Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C₂₃H₂₇Cl₂N₃O₂ and its molecular weight is 448.38. The chemical structure is:

ABILIFY (aripiprazole) Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include 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 (aripiprazole) DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, cr????me 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 (aripiprazole) Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors.

ABILIFY (aripiprazole) Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether ?-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection.

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

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 immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, fainting, mental/mood changes (e.g., increased anxiety, depression, suicidal thoughts), weakness, feelings of restlessness, mask-like facial expression, shakiness (tremors), muscle spasm/stiffness, trouble swallowing, swelling of the ankles/feet.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, signs of infection (such as fever, persistent sore throat).

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

This drug may infrequently cause a serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). Seek immediate medical attention if you notice any of the following rare but very serious side effects: confusion, fever, fast heartbeat, muscle stiffness, increased sweating, change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.

PRECAUTIONS: See also the Warning section.

Before taking aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems with blood flow in the brain (cerebrovascular disease, stroke), a severe loss of body water (dehydration), diabetes, heart problems (e.g., low blood pressure, coronary artery disease, heart failure, irregular heartbeat), nervous system problems (e.g., dementia, NMS, seizures), obesity, trouble swallowing, alcohol/drug abuse, low white blood cell count.

This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

This medication can increase your risk of heat stroke. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using a hot tub). Drink plenty of fluids, dress lightly and stay in cooler/air-conditioned areas when the weather is hot.

This drug may infrequently increase your blood sugar level, causing or worsening 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/urination. If you already have diabetes, be sure to check your blood sugar levels regularly as directed by your doctor. Your anti-diabetic medication or diet may need to be adjusted.

Liquid preparations of this product may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about the safe use of this product.

The rapidly dissolving tablets may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding using this medicine safely.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially seizures, swallowing problems, and other serious (rarely fatal) side effects. (See also the Warning section.)

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

It is not known whether this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.