Like all medicines, ABILIFY can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention very common affects more than 1 user in 10 common uncommon rare very rare not known affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data
Common side effects of ABILIFY solution for injection include sleepiness, dizziness, headache, restlessness, nausea and vomiting.
Uncommon side effects: some people may have changes in blood pressure, may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate, dry mouth or fatigue.
In addition, the following side effects have been seen in patients treated with oral formulations of ABILIFY:
Common side effects: uncontrollable twitching or jerking movements, headache, tiredness, nausea, vomiting, an uncomfortable feeling in the stomach, constipation, increased production of saliva, light-headedness, trouble sleeping, restlessness, feeling anxious, sleepiness, shaking and blurred vision.
Uncommon side effects: some people may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate.
Some people may feel depressed.
The following side effects have been reported since the marketing of ABILIFY but the frequency for them to occur is not known:
Changes in the levels of some blood cells; unusual heart beat, sudden unexplained death, heart attack; allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, rash); hig h blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodiumlevel in the blood; weight gain, weight loss, anorexia; nervousness, agitation, feeling anxious; thoughts of suicide, suicide attempt and suicide; speech disorder, seizure, combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate; fainting, high blood pressure, blood clots in the veins especially in the legs (symptoms
include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately); spasm of the muscles around the voice box, accidental inhalation of food withrisk of pneumonia, difficu lty in swallowing; inflammation of the pancreas; inflammation of the liver, yellowing of the skin and white part of eyes, reports of abnormal liver test values, abdominal and stomach discomfort, diarrhoea; skin rash and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty in passing urine; prolonged and/or painful erection; difficulty controlling core body temperature or
overheating, chest pain, and swelling of hands, ankles or feet.
Adolescents 15 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness and uncontrollable twitching or jerking movements were very common (greater than 1 in 10 patients) and dry mouth, increased appetite, and feeling dizzy, especially when getting up from a lying or sitting position, were common.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,please
tell your doctor or pharmacist.
