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)
Hypertensive crisis24.08.01.0010.000080%Not Available
Hyperthermia12.05.01.002; 08.05.01.0010.000107%Not Available
Hyperthyroidism14.11.01.011; 05.02.02.0010.000099%
Hypertonia17.05.02.001; 15.05.04.0070.000027%Not Available
Hyperventilation22.02.01.006; 19.01.02.0040.000107%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.001593%Not Available
Hypohidrosis08.01.03.029; 23.02.03.0050.000059%
Hypokinesia17.01.02.0090.000085%Not Available
Hypomania19.16.02.0010.007232%Not Available
Hyponatraemia14.05.04.0020.001252%
Hypopnoea22.02.01.0210.000027%Not Available
Hypothyroidism14.11.01.012; 05.02.03.001--
Hypotonia17.05.02.002; 15.05.04.0080.000093%Not Available
Hypotonia neonatal17.05.02.010; 18.04.01.006; 15.05.04.0120.000027%Not Available
Impaired gastric emptying07.02.02.0040.000027%
Incontinence17.05.01.006; 07.01.06.011; 20.02.02.0040.000027%Not Available
Increased appetite14.03.01.003; 08.01.09.0270.000162%Not Available
Increased tendency to bruise24.07.06.012; 23.06.01.009; 01.01.03.005--Not Available
Indifference19.05.01.0040.000027%Not Available
Influenza11.05.03.001; 22.07.02.001--Not Available
Influenza like illness08.01.03.0100.001809%
Initial insomnia19.02.01.005; 17.15.03.0050.000085%Not Available
Insomnia19.02.01.002; 17.15.03.0020.043571%
Intentional self-injury19.12.01.002; 12.01.08.0360.000810%Not Available
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Irritability19.04.02.013; 08.01.03.0110.041581%
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.0040.000147%Not Available
Joint stiffness15.01.02.003--Not Available
Judgement impaired19.05.01.009; 17.03.03.0050.000027%Not Available
Laryngitis22.07.03.001; 11.01.13.001--
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