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 Labeled indication include: major depressive disorder (MDD), moderate to severe bulimia nervosa, obsessive-compulsive disorder (OCD), premenstrual dysphoric disorder (PMDD), panic disorder with or without agoraphobia, and combination treatment with olanzapine for treatment-resistant or bipolar I depression. Unlabeled indications include: selective mutism, mild dementia-associated agitation in nonpsychotic patients, post-traumatic stress disorder (PTSD), social anxiety disorder, chronic neuropathic pain, fibromyalgia, and Raynaud's phenomenon.
Marketing Status Prescription; Discontinued
ATC Code N06AB03
DrugBank ID DB00472
KEGG ID D00326
MeSH ID D005473
PubChem ID 3386
TTD Drug ID D0TR5X
NDC Product Code 0093-7188; 50090-3332; 50228-420; 67296-1198; 63304-632; 70934-712; 63187-233; 50111-647; 61919-253; 0904-5785; 50228-421; 59651-324; 61919-885; 58118-0645; 59651-308; 53002-2305; 42708-025; 16714-112; 68071-4033; 42291-397; 16714-113; 23155-030; 71209-041; 42291-398; 0093-7198; 63629-2201; 59651-309; 61919-745; 46708-272; 53002-5016; 16714-353; 23155-029; 68001-129; 0093-0807; 62332-242; 46708-273; 71335-0924; 61919-869; 62332-022; 65862-306; 68071-4606; 46708-271; 72241-007; 43063-839; 55111-150; 50090-2776; 0615-8093; 49884-468; 16714-351; 23155-028; 71610-464; 0093-5262; 0904-5784; 68645-130; 43598-566; 60760-259; 55154-1341; 16714-352; 13668-473; 71205-178; 13668-443; 61919-100; 55700-089; 0615-7625; 50090-0744; 42291-396; 62332-243; 63187-089; 72241-008; 71335-1048; 50111-648; 71209-040; 72241-009; 71205-188; 61919-490; 71335-0565; 62332-024; 68645-131; 63629-8179; 62332-023; 71209-042
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Clonus17.02.05.0020.000182%Not Available
Coagulopathy01.01.02.0010.000136%Not Available
Coarctation of the aorta24.04.01.002; 03.07.08.0010.000284%Not Available
Cogwheel rigidity17.01.05.001; 15.05.04.0060.000136%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000136%Not Available
Colitis07.08.01.001--
Coma17.02.09.0010.001225%Not Available
Completed suicide08.04.01.010; 19.12.01.0010.001267%Not Available
Compulsions19.06.05.0030.000136%Not Available
Conduction disorder02.03.01.0080.000182%
Confusional state19.13.01.001; 17.02.03.0050.002677%
Congenital central nervous system anomaly17.19.01.003; 03.10.02.0040.000363%Not Available
Congenital diaphragmatic hernia22.09.02.003; 07.16.01.003; 03.16.03.0010.000036%Not Available
Conjunctivitis06.04.01.002; 11.01.06.012--
Constipation07.02.02.001--
Conversion disorder19.24.01.001--Not Available
Convulsion neonatal18.04.04.003; 17.12.03.0170.000272%Not Available
Coordination abnormal17.02.02.0040.000091%Not Available
Corneal lesion06.06.03.004--Not Available
Cough22.02.03.001--
Cough decreased22.02.03.006--Not Available
Crohn's disease10.02.01.005; 07.08.01.015--Not Available
Crying17.02.05.013; 12.02.11.001; 08.01.03.005; 19.04.02.0020.000726%Not Available
Cryptorchism21.15.01.001; 05.05.02.002; 03.03.01.0010.000227%Not Available
Cyanosis24.03.01.007; 22.02.02.007; 02.01.02.0020.000363%
Cyclothymic disorder19.16.01.0040.000136%Not Available
Cystitis20.03.02.002; 11.01.14.001--
Deafness04.02.01.0010.000454%Not Available
Deafness neurosensory17.04.07.001; 04.02.01.0020.000227%Not Available
Death08.04.01.001--
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