Applies to stiripentol: oral capsule, oral powder for suspension.
Serious side effects of Stiripentol
Along with its needed effects, stiripentol 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 stiripentol:
More common
- Aggression
- anxiety
- chest tightness
- cough producing mucus
- dry mouth
- fever
- headache
- irregular heartbeat
- irritability
- loss of strength or energy
- muscle pain or weakness
- nervousness
- restlessness
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- slurred speech
- sore throat
- stuffy or runny nose
- trouble breathing
- trouble sleeping
- trouble speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual tiredness or weakness
Other side effects of Stiripentol
Some side effects of stiripentol 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
- Decreased appetite
- increased watering of the mouth
- nausea
- vomiting
- weight changes
For Healthcare Professionals
Applies to stiripentol: oral capsule, oral powder for reconstitution.
General
The most common adverse reactions were somnolence, decreased appetite, agitation, ataxia, decreased weight, hypotonia, nausea, tremor, dysarthria, insomnia, and dystonia.[Ref]
Dermatologic
Common (1% to 10%): Face erythema, dry skin, urticaria
Uncommon (0.1% to 1%): Photosensitivity, rash, cutaneous allergy
Gastrointestinal
Very common (10% or more): Nausea (up to 15%)
Common (1% to 10%): Vomiting, salivary hypersecretion (includes sialorrhea), abdominal pain
Genitourinary
Common (1% to 10%): Dysuria
Hematologic
In controlled studies in patients with Dravet syndrome, baseline and end-of-study neutrophil and platelet counts were obtained in 31 patients treated with this drug. Decreases in neutrophil count (from normal at baseline to less than 1500 cells/mm3 during the trial) and decreases in platelet count (from normal at baseline to less than 150,000/mcL during the trial) were both observed in 13% of these 31 patients, but not in any placebo-treated patients.
Very common (10% or more): Decreased neutrophil count (up to 13%), decreased platelet count (up to 13%)
Common (1% to 10%): Neutropenia, thrombocytopenia, eosinophilia
Hepatic
Common (1% to 10%): Increased GGT, increased AST
Rare (0.01% to 0.1%): Abnormal liver function test
Metabolic
In controlled studies in patients with Dravet syndrome, the incidence of decreased appetite was 46% in patients treated with this drug, compared to 10% in patients receiving placebo.
Very common (10% or more): Decreased appetite (includes anorexia, loss of appetite; up to 46%)
Nervous system
In controlled studies in patients with Dravet syndrome, the incidence of somnolence was 67% in patients treated with this drug, compared to 23% in patients receiving placebo. All patients in both groups were on concomitant clobazam, which was also known to cause somnolence.
Very common (10% or more): Somnolence (includes drowsiness, sleepiness; up to 67%), ataxia (up to 27%), hypotonia (up to 24%), tremor (up to 15%), dysarthria (up to 12%), dystonia
Common (1% to 10%): Hyperkinesia, status epilepticus, impaired balance (includes equilibrium disorders), intellectual slowing
Ocular
Uncommon (0.1% to 1%): Diplopia
Other
Very common (10% or more): Decreased weight (includes weight loss; up to 27%), increased weight (includes weight gain; up to 15%)
Common (1% to 10%): Fatigue (includes asthenia), pyrexia
In controlled studies in patients with Dravet syndrome, the incidence of decreased weight was 27% in patients treated with this drug, compared to 6% in patients receiving placebo.
Psychiatric
Very common (10% or more): Agitation (includes hyperexcitability; up to 27%), insomnia (includes nightmares; up to 12%)
Common (1% to 10%): Aggression (includes aggressiveness), irritability, behavior disorders, opposing behavior, sleep disorders
Respiratory
Common (1% to 10%): Bronchitis, nasopharyngitis, rhinitis
