Abilify Side Effects

Before jumping right in to the Abilify side effects, here's some basic information about Abilify that you should know. Abilify belongs to a class of drugs known as "atypical antipsychotics" and it comes in both oral and injectable forms. These two forms of the medication are used for different things. Whilst the injectable form is indicated for the treatment of adults with agitation which is associated with schizophrenia or bipolar I disorder (manic or mixed episodes), the oral form is used to treat more conditions and they are as follows:

• schizophrenia in adults and adolescents aged 13-17 years old
• manic or mixed episodes associated with bipolar I disorder (alone or in combination with other medications) in adults and children ages 10-17 years old
• major depressive disorder (as an add-on treatment)

The Abilify side effects listed below will be grouped according to what is being treated and age group i.e. adults vs. children.

In addition to the Abilify side effects listed below, this particular drug also comes with a black box warning. This is a special warning that the FDA has determined the drug manufacturer must inform all users of this medication of. The warning is as follows:

• Even though Abilify is not approved for the treatment of patients with dementia-related psychosis, it should be noted that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• Children, adolescents, and young adults who are taking antidepressants for major depressive disorder and other psychiatric disorders are at an increased risk of suicidal thinking and behavior

Most Common Side Effects in Adults (in general overall for all conditions it is used for):

• Akathisia - restlessness or an inability to sit still or remain still; a feeling of inner restlessness
• Anxiety
• Constipation
• Dizziness
• Headache
• Insomnia
• Nausea
• Restlessness
• Vomiting

Most Common Side Effects in Children (in general overall for all conditions it is used for):

• Extrapyramidal disorder - certain specific movement disorder
• Headache
• Nausea
• Somnolence

Abilify Side Effects in Adults

Frequently Occur

Schizophrenia:

• Akathisia - restlessness or an inability to sit still or remain still; a feeling of inner restlessness

Bipolar Mania:

• Akathisia - restlessness or an inability to sit still or remain still; a feeling of inner restlessness
• Extrapyramidal disorder - certain specific movement disorder
• Restlessness
• Sedation
• Tremor

Major Depression:

• Akathisia - restlessness or an inability to sit still or remain still; a feeling of inner restlessness
• Blurred vision
• Constipation
• Fatigue
• Insomnia
• Restlessness

Sometimes Occur (both Schizophrenia and Bipolar Mania combined)

• Abdominal discomfort
• Agitation
• Anxiety
• Blurred vision
• Constipation
• Cough
• Dizziness
• Dry mouth
• Dyspepsia - indigestion
• Extrapyramidal disorder (in schizophrenia) - certain specific movement disorder
• Fatigue
• Headache
• Insomnia
• Muscle spasms
• Musculoskeletal stiffness - muscle and bone/joint stiffness
• Myalgia - muscle pain
• Nausea
• Pain
• Pain in arms and legs
• Pharyngolaryngeal pain - pain in the throat and voice box area
• Restlessness (in schizophrenia)
• Sedation (in schizophrenia)
• Somnolence
• Stomach discomfort
• Toothache
• Tremor (in schizophrenia)
• Vomiting

Sometimes Occur (Major Depression):

• Arthralgia - pain in the joints
• Disturbance in attention
• Dizziness
• Extrapyramidal disorder - certain specific movement disorder
• Feeling jittery
• Increase in appetite
• Increase in weight
• Myalgia - muscle pain
• Sedation
• Somnolence
• Tremor
• Upper respiratory tract infection

Frequently Occur When Used as Part of a Combo Therapy for Bipolar Mania:

• Akathisia - restlessness or an inability to sit still or remain still; a feeling of inner restlessness
• Extrapyramidal disorder (in schizophrenia) - certain specific movement disorder
• Insomnia

Sometimes Occur When Used as Part of a Combo Therapy for Bipolar Mania:

• Anxiety
• Dizziness
• Dry mouth
• Increase in weight
• Nasopharyngitis - common cold
• Nausea
• Restlessness
• Salivary Hypersecretion - excess production of saliva
• Sedation
• Tremor
• Vomiting

