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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Periodic limb movement disorder15.05.03.034; 17.15.04.006; 19.02.05.0090.000091%Not Available
Tachyphrenia17.03.03.007; 19.10.03.0100.000136%Not Available
Oral cavity fistula07.11.05.0140.000091%
Central nervous system necrosis17.02.10.020; 24.04.06.0320.000091%
VACTERL syndrome02.08.02.010; 03.02.01.013; 07.11.04.011; 15.03.01.026; 22.04.07.012; 24.03.02.0300.000182%Not Available
Congenital central hypoventilation syndrome03.10.02.009; 17.05.01.024; 22.02.01.0290.000182%Not Available
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.000272%Not Available
Tethered cord syndrome17.10.01.023; 20.03.03.0070.000182%Not Available
Velopharyngeal incompetence07.05.01.020; 22.04.05.0200.000136%Not Available
Mitral valve atresia02.07.01.006; 03.07.05.0140.000136%Not Available
Aortic valve atresia02.07.03.005; 03.07.05.0020.000182%Not Available
Congenital renal disorder03.06.01.008; 20.01.02.0150.000024%Not Available
Right atrial dilatation02.04.02.0320.000091%Not Available
Heart valve incompetence02.07.02.0030.000136%Not Available
Congenital tricuspid valve incompetence02.07.05.003; 03.07.05.0120.000136%Not Available
Foetal hypokinesia18.03.02.0150.000318%Not Available
Gross motor delay17.01.02.021; 19.22.01.0040.000091%Not Available
Motor developmental delay17.01.02.023; 19.22.01.0050.000408%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 syndrome15.05.04.020; 17.02.05.058; 18.04.04.010; 22.11.02.0070.000590%Not Available
Genital paraesthesia17.02.06.032; 21.10.05.0160.000136%Not Available
Junctional ectopic tachycardia02.03.03.019; 12.02.01.026; 18.04.07.0070.000091%Not Available
Burn oral cavity07.11.01.021; 12.05.04.0060.000091%Not Available
Rapid eye movement sleep behaviour disorder17.15.04.008; 19.02.03.0100.000182%Not Available
Infantile apnoea18.04.15.003; 22.11.02.0040.000182%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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ADReCS-Target
Drug Name ADR Term Target
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