Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Midazolam
Drug ID BADD_D01459
Description Midazolam is a short-acting hypnotic-sedative drug with anxiolytic, muscle relaxant, anticonvulsant, sedative, hypnotic, and amnesic properties.[A173842] It belongs to a class of drugs called _benzodiazepines_. This drug is unique from others in this class due to its rapid onset of effects and short duration of action.[A173842] Midazolam is available by oral, rectal, intranasal, intramuscular (IM), and intravenous (IV) routes and has been used in various biomedical applications, including dentistry, cardiac surgery, and endoscopic procedures as pre-anesthetic medication, and as an adjunct to local anesthesia.[F2977] This drug was initially approved by the US FDA in 1985, and has been approved for various indications since.[FDA label] In late 2018, the intramuscular preparation was approved by the FDA for the treatment of status epilepticus in adults.[FDA label] In May 2019, the nasal spray of midazolam was approved for the acute treatment of distinctive intermittent, stereotypic seizure episodes in patients 12 years of age and older. Midazolam is considered a schedule IV drug in the United States due to the low potential for abuse and low risk of dependence.[L5074]
Indications and Usage The midazolam injection is indicated for preoperative sedation/anziolysis/amnesia. It is also an agent for sedation/anziolysis/amnesia prior to or during diagnostic, therapeutic, or endoscopic procedures. Midazolam can also be given intravenously for induction of general anaesthesia.
Marketing Status Prescription; Discontinued
ATC Code N05CD08
DrugBank ID DB00683
KEGG ID D00550
MeSH ID D008874
PubChem ID 4192
TTD Drug ID D0U6LM
NDC Product Code 0404-9912; 72611-749; 79037-001; 52584-596; 0641-6057; 0404-9915; 72611-741; 52584-059; 82393-117; 72572-432; 48087-0098; 50090-0683; 51552-1023; 72572-430; 0404-9913; 0641-6060; 0641-6210; 0641-6059; 0641-6063; 52584-081; 17511-115; 67763-100; 0641-6211; 0641-6061; 0641-6209; 12828-0069; 0641-6056; 51927-0001; 0641-6190; 50090-0738; 63275-9925; 38779-2684; 50474-500; 49452-4721
Synonyms Midazolam | Midazolam Maleate | Maleate, Midazolam | Dormicum | Versed | Midazolam Hydrochloride | Hydrochloride, Midazolam | Ro 21-3981 | Ro 21 3981 | Ro 213981
Chemical Information
Molecular Formula C18H13ClFN3
CAS Registry Number 59467-70-8
SMILES CC1=NC=C2N1C3=C(C=C(C=C3)Cl)C(=NC2)C4=CC=CC=C4F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Cytokine release syndromeInterleukin-6P05231T3257826345937
Cytokine release syndromeInterleukin-1 betaP01584T4200026345937
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Diplopia17.17.01.005; 06.02.06.002--Not Available
Disinhibition19.05.01.002--Not Available
Disorientation17.02.05.015; 19.13.01.002--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drooling17.02.05.005--Not Available
Drug withdrawal convulsions17.12.03.016; 08.06.02.003--Not Available
Drug withdrawal syndrome08.06.02.004; 19.07.02.011--Not Available
Dry mouth07.06.01.002--
Dysarthria19.19.03.001; 17.02.08.001--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
Dysphonia19.19.03.002; 22.02.05.005; 17.02.08.004--
Dysphoria19.04.02.004--Not Available
Dyspnoea22.02.01.004; 02.01.03.002--
Emotional disorder19.04.02.005--Not Available
Erythema23.03.06.001--Not Available
Euphoric mood19.04.02.006--
Extrasystoles02.03.02.003--Not Available
Eye disorder06.08.03.001--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Feeling hot08.01.09.009--Not Available
Fracture15.08.02.001; 12.04.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Haematoma24.07.01.001--
Hallucination19.10.02.002--
Headache17.14.01.001--
Hiccups22.02.04.002; 07.01.06.009--
Hostility19.05.01.003--Not Available
Hypercapnia22.02.02.002; 14.01.04.001--Not Available
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