FDA approved
Approval / market date · Not reported
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This is a locally preserved regulatory record. Source labeling does not by itself prove efficacy for a condition.
Regulatory product record. The connected regulator reports this product as approved, authorised or currently marketed.
Product data
Linked local records
Substance links use source-reported active ingredients. Condition links come from registered study context and are not efficacy claims.
Regulatory record
Patent and exclusivity fields are preserved from the regulator. They are not a legal opinion and are separate from clinical development.
Approval / market date · Not reported
Approval / market date · 2017-03-23
| Patent | Source-reported expiry | Use code |
|---|---|---|
| 10265293 | 2028-08-06 | - |
| 11253472 | 2028-08-06 | - |
| 8222292 | 2028-08-06 | - |
| 9345771 | 2028-08-06 | - |
Clinical development
Phases and statuses are source-reported study stages matched by governed token phrases. They do not prove medicine identity, approval or efficacy.
DRUG · Dronabinol
Blood PressureDRUG · Dronabinol
Cannabis Use DisorderDRUG · Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)
Osteoarthritis, Knee · Osteoarthritis of the KneeDRUG · Dronabinol 2.5mg Capsule
COPD · Breathlessness · CannabisDRUG · Dronabinol
Obstructive Sleep ApneaDRUG · IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
Obstructive Sleep Apnea (OSA)Source-reported use
1 INDICATIONS AND USAGE 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. SYNDROS is a cannabinoid indicated in adults for the treatment of: anorexia associated with weight loss in patients with AIDS. ( 1 ) nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
1 INDICATIONS AND USAGE Dronabinol oral solution 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. Dronabinol oral solution is a cannabinoid indicated in adults for the treatment of: anorexia associated with weight loss in patients with AIDS. ( 1 ) nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
Medicine identity matching
RxNorm normalizes identity; FAERS supplies non-causal post-market signals.
Matched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: syndros
Official RxNorm recordMatched from: dronabinol
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: syndros
Safety signals
FAERS/AEMS reports are post-market signals. Counts do not establish causality or incidence and may contain duplicates or reporting bias.
Sources and provenance
3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89 · version 1
Retrieved 22/08/2026, 21:20:19Verify at source44205ae6-b86a-485c-baf6-233a2c878640 · version 1
Retrieved 22/08/2026, 21:20:19Verify at source495aabae-3597-49dc-a5af-e328bcd937b7 · version 1
Retrieved 22/08/2026, 21:20:19Verify at sourcea7801c70-995d-46a2-91ee-141ef427c6b5 · version 9
Retrieved 22/08/2026, 21:20:19Verify at sourceNDA205525:001 · version d6a5fe5ae6834d4ffa421948a56cd423f489d4c5b0c2849ca3e240439e70d3a0
Retrieved 25/08/2026, 09:57:07Verify at source3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89 · version 1
Retrieved 31/07/2026, 13:05:37Verify at source44205ae6-b86a-485c-baf6-233a2c878640 · version 1
DRUG · IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
DRUG · IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
Obstructive Sleep Apnea (OSA)DRUG · IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
