Diacomit Side Effects

Generic name: stiripentol

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 16, 2024.

Note: This document provides detailed information about Diacomit.

Applies to stiripentol: oral capsule, oral powder for suspension Side Effects associated with stiripentol. Some dosage forms listed on this page may not apply specifically to the brand name Diacomit.

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

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may make you or your child drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with stiripentol (the active ingredient contained in Diacomit) may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Stiripentol may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

Stiripentol may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Diacomit

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 side effects

• 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 side effects

• decreased appetite
• increased watering of the mouth
• nausea
• vomiting
• weight changes

For healthcare professionals

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

General adverse events

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

• Very common (10% or more): Decreased neutrophil count (up to 13%), decreased platelet count (up to 13%)
• Common (1% to 10%): Neutropenia, thrombocytopenia, eosinophilia

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.

Hepatic

• Common (1% to 10%): Increased GGT, increased AST
• Rare (0.01% to 0.1%): Abnormal liver function test

Metabolic

• Very common (10% or more): Decreased appetite (includes anorexia, loss of appetite; up to 46%)

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.

Nervous system

• 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

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.

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

See also:

Frequently asked questions

• What type of epilepsy is Diacomit used to treat?

Further information

Diacomit side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer