changes in the Assessments of Involuntary Movement Scales were similar for adjunctive aripiprazole tablets and adjunctive placebo.

Major Depressive Disorder

In the short-term, placebo-controlled trials in major depressive disorder, the incidence of reported EPS-related events, excluding events related to akathisia, for adjunctive aripiprazole-treated patients was 8% vs. 5% for adjunctive placebo-treated patients; and the incidence of akathisia-related events for adjunctive aripiprazole-treated patients was 25% vs. 4% for adjunctive placebo-treated patients.

In the major depressive disorder trials, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive aripiprazole tablets and adjunctive placebo (aripiprazole tablets, 0.31; placebo, 0.03 and aripiprazole tablets, 0.22; placebo, 0.02). Changes in the Assessments of Involuntary Movement Scales were similar for the adjunctive aripiprazole tablets and adjunctive placebo groups.

Dystonia

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Skin Irritation For MYCITE Patch

Symptoms of skin irritation localized at the site of the MYCITE Patch may occur in some patients. In clinical studies, sixty-one patients (12.4%) experienced skin rashes localized at the site of patch placement.

Adverse Reactions In Long-Term, Double-Blind, Placebo-Controlled Trials

The adverse reactions reported in a 26 week, double-blind trial comparing oral aripiprazole and placebo in patients with schizophrenia were generally consistent with those reported in the short-term, placebo-controlled trials, except for a higher incidence of tremor [8% (12/153) for aripiprazole tablets vs. 2% (3/153) for placebo]. In this study, the majority of the cases of tremor were of mild intensity (8/12 mild and 4/12 moderate), occurred early in therapy (9/12 ≤49 days), and were of limited duration (7/12 ≤10 days). Tremor led to discontinuation (<1%) of aripiprazole tablets. In addition, in a long-term (52 week), active-controlled study, the incidence of tremor was 5% (40/859) for aripiprazole tablets. A similar profile was observed in a long-term monotherapy study and a long-term adjunctive study with lithium and valproate in bipolar disorder.

Other Adverse Reactions Observed During The Premarketing Evaluation Of Aripiprazole

Other adverse reactions associated with aripiprazole are presented below. The listing does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.

Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients:

  • Blood and Lymphatic System Disorders: rare - thrombocytopenia
  • Cardiac Disorders: infrequent – bradycardia, palpitations, rare – atrial flutter, cardio-respiratory arrest, atrioventricular block, atrial fibrillation, angina pectoris, myocardial ischemia, myocardial infarction, cardiopulmonary failure
  • Eye Disorders: infrequent – photophobia; rare - diplopia
  • Gastrointestinal Disorders: infrequent - gastroesophageal reflux disease
  • General Disorders and Administration Site Conditions: frequent - asthenia; infrequent – peripheral –face edema
  • Hepatobiliary Disorders: rare - hepatitis, jaundice
  • Immune System Disorders: rare- hypersensitivity
  • Injury, Poisoning, and Procedural Complications: infrequent – fall; rare – heat stroke
  • Investigations: frequent - weight decreased, infrequent - hepatic enzyme increased, blood glucose increased, blood lactate dehydrogenase increased, gamma glutamyl transferase increased; rare – blood prolactin increased, blood urea increased, blood creatinine increased, blood bilirubin
  • Metabolism and Nutrition Disorders: frequent – anorexia; rare - hypokalemia, hyponatremia,
  • Musculoskeletal and Connective Tissue Disorders: infrequent - muscular weakness, muscle tightness; rare–rhabdomyolysis, mobility decreased
  • Nervous System Disorders: infrequent - parkinsonism, memory impairment, cogwheel rigidity, hypokinesia, bradykinesia; rare – akinesia, myoclonus, coordination abnormal, speech disorder, <1/10,000patients - choreoathetosis
  • Psychiatric Disorders: infrequent – aggression, loss of libido, delirium; rare – libido increased,
  • Renal and Urinary Disorders: rare - urinary retention, nocturia
  • Reproductive System and Breast Disorders: infrequent - erectile dysfunction; rare – gynaecomastia,
  • Respiratory, Thoracic, and Mediastinal Disorders: infrequent - nasal congestion, dyspnea
  • Skin and Subcutaneous Tissue Disorders: infrequent - rash, hyperhidrosis, pruritus, photosensitivity rare- urticaria
  • Vascular Disorders: infrequent – hypotension, hypertension

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of aripiprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological gambling, hiccups and blood glucose fluctuation.

Read the entire FDA prescribing information for Abilify MyCite (Aripiprazole Tablets with Sensor)

SLIDESHOW

Schizophrenia: Symptoms, Types, Causes, Treatment See Slideshow
Related Resources for Abilify MyCite

© Abilify MyCite Patient Information is supplied by Cerner Multum, Inc. and Abilify MyCite Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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