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-1 betaP01584T4200026345937
Cytokine release syndromeInterleukin-6P05231T3257826345937
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.007--Not Available
Anger19.04.02.001--Not Available
Anterograde amnesia19.20.01.005; 17.03.02.005--Not Available
Anxiety19.06.02.002--
Apnoea22.02.01.001--
Application site pain12.07.01.004; 08.02.01.004--Not Available
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Athetosis17.01.01.004--Not Available
Bradycardia02.03.02.002--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Carbon dioxide increased13.02.01.011--Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Chills15.05.03.016; 08.01.09.001--
Clonus17.02.05.002--Not Available
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Delirium19.13.02.001--
Delusion19.10.01.001--
Dependence19.07.02.003--Not Available
Depressed level of consciousness17.02.04.002--
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
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