Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dronabinol
Drug ID BADD_D00729
Description Dronabinol (marketed as Marinol) is a synthetic form of delta-9-tetrahydrocannabinol (Δ⁹-THC), the primary psychoactive component of cannabis (marijuana). THC demonstrates its effects through weak partial agonist activity at Cannabinoid-1 (CB1R) and Cannabinoid-2 (CB2R) receptors, which results in the well-known effects of smoking cannabis such as increased appetite, reduced pain, and changes in emotional and cognitive processes. Due to its evidence as an appetite stimulant and an anti-nauseant, Dronabinol is approved for use in anorexia associated with weight loss in patients with AIDS and for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments [FDA Label]. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the two most abundant cannabinoids found naturally in the resin of the marijuana plant, both of which are pharmacologically active due to their interaction with cannabinoid receptors that are found throughout the body [A32830]. While both CBD and THC are used for medicinal purposes, they have different receptor activity, function, and physiological effects. If not provided in their activated form (such as through synthetic forms like Dronabinol or [DB00486]), THC and CBD are obtained through conversion from their precursors, tetrahydrocannabinolic acid-A (THCA-A) and cannabidiolic acid (CBDA), through decarboxylation reactions. This can be achieved through heating, smoking, vaporization, or baking of dried unfertilized female cannabis flowers. From a pharmacological perspective, Cannabis' diverse receptor profile explains its potential application for such a wide variety of medical conditions. Cannabis contains more than 400 different chemical compounds, of which 61 are considered cannabinoids, a class of compounds that act upon endogenous cannabinoid receptors of the body [A32584]. The endocannabinoid system is widely distributed throughout the central and peripheral nervous system (via the Cannabinoid Receptors CB1 and CB2) and plays a role in many physiological processes such as inflammation, cardiovascular function, learning, pain, memory, stress and emotional regulation, and the sleep/wake cycle among many others [A32824]. CB1 receptors are found in both the central and peripheral nervous system, and are most abundant in the hippocampus and amygdala, which are the areas of the brain responsible for short-term memory storage and emotional regulation. CB2 receptors are mainly located in the peripheral nervous system and can be found on lymphoid tissue where they are involved in regulation of immune function [A32676].
Indications and Usage For the treatment of anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments
Marketing Status approved; illicit
ATC Code A04AD10
DrugBank ID DB00470
KEGG ID D00306
MeSH ID D013759
PubChem ID 16078
TTD Drug ID D0P1FO
NDC Product Code 73548-2358; 60687-375; 0527-1450; 0904-7145; 31722-962; 42858-868; 63629-9166; 12502-5289; 0904-7144; 53097-571; 67877-754; 67877-755; 72162-1878; 10888-8256; 17478-762; 53097-572; 53097-573; 60687-386; 67877-753; 0527-1451; 0527-4125; 17478-763; 0527-1452; 72162-1880; 17478-761; 72162-1879; 10888-8230; 31722-960; 31722-961; 53097-569; 53097-570; 63629-8861; 63629-8862; 78613-201; 10888-8228; 10888-8229; 53834-001; 53097-568; 42858-867; 42858-869
UNII 7J8897W37S
Synonyms Dronabinol | delta(9)-THC | 9-ene-Tetrahydrocannabinol | 9 ene Tetrahydrocannabinol | THC | delta(1)-Tetrahydrocannabinol | delta(1)-THC | delta(9)-Tetrahydrocannabinol | Tetrahydrocannabinol | Tetrahydrocannabinol, (6a-trans)-Isomer | Tetrahydrocannabinol, Trans-Isomer | Tetrahydrocannabinol, Trans Isomer | Tetrahydrocannabinol, (6aS-cis)-Isomer | Tetrahydrocannabinol, Trans-(+-)-Isomer | Marinol | Tetrahydrocannabinol, (6aR-cis)-Isomer
Chemical Information
Molecular Formula C21H30O2
CAS Registry Number 1972-08-3
SMILES CCCCCC1=CC(=C2C3C=C(CCC3C(OC2=C1)(C)C)C)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.0020.012995%
Abdominal pain upper07.01.05.0030.006498%
Aggression19.05.01.0010.006498%-
Amnesia17.03.02.001; 19.20.01.001--
Anxiety19.06.02.0020.006498%
Asthenia08.01.01.0010.006498%-
Ataxia08.01.02.004; 17.02.02.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.009747%-
Chills08.01.09.001; 15.05.03.016--
Confusional state17.02.03.005; 19.13.01.0010.009747%
Conjunctivitis06.04.01.002; 11.01.06.012--
Constipation07.02.02.0010.006498%
Cough22.02.03.001--
Death08.04.01.0010.042235%
Depression19.15.01.0010.009747%
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Discomfort08.01.08.003---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.031839%
Drug ineffective08.06.01.0060.055230%-
Dry mouth07.06.01.002--
Dysgeusia07.14.03.001; 17.02.07.0030.014295%
Dysphagia07.01.06.0030.014295%
Euphoric mood19.04.02.0060.047433%
Fatigue08.01.01.0020.020793%
Feeling abnormal08.01.09.0140.036387%-
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.006498%
Gastrointestinal pain07.01.05.005--
Hallucination19.10.04.003--
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