Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diazepam
Drug ID BADD_D00648
Description A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of gamma-aminobutyric acid activity. It is used in the treatment of severe anxiety disorders, as a hypnotic in the short-term management of insomnia, as a sedative and premedicant, as an anticonvulsant, and in the management of alcohol withdrawal syndrome. (From Martindale, The Extra Pharmacopoeia, 30th ed, p589) Given diazepam's storied history as a commonly used and effective medication for a variety of indications, contemporary advancements in the formulation and administration of the agent include the development and US FDA approval of an auto-injectable formulation for the rapid treatment of uncontrolled seizures in 2015-2016 [L5200]. Combining diazepam, a proven effective therapy for acute repetitive seizures, with an auto-injector designed for subcutaneous administration that is quickly and easily administered offers the potential for complete, consistent drug absorption and rapid onset of effect [L5200]. This current development is subsequently an important addition to the rescue therapy tool chest for patients with epilepsy [L5200].
Indications and Usage In general, diazepam is useful in the symptomatic management of mild to moderate degrees of anxiety in conditions dominated by tension, excitation, agitation, fear, or aggressiveness such as may occur in psychoneurosis, anxiety reactions due to stress conditions, and anxiety states with somatic expression.[F3160] Moreover, in acute alcoholic withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, and impending acute delirium tremens.[F3160] Furthermore, diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathologies, such as inflammation of the muscle and joints or secondary to trauma; spasticity caused by upper motor neuron disorders, such as cerebral palsy and paraplegia; athetosis and the rare "stiff man syndrome".[F3160] Particular label information from the United Kingdom also lists particular age-specific indications, including for adults: (1) The short-term relief (2-4 weeks) only, of anxiety which is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness, (2) cerebral palsy, (3) muscle spasm, (4) as an adjunct to certain types of epilepsy (eg. myoclonus), (5) symptomatic treatment of acute alcohol withdrawal, (6) as oral premedication for the nervous dental patient, and (7) for premedication before surgery.[L5188] In the same UK label information, diazepam is indicated in children for: (1) control of tension and irritability in cerebral spasticity in selected cases, (2) as an adjunct to the control of muscle spasm in tetanus, and for (3) oral premedication.[L5188] A diazepam nasal spray is indicated in patients 6 years and older to treat intermittent, stereotypic episodes of frequent seizure activity that are different than the patient's usual seizure pattern.[L11247]
Marketing Status approved; illicit; investigational; vet_approved
ATC Code N05BA01
DrugBank ID DB00829
KEGG ID D00293
MeSH ID D003975
PubChem ID 3016
NDC Product Code 11014-0400; 43353-825; 45865-482; 49999-018; 58118-3926; 0404-9849; 68682-652; 68788-9207; 71610-460; 72252-510; 76420-533; 80425-0120; 11014-0401; 12828-0013; 38779-0925; 51927-1014; 43353-281; 45865-423; 50090-1913; 55289-092; 63187-544; 0404-9848; 68094-750; 68682-655; 71610-427; 72189-400; 72252-520; 0140-0006; 43063-718; 43353-276; 43353-278; 0172-3927; 45865-140; 63629-1523; 63629-7328; 0378-0271; 0378-0345; 66490-650; 68071-4922; 68788-8281; 69339-136; 70518-2358; 0615-7799; 72189-193; 58118-0640; 67296-0084; 68682-650; 0054-3188; 71610-270; 71610-424; 0641-6243; 80425-0151; 80725-005; 64330-010; 43063-840; 0172-3926; 0187-0659; 51079-286; 58118-3925; 63187-846; 68071-2826; 68788-8466; 69339-137; 76045-204; 43063-970; 51862-942; 58118-4047; 61919-906; 63739-073; 0378-0477; 67544-019; 67544-020; 71335-2196; 72189-401; 80725-006; 51927-0051; 35356-812; 43063-987; 50090-1726; 51079-285; 51862-943; 55154-5074; 55154-5554; 61919-409; 67296-0291; 68071-4770; 68788-8462; 70518-1713; 71872-7259; 72252-515; 72572-140; 11014-0399; 11704-600; 0140-0004; 0187-0658; 60687-755; 63629-2948; 0409-1273; 0527-1768; 71335-0444; 72252-505; 80725-004; 48087-0005; 48087-0112; 0172-3925; 51079-284; 51862-941; 63187-173; 63187-867; 68071-2828; 70518-0014; 71335-2197; 71335-2198; 71610-459; 0615-7800; 0904-7117; 51552-1025; 0140-0005; 52584-213; 53002-3340; 55700-058; 68071-3406; 0409-3213; 68788-7452; 70518-0162; 71335-1584; 71872-7260; 0641-6244; 71554-118; 0121-0905
Synonyms Diazepam | 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one | Diazemuls | Faustan | Valium | Seduxen | Sibazon | Stesolid | Apaurin | Relanium
Chemical Information
Molecular Formula C16H13ClN2O
CAS Registry Number 439-14-5
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)
Abdominal pain07.01.05.002--
Abdominal tenderness07.01.05.0040.000050%Not Available
Abnormal dreams17.15.02.001; Available
Abnormal faeces07.01.03.001--Not Available
Accommodation disorder06.02.04.0010.000050%Not Available
Acute febrile neutrophilic dermatosis23.03.03.033; Available
Acute hepatic failure09.01.03.0010.000201%Not Available
Acute respiratory distress syndrome10.02.01.067;;
Acute respiratory failure22.02.06.001; Available
Affective disorder19.04.04.0010.000050%Not Available
Aggression19.05.01.0010.000675%Not Available
Agranulocytosis01.02.03.0010.000277%Not Available
Alcohol abuse19.07.06.0010.000529%Not Available
Alcoholism19.07.06.0060.000196%Not Available
Altered state of consciousness19.07.01.003; Available
Amblyopia06.02.01.001--Not Available
Anaphylactic shock24.06.02.004; Available
Anger19.04.02.001--Not Available
Angioedema22.04.02.008;; Available
Anorectal disorder07.03.01.001--Not Available
Anterograde amnesia19.20.01.005; Available
Anticholinergic syndrome17.05.01.0010.000076%Not Available
Anuria20.01.03.0020.000126%Not Available
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