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)
Influenza like illness08.01.03.010--
Initial insomnia19.02.01.005; 17.15.03.005--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Irritability19.04.02.013; 08.01.03.011--
Irritable bowel syndrome19.24.01.003; 07.02.04.003--Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Laryngeal pain22.12.03.010--
Laryngitis11.01.13.001; 22.07.03.001--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukopenia01.02.02.001--Not Available
Libido decreased19.08.03.001; 21.03.02.005--
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.004--Not Available
Loss of libido19.08.03.003--Not Available
Lymphadenopathy01.09.01.002--Not Available
Macular degeneration06.09.03.001--Not Available
Maculopathy06.09.03.007--Not Available
Malaise08.01.01.003--
Mania19.16.02.002--
Melaena24.07.02.013; 07.12.02.004--Not Available
Menopausal symptoms21.02.02.002--Not Available
Menstrual disorder21.01.01.004--Not Available
Micturition urgency20.02.02.006--
Middle insomnia19.02.01.003; 17.15.03.003--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Musculoskeletal pain15.03.04.007--
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