pharmacopeia
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/api/v1/drug/dronabinol

Mechanism of action

Sourced from openFDA

Dronabinol is an orally active cannabinoid that has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues.

Cannabinoid Receptor

Indications

Sourced from openFDA
  • SYNDROS is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.ICD-10: R11.2

Contraindications

Sourced from openFDA
  • SYNDROS is contraindicated in patients: with a history of a hypersensitivity reaction to dronabinol. Reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Adverse Reactions ( 6.2 )] .contraindicated

Dosage & administration

Sourced from openFDA

Administration ( 2.1 ): Always use the enclosed calibrated oral dosing syringe. The calibrated oral syringe measures a maximum SYNDROS dose of 5 mg. If the prescribed dose is greater than 5 mg, the total dose will need to be divided and drawn up in two or more portions using the oral syringe. Take SYNDROS with a full glass of water (6 to 8 ounces). SYNDROS can be administered via silicone enteral feeding tubes. Anorexia Associated with Weight Loss in Adult Patients with AIDS ( 2.2 ): The recommended starting dosage is 2.1 mg orally twice daily, one hour before lunch and dinner. See the full prescribing information for dosage titration to manage adverse reactions and to achieve desired therapeutic effect. Nausea and Vomiting Associated with Chemotherapy in Adult Patients Who Failed Conventional Antiemetics ( 2.3 ): The recommended starting dosage is 4.2 mg/m 2 , administered 1 to 3 hours prior to chemotherapy, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day. Administer the first dose on an empty stomach at least 30 minutes prior to eating; subsequent doses can be taken without regard to meals. See the full prescribing information for dosage titration to manage adverse reactions and to achieve desired therapeutic effect. 2.1 Important Administration Instructions Oral Administration Always use the enclosed calibrated oral dosing syringe when administering SYNDROS to ensure the dose is measured and administered accurately. The calibrated oral syringe measures a maximum SYNDROS dose of 5 mg.

Warnings & precautions

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Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects and impair mental and/or physical abilities. Avoid use in patients with a psychiatric history. Monitor for symptoms and avoid concomitant use of drugs with similar effects. Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that SYNDROS does not affect them adversely. ( 5.1 ) Hemodynamic Instability : Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia. Avoid concomitant use of drugs with similar effects and monitor for hemodynamic changes after initiating or increasing the dosage of SYNDROS. ( 5.2 ) Interaction with Disulfiram and Metronidazole : May cause disulfiram-like reaction. Discontinue products containing disulfiram or metronidazole at least 14 days before and do not administer 7 days after treatment with SYNDROS. ( 4 , 5.3 , 7.1 ) Seizures and Seizure-like Activity : Weigh the potential risk versus benefits before prescribing SYNDROS to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold. Monitor patients and discontinue if seizures occur. ( 5.4 ) Multiple Substance Abuse : Assess risk for abuse or misuse in patients with a history of substance abuse or dependence, prior to prescribing SYNDROS and monitor for the development of associated behaviors or conditions.

Adverse reactions

Sourced from openFDA

Most common adverse reactions (≥3%) are: abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, thinking abnormal, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wellhouse Pharma, LLC at 1-844-558-8289 or FDA at MedWatch phone number 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are described below and elsewhere in the labeling. Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.1 )] Hemodynamic Instability [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.4 )] Paradoxical Nausea, Vomiting, and Abdominal Pain [see Warnings and Precautions ( 5.6 )] Toxicity in Preterm Neonates [see Warnings and Precautions ( 5.7 )] The safety of SYNDROS has been established based on studies of dronabinol capsules. Studies of AIDS-related weight loss included 157 patients receiving dronabinol capsules and 67 receiving placebo. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving dronabinol capsules and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to dronabinol capsules in studies.

