The Short Answer

One cannabis-derived drug is FDA approved for children: Epidiolex (cannabidiol). It treats seizures in three rare conditions, in patients age 1 and older. No other cannabis product, including CBD sold online, holds FDA approval for pediatric use. Most children who receive cannabis do so under state medical cannabis programs, which operate outside federal law.

What Is FDA Approved

Epidiolex is a purified cannabidiol oral solution. Approval covers seizures linked to:

  • Lennox-Gastaut syndrome
  • Dravet syndrome
  • Tuberous sclerosis complex

The DEA placed Epidiolex in Schedule V. Marinol (dronabinol), Syndros, and Cesamet (nabilone) are synthetic cannabinoids approved for chemotherapy-induced nausea and vomiting and for AIDS-related weight loss. Their labels cover adults, and pediatric use is off label.

State Medical Cannabis Programs

Rules for minors vary by state. Common requirements include:

  • A parent or legal guardian registers as the child's caregiver.
  • One or two physicians certify the patient. Some states require a specialist.
  • Products may be limited to low-THC or high-CBD extracts.
  • Smoked and inhaled forms are barred for minors in some states.

State registration does not shield a family from federal law. School policies on carrying the product vary by district, and some districts bar it on campus.

What the Evidence Covers

The strongest pediatric evidence is for drug-resistant epilepsy. Cochrane reviews rate this evidence as low to moderate certainty, with reductions in seizure frequency for some patients and no benefit for others. For autism, ADHD, chronic pain, and anxiety in children, trial data are thin: small samples, short follow-up, and mixed results. Limited evidence is not proof of benefit.

Risks and Drug Interactions

  • Somnolence, sedation, and fatigue
  • Decreased appetite and diarrhea
  • Elevated liver enzymes, with higher risk when valproate is taken at the same time
  • Interactions with clobazam and other drugs processed by CYP enzymes
  • THC exposure in children may affect memory and attention. Brain tissue is still developing.

CBD products sold outside pharmacies are not tested to a federal standard. Labels on unregulated products often list amounts that do not match lab results.

Questions for the Clinician

  1. Which diagnosis is being treated, and what evidence supports cannabis for it?
  2. What product, dose, and schedule, and who adjusts the dose?
  3. What interactions with the child's current drugs are known?
  4. Which labs are needed at baseline and how often after that?
  5. What outcome counts as improvement, and when do we stop?

Bring a written medication list to every visit. Report side effects that appear within days of a dose change.