Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Duloxetine
Drug ID BADD_D00734
Description Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor.[label] It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686.[A178741] Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder.[L6454] It has since received approval for a variety of indications including the treatment of neuropathic pain, Generalized Anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.
Indications and Usage Authors unspecified: Duloxetine: new indication. Depression and diabetic neuropathy: too many adverse effects. Prescrire Int. 2006 Oct;15(85):168-72.
Marketing Status Prescription
ATC Code N06AX21
DrugBank ID DB00476
KEGG ID D07880
MeSH ID D000068736
PubChem ID 60835
TTD Drug ID D01AXB
NDC Product Code 55700-605; 60760-461; 53002-1561; 50436-0198; 71610-403; 47335-383; 70518-3287; 71205-005; 0228-2890; 43547-381; 61919-422; 53002-1494; 71205-358; 46708-279; 70710-1539; 68788-7672; 43547-379; 63629-5174; 80425-0119; 47335-616; 70710-1537; 55154-4981; 68180-294; 65841-801; 55154-4980; 45865-816; 70518-1128; 46708-278; 46708-280; 63629-8748; 47335-382; 70710-1538; 49252-007; 68382-386; 71205-602; 70771-1345; 68084-692; 61919-483; 50090-4011; 50090-4709; 51655-237; 67877-263; 47335-618; 71205-445; 70771-1344; 68382-387; 71335-2017; 68788-7935; 27241-099; 50268-288; 68180-296; 65841-799; 71335-1672; 70518-1011; 31722-168; 0228-2892; 63629-5202; 67877-265; 68180-295; 27241-164; 65977-0035; 47335-381; 70518-1054; 60760-462; 50090-5940; 47335-619; 68382-385; 31722-169; 50268-287; 45865-813; 68084-683; 63629-8051; 70771-1346; 65841-800; 43547-380; 49252-008; 71205-525; 68071-4700; 50090-4708; 55700-628; 70518-2855; 68180-297; 47335-617; 70518-3177; 31722-581; 70518-1139; 31722-582; 27241-098; 49252-009; 27241-097; 55700-727; 71335-0402; 67877-264; 68788-7828; 31722-583; 71335-1964; 68084-675; 0228-2891; 50436-0199; 50268-286; 31722-170; 70518-2630
Synonyms Duloxetine Hydrochloride | Hydrochloride, Duloxetine | Duloxetine HCl | HCl, Duloxetine | LY 248686 | LY-248686 | LY248686 | Duloxetine Ethanedioate (1:1), (+-)-isomer - T353987 | LY 227942 | LY-227942 | LY227942 | Duloxetine | N-methyl-3-(1-naphthalenyloxy)-3-(2-thiophene)propanamide | N-methyl-3-(1-naphthalenyloxy)-2-thiophenepropanamine | Duloxetine, (+)-isomer | Cymbalta
Chemical Information
Molecular Formula C18H19NOS
CAS Registry Number 116539-59-4
SMILES CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Full blood count decreased13.01.07.004--Not Available
Gastroschisis07.16.06.006; 03.04.07.0090.000132%Not Available
Hyperbilirubinaemia neonatal14.11.01.038; 09.01.01.014; 18.04.08.003; 17.13.01.0090.000132%Not Available
Impulsive behaviour19.18.01.0010.000397%Not Available
Jaw fracture15.08.02.006; 12.04.05.0010.000132%Not Available
Large for dates baby18.04.02.0040.000132%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000035%Not Available
Maternal drugs affecting foetus18.03.03.009; 12.03.03.0060.000198%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000397%Not Available
Nuclear magnetic resonance imaging abnormal13.18.03.0030.000132%Not Available
Nuclear magnetic resonance imaging brain abnormal13.07.07.0010.000198%Not Available
Persecutory delusion19.10.01.0070.000132%Not Available
Post-traumatic stress disorder19.06.06.0020.000331%Not Available
Social anxiety disorder19.06.03.0100.000132%Not Available
Spinal column stenosis15.10.04.003; 17.10.01.0110.000132%Not Available
Uraemic encephalopathy20.01.01.011; 14.10.01.009; 17.13.01.0120.000463%Not Available
Violence-related symptom19.05.01.0220.000132%Not Available
Feeling guilty19.15.02.0100.000132%Not Available
Pulmonary oedema neonatal22.01.03.011; 18.04.09.009; 02.05.02.0070.000132%Not Available
Impaired self-care19.01.02.014; 08.01.03.0710.000265%Not Available
Opsoclonus myoclonus17.13.02.010; 06.05.02.0220.000397%Not Available
Lip injury12.01.09.016; 07.05.01.0170.000132%Not Available
Phobia of driving19.06.03.0090.000132%Not Available
Poor sucking reflex18.04.04.011; 17.02.01.0080.000132%Not Available
Negative thoughts19.15.02.0120.000198%Not Available
Sopor19.02.04.002; 17.02.04.0210.001058%Not Available
Psychogenic seizure19.24.01.0070.000132%Not Available
Communication disorder19.19.01.0080.000463%Not Available
Foot deformity15.10.03.0050.000132%Not Available
Antidepressant drug level above therapeutic13.17.01.0250.000331%Not Available
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