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)
Sleep sex19.02.03.011; 17.15.02.0080.000027%Not Available
Stiff person syndrome17.05.02.018; 15.05.04.021; 10.04.10.0170.000173%Not Available
Neonatal behavioural syndrome22.11.02.007; 18.04.04.010; 17.02.05.058; 15.05.04.0200.000040%Not Available
Thunderclap headache17.14.01.0180.000040%Not Available
Intensive care unit acquired weakness17.09.01.004; 15.05.05.0120.000053%Not Available
Rapid eye movement sleep behaviour disorder19.02.03.010; 17.15.04.0080.000240%Not Available
Selective eating disorder19.09.01.012; 14.03.02.0240.000144%Not Available
Central sleep apnoea syndrome22.02.01.035; 19.02.05.011; 17.15.05.0020.000067%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.038--Not Available
Electric shock sensation17.02.07.024; 08.06.02.0230.000234%Not Available
Fumbling17.01.02.0300.000027%Not Available
Gait inability17.02.05.069; 08.01.02.0110.000152%Not Available
Hepatic cytolysis09.01.07.0360.000027%Not Available
Histrionic personality disorder19.05.03.001--Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.013--Not Available
Inadequate analgesia12.02.20.006; 08.06.01.0400.000091%Not Available
Inhibitory drug interaction08.06.03.0140.000059%Not Available
Intestinal prolapse07.11.01.0140.000027%Not Available
Lung opacity22.12.01.0060.000027%Not Available
Lymphocytic oesophagitis07.08.05.008; 01.02.05.0040.000040%Not Available
Neonatal seizure18.04.04.019; 17.12.03.0380.000040%Not Available
Oesophageal hypomotility07.02.02.0210.000040%Not Available
Paedophilia19.08.06.0030.000027%Not Available
Pharyngeal swelling22.04.05.028--Not Available
Psychotic symptom19.03.01.0120.000040%Not Available
Spinal stenosis17.10.01.031; 15.10.04.0140.000027%Not Available
Taste disorder07.14.03.004; 17.02.07.029--Not Available
Therapeutic product effect decreased08.06.01.0500.000533%Not Available
Therapeutic product effect delayed08.06.01.0510.000059%Not Available
Therapeutic product ineffective08.06.01.0570.000104%Not Available
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