Abilify (generic: aripiprazole) is a prescription medication used to treat mental conditions such as schizophrenia, bipolar disorder, and autism. It can also be used in combination with an anti-depressant to treat depression. Abilify belongs to a group of drugs called atypical antipsychotics. These medications work by acting on certain receptors in the brain that affect mood and behavior.
This medication comes in tablet form to be taken once daily, with or without food, swallowed whole. It is also available in a dissolvable tablet (Abilify discmelt) and a liquid. Abilify also comes in a once-monthly injectable form (Abilify Maintena).
Some common side effects of Abilify include drowsiness, insomnia, fatigue, anxiety, and headache.
Abilify is a prescription medicine used to treat:
- schizophrenia in people age 13 years and older
- bipolar I disorder in people age 10 years and older, including:
- manic or mixed episodes that happen with bipolar I disorder
- manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate
- long-term treatment of bipolar I disorder
- major depression in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone
- irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old
- agitation associated with schizophrenia or bipolar disorder
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Serious side effects have been reported with Abilify. See "Drug Precautions" section.
Common side effects of Abilify in adults include:
- an inner sense of restlessness/the need to move (akathisia)
- pain at injection site (Abilify Maintena)
Common side effects of Abilify in children include:
- increased appetite
- stuffy nose
- weight gain
- uncontrolled movement (restlessness, tremor, muscle stiffness)
- pain at injection site (Abilify Maintena)
This is not a complete list of Abilify side effects. Ask your doctor or pharmacist for more information.
Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Especially tell your doctor if you take:
- antidepressants (mood elevators)
- antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
- bupropion (Wellbutrin)
- carbamazepine (Tegretol)
- clarithromycin (Biaxin)
- fluoxetine (Prozac, Sarafem)
- HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
- ipratropium (Atrovent)
- medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
- paroxetine (Paxil, Pexeva)
- rifampin (Rifadin, Rimactane)
- sleeping pills
- telithromycin (Ketek)
This is not a complete list of Abilify drug interactions. Ask your doctor or pharmacist for more information.
Serious side effects have been reported with Abilify including:
- Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms of this life-threatening nervous system disorder:
- high fever,
- stiff muscles,
- changes in pulse, heart rate, and blood pressure.
- High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take Abilify.
Call your healthcare provider if you have any of these symptoms of high blood sugar while taking ABILIFY:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
- Increase in weight: Weight gain has been reported in patients taking medicines like Abilify, so you and your healthcare provider should check your weight regularly. For children and adolescent patients (6 to 17 years of age) weight gain should be compared against that expected with normal growth.
- Difficulty swallowing: may lead to aspiration and choking.
- Tardive dyskinesia: Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking Abilify. Tardive dyskinesia may also start after you stop taking Abilify.
- Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting when rising too quickly from a sitting or lying position.
- Low white blood cell count
- Seizures (convulsions)
Important information about antidepressant medicines:
- Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
- Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
- Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
- Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
- Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Abilify affects you. Abilify may make you drowsy. Do not drink alcohol while taking Abilify.
Avoid getting over-heated or dehydrated. Do not over-exercise. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much or heavy clothing.
Drink plenty of water while taking Abilify.
Grapefruit and grapefruit juice may interact with Abilify and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before taking Abilify, tell your doctor about all of your medical conditions. Especially tell your doctor if you have or had:
- seizures (convulsions)
- low or high blood pressure
- heart problems or stroke
- low white blood cell count
- phenylketonuria. Abilify DISCMELT Orally Disintegrating Tablets contain phenylalanine.
- any other medical conditions
Tell your doctor if you are pregnant or breastfeeding.
Tell your doctor about all the medicines that you take including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.
Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Abilify will harm your unborn baby.
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Abilify is excreted in human breast milk or if it will harm your baby.
- Take Abilify exactly as prescribed. Do not change the dose or stop taking Abilify without talking to your doctor.
- Abilify can be taken with or without food.
- Swallow Abilify tablets whole.
- If you miss a dose of Abilify, take it as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of Abilify at the same time.
If you have been prescribed Abilify DISCMELT, take it as follows:
- Do not open the blister until ready to take the DISCMELT tablet.
- To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet.
- Do not push the tablet through the foil because this could damage the tablet.
- Immediately upon opening the blister, using dry hands, remove the tablet and place the entire Abilify DISCMELT Orally Disintegrating Tablet on the tongue.
- Tablet disintegration occurs rapidly in saliva. It is recommended that Abilify DISCMELT be taken without liquid. However, if needed, it can be taken with liquid.
- Do not attempt to split the DISCMELT tablet.
How should I receive Abilify Maintena?
- Abilify Maintena is an injection given in the buttock by a healthcare provider once a month.
- After your first injection of Abilify Maintena you should continue your current antipsychotic medicine for 2 weeks.
- You should not miss a dose of Abilify Maintena. If you miss a dose, call your healthcare provider right away to discuss what you should do next.
Take Abilify exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended dose varies depending upon which condition is being treated as well as other factors.
Generally, adults being treated for schizophrenia will start at 10 mg or 15 mg by mouth daily and may increase to 30 mg daily after 2 weeks. In adolescents (13 to 17 year olds) will start at 2 mg by mouth daily and following several small dose increases as necessary may go up to a maximum of 30 mg daily.
When Abilify is used in combination with another medicine, adults will usually start with 2 mg to 5 mg by mouth daily. This may be increased to 15 mg.
If you take too much Abilify seek emergency medical treatment or call your local Poison Control Center right away.
Active ingredient: aripiprazole
Tablets (2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg): cornstarch, hydroxypropyl, cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.
Abilify DISCMELT Orally Disintegrating Tablets (10 mg, 15 mg): acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.
Abilify Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors.
Abilify Injection (9.75 mg/1.3 mL): sulfobutylether beta-cyclodextrin, tartaric acid, sodium hydroxide.
- Store Abilify at room temperature, between 59°F to 86°F (15°C to 30°C).
- Opened bottles of Abilify Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.
Keep Abilify and all medicines out of the reach of children.
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Abilify (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis.
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive Abilify or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Abilify is not approved for use in pediatric patients with depression.