Applies to istradefylline: oral tablet.
Serious side effects of Istradefylline
Along with its needed effects, istradefylline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking istradefylline:
More common
- Seeing, hearing, or feeling things that are not there
- twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs
Less common
- Actions that are out of control
- anxiety
- attack, assault, force
- confusion
- confusion as to time, place, or person
- delusions of persecution, mistrust, suspiciousness, or combativeness
- dry mouth
- false beliefs that cannot be changed by facts
- hyperventilation
- increased sexual urges
- irregular heartbeats
- irritability
- restlessness
- shaking
- shortness of breath
- talking, feeling, and acting with excitement
- trouble sleeping
- unusual excitement, nervousness, or restlessness
Other side effects of Istradefylline
Some side effects of istradefylline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Difficulty having a bowel movement (stool)
- nausea
Less common
- Decreased appetite
- diarrhea
- dizziness
- rash
For Healthcare Professionals
Applies to istradefylline: oral tablet.
General
The most commonly reported adverse reactions have included dyskinesia, dizziness, constipation, nausea, hallucinations, and insomnia.[Ref]
Nervous system
Across clinical trials, dyskinesia occurred in 15% of patients receiving 20 mg once a day and 17% of patients receiving 40 mg once a day (compared to 8% for placebo); 1% of patients discontinued treatment because of dyskinesia.
Very common (10% or more): Dyskinesia (up to 17%)
Common (1% to 10%): Dizziness
Gastrointestinal
Common (1% to 10%): Constipation, nausea
Dermatologic
Common (1% to 10%): Rash
Metabolic
Common (1% to 10%): Decreased appetite, increased blood glucose
Hepatic
Common (1% to 10%): Blood alkaline phosphatase increased
Respiratory
Common (1% to 10%): Upper respiratory tract inflammation
Renal
Common (1% to 10%): Blood urea increased
Psychiatric
Common (1% to 10%): Hallucinations, abnormal thinking and behavior, insomnia
Rare (less than 0.1%): Impulse control disorder
Postmarketing reports: Increased libido
Across clinical trials, hallucinations occurred in 2% of patients receiving 20 mg once a day and 6% of patients receiving 40 mg once a day (compared to 3% for placebo); 1% of patients discontinued treatment because of hallucinations. Across clinical trials, abnormal thinking and behavior (paranoid ideation, delusions, confusion, mania, disorientation, aggressive behavior, agitation, or delirium) occurred in 1% of patients receiving 20 mg once a day and 2% of patients receiving 40 mg once a day (compared to 1% for placebo). Across clinical trials, 1 patient taking 40 mg/day reported an impulse control disorder. There were no reports in the patients taking 20 mg/day or placebo.
