Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Clonazepam
Drug ID BADD_D00501
Description A benzodiazepine used to treat various seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop [FDA Label] [L5572, F3763, F3787, F3796]. The agent has also been indicated for treating panic disorder [FDA Label] [A175438, L5572, F3763, F3787, F3796]. The mechanism of action appears to involve the enhancement of gamma-aminobutyric acid receptor responses [FDA Label] [A175438, A175441, L5572, F3763, F3787, F3796]. Since being first patented in 1960 and then released for sale from Roche in the US in 1975 [T469, T472], clonazepam has experienced a storied history in the treatment of the aforementioned medical conditions. Now available as a generic medication, the agent continues to see exceptionally high use as millions of prescriptions are written for the medication internationally every year. Unfortunately, however, like most benzodiazepines, clonazepam use has also been associated with recreational use and drug abuse [FDA Label] [L5572, F3763, F3787, F3796].
Indications and Usage Clonazepam is indicated as monotherapy or as an adjunct in the treatment of Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures [FDA Label] [F3787]. Furthermore, clonazepam may also be of some value in patients with absence spells (petit mal) who have failed to respond to succinimides [FDA Label] [F3787]. Additionally, clonazepam is also indicated for the treatment of panic disorder, with or without agoraphobia, as defined in the DSM-V [FDA Label]. Alternatively, some regional prescribing information note that clonazepam is indicated for all clinical forms of epileptic disease and seizures in adults, especially absence seizures (petit mal) including atypical absence; primary or secondarily generalised tonic-clonic (grand mal), tonic or clonic seizures; partial (focal) seizures with elementary or complex symptomatology; various forms of myoclonic seizures, myoclonus and associated abnormal movements [L5572, F3796]. Such regional label data also has clonazepam indicated for most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalized epilepsy or to secondary generalization of partial epilepsy [F3796].
Marketing Status approved; illicit
ATC Code N03AE01
DrugBank ID DB01068
KEGG ID D00280
MeSH ID D002998
PubChem ID 2802
TTD Drug ID D0CP4E
NDC Product Code 72789-307; 48087-0014; 71554-021; 16729-138; 0093-9294; 43063-788; 46708-364; 50268-175; 53002-1306; 57664-783; 63629-8226; 68788-7181; 71205-252; 51552-1567; 59651-722; 59651-723; 0093-9292; 49884-308; 51407-524; 61269-620; 63629-1203; 68071-2954; 70518-2334; 70518-3144; 72189-475; 0093-0832; 43063-794; 43547-408; 49884-310; 57664-784; 62332-367; 63629-1201; 63629-1202; 63629-7649; 63629-8988; 70518-1353; 70518-1521; 70518-2507; 72189-081; 67544-529; 68071-2310; 71205-529; 71335-1843; 71335-1856; 71610-040; 72789-315; 72888-152; 72888-153; 0904-7227; 16729-136; 0093-9291; 49884-307; 60760-273; 62332-368; 63629-1116; 68788-7738; 70518-2485; 70518-3583; 71335-0022; 71335-1810; 71610-368; 72888-154; 80425-0125; 80425-0135; 0004-0058; 0004-0068; 0093-9293; 57664-785; 57664-787; 58118-0832; 59651-724; 61269-605; 63187-226; 68788-8420; 70518-1297; 70518-1559; 70518-2533; 71610-039; 0904-7728; 48087-0038; 46708-365; 50090-2088; 50268-173; 50268-174; 61269-610; 62332-364; 63187-888; 63629-1206; 68071-5247; 70518-2232; 71335-0113; 71335-0333; 12828-0060; 64330-019; 0093-3212; 46708-368; 49884-309; 55700-564; 55700-830; 63629-1207; 68788-8401; 70518-2392; 43063-797; 49884-306; 57664-786; 60687-544; 62332-365; 63629-1204; 68788-7394; 68788-8473; 71610-084; 72789-314; 0093-3213; 0093-9290; 43547-407; 46708-366; 46708-367; 60687-555; 61919-485; 62332-366; 63187-603; 63629-1205; 70518-2467; 70518-3745; 71335-9747; 71610-023; 71610-061; 51927-0288; 16729-137; 43547-406; 45865-575; 50090-2022
UNII 5PE9FDE8GB
Synonyms Clonazepam | 2H-1,4-Benzodiazepin-2-one, 5-(2-chlorophenyl)-1,3-dihydro-7-nitro- | Rivotril | Klonopin | Antelepsin | Ro 5-4023 | Ro 54023
Chemical Information
Molecular Formula C15H10ClN3O3
CAS Registry Number 1622-61-3
SMILES C1C(=O)NC2=C(C=C(C=C2)[N+](=O)[O-])C(=N1)C3=CC=CC=C3Cl
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 discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.0010.000110%Not Available
Accident12.01.08.001--Not Available
Acidosis14.01.03.0020.000059%
Acne23.02.01.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000059%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000178%
Acute respiratory failure14.01.04.004; 22.02.06.0010.000059%Not Available
Adams-Stokes syndrome17.02.04.010; 02.03.01.0010.000030%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.0010.000418%Not Available
Agitation17.02.05.012; 19.06.02.0010.000742%
Agoraphobia19.06.03.004--Not Available
Akathisia19.06.02.006; 17.01.02.0020.000030%
Akinesia17.01.02.003--Not Available
Alcohol poisoning19.07.06.002; 12.03.01.017--Not Available
Alcoholism19.07.06.0060.000202%Not Available
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.000297%Not Available
Amnesia19.20.01.001; 17.03.02.0010.000131%
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anger19.04.02.0010.000211%Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Angle closure glaucoma06.03.01.0010.000030%Not Available
Anhedonia19.15.02.007--Not Available
Anterograde amnesia19.20.01.005; 17.03.02.005--Not Available
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