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Diacomit Side Effects

Generic Name: stiripentol

Medically reviewed by Drugs.com. Last updated on July 6, 2020.

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

For the Consumer

Applies to stiripentol: oral capsule, oral powder for suspension

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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 more frequently occurring adverse reactions have included somnolence, decreased appetite, agitation, ataxia, decreased weight, hypotonia, nausea, tremor, dysarthria, and insomnia.[Ref]

Nervous system

During clinical trials, 1 patient discontinued therapy due to status epilepticus. A second patient discontinued therapy due to impaired balance, somnolence, and sialorrhea.[Ref]

Very common (10% or more): Somnolence (67%), ataxia (27%), hypotonia (18%), tremor (15%)

Rare (less than 0.1%): Status epilepticus, impaired balance[Ref]

Gastrointestinal

Very common (10% or more): Nausea (15%)

Common (1% to 10%): Vomiting, salivary hypersecretion[Ref]

Metabolic

Very common (10% or more): Decreased appetite (46%), decreased weight (27%)

Common (1% to 10%): Increased weight[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia[Ref]

Psychiatric

Very common (10% or more): Agitation (27%), insomnia (12%)

Common (1% to 10%): Aggression[Ref]

Hematologic

During clinical trials, a decrease in neutrophil count (normal to less than 1500 cells/mm3) occurred in 13% of stiripentol-treated patients (n=31) compared to no occurrences in placebo patients. Platelet counts dropped significantly (normal to less than 150,000/microliter) in 13% of stiripentol-treated patients compared to no occurrences in placebo patients.[Ref]

Very common (10% or more): Decrease in neutrophil count (13%), decrease in platelet count (13%)[Ref]

Dermatologic

Frequency not reported: Rash, cutaneous allergy, urticaria, photosensitivity[Ref]

Ocular

Frequency not reported: Diplopia[Ref]

Musculoskeletal

Very common (10% or more): Dysarthria ((12%)

Respiratory

Common (1% to 10%): Bronchitis, nasopharyngitis

References

1. "Product Information. Diacomit (stiripentol)." Biocodex Inc, Creswell, OR.

2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

Frequently asked questions

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.