September 3, 2015
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Abilify

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Abilify




Abilify Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Last reviewed on RxList 4/17/2015

Abilify (aripiprazole) is a psychotropic drug (antipsychotic) that alters brain chemical activity used to treat schizophrenia, mania, depression, bipolar disorders, autistic disorder, and some irritable behavior disorders. Generic Abilify is not available in the U.S., but is available in other countries under the name aripiprazole. Common side effects of Abilify include dizziness, weakness, lightheadedness, nausea, vomiting, stomach upset, tiredness, excess saliva or drooling, choking or trouble swallowing, blurred vision, headache, anxiety, weight gain, drowsiness, sleep problems (insomnia), and constipation.

Abilify is available in tablet, orally disintegrating tablets, oral solution and injectable formulations. Dosage is variable and depends on multiple factors such as the ongoing mental problem, patient age, and other factors to be determined by the prescribing doctor. Abilify has been used in the pediatric population but such use should be discussed with a pediatric specialist. Abilify has the potential for serious side effects such as no approval for use in older adults with dementia, and suicidal thoughts are known to occur in some patients, especially children, teens, and young adults. Deepening depression in patients taking Abilify is a serious side effect that needs evaluation by the patient's doctor. Other serious side effects may include tardive dyskinesia, neuroleptic malignant syndrome, tremors, muscle spasms, and weakness. Benefits should outweigh risks in pregnant women. Women who are breastfeeding should not take Abilify.

Our Abilify 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Abilify in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using aripiprazole and call your doctor at once if you have a serious side effect such as:

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • jerky muscle movements you cannot control;
  • sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • increased thirst or urination, loss of appetite, fruity breath odor, drowsiness, dry skin, nausea, and vomiting;
  • seizure (convulsions);
  • thoughts of hurting yourself;
  • feeling like you might pass out;
  • jaundice (yellowing of your skin or eyes); or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • choking or trouble swallowing;
  • dizziness, drowsiness, or weakness;
  • constipation, mild stomach upset;
  • headache, anxiety;
  • sleep problems (insomnia); or
  • weight gain.

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.

Read the entire detailed patient monograph for Abilify (Aripiprazole)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Abilify Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Dizziness, lightheadedness, drowsiness, nausea, vomiting, tiredness, excess saliva/drooling, blurred vision, weight gain, constipation, headache, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, mental/mood changes (such as increased anxiety, depression, suicidal thoughts), trouble swallowing, restlessness (especially in the legs), shaking (tremor), muscle spasm, mask-like expression of the face, seizures, signs of infection (such as fever, persistent sore throat).

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Rarely, very serious conditions such as diabetic coma may occur. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may rarely cause a condition called tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Abilify (Aripiprazole)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Abilify FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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

The most common adverse reactions in the pediatric clinical trials ( ≥ 10%) were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased.

ABILIFY has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, Dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately 7619 patient-years of exposure to oral ABILIFY and 749 patients with exposure to ABILIFY injection. A total of 3390 patients were treated with oral ABILIFY for at least 180 days and 1933 patients treated with oral ABILIFY had at least 1 year of exposure.

ABILIFY has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's disorder and who had approximately 1,342 patient-years of exposure to oral ABILIFY. A total of 959 pediatric patients were treated with oral ABILIFY for at least 180 days and 556 pediatric patients treated with oral ABILIFY had at least 1 year of exposure.

The conditions and duration of treatment with ABILIFY (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.

Clinical Trials Experience

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 ABILIFY was administered in doses ranging from 2 to 30 mg/day.

Commonly Observed Adverse Reactions

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

Adult Patients with Bipolar Mania

Monotherapy

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

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in patients with bipolar mania (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 16.

Table 16: Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Adult Patients with Bipolar Mania Treated with Oral ABILIFY Monotherapy

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

Less Common Adverse Reactions in Adults

Table 17 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 ABILIFY (doses ≥ 2 mg/day) and for which the incidence in patients treated with ABILIFY was greater than the incidence in patients treated with placebo in the combined dataset.

Table 17: Adverse Reactions in Short-Term, Placebo-Controlled Trials in Adult Patients Treated with Oral ABILIFY

System Organ Class
Preferred Term
Percentage of Patients Reporting Reactiona
ABILIFY
(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
a Adverse reactions reported by at least 2% of patients treated with oral ABILIFY, 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 ABILIFY was administered at doses of 15 or 30 mg/day as adjunctive therapy with lithium or valproate.

Adverse Reactions Associated with Discontinuation of Treatment

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

Commonly Observed Adverse Reactions

The commonly observed adverse reactions associated with adjunctive ABILIFY 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.

Less Common Adverse Reactions in Adult Patients with Adjunctive Therapy in Bipolar Mania

Table 18 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 ABILIFY (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 18: Adverse Reactions in a Short-Term, Placebo-Controlled Trial of Adjunctive Therapy in Patients with Bipolar Disorder

System Organ Class
Preferred Term
Percentage of Patients Reporting Reactiona
ABILIFY +Li or Val*
(n=253)
Placebo +Li or Val*
(n=130)
Gastrointestinal Disorders
  Nausea 8 5
  Vomiting 4 0
  Salivary Hypersecretion 4 2
  Dry Mouth 2 1
Infections and Infestations
  Nasopharyngitis 3 2
Investigations
  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
a Adverse reactions reported by at least 2% of patients treated with oral ABILIFY, except adverse reactions which had an incidence equal to or less than placebo.
* Lithium or Valproate

Pediatric Patients (13 to 17 years) with Schizophrenia

The following findings are based on one 6-week, placebo-controlled trial in which oral ABILIFY was administered in doses ranging from 2 to 30 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (13 to 17 years) was 5% and 2%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in adolescent patients with schizophrenia (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) were extrapyramidal disorder, somnolence, and tremor.

Pediatric Patients (10 to 17 years) with Bipolar Mania

The following findings are based on one 4-week, placebo-controlled trial in which oral ABILIFY was administered in doses of 10 or 30 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (10 to 17 years) was 7% and 2%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in pediatric patients with bipolar mania (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 19.

Table 19: Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (10 to 17 years) with Bipolar Mania Treated with Oral ABILIFY

Preferred Term Percentage of Patients Reporting Reaction
ABILIFY
(n=197)
Placebo
(n=97)
Somnolence 23 3
Extrapyramidal Disorder 20 3
Fatigue 11 4
Nausea 11 4
Akathisia 10 2
Blurred Vision 8 0
Salivary Hypersecretion 6 0
Dizziness 5 1

Pediatric Patients (6 to 17 years) with Autistic Disorder

The following findings are based on two 8-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 15 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (6 to 17 years) was 10% and 8%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in pediatric patients with autistic disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 20.

Table 20: Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 17 years) with Autistic Disorder Treated with Oral ABILIFY

Preferred Term Percentage of Patients Reporting Reaction
ABILIFY
(n=212)
Placebo
(n=101)
Sedation 21 4
Fatigue 17 2
Vomiting 14 7
Somnolence 10 4
Tremor 10 0
Pyrexia 9 1
Drooling 9 0
Decreased Appetite 7 2
Salivary Hypersecretion 6 1
Extrapyramidal Disorder 6 0
Lethargy 5 0

Pediatric Patients (6 to 18 years) with Tourette's Disorder

The following findings are based on one 8-week and one 10-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 20 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (6 to 18 years) was 7% and 1%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in pediatric patients with Tourette's disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 21.

Table 21: Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 18 years) with Tourette's Disorder Treated with Oral ABILIFY

Preferred Term Percentage of Patients Reporting Reaction
ABILIFY
(n=121)
Placebo
(n=72)
Sedation 13 6
Somnolence 13 1
Nausea 11 4
Headache 10 3
Nasopharyngitis 9 0
Fatigue 8 0
Increased Appetite 7 1

Less Common Adverse Reactions in Pediatric Patients (6 to 18 years) with Schizophrenia, Bipolar Mania, Autistic Disorder, or Tourette's Disorder

Table 22 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks in schizophrenia, up to 4 weeks in bipolar mania, up to 8 weeks in autistic disorder, and up to 10 weeks in Tourette's disorder), including only those reactions that occurred in 2% or more of pediatric patients treated with ABILIFY (doses ≥ 2 mg/day) and for which the incidence in patients treated with ABILIFY was greater than the incidence in patients treated with placebo.