Abilify Side Effects in Children & Adolescents

Frequently Occur

Schizophrenia (13-17 years old):

• Extrapyramidal disorder - certain specific movement disorder
• Somnolence
• Tremor

Bipolar Mania (10-17 years old):

• Akathisia - restlessness or an inability to sit still or remain still; a feeling of inner restlessness
• Blurred Vision
• Dizziness
• Extrapyramidal disorder - certain specific movement disorder
• Fatigue
• Nausea
• Salivary Hypersecretion
• Somnolence

Sometimes Occur (both Schizophrenia and Bipolar Mania combined)

• Akathisia (in Schizophrenia) - restlessness or an inability to sit still or remain still; a feeling of inner restlessness
• Arthralgia - pain in the joints
• Blurred vision
• Diarrhea
• Dizziness
• Dry mouth
• Dyskinesia - involuntary and uncontrollable muscle movements
• Dystonia - involuntary, slow, twisting muscle movements
• Extrapyramidal disorder - certain specific movement disorder
• Fatigue
• Headache
• Increased appetite
• Increase in weight
• Nasopharyngitis - common cold
• Nausea
• Orthostatic hypotension - a drop in blood pressure that occurs particularly when one stands up
• Pyrexia - fever; a rise in body temperature
• Rash
• Salivary hypersecretion - excessive secretion/production of saliva
• Sedation
• Somnolence
• Stomach discomfort
• Tremor

Injectable Abilify Side Effects

Frequently Occur:

• Nausea

Sometimes Occur:

• Akathisia (in Schizophrenia) - restlessness or an inability to sit still or remain still; a feeling of inner restlessness
• Dizziness
• Fatigue
• Headache
• Sedation
• Somnolence
• Tachycardia - fast heart rate or an increase in heart rate
• Vomiting

More Abilify Side Effects in Adults Across All Conditions

Frequently Occur:

• Abnormal coordination
• Aspiration pneumonia
• Asthenia - abnormal weakness and drowsiness along with a loss of strength and energy
• Chest pain
• Decrease in weight
• Decreased appetite
• Dyspnea - difficulty breathing
• Fall
• Hyperhydrosis - excessive sweating
• Hypertension - high blood pressure
• Increase in creatine phosphokinase level - CPK is a muscle, heart and brain enzyme; high levels could mean the presence of certain diseases and conditions
• Irritability
• Nasal congestion
• Peripheral edema - swelling in the extremities (arms and legs)
• Rash (including erythematous, exfoliative, generalized, macular, maculopapular, papular rash; acneiform, allergic, contact, exfoliative, seborrheic dermatitis, neurodermatitis, and drug eruption)
• Suicidal ideation

Sometimes Occur:

