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)
Grandiosity19.05.01.0190.000027%Not Available
Hyperbilirubinaemia neonatal18.04.08.003; 17.13.01.009; 14.11.01.038; 09.01.01.0140.000027%Not Available
Impulsive behaviour19.18.01.0010.000099%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000027%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000053%Not Available
Persecutory delusion19.10.01.0070.000053%Not Available
Post-traumatic stress disorder19.06.06.0020.000112%Not Available
Posturing19.11.03.008; 17.01.02.0240.000027%Not Available
Social anxiety disorder19.06.03.0100.000059%Not Available
Throat cancer22.08.02.008; 16.19.02.0070.000040%Not Available
Tremor neonatal18.04.04.012; 17.01.06.0100.000027%Not Available
Uraemic encephalopathy20.01.01.011; 17.13.01.012; 14.10.01.0090.000040%Not Available
Violence-related symptom19.05.01.0220.000040%Not Available
Feeling guilty19.15.02.0100.000053%Not Available
Pulmonary oedema neonatal02.05.02.007; 22.01.03.011; 18.04.09.0090.000027%Not Available
Tongue biting12.01.17.023; 17.02.05.064; 07.14.01.013--Not Available
Opsoclonus myoclonus17.13.02.010; 06.05.02.0220.000133%Not Available
Phobia of driving19.06.03.0090.000091%Not Available
Poor sucking reflex18.04.04.011; 17.02.01.0080.000027%Not Available
Negative thoughts19.15.02.0120.000040%Not Available
Sopor19.02.04.002; 17.02.04.0210.000240%Not Available
Psychogenic seizure17.12.03.042; 19.24.01.0070.000027%Not Available
Communication disorder19.19.01.0080.000144%Not Available
Disturbance in social behaviour19.05.01.018--Not Available
Foot deformity15.10.03.0050.000027%Not Available
Charles Bonnet syndrome19.10.04.001; 06.02.06.0160.000027%Not Available
Tachyphrenia17.03.03.007; 19.10.03.0100.000341%Not Available
Hyponatraemic encephalopathy17.13.01.011; 14.05.04.0070.000120%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000093%Not Available
Sleep-related eating disorder19.02.03.012; 17.15.02.009; 14.03.01.0120.000027%Not Available
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