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)
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Alveolitis allergic22.01.01.002; 10.01.03.008--Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea05.05.01.002; 21.01.02.001--
Amnesia19.20.01.001; 17.03.02.0010.000635%
Anaemia01.03.02.001--
Anaemia neonatal01.03.02.011; 18.04.03.0020.000136%Not Available
Anal atresia03.04.06.001; 07.13.05.0010.000182%Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.0070.000091%Not Available
Anencephaly17.19.03.001; 03.10.03.0010.000071%Not Available
Anger19.04.02.0010.000590%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Angle closure glaucoma06.03.01.0010.000681%Not Available
Anhedonia19.15.02.007--Not Available
Anorgasmia19.08.01.0010.000681%
Anterograde amnesia17.03.02.005; 19.20.01.0050.000182%Not Available
Antisocial behaviour19.05.01.0100.000182%Not Available
Antisocial personality disorder19.05.03.002--Not Available
Anxiety19.06.02.0020.005082%
Aortic stenosis24.04.01.0010.000136%Not Available
Aortic valve incompetence02.07.03.0010.000272%Not Available
Aortic valve stenosis02.07.03.0040.000136%Not Available
Apathy19.04.04.0020.000908%Not Available
Apgar score low13.15.01.0120.000318%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000318%
Aphthous ulcer07.05.06.0020.000091%Not Available
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