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)
Aplastic anaemia01.03.03.002--Not Available
Apnoea22.02.01.0010.000272%
Appendicitis07.19.01.001; 11.01.07.0010.000091%
Arrhythmia02.03.02.0010.000499%Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Ascites02.05.04.002; 07.07.01.001; 09.01.05.003--
Asocial behaviour19.05.01.011--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Asthenopia06.01.01.0020.000091%Not Available
Asthma10.01.03.010; 22.03.01.0020.000998%Not Available
Ataxia08.01.02.004; 17.02.02.0010.000182%
Atelectasis22.01.02.0010.000182%
Atrial fibrillation02.03.03.002--
Atrial flutter02.03.03.0030.000091%
Atrial septal defect02.04.02.009; 03.07.02.0020.005536%Not Available
Atrial tachycardia02.03.03.0040.000136%
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block first degree02.03.01.004--
Atrophy08.03.04.0010.000024%Not Available
Attention deficit/hyperactivity disorder19.21.04.0010.001271%Not Available
Autism17.03.05.001; 19.22.02.0010.001044%Not Available
Autonomic nervous system imbalance08.01.01.010; 17.05.01.011; 24.06.01.0050.000091%Not Available
Azoospermia21.03.03.001--
Back pain15.03.04.005--
Biliary colic09.02.01.001--Not Available
Bipolar I disorder19.16.01.0020.000136%Not Available
Bladder pain20.02.02.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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