Diacomit Side Effects

Generic name: stiripentol

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 18, 2023.

Note: This document contains side effect information about stiripentol. Some dosage forms listed on this page may not apply to the brand name Diacomit.

Applies to stiripentol: oral capsule, oral powder for suspension.

Serious side effects of Diacomit

Along with its needed effects, stiripentol (the active ingredient contained in Diacomit) 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 Diacomit

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

Frequently asked questions

• What type of epilepsy is Diacomit used to treat?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer