Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Fluoxetine
Drug ID BADD_D00932
Description Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI).[A181673] It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.[L7721]
Indications and Usage Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa; however, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present.[L7664] Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression.[L7664]
Marketing Status approved; vet_approved
ATC Code N06AB03
DrugBank ID DB00472
KEGG ID D00326
MeSH ID D005473
PubChem ID 3386
TTD Drug ID D0TR5X
NDC Product Code 0093-0807; 43063-839; 53002-2305; 61919-869; 62332-243; 71335-0924; 0615-8093; 0093-7198; 50090-3180; 50111-647; 50228-421; 59651-308; 68645-130; 0615-7625; 72241-009; 0904-5785; 0904-7195; 49884-468; 55111-150; 59651-324; 62332-242; 65862-306; 71209-041; 61919-885; 63304-632; 72241-008; 80426-044; 63187-233; 63629-8179; 70518-3752; 71335-0565; 80425-0313; 59651-309; 13668-443; 46708-273; 68645-131; 80426-045; 23155-028; 23155-030; 42291-398; 42571-388; 62332-024; 63187-089; 71335-1048; 0904-5784; 23155-029; 42291-396; 42571-389; 62332-022; 72162-1506; 72241-007; 16714-112; 16714-113; 42291-397; 42571-387; 43598-566; 46708-272; 50228-420; 58118-0645; 70518-1619; 71209-042; 13668-473; 50111-648; 55154-1341; 61919-100; 62332-023; 63629-2201; 71205-178; 71205-188; 71209-040; 42708-025; 46708-271; 53002-5016
UNII 01K63SUP8D
Synonyms Fluoxetine | Fluoxetin | N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine | Lilly-110140 | Lilly 110140 | Lilly110140 | Sarafem | Fluoxetine Hydrochloride | Prozac
Chemical Information
Molecular Formula C17H18F3NO
CAS Registry Number 54910-89-3
SMILES CNCCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F
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)
Psychomotor retardation19.15.02.0020.000030%Not Available
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.0020.000043%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary fibrosis22.01.02.0060.000039%
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000030%
Pulmonary hypertension24.08.03.002; 22.06.01.0010.000118%
Pulmonary oedema02.05.02.003; 22.01.03.003--
Pulmonary valve incompetence02.07.04.0010.000118%Not Available
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyelonephritis20.01.09.001; 11.01.14.002--Not Available
Pyrexia08.05.02.003--
Pyuria20.08.02.016; 11.01.08.043--Not Available
Rash23.03.13.001--Not Available
Rash macular23.03.13.003--Not Available
Rash maculo-papular23.03.13.004--
Rash morbilliform23.03.13.0050.000030%Not Available
Rash pustular23.03.10.003; 11.01.12.002--
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal colic20.02.03.0100.000020%
Renal failure20.01.03.005--Not Available
Renal pain20.02.03.003--Not Available
Renal tubular necrosis20.01.07.0030.000020%Not Available
Respiratory acidosis22.02.02.004; 14.01.04.0020.000020%Not Available
Respiratory arrest22.02.01.0090.000118%Not Available
Respiratory depression22.02.01.010; 17.02.05.0470.000059%Not Available
Respiratory disorder22.02.07.002--Not Available
Respiratory distress22.02.01.0120.000177%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000177%
Restlessness19.11.02.002; 17.02.05.0210.000409%
Retching07.01.07.0020.000063%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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