Obstructive Sleep Apnea (OSA)DRUG · IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
Obstructive Sleep Apnea (OSA)DRUG · IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
Obstructive Sleep Apnea (OSA)DRUG · IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
Obstructive Sleep Apnea (OSA)DRUG · IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
Obstructive Sleep Apnea (OSA)DRUG · IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
Obstructive Sleep Apnea (OSA)DRUG · Dronabinol
Obstructive Sleep ApneaDRUG · Dronabinol
Obstructive Sleep ApneaDRUG · Tetrahydrocannabinol (THC)
Multiple Sclerosis · Sleep · PainDRUG · Dronabinol 10 MG
Pain, Tolerance · Oral vs Vaporized THC · Abuse LiabilityDRUG · Dronabinol 5 MG
Pain, Tolerance · Oral vs Vaporized THC · Abuse LiabilityDRUG · Dronabinol
PainDRUG · Dronabinol
PainOTHER · Placebo Dronabinol
Opioid Use DisorderDRUG · Dronabinol Capsules
Opioid Use DisorderDRUG · Dronabinol
Knee Osteoarthritis · Knee Injuries · Meniscus Tear · Synovitis of Knee · Knee Ligament Injury · Chondral Injury of Left Knee · Chondral Injury of Right Knee · Loose Body KneeDRUG · Dronabinol
Low Back Pain · Chronic Pain · Back InjuriesDRUG · Dronabinol
Pregnancy Related · Cannabis UseDRUG · Active Dronabinol
Cannabis · Alcohol Effect · Driving Under the Influence of Alcohol and Other DrugsDRUG · Dronabinol 5mg Cap
Total Knee Arthroplasty · Opioid UseDRUG · Dronabinol Capsules
Endometriosis · Endometriosis Related Pain · Endometriosis, PainDRUG · THC (Syndros)
Neuropathic Pain · Peripheral Neuropathic PainDRUG · Dronabinol Oral Solution
Agitation in DementiaDRUG · Dronabinol
Sleep · THC · Marijuana · CannabisDRUG · 5 mg Dronabinol (Marinol®) + Alcohol Beverage
Cannabis, Drug Effects · Driving PerformanceDRUG · 10 mg Dronabinol (Marinol®) + Alcohol Beverage
Cannabis, Drug Effects · Driving PerformanceDRUG · 10 mg Dronabinol (Marinol®) + Placebo Beverage
Cannabis, Drug Effects · Driving PerformanceDRUG · 5 mg Dronabinol (Marinol®) + Placebo Beverage
Cannabis, Drug Effects · Driving PerformanceDRUG · Dronabinol
Pain · Abuse, Drug · Intoxication; CannabinoidsDRUG · Dronabinol
Schizophrenia · Dual Diagnosis · Psychotic Disorder · Cannabis Use DisorderDRUG · Dronabinol
Breast Carcinoma · Chemotherapy-Induced Peripheral Neuropathy · Colon CarcinomaDRUG · Dronabinol Capsules
HIVDRUG · Dronabinol
Post-Traumatic Stress DisorderDRUG · Dronabinol
Sickle Cell DiseaseDRUG · Dronabinol Cap 10 milligrams (MG)
PostTraumatic Stress DisorderDRUG · Dronabinol Cap 5 milligrams (MG)
PostTraumatic Stress DisorderDRUG · oral cannabinoid
Photorefractive Keratectomy · Myopia · HyperopiaDRUG · Dronabinol 7.5 milligram oral capsule
Posttraumatic Stress DisorderDRUG · Dronabinol
Trauma InjuryDRUG · Dronabinol
CannabisDRUG · Dronabinol 10 MG
Retinal Blood FlowDRUG · Dronabinol 5 MG
Retinal Blood FlowDRUG · Dronabinol (Marinol®)
Alzheimer's DiseaseDRUG · Dronabinol in Oral Dosage Form
Pancreatic Cancer Non-resectable · Chemotherapy-induced Nausea and Vomiting · Pancreatic Cancer MetastaticDRUG · Delta-9-tetrahydrocannabinol
Healthy Volunteers · Modeling PsychosisDRUG · Dronabinol 2.5 mg
Post Traumatic Stress DisorderDRUG · Dronabinol
Intrusive MemoriesDRUG · Dronabinol 2.5 MG
Obstructive Sleep ApneaDRUG · Dronabinol
Measuring THC-induced Cognitive Impairment Using a Mobile ApplicationDRUG · Dronabinol Pill
Cannabis Use DisorderDRUG · dronabinol
Appetite RegulationDRUG · Dronabinol
Dementia Moderate · Dementia Severe · Agitation,Psychomotor · Behavioral SymptomsDRUG · Dronabinol
Differential Female Response to Δ9-tetrahydrocannabinol (THC)DRUG · Dronabinol
Bipolar DisorderDRUG · Dronabinol 5mg Cap
Knee Replacement · Arthropathy of KneeDRUG · Dronabinol
Tolerance · Adolescent Behavior · THCDRUG · Dronabinol
Tolerance · Adolescent Behavior · THCDRUG · dronabinol
Cannabis · Low Back Pain · Neuropathic PainDRUG · AD313
Obstructive Sleep ApneaDRUG · Dronabinol
Trichotillomania · Obsessive Compulsive DisorderDRUG · Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator
Nausea Post Chemotherapy · Vomiting · Cancer Pain · Cancer Related Pain · NeoplasmsDRUG · Dronabinol
Osteoarthritis, KneeDRUG · Dronabinol
Oncologic Complications · Quality of Life · Nutrition Poor · Head and Neck Cancer · Lung Cancer · Pancreatic CancerDRUG · Placebo dronabinol
Intoxication Alcohol · Intoxication THC · Intoxication Combined Alcohol THCDRUG · Dronabinol
Intoxication Alcohol · Intoxication THC · Intoxication Combined Alcohol THCDRUG · Adjunctive dronabinol
Traumatic Injury · Pain, AcuteDRUG · Dronabinol
Trichotillomania · Skin-PickingDRUG · THC 10
Cannabis · Alcohol Drinking · Accident, TrafficDRUG · THC 5
Cannabis · Alcohol Drinking · Accident, TrafficDRUG · THC 0
Cannabis · Alcohol Drinking · Accident, TrafficDRUG · Active Dronabinol
HealthyDRUG · Placebo Dronabinol
HealthyDRUG · SCI -110
Alzheimer DiseaseDRUG · Placebo (for Dronabinol)
Sleep Apnea, ObstructiveDRUG · Dronabinol
Sleep Apnea, ObstructiveDRUG · Dronabinol
Schizophrenia · Dual Diagnosis · Schizoaffective Disorder · Psychotic Disorder · Cannabis Use DisorderDRUG · Syndros
Bone Metastases · Breast Cancer · PainDRUG · Dronabinol 2.5mg Cap
Post-operative PainDRUG · Dronabinol 2.5 MG
Sickle Cell DiseaseDRUG · dronabinol
Chemotherapy-induced Nausea and Vomiting · Unspecified Adult Solid Tumor, Protocol SpecificDRUG · Dronabinol 5mg Cap
Medical Abortion · PainDRUG · Dronabinol and Palmitoylethanolamide
Tourette SyndromeDRUG · Dronabinol
Esophageal DiseasesDRUG · Dronabinol
Marijuana DependenceDRUG · Dronabinol
Nausea · Vomiting · Familial DysautonomiaDRUG · Dronabinol
Cannabis Dependence · Marijuana DependenceDRUG · Dronabinol
Marijuana AbuseDRUG · Dronabinol
Retinal Blood FlowDRUG · Dronabinol
Chronic PainDRUG · Dronabinol
Cannabis Dependence · Marijuana DependenceDRUG · THX-110 (dronabinol plus PEA)
Tourette SyndromeDRUG · injectable naltrexone and dronabinol
Opioid DependenceMatched from: dronabinol
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: dronabinol
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: syndros
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: syndros
Official RxNorm recordMatched from: syndros
Official RxNorm recordMatched from: syndros
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: dronabinol
Official RxNorm recordMatched from: dronabinol
Official RxNorm recordMatched from: dronabinol
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: dronabinol
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: syndros
Official RxNorm recordMatched from: SYNDROS
Official RxNorm recordMatched from: SYNDROS
Official RxNorm record495aabae-3597-49dc-a5af-e328bcd937b7 · version 1
Retrieved 31/07/2026, 13:05:37Verify at sourcea7801c70-995d-46a2-91ee-141ef427c6b5 · version 9
Retrieved 31/07/2026, 13:05:37Verify at sourceNDA205525:001 · version 2026-08-19
Retrieved 20/08/2026, 10:33:18Verify at source