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)
Hyperkinesia17.01.02.008--Not Available
Hypersensitivity10.01.03.003--
Hyperventilation22.02.01.006; 19.01.02.004--Not Available
Hypopnoea22.02.01.021--Not Available
Hypotension24.06.03.002--
Hypoventilation22.02.01.007--Not Available
Hypoxia22.02.02.003--
Immune system disorder10.02.01.001--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injury12.01.08.004--Not Available
Instillation site pain12.07.01.008; 08.02.01.008--Not Available
Irritability19.04.02.013; 08.01.03.011--
Laryngospasm22.04.02.002--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Local reaction08.01.03.012--Not Available
Mean arterial pressure13.14.03.018--Not Available
Mean arterial pressure decreased13.14.03.016--Not Available
Miosis17.02.11.002; 06.05.03.003--Not Available
Mood swings19.04.03.001--Not Available
Movement disorder17.01.02.010--Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Nasopharyngitis11.01.13.002; 22.07.03.002--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Nightmare19.02.03.003--Not Available
Nodal rhythm02.03.02.006--Not Available
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