Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Imipramine hydrochloride
Drug ID BADD_D01140
Description Imipramine, the prototypical tricyclic antidepressant (TCA), is a dibenzazepine-derivative TCA. TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, imipramine does not affect mood or arousal, but may cause sedation. In depressed individuals, imipramine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. Tertiary amine TCAs, such as imipramine and amitriptyline, are more potent inhibitors of serotonin reuptake than secondary amine TCAs, such as nortriptyline and desipramine. TCAs also block histamine H1 receptors, α1-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively [A6584]. Imipramine has less sedative and anticholinergic effects than the tertiary amine TCAs, amitriptyline and clomipramine. Imipramine may be used to treat depression and nocturnal enuresis in children [FDA Label]. Unlabeled indications include chronic and neuropathic pain (including diabetic neuropathy), panic disorder, attention-deficit/hyperactivity disorder (ADHD), and post-traumatic stress disorder (PTSD) [L1349,L1348,A31900,L1351,L1352,L1353,A31904].
Indications and Usage For the relief of symptoms of depression and as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older [FDA Label]. May also be used off-label to manage panic disorders with or without agoraphobia, as a second line agent for ADHD in children and adolescents, to manage bulimia nervosa, for short-term management of acute depressive episodes in bipolar disorder and schizophrenia, for the treatment of acute stress disorder and posttraumatic stress disorder, and for symptomatic treatment of postherpetic neuralgia and painful diabetic neuropathy [L1349,L1348,A31900,L1351,L1352,L1353,A31904].
Marketing Status approved
ATC Code N06AA02
DrugBank ID DB00458
KEGG ID D00815
MeSH ID D007099
PubChem ID 8228
TTD Drug ID D06ZUK
NDC Product Code 72789-243; 72789-240; 80425-0294; 42291-346; 49884-054; 49884-056; 55700-709; 49884-055; 60429-095; 60429-096; 60429-097; 68071-2730; 69315-134; 69584-427; 70518-1588; 70518-2047; 72789-244; 71554-008; 42291-347; 63629-2208; 70868-810; 63629-2209; 64380-169; 50436-2022; 63629-2210; 69584-426; 70518-1793; 38779-0443; 64380-171; 69315-135; 71205-804; 15894-0034; 67763-112; 50090-3148; 63629-8149; 64380-170; 69315-133; 70518-3526; 80425-0342; 49452-3665; 42291-345; 69584-425; 70518-3438
UNII BKE5Q1J60U
Synonyms Imipramine | Norchlorimipramine | Imidobenzyle | Imizin | Tofranil | Janimine | Melipramine | Pryleugan | Imipramine Pamoate | 4,4'-Methylenebis(3-hydroxy-2-naphthoic acid)-3-(10,11-dihydro-5H-dibenzo(b,f)azepin-5-yl)-N,N-dimethyl-1-propanamine (1:2) | Imipramine Hydrochloride | Imipramine Monohydrochloride
Chemical Information
Molecular Formula C19H25ClN2
CAS Registry Number 113-52-0
SMILES CN(C)CCCN1C2=CC=CC=C2CCC3=CC=CC=C31.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)
Abdominal pain07.01.05.002--
Accommodation disorder06.02.04.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alopecia23.02.02.001--
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Atrioventricular block02.03.01.002--Not Available
Blood glucose abnormal13.02.02.008--Not Available
Breast enlargement21.05.04.001--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Coordination abnormal17.02.02.004--Not Available
Delusion19.10.01.001--
Diarrhoea07.02.01.001--
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness24.06.02.007; 02.11.04.006; 17.02.05.003--
Dry mouth07.06.01.002--
Electrocardiogram abnormal13.14.05.001--Not Available
Electroencephalogram abnormal13.07.03.001--Not Available
Eosinophilia01.02.04.001--
Extrapyramidal disorder17.01.02.007--
Fall12.01.08.002--
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
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