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)
Brain stem haemorrhage24.07.04.015; 17.08.01.0310.000036%Not Available
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast engorgement21.05.05.002; 18.08.02.001--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
Bronchiolitis22.03.02.004; 11.05.04.0080.000091%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Bronchopulmonary dysplasia22.11.01.001; 18.04.10.0010.000047%Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Bruxism19.11.03.001; 07.01.06.0080.000363%Not Available
Buccoglossal syndrome17.01.02.013; 07.14.02.010--Not Available
Bundle branch block02.03.01.009--Not Available
Bundle branch block left02.03.01.0070.000363%Not Available
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Bursitis15.04.01.0010.000182%Not Available
C-reactive protein increased13.09.01.007--Not Available
Cachexia14.03.02.001; 08.01.01.009; 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 shock24.06.02.006; 02.05.01.0030.000318%Not Available
The 5th Page    First    Pre   5 6 7 8 9    Next   Last    Total 40 Pages