Use in specific populations

Sourced from openFDA

Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Advise HIV infected women not to breastfeed due to the potential for HIV transmission. ( 8.2 ) Geriatric Use: Elderly patients may be more sensitive to the neuropsychiatric and postural hypotensive effects. Consider a lower starting dose in elderly patients. ( 2.2 , 2.3 , 5.1 , 5.2 , 8.5 ) 8.1 Pregnancy Risk Summary SYNDROS, a synthetic cannabinoid containing alcohol, may cause fetal harm. Avoid use of SYNDROS in pregnant women. Although there is little published data on the use of synthetic cannabinoids during pregnancy, use of cannabis (e.g., marijuana) and use of alcohol during pregnancy have been associated with adverse fetal/neonatal outcomes (see Clinical Considerations ) . Cannabinoids have been found in the umbilical cord blood from pregnant women who smoke cannabis. In animal reproduction studies, no teratogenicity was reported in mice administered dronabinol (delta-9-THC) at up to 30 times the MRHD (maximum recommended human doses) and up to 5 times the MRHD for patients with AIDS and cancer, respectively. Similar findings were reported in pregnant rats administered dronabinol at up to 5 to 20 times the MRHD and 3 times the MRHD for patients with AIDS and cancer, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Dronabinol (delta-9-THC) is almost completely absorbed (90 to 95%) after a single oral dose. Due to the combined effects of first pass hepatic metabolism and high lipid solubility, only 10 to 20% of the administered dose reaches the systemic circulation.

Overdosage

Sourced from openFDA

SYNDROS contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol. Ingestion of the product over the recommended dose could result in significant toxicity. Dronabinol Signs and symptoms of dronabinol overdose include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth, tachycardia, memory impairment, depersonalization, mood alteration, urinary retention, reduced bowel motility, decreased motor coordination, lethargy, slurred speech, and postural hypotension. Patients may also experience panic reactions if they have a prior history of nervousness or anxiety and seizures may occur in patients with existing seizure disorders. It is not known if dronabinol can be removed by dialysis in cases of overdose. Alcohol Signs and symptoms of alcohol overdose include changes in mood or behavior, impaired judgment or social functioning, and one or more physical signs such as slurred speech, unsteadiness, lack of coordination, increased or irregular heart rate, respiratory depression, impaired attention, or loss of consciousness.

Approval history

Sourced from openFDA
  • May 31, 1985NDANDA018651Alkem Labs Ltd
  • Jul 1, 2016NDANDA205525Wellhouse Pharma
  • Feb 7, 2020ANDAANDA207421Ascent Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
7,894 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea88611%
  2. 2Fatigue7018.9%
  3. 3Diarrhoea6087.7%
  4. 4Death5967.6%
  5. 5Vomiting5897.5%
  6. 6Off Label Use4956.3%
  7. 7Decreased Appetite4515.7%
  8. 8Pain4335.5%
  9. 9Weight Decreased4155.3%
  10. 10Dyspnoea3794.8%
  11. 11Asthenia3764.8%
  12. 12Toxicity To Various Agents3264.1%
  13. 13Drug Ineffective3214.1%
  14. 14Headache3144.0%
  15. 15Pneumonia3043.9%

Literature

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Recent PubMed references pinned to Dronabinol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 371 ClinicalTrials.gov registrations naming Dronabinol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Dronabinol. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2C9CPIC B/C (provisional)FDA label: Actionable PGx

Frequently asked questions

How does Dronabinol work?
Dronabinol is an orally active cannabinoid that has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues.
What is Dronabinol used for?
According to FDA labeling, Dronabinol carries indications including: SYNDROS is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dronabinol?
Dronabinol is classified as Other antiemetics, Cannabinoid, Cannabinoid Receptor Agonists, Decreased Endorphin Activity, Decreased Prostaglandin Production, Emesis Suppression.
What are the brand names for Dronabinol?
Dronabinol is marketed under brand names including Marinol, Syndros.
What are the contraindications for Dronabinol?
Dronabinol labeling lists contraindications including: SYNDROS is contraindicated in patients: with a history of a hypersensitivity reaction to dronabinol. Reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Adverse Reactions ( 6.2 )] .. Always consult the full prescribing information and a clinician.
Note. Data for dronabinol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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