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)
Brain stem haemorrhage17.08.01.031; 24.07.04.0150.000036%Not Available
Breast cancer16.10.01.001; 21.05.01.003--Not Available
Breast engorgement18.08.02.001; 21.05.05.002--Not Available
Breast enlargement21.05.04.001--Not Available
Breast feeding26.05.01.001--Not Available
Breast pain21.05.05.0030.000091%
Breech presentation18.03.04.0010.000817%Not Available
Bronchial obstruction22.03.01.0130.000136%
Bronchiectasis22.03.02.0050.000272%Not Available
Bronchiolitis11.05.04.008; 22.03.02.0040.000091%Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Bronchopulmonary dysplasia18.04.10.001; 22.11.01.0010.000047%Not Available
Bronchospasm10.01.03.012; 22.03.01.004--
Bruxism07.01.06.008; 19.11.03.0010.000363%Not Available
Buccoglossal syndrome07.14.02.010; 17.01.02.013--Not Available
Bundle branch block02.03.01.009--Not Available
Bundle branch block left02.03.01.0070.000363%Not Available
Burning sensation08.01.09.029; 17.02.06.001--Not Available
Bursitis15.04.01.0010.000182%Not Available
C-reactive protein increased13.09.01.007--Not Available
Cachexia08.01.01.009; 14.03.02.001; 16.32.03.011--Not Available
Calculus urinary20.04.02.001--Not Available
Carcinogenicity12.03.01.038--Not Available
Cardiac arrest02.03.04.0010.000237%
Cardiac failure02.05.01.001--
Cardiac failure acute02.05.01.0050.000024%Not Available
Cardiac failure congestive02.05.01.002--Not Available
Cardiac murmur13.14.01.0010.002450%Not Available
Cardio-respiratory arrest02.03.04.002; 22.02.06.0070.000213%Not Available
Cardiogenic shock02.05.01.003; 24.06.02.0060.000318%Not Available
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ADReCS-Target
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