Table 22: Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 18 years) Treated with Oral ABILIFY

System Organ Class
Preferred Term
Percentage of Patients Reporting Reactiona
ABILIFY
(n=732)
Placebo
(n=370)
Eye Disorders
  Blurred Vision 3 0
Gastrointestinal Disorders
  Abdominal Discomfort 2 1
  Vomiting 8 7
  Nausea 8 4
  Diarrhea 4 3
  Salivary Hypersecretion 4 1
  Abdominal Pain Upper 3 2
  Constipation 2 2
General Disorders and Administration Site Conditions
  Fatigue 10 2
  Pyrexia 4 1
  Irritability 2 1
  Asthenia 2 1
Infections and Infestations
  Nasopharyngitis 6 3
Investigations
  Weight Increased 3 1
Metabolism and Nutrition Disorders
  Increased Appetite 7 3
  Decreased Appetite 5 4
Musculoskeletal and Connective Tissue Disorders
  Musculoskeletal Stiffness 2 1
  Muscle Rigidity 2 1
Nervous System Disorders
  Somnolence 16 4
  Headache 12 10
  Sedation 9 2
  Tremor 9 1
  Extrapyramidal Disorder 6 1
  Akathisia 6 4
  Drooling 3 0
  Lethargy 3 0
  Dizziness 3 2
  Dystonia 2 1
Respiratory, Thoracic, and Mediastinal Disorders
  Epistaxis 2 1
Skin and Subcutaneous Tissue Disorders
  Rash 2 1
a Adverse reactions reported by at least 2% of pediatric patients treated with oral ABILIFY, except adverse reactions which had an incidence equal to or less than placebo.

Adult Patients Receiving ABILIFY 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 ABILIFY was administered at doses of 2 mg to 20 mg as adjunctive treatment to continued antidepressant therapy.

Adverse Reactions Associated with Discontinuation of Treatment

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

Commonly Observed Adverse Reactions

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

Less Common Adverse Reactions in Adult Patients with Major Depressive Disorder

Table 23 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 ABILIFY (doses ≥ 2 mg/day) and for which the incidence in patients treated with adjunctive ABILIFY was greater than the incidence in patients treated with adjunctive placebo in the combined dataset.

Table 23: Adverse Reactions in Short-Term, Placebo-Controlled Adjunctive Trials in Patients with Major Depressive Disorder

System Organ Class
Preferred Term
Percentage of Patients Reporting Reactiona
ABILIFY + ADT*
(n=371)
Placebo + ADT*
(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
aAdverse reactions reported by at least 2% of patients treated with adjunctive ABILIFY, except adverse reactions which had an incidence equal to or less than placebo.
* Antidepressant Therapy

Patients with Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)

The following findings are based on a pool of three placebo-controlled trials of patients with agitation associated with schizophrenia or bipolar mania in which ABILIFY injection was administered at doses of 5.25 mg to 15 mg.

Commonly Observed Adverse Reactions

There was one commonly observed adverse reaction (nausea) associated with the use of ABILIFY injection in patients with agitation associated with schizophrenia and bipolar mania (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo).

Less Common Adverse Reactions in Patients with Agitation Associated with Schizophrenia or Bipolar Mania

Table 24 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (24-hour), including only those adverse reactions that occurred in 2% or more of patients treated with ABILIFY injection (doses ≥ 5.25 mg/day) and for which the incidence in patients treated with ABILIFY injection was greater than the incidence in patients treated with placebo in the combined dataset.

Table 24: Adverse Reactions in Short-Term, Placebo-Controlled Trials in Patients Treated with ABILIFY Injection

aAdverse reactions reported by at least 2% of patients treated with ABILIFY injection, except adverse reactions which had an incidence equal to or less than placebo.
System Organ Class
Preferred Term
Percentage of Patients Reporting Reactiona
ABILIFY
(n=501)
Placebo
(n=220)
Cardiac Disorders
  Tachycardia 2 < 1
Gastrointestinal Disorders
  Nausea 9 3
  Vomiting 3 1
General Disorders and Administration Site Conditions
  Fatigue 2 1
Nervous System Disorders
  Headache 12 7
  Dizziness 8 5
  Somnolence 7 4
  Sedation 3 2
  Akathisia 2 0

Dose-Related Adverse Reactions

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 ABILIFY 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%).

In the study of pediatric patients (13 to 17 years of age) with schizophrenia, three common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder (incidences were placebo, 5.0%; 10 mg, 13.0%; 30 mg, 21.6%); somnolence (incidences were placebo, 6.0%; 10 mg, 11.0%; 30 mg, 21.6%); and tremor (incidences were placebo, 2.0%; 10 mg, 2.0%; 30 mg, 11.8%).

