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)
Cardiomegaly02.04.02.0010.000189%Not Available
Cardiomyopathy02.04.01.0010.000408%Not Available
Cardiovascular disorder02.01.01.001; 24.03.02.009--Not Available
Cataract06.06.01.001--
Catatonia19.11.01.0010.000272%Not Available
Cellulitis23.09.01.001; 11.02.01.0010.000318%Not Available
Cerebral artery embolism24.01.04.001; 17.08.01.001--Not Available
Cerebral atrophy17.11.01.0010.000091%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.0050.000136%
Cerebral palsy18.04.04.004; 17.19.03.002; 03.10.03.0020.000182%Not Available
Cerebral venous thrombosis24.01.04.005; 17.08.03.0020.000024%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cervical incompetence21.06.01.008; 18.02.02.0090.000227%Not Available
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.0090.000590%Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.0110.001271%Not Available
Chills08.01.09.001; 15.05.03.016--
Choking22.02.05.0010.000091%Not Available
Cholecystitis09.03.01.001--
Cholecystitis acute09.03.01.0030.000091%Not Available
Cholecystitis chronic09.03.01.0040.000136%Not Available
Cholelithiasis09.03.01.0020.000182%Not Available
Cholestasis09.01.01.0010.000408%Not Available
Cholinergic syndrome17.05.01.0020.000136%Not Available
Chondrodystrophy15.11.03.001; 03.11.03.001--Not Available
Chromaturia20.02.01.0020.000408%
Circulatory collapse24.06.02.0010.000272%Not Available
Cleft lip03.11.05.002; 15.11.05.002; 07.05.08.0020.000908%Not Available
Cleft lip and palate07.05.08.003; 03.04.02.0030.000862%Not Available
Cleft palate07.05.08.001; 03.04.02.0010.001361%Not Available
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