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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.003837%
Abdominal pain upper07.01.05.0030.003043%
Abdominal tenderness07.01.05.0040.000132%Not Available
Abnormal dreams19.02.03.001; 17.15.02.0010.001323%Not Available
Abnormal sensation in eye06.01.01.0010.000132%Not Available
Abortion18.01.01.0010.000265%Not Available
Abortion spontaneous18.01.04.001--Not Available
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.0010.000069%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.001--Not Available
Affective disorder19.04.04.0010.000265%Not Available
Aggression19.05.01.0010.010915%Not Available
Agitation19.06.02.001; 17.02.05.0120.127940%
Agoraphobia19.06.03.0040.000265%Not Available
Akathisia19.06.02.006; 17.01.02.0020.000397%
Alanine aminotransferase decreased13.03.01.0020.000132%Not Available
Alanine aminotransferase increased13.03.01.0030.002249%
Alcohol abuse19.07.02.0070.000198%Not Available
Alcoholism19.07.02.0010.000529%Not Available
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.000794%Not Available
Amnesia19.20.01.001; 17.03.02.0010.003374%
Amylase increased13.05.01.0090.000132%
Amyotrophic lateral sclerosis17.05.05.0040.000331%Not Available
Anaemia01.03.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.000132%Not Available
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