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 **Intravenous** Indicated for promoting preoperative sedation, anxiolysis, anesthesia induction, or amnesia.[F2434] **Intramuscular** Indicated for the treatment of status epilepticus in adults.[FDA label] **Nasal** Indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.[L6559]
Marketing Status approved; illicit
ATC Code N05CD08
DrugBank ID DB00683
KEGG ID D00696
MeSH ID D008874
PubChem ID 43032
TTD Drug ID D0U6LM
NDC Product Code 0904-7113; 11704-650; 23155-600; 51754-2131; 55154-4743; 0409-2308; 0904-7114; 51754-2130; 60687-576; 0409-2305; 76045-002; 76045-003; 63323-411; 68094-764; 70860-600; 70860-601; 0574-0150; 76045-001; 17511-134; 23155-601; 44567-611; 63323-412; 0054-3566; 17478-523; 0404-9916; 17478-524; 68094-762; 48087-0103; 44567-610; 63629-2534; 68083-108; 52584-308; 68083-106; 0409-2587; 0409-2596; 76045-211
UNII W7TTW573JJ
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
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)
Aggression19.05.01.001---
Agitation17.02.05.012; 19.06.02.001--
Anaesthesia17.02.06.036---
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Anxiety19.06.02.002--
Apnoea22.02.01.001--
Asthenia08.01.01.001---
Ataxia08.01.02.004; 17.02.02.001--
Blood pressure abnormal13.14.03.001---
Bradycardia02.03.02.002---
Bronchospasm10.01.03.012; 22.03.01.004--
Chills08.01.09.001; 15.05.03.016--
Choreoathetosis17.01.01.003---
Confusional state17.02.03.005; 19.13.01.001--
Cough22.02.03.001--
Delirium19.13.02.001--
Diplopia06.02.06.002; 17.17.01.005---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysarthria17.02.08.001; 19.19.03.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Dysphonia17.02.08.004; 19.19.03.002; 22.12.03.006--
Dysphoria19.04.02.004---
Dyspnoea02.11.05.003; 22.02.01.004--
Ear disorder04.03.01.001---
Erythema23.03.06.001---
Euphoric mood19.04.02.006--
Extrasystoles02.03.02.003---
Haematoma24.07.01.001--
Hallucination19.10.04.003--
Headache17.14.01.001--
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