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)
Cataract06.06.01.001--
Catatonia19.11.01.0010.000059%Not Available
Cerebral artery embolism24.01.04.001; 17.08.01.001--Not Available
Cerebral atrophy17.11.01.0010.000020%Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.0050.000039%
Cerebral venous thrombosis24.01.04.005; 17.08.03.0020.000020%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cervical incompetence18.02.02.009; 21.06.01.0080.000096%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.000390%Not Available
Chills15.05.03.016; 08.01.09.001--
Choking22.12.03.0030.000020%Not Available
Cholecystitis09.03.01.001--
Cholecystitis acute09.03.01.0030.000020%Not Available
Cholecystitis chronic09.03.01.0040.000020%Not Available
Cholelithiasis09.03.01.0020.000098%Not Available
Cholestasis09.01.01.0010.000089%Not Available
Cholinergic syndrome17.05.01.0020.000030%Not Available
Chromaturia20.02.01.0020.000098%
Circulatory collapse24.06.02.0010.000059%Not Available
Clonus17.02.05.0020.000089%Not Available
Coagulopathy01.01.02.0010.000030%Not Available
Cogwheel rigidity17.01.05.001; 15.05.04.0060.000053%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000030%Not Available
Colitis07.08.01.001--
Coma17.02.09.0010.000384%Not Available
Completed suicide08.04.01.010; 19.12.01.0010.001289%Not Available
Compulsions19.06.05.0030.000030%Not Available
Condition aggravated08.01.03.0040.001439%Not Available
Conduction disorder02.03.01.0080.000089%
Confusional state17.02.03.005; 19.13.01.0010.000894%
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ADReCS-Target
Drug Name ADR Term Target
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