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)
Poor quality sleep19.02.05.005; 17.15.04.0020.000261%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000093%Not Available
Head titubation17.01.06.006--Not Available
Suicidal behaviour19.12.01.0060.000093%Not Available
Activation syndrome19.06.02.008; 17.02.05.0410.000053%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000107%Not Available
Pharyngeal disorder22.04.05.0070.000027%Not Available
Psychiatric decompensation19.01.02.0100.000072%Not Available
Oral disorder07.05.01.0050.000059%Not Available
Vulvovaginal burning sensation21.08.02.0070.000027%Not Available
Spasmodic dysphonia22.12.03.026; 17.01.03.0070.000040%Not Available
Abdominal wall haemorrhage12.01.17.002; 24.07.02.036; 07.16.05.002--Not Available
Cholestatic liver injury09.01.07.0160.000027%Not Available
Hypertransaminasaemia09.01.02.0050.000059%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Osmotic demyelination syndrome17.16.02.0040.000067%Not Available
Foetal growth restriction18.03.01.0020.000053%
Functional gastrointestinal disorder07.11.01.0160.000059%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000440%Not Available
Medication overuse headache17.14.01.015; 08.06.02.0150.000027%Not Available
Reversible cerebral vasoconstriction syndrome24.04.06.026; 18.06.01.004; 17.08.02.0140.000107%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000053%Not Available
Blood pressure measurement13.14.03.022--Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000085%
Frustration tolerance decreased19.04.02.0160.000067%Not Available
Depersonalisation/derealisation disorder19.14.01.0040.000027%Not Available
Cervical spinal stenosis17.10.02.006; 15.10.04.0060.000027%Not Available
Concomitant disease aggravated08.01.03.063--Not Available
Drug withdrawal headache17.14.01.006; 08.06.02.0110.000117%Not Available
Flashback19.10.05.0050.000027%Not Available
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