• Aggression
• Akinesia - inability ot move
• Alopecia - hair loss
• Amenorrhea - absence or lack of menstrual period
• Anger
• Angina pectoris
• Angioedema
• Anorexia - loss of appetite
• Anorgasmia - failure or an inability to achieve an orgasm
• Atrial fibrillation - a type of abnormal heart rhythm
• Atrioventricular block - a type of heart disorder
• Bradycardia - slow heart rate
• Bradykinesia - slow movement i.e. difficulty initiating or continuing movement
• Breast pain
• Cardiopulmonary failure
• Cardio-respiratory arrest
• Cerebrovascular accident - stroke
• Cogwheel rigidity
• Completed suicide
• Decreased mobility
• Delirium
• Diabetes mellitus - with symptoms which include blood insulin increased, carbohydrate tolerance decreased, non-insulin dependent diabetes mellitus (NIDDM), impaired glucose tolerance, glycosuria (sugar in the urine)
• Diplopia - double vision
• Erectile dysfunction
• Esophagitis - inflammation of the esophagus
• Extrasystoles - a type of heart rhythm disorder
• Eyelid edema - swelling of the eyelid
• Face edema - facial swelling
• Gastroesophageal reflux disease (GERD)
• Homicidal ideation
• Hostility
• Hyperglycemia - high blood sugar
• Hyperlipidemia
• Hypersensitivity
• Hypertonia - increased muscle tone which eventually leads to muscle stiffness
• Hypoglycemia - low blood sugar
• Hypokalemia -
• low potassium level
• Hypokinesia - slow or decreased body movements
• Hyponatremia - low sodium level
• Hypotension - low blood pressure
• Hypotonia - loss of muscle tone/decreased tension in the muscles which results in floppiness
• Increase in blood bilirubin level
• Increase in blood creatinine level
• Increase in blood glucose levels
• Increase in blood prolactin level
• Increase in blood urea level
• Increase in libido
• Increase in liver enzyme levels
• Intentional self injury
• Irregular menstruation
• Leukopenia - low white blood cell count
• Loss of libido
• Memory impairment
• Muscle rigidity
• Muscle tightness
• Muscular weakness
• Myocardial infarction
• Myocardial ischemia
• Myoclonus - involuntary jerking movements of the hands and legs
• Neutropenia - low white blood cell count
• Nocturia - frequent nighttime urination
• Palpitations
• Parkinsonism
• Photophobia - sensitivity to light
• Photopsia - seeing flashes of light in your visual field
• Photosensitivity reaction
• Polydipsia - excessive thirst
• Polyuria - frequent urination and in large amounts
• Prolonged QT interval - an abnormal heart test reading
• Pruritus - itching
• Self mutilation
• Sinus tachycardia - an abnormal type of heart rhythm
• Speech disorder
• Suicide attempt
• Swollen tongue
• Tardive dyskinesia - involuntary muscle movements of the tongue and muscles of the face, limbs and trunk
• Thirst
• Thrombocytopenia - low platelet count
• Tic
• Urinary retention
• Urticaria - hives

Rarely Occur:

• Atrial flutter - a type of abnormal heart rhythm
• Catatonia - extreme muscle rigidity
• Choreoathetosis - uncontrollable movements of the arms and legs (put very simply)
• Diabetic ketoacidosis
• Grand Mal convulsion
• Gynecomastia - abnormal enlargement of breasts in boys/men
• Heat stroke
• Hepatitis
• Hypothermia - extremely low body temperature
• Increase in blood lactate dehydrogenase level - this is a type of enzyme produced by the liver, a rise in this enzyme can indicate various possible diseases
• Increase in gamma-glutamyl transferase level - this is a type of enzyme produced by the liver, a rise in this enzyme can indicate various possible diseases
• Increase in glycosylated hemoglobin level
• Jaundice
• Pancreatitis
• Priapism
• Rhabdomyolysis
• Sleep walking
• Supraventricular tachycardia - a type of abnormal heart rhythm
• Ventricular tachycardia - a type of abnormal heart rhythm

Injectable Abilify

Frequently Occur:

• Injection site reaction

Sometimes Occur:

• Venipuncture site bruise

More Abilify Side Effects in Children Across All Conditions

Frequently Occur:

• Increase in blood insulin

Sometimes Occur:

• Dry tongue
• Hirsutism - excessive hair growth or excessive hairiness
• Sleep talking
• Tongue spasm

Post-Marketing Abilify Side Effects

The following Abilify side effects were reported after Abilify was approved and being used by the general population. You should note though that they were reported voluntarily by folks in the general population so there is therefore no way to determine how often they occur or if there is even really a true connection between them and Abilify. They are as follows:

• Allergic reaction - including the following symptoms -->anaphylactic reaction consisting of angioedema, laryngospasm i.e.spasm in the throat, pruritus/urticaria i.e.itching and rash, or oropharyngeal spasm i.e.spasm in the mouth/throat area
• Blood glucose fluctuation

It is much more important to know what sort of a patient has a disease
than what sort of a disease a patient has.
- William Osler

Drug Manufacturer Information

Bristol Myers Squibb & Otsuka America Pharmaceutical Inc.
345 Park Avenue
New York, New York 10154
800-321-1335 (US only)
609-897-6669

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July 23, 2009

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