Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Midazolam hydrochloride
Drug ID BADD_D01460
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 D00696
MeSH ID D008874
PubChem ID 43032
TTD Drug ID D0U6LM
NDC Product Code 68083-108; 76045-003; 0409-2308; 17856-3566; 76045-001; 17478-524; 0904-7113; 44567-610; 68083-106; 68094-762; 76045-002; 76045-211; 17511-134; 52584-589; 17478-523; 50090-3435; 55154-4743; 0404-9916; 52584-308; 70860-601; 70860-600; 63323-411; 23155-600; 0409-2305; 50090-5472; 48087-0103; 47781-589; 23155-601; 0409-2587; 63629-2534; 50090-5342; 63323-412; 17856-0146; 11704-650; 0054-3566; 44567-611; 0904-7114; 0409-2596; 68094-764; 0574-0150; 60687-576
Synonyms Midazolam | Midazolam Maleate | Maleate, Midazolam | Dormicum | Versed | Midazolam Hydrochloride | Hydrochloride, Midazolam | Ro 21-3981 | Ro 21 3981 | Ro 213981
Chemical Information
Molecular Formula C18H14Cl2FN3
CAS Registry Number 59467-96-8
SMILES CC1=NC=C2N1C3=C(C=C(C=C3)Cl)C(=NC2)C4=CC=CC=C4F.Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Cytokine release syndromeInterleukin-1 betaP01584T42000Not Available
Cytokine release syndromeInterleukin-6P05231T32578Not Available
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--
Anaesthesia17.02.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anxiety19.06.02.002--
Apnoea22.02.01.001--
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Blood pressure abnormal13.14.03.001--Not Available
Bradycardia02.03.02.002--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Chills15.05.03.016; 08.01.09.001--
Choreoathetosis17.01.01.003--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Cough22.02.03.001--
Delirium19.13.02.001--
Diplopia06.02.06.002; 17.17.01.005--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dysarthria19.19.03.001; 17.02.08.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Dysphonia19.19.03.002; 17.02.08.004; 22.02.05.005--
Dysphoria19.04.02.004--Not Available
Dyspnoea22.02.01.004; 02.01.03.002--
Ear disorder04.03.01.001--Not Available
Erythema23.03.06.001--Not Available
Euphoric mood19.04.02.006--
Extrasystoles02.03.02.003--Not Available
Haematoma24.07.01.001--
Hallucination19.10.02.002--
Headache17.14.01.001--
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