Bipolar Mania

In the study of pediatric patients (10 to 17 years of age) with bipolar mania, four common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder (incidences were placebo, 3.1%; 10 mg, 12.2%; 30 mg, 27.3%); somnolence (incidences were placebo, 3.1%; 10 mg, 19.4%; 30 mg, 26.3%); akathisia (incidences were placebo, 2.1%; 10 mg, 8.2%; 30 mg, 11.1%); and salivary hypersecretion (incidences were placebo, 0%; 10 mg, 3.1%; 30 mg, 8.1%).

Autistic Disorder

In a study of pediatric patients (6 to 17 years of age) with autistic disorder, one common adverse reaction had a possible dose response relationship: fatigue (incidences were placebo, 0%; 5 mg, 3.8%; 10 mg, 22.0%; 15 mg, 18.5%).

Tourette's Disorder

In a study of pediatric patients (7 to 17 years of age) with Tourette's disorder, no common adverse reaction(s) had a dose response relationship.

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 ABILIFY-treated patients was 13% vs. 12% for placebo; and the incidence of akathisia-related events for ABILIFY-treated patients was 8% vs. 4% for placebo. In the short-term, placebo-controlled trial of schizophrenia in pediatric patients (13 to 17 years), the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 25% vs. 7% for placebo; and the incidence of akathisia-related events for ABILIFY-treated patients was 9% vs. 6% 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 ABILIFY and placebo, with the exception of the Barnes Akathisia Scale (ABILIFY, 0.08; placebo, -0.05). In the pediatric (13 to 17 years) schizophrenia trial, the objectively collected data did not show a difference between ABILIFY and placebo, with the exception of the Simpson Angus Rating Scale (ABILIFY, 0.24; placebo, -0.29).

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 ABILIFY and placebo.

Bipolar Mania

In the short-term, placebo-controlled trials in bipolar mania in adults, the incidence of reported EPS-related events, excluding events related to akathisia, for monotherapy ABILIFY-treated patients was 16% vs. 8% for placebo and the incidence of akathisia-related events for monotherapy ABILIFY-treated 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 ABILIFY-treated patients was 15% vs. 8% for adjunctive placebo and the incidence of akathisia-related events for adjunctive ABILIFY-treated patients was 19% vs. 5% for adjunctive placebo. In the short-term, placebo-controlled trial in bipolar mania in pediatric (10 to 17 years) patients, the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 26% vs. 5% for placebo and the incidence of akathisia-related events for ABILIFY-treated patients was 10% vs. 2% for placebo.

In the adult bipolar mania trials with monotherapy ABILIFY, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between ABILIFY and placebo (ABILIFY, 0.50; placebo, -0.01 and ABILIFY, 0.21; placebo, -0.05). Changes in the Assessments of Involuntary Movement Scales were similar for the ABILIFY and placebo groups. In the bipolar mania trials with ABILIFY as adjunctive therapy with either lithium or valproate, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive ABILIFY and adjunctive placebo (ABILIFY, 0.73; placebo, 0.07 and ABILIFY, 0.30; placebo, 0.11). Changes in the Assessments of Involuntary Movement Scales were similar for adjunctive ABILIFY and adjunctive placebo. In the pediatric (10 to 17 years), short-term, bipolar mania trial, the Simpson Angus Rating Scale showed a significant difference between ABILIFY and placebo (ABILIFY, 0.90; placebo, -0.05). Changes in the Barnes Akathisia Scale and the Assessments of Involuntary Movement Scales were similar for the ABILIFY and placebo groups.

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 ABILIFY-treated patients was 8% vs. 5% for adjunctive placebo-treated patients; and the incidence of akathisia-related events for adjunctive ABILIFY-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 ABILIFY and adjunctive placebo (ABILIFY, 0.31; placebo, 0.03 and ABILIFY, 0.22; placebo, 0.02). Changes in the Assessments of Involuntary Movement Scales were similar for the adjunctive ABILIFY and adjunctive placebo groups.

Autistic Disorder

In the short-term, placebo-controlled trials in autistic disorder in pediatric patients (6 to 17 years), the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 18% vs. 2% for placebo and the incidence of akathisia-related events for ABILIFY-treated patients was 3% vs. 9% for placebo.

