Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Duloxetine hydrochloride
Drug ID BADD_D00735
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 D01179
MeSH ID D000068736
PubChem ID 60834
TTD Drug ID D01AXB
NDC Product Code 0110-3235; 43063-877; 43353-960; 50090-3205; 51991-746; 59651-280; 60687-745; 71335-0392; 71610-401; 0110-3270; 0110-9542; 0904-7043; 59651-282; 62128-0386; 73476-750; 51407-817; 63187-720; 82009-032; 65015-713; 25000-610; 33342-161; 43353-106; 51407-818; 57237-019; 63187-181; 63187-612; 68001-413; 57237-018; 61919-482; 63629-1990; 68788-8362; 71335-0165; 55111-859; 55745-0004; 59651-279; 68071-2711; 68788-7897; 71335-0509; 71610-402; 82009-029; 82009-030; 0110-9544; 49587-111; 73476-747; 25000-609; 60429-164; 60429-166; 60687-723; 61919-042; 68001-414; 68001-415; 82009-031; 0904-7044; 43353-025; 45865-815; 50090-2226; 55154-2341; 70518-0937; 0110-9543; 17337-0017; 51927-0059; 71554-015; 73476-746; 33342-162; 0002-3270; 51407-819; 60429-165; 63187-716; 63629-1991; 63629-2063; 68788-9301; 59286-1046; 68108-0705; 25000-608; 33342-160; 0002-3235; 43063-878; 51991-747; 51991-748; 60505-2995; 60687-734; 63187-666; 63187-702; 63187-735; 63629-1992; 63629-9187; 17337-0046; 73476-748; 0002-3240; 51991-750; 55154-2342; 57237-017; 63187-172; 68001-368; 71610-218; 0110-3240; 0110-9545; 14501-0005; 0904-7045; 51927-4999; 65862-463
UNII 9044SC542W
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 C18H20ClNOS
CAS Registry Number 136434-34-9
SMILES CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32.Cl
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)
Phlebitis24.12.03.004; 12.02.01.002--
Photopsia17.17.01.006; 06.02.06.004--
Photosensitivity reaction23.03.09.003--
Pollakiuria20.02.02.007--
Polyuria20.02.03.002--Not Available
Premature ejaculation21.03.01.008; 19.08.01.002--Not Available
Pressure of speech19.19.03.006--Not Available
Prurigo23.03.04.017--Not Available
Pruritus23.03.12.001--
Psychomotor hyperactivity19.11.02.003; 17.01.02.011--Not Available
Rash23.03.13.001--Not Available
Rash erythematous23.03.13.029--Not Available
Renal failure20.01.03.005--Not Available
Restlessness19.11.02.002; 17.02.05.021--
Retinal detachment12.01.04.004; 06.09.03.003--
Rhabdomyolysis15.05.05.002--
Secondary hypertension24.08.02.015--Not Available
Sedation17.02.04.005--Not Available
Seizure17.12.03.001--
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.041--Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Sjogren's syndrome07.06.01.010; 06.08.02.011; 15.06.01.015; 10.04.04.009--Not Available
Skin disorder23.03.03.007--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Sleep disorder19.02.04.001--Not Available
Sluggishness08.01.01.004--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
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