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)
Visual acuity reduced06.02.10.012; 17.17.01.0110.000112%
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Visual impairment06.02.10.0130.001137%Not Available
Volvulus07.13.01.0120.000027%Not Available
Vomiting07.01.07.0030.020215%
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Withdrawal syndrome19.07.06.023; 08.06.02.0120.003820%Not Available
Yawning22.12.03.0370.000072%Not Available
Mental status changes19.07.01.0010.000264%Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000210%Not Available
Fibromyalgia15.05.02.0020.000386%Not Available
Energy increased08.01.03.0170.000099%Not Available
Acute generalised exanthematous pustulosis11.07.01.018; 10.01.01.034; 23.03.10.002; 12.03.01.0050.000160%Not Available
Localised oedema08.01.07.011; 02.05.04.006; 14.05.06.0090.000027%
Brain oedema17.07.02.003; 12.01.10.0100.000053%
Weight fluctuation14.03.02.0020.000027%Not Available
Muscle fatigue15.05.03.006--Not Available
Homicidal ideation19.05.01.0080.000160%Not Available
Left ventricular hypertrophy02.04.02.0140.000027%Not Available
Muscle tightness15.05.03.0070.000093%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000932%Not Available
Impatience19.05.01.0140.000040%Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.000080%Not Available
Abulia19.01.02.009; 17.02.05.0400.000059%Not Available
Sudden onset of sleep17.15.04.0030.000085%Not Available
Dysstasia17.02.02.012; 15.03.05.011; 08.01.03.0890.000099%Not Available
Intervertebral disc protrusion15.10.01.0040.000085%Not Available
Lupus-like syndrome15.06.02.004; 10.04.03.003; 23.03.02.0040.000027%Not Available
Self-injurious ideation19.12.01.0070.000120%Not Available
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