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)
Periodic limb movement disorder19.02.05.009; 17.15.04.006; 15.05.03.0340.000091%Not Available
Tachyphrenia19.10.03.010; 17.03.03.0070.000136%Not Available
Oral cavity fistula07.11.05.0140.000091%
Central nervous system necrosis24.04.06.032; 17.02.10.0200.000091%
VACTERL syndrome02.08.02.010; 24.03.02.030; 22.04.07.012; 15.03.01.026; 07.11.04.011; 03.02.01.0130.000182%Not Available
Congenital central hypoventilation syndrome22.02.01.029; 17.05.01.024; 03.10.02.0090.000182%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000272%Not Available
Tethered cord syndrome20.03.03.007; 17.10.01.0230.000182%Not Available
Velopharyngeal incompetence22.04.05.020; 07.05.01.0200.000136%Not Available
Mitral valve atresia03.07.05.014; 02.07.01.0060.000136%Not Available
Aortic valve atresia03.07.05.002; 02.07.03.0050.000182%Not Available
Congenital renal disorder20.01.02.015; 03.06.01.0080.000024%Not Available
Right atrial dilatation02.04.02.0320.000091%Not Available
Heart valve incompetence02.07.02.0030.000136%Not Available
Congenital tricuspid valve incompetence03.07.05.012; 02.07.05.0030.000136%Not Available
Foetal hypokinesia18.03.02.0150.000318%Not Available
Gross motor delay19.22.01.004; 17.01.02.0210.000091%Not Available
Motor developmental delay19.22.01.005; 17.01.02.0230.000408%Not Available
Mycobacterium tuberculosis complex test positive13.08.05.0040.000091%Not Available
Limb asymmetry15.10.03.0090.000091%
Hyporesponsive to stimuli17.02.05.0570.000136%Not Available
Eye colour change06.06.06.0080.000136%Not Available
Neonatal behavioural syndrome22.11.02.007; 18.04.04.010; 17.02.05.058; 15.05.04.0200.000590%Not Available
Genital paraesthesia21.10.05.016; 17.02.06.0320.000136%Not Available
Junctional ectopic tachycardia18.04.07.007; 12.02.01.026; 02.03.03.0190.000091%Not Available
Burn oral cavity12.05.04.006; 07.11.01.0210.000091%Not Available
Rapid eye movement sleep behaviour disorder19.02.03.010; 17.15.04.0080.000182%Not Available
Infantile apnoea22.11.02.004; 18.04.15.0030.000182%Not Available
Obsessive-compulsive symptom19.06.05.0100.000091%Not Available
Selective eating disorder14.03.02.024; 19.09.01.0120.000227%Not Available
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