The risks of these drugs are provided so the public can make informed, educated decisions. Abilify is a newer antipsychotic drug. The U.S. Food and Drug Administration issued a black box warning about antipsychotics increasing the risk of death in elderly with dementia. It is also known as Aripiprazole.
To see the total figures from IQVia on the number of people taking antipsychotic drugs in the U.S., click here.
Please note: No one should attempt to get off of psychiatric drugs without a doctor’s supervision. To help find medical practitioners in your area, click here.
Also, read the FDA’s Abilify Medication Guide for more information. MedGuides include “the particular serious and significant public health concern that has created the need for the Medication Guide” and notes “pediatric risks.” (Note: Unfortunately, the FDA MedGuides only work on a desktop, not on a mobile device. Please complain to the FDA to make their public advisories accessible to all. 1-888-INFO-FDA or 1-888-463-6332.)
Abilify Drug Warnings:
There have been 20 drug regulatory agency warnings from seven countries (Australia, Canada, Denmark, Japan, South Africa, United Kingdom and United States) on Abilify (or aripiprazole). These include the following (note that some warnings cite more than one side effect, so the list below may not be equal to the total number of warnings):
4 warnings on Abilify causing death or increased risk of death
4 warnings on Abilify causing abnormal behavior
3 warnings on Abilify causing cardiovascular disorders
3 warnings on Abilify causing nervous system disorders
3 warnings on Abilify causing blood pressure changes or high or low blood pressure
2 warnings on Abilify causing blood disorders
2 warnings on Abilify causing metabolic disorders
2 warnings on Abilify causing newborn complications (including infant withdrawal symptoms)
2 warnings on Abilify causing weight gain
2 warnings on Abilify causing involuntary movements
2 warnings on Abilify causing muscle problems
2 warnings on Abilify causing sleep problems
1 warning on Abilify causing stroke
1 warning on Abilify causing diabetes
1 warning on Abilify causing liver problems
1 warning on Abilify causing seizures or convulsions
1 warning on Abilify causing sexual dysfunction
1 warning on Abilify causing hallucinations
1 warning on Abilify causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 warning on Abilify causing cognitive impairment
1 warning on Abilify causing aggression
1 warning on Abilify causing risk of fractures
Abilify Drug Studies:
There have been 30 studies done in 11 countries (Australia, Canada, China, Denmark, France, India, Japan, Taiwan, Turkey, United Kindom and United States) on Abilify (or aripiprazole). These include the following (note that some studies cite more than one side effect, so the list below may not be equal to the total number of studies):
6 studies on Abilify causing death or increased risk of death
5 studies on Abilify causing cardiovascular disorders
5 studies on Abilify causing nervous system disorders
5 studies on Abilify causing weight gain
5 studies on Abilify causing involuntary movements
4 studies on Abilify causing diabetes
3 studies on Abilify causing metabolic disorders
2 studies on Abilify causing heart problems
2 studies on Abilify causing sexual dysfunction
2 studies on Abilify causing lack of efficacy
2 studies on Abilify causing muscle problems
2 studies on Abilify causing skin conditions
1 study on Abilify causing stroke
1 study on Abilify causing newborn complications
1 study on Abilify causing heart attacks
1 study on Abilify causing blood pressure changes or high or low blood pressure
1 study on Abilify causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 study on Abilify causing pregnancy complications
1 study on Abilify causing abnormal behavior
1 study on Abilify causing allergic reactions
1 study on Abilify causing premature birth
1 study on Abilify causing suicide risk or completed suicide
1 study on Abilify causing swelling
1 study on Abilify causing violence
1 study on Abilify causing homicidal ideation
1 study on Abilify causing infant withdrawal symptoms
Adverse Reaction Reports Filed with the US FDA: There have been 13,445 adverse reactions reported to the US FDA in connection with Abilify (aripiprazole).
The FDA estimates that less than 1% of all serious events are ever reported to it, so the actual number of side effects occurring are most certainly higher.
- 899 cases of weight increased
- 765 cases of tardive dyskinesia (involuntary muscle movements)
- 617 cases of tremors
- 490 cases of insomnia
- 478 cases of akathisia (motor restlessness)
- 456 cases of dyskinesia (involuntary muscle movements)
- 372 cases of the drug being ineffective
- 368 cases of dystonia (repetitive muscle contractions)
- 345 cases of psychotic disorder
- 341 cases of nausea
Documented Side Effects of Abilify:
Source: Physicians Desk Reference, National Institutes of Health’s Medline Plus, and/or the drug label.
Anxiety
Blurred vision
Body restlessness
Changes in vision
Chest pain
Confusion
Difficulty breathing/ swallowing
Dizziness
High fever
Hives
Insomnia
Nervousness
Pain, especially in the arms, legs or joints
Slow, fast, or irregular heartbeat
Somnolence
Swelling of the face, tongue, throat, hands, feet, ankles, or lower legs
Tightness in the throat
Unusual movements of the body or face
Weight gain
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