In the pediatric (6 to 17 years) short-term autistic disorder trials, the Simpson Angus Rating Scale showed a significant difference between ABILIFY and placebo (ABILIFY, 0.1; placebo, -0.4). Changes in the Barnes Akathisia Scale and the Assessments of Involuntary Movement Scales were similar for the ABILIFY and placebo groups.

Tourette's Disorder

In the short-term, placebo-controlled trials in Tourette's disorder in pediatric patients (6 to 18 years), the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 7% vs. 6% for placebo and the incidence of akathisia-related events for ABILIFY-treated patients was 4% vs. 6% for placebo.

In the pediatric (6 to 18 years) short-term Tourette's disorder trials, changes in the Simpson Angus Rating Scale, Barnes Akathisia Scale and Assessments of Involuntary Movement Scale were not clinically meaningfully different for ABILIFY and placebo.

Agitation Associated with Schizophrenia or Bipolar Mania

In the placebo-controlled trials in patients with agitation associated with schizophrenia or bipolar mania, the incidence of reported EPS-related events excluding events related to akathisia for ABILIFY-treated patients was 2% vs. 2% for placebo and the incidence of akathisia-related events for ABILIFY-treated patients was 2% vs. 0% for placebo. Objectively collected data on the Simpson Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) for all treatment groups did not show a difference between ABILIFY and placebo.

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.

Additional Findings Observed in Clinical Trials

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

The adverse reactions reported in a 26-week, double-blind trial comparing oral ABILIFY 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 ABILIFY 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 infrequently led to discontinuation ( < 1%) of ABILIFY. In addition, in a long-term (52-week), active-controlled study, the incidence of tremor was 5% (40/859) for ABILIFY. 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 ABILIFY

The following 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:

Adults - Oral Administration

Blood and Lymphatic System Disorders: rare - thrombocytopenia

Cardiac Disorders:infrequent - bradycardia, palpitations, rare - atrial flutter, cardiorespiratory 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 edema, chest pain; rare - 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 inceased, blood creatinine increased, blood bilirubin increased, electrocardiogram QT prolonged, glycosylated hemoglobin increased

Metabolism and Nutrition Disorders: frequent - anorexia; infrequent - rare - hypokalemia, hyponatremia, hypoglycemia

Musculoskeletal and Connective Tissue Disorders: infrequent - muscular weakness, muscle tightness; rare - rhabdomyolysis, mobility decreased

Nervous System Disorders: infrequent - parkinsonism, memory impairment, cogwheel rigidity, hypokinesia, myoclonus, bradykinesia; rare - akinesia, myoclonus, coordination abnormal, speech disorder, Grand Mal convulsion; < 1/10,000 patients - choreoathetosis

Psychiatric Disorders: infrequent - aggression, loss of libido, delirium; rare - libido increased, anorgasmia, tic, homicidal ideation, catatonia, sleep walking

Renal and Urinary Disorders: rare - urinary retention, nocturia

Reproductive System and Breast Disorders: infrequent - erectile dysfunction; rare - gynaecomastia, menstruation irregular, amenorrhea, breast pain, priapism

Respiratory, Thoracic, and Mediastinal Disorders: infrequent - nasal congestion, dyspnea

Skin and Subcutaneous Tissue Disorders: infrequent - rash, hyperhidrosis, pruritus, photosensitivity reaction, alopecia; rare - urticaria

Vascular Disorders: infrequent - hypotension, hypertension

Pediatric Patients - Oral Administration

Most adverse events observed in the pooled database of 1,686 pediatric patients, aged 6 to 18 years, were also observed in the adult population. Additional adverse reactions observed in the pediatric population are listed below.

Eye Disorders: infrequent - oculogyric crisis

Gastrointestinal Disorders: infrequent - tongue dry, tongue spasm

Investigations: frequent - blood insulin increased

Nervous System Disorders: infrequent - sleep talking

Renal and Urinary Disorders: frequent - enuresis

Skin and Subcutaneous Tissue Disorders: infrequent - hirsutism

Adults - Intramuscular Injection

Most adverse reactions observed in the pooled database of 749 adult patients treated with ABILIFY injection, were also observed in the adult population treated with oral ABILIFY. Additional adverse reactions observed in the ABILIFY injection population are listed below.

General Disorders and Administration Site Conditions: ≥ 1/100 patients - injection site reaction; ≥ 1/1000 patients and < 1/100 patients - venipuncture site bruise

Postmarketing Experience

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

Read the entire FDA prescribing information for Abilify (Aripiprazole)

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