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 **Indicated** for: 1) Management of Major Depressive Disorder.[label] 2) Management of Generalized Anxiety Disorder.[label] 3) Management of diabetic peripheral neuropathy.[label] 4) Management of fibromyalgia.[label] 5) Management of chronic musculoskeletal pain.[label] 6) Management of osteoarthritis of the knee in adults.[L6364] 7) Management of chronic lower back pain in adults.[L6364] 8) Management of stress urinary incontinence in adult women.[L6367] **Off-label** uses include: 1) Management of chemotherapy-induced peripheral neuropathy.[A178603] 2) Management of stress urinary incontinence in adult men after prostatectomy until recovery is complete.[L6370]
Marketing Status approved
ATC Code N06AX21
DrugBank ID DB00476
KEGG ID D07880
MeSH ID D000068736
PubChem ID 60835
TTD Drug ID D01AXB
NDC Product Code 49252-007; 50268-269; 50268-270; 51655-237; 55700-605; 61919-422; 63629-5174; 65841-799; 71205-358; 71205-445; 71205-525; 71205-602; 31722-582; 47335-616; 47335-617; 50268-286; 0228-2892; 60760-559; 70518-1054; 71205-005; 71610-403; 27241-098; 31722-170; 43547-380; 43547-381; 47335-382; 47335-619; 55700-628; 60760-462; 61919-483; 67877-264; 68084-692; 68180-295; 68180-296; 55700-727; 63629-5202; 70518-2630; 76420-236; 31722-169; 47335-383; 47335-618; 49252-009; 50090-6406; 55154-4981; 63629-8051; 63629-8748; 68180-294; 68180-297; 70518-1128; 70518-1139; 70518-3287; 70710-1538; 27241-164; 50268-287; 53002-1494; 60760-461; 65841-801; 67877-265; 70518-2855; 71335-1672; 71335-1964; 46708-278; 68071-2709; 68084-683; 68382-387; 70518-3601; 71335-0402; 71335-2017; 27241-097; 27241-099; 31722-168; 49252-008; 0228-2891; 53002-1561; 68788-7672; 70710-1539; 70771-1344; 70771-1346; 80425-0311; 65977-0035; 46708-280; 47335-381; 50090-6040; 65841-800; 68382-385; 68788-7935; 70710-1537; 70771-1345; 80425-0119; 31722-581; 46708-279; 50090-6281; 50268-288; 55154-4980; 67877-263; 68084-675; 68382-386; 70518-1011; 70518-3177; 31722-583; 43547-379; 45865-813; 50090-4708; 50090-5940; 50268-271; 0228-2890
UNII O5TNM5N07U
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
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)
Disturbance in sexual arousal19.08.04.0030.000059%Not Available
Early satiety14.03.01.010; 08.01.09.004; 07.01.06.0270.000072%Not Available
Anogenital warts23.10.01.003; 21.10.03.004; 16.26.01.003; 11.05.07.002; 07.19.04.0020.000027%Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.0050.001279%
Adverse event08.06.01.010--Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000131%Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.000112%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000067%Not Available
Limb discomfort15.03.04.014--Not Available
Ischaemia24.04.02.0040.000107%Not Available
Learning disorder19.21.05.0010.000027%Not Available
Malnutrition14.03.02.0040.000040%Not Available
Mental disorder19.07.01.0020.000456%Not Available
Motor dysfunction17.01.02.031; 15.05.06.0060.000093%Not Available
Oesophageal disorder07.11.02.0010.000040%Not Available
Partial seizures17.12.03.0100.000027%Not Available
Therapeutic reaction time decreased08.06.01.015--Not Available
Abnormal behaviour19.01.01.0010.000538%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.001793%
Feeling of body temperature change08.01.09.0120.000157%Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.000256%
Psychiatric symptom19.01.02.0010.000093%Not Available
Respiratory disorder neonatal22.11.01.002; 18.04.09.0020.000053%Not Available
Urinary tract obstruction20.08.01.0040.000027%
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.000027%Not Available
Adverse drug reaction08.06.01.009--Not Available
Psychotic disorder19.03.01.0020.000232%
Gastrointestinal obstruction07.13.01.0050.000040%Not Available
Hyperlipidaemia14.08.03.001--
Sympathomimetic effect17.05.01.016; 08.06.01.0200.000053%Not Available
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