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)
Bleeding time prolonged13.01.02.002--Not Available
Blepharitis06.04.04.001; 23.03.04.012--Not Available
Blindness17.17.01.003; 06.02.02.0010.000318%Not Available
Blindness unilateral17.17.01.016; 06.02.02.0090.000182%Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Blood bicarbonate increased13.11.01.0010.000136%Not Available
Blood chloride decreased13.11.01.0040.000091%Not Available
Blood cholesterol increased13.12.01.0020.000227%
Blood creatine phosphokinase increased13.04.01.0010.000635%
Blood glucose decreased13.02.02.0010.000091%Not Available
Blood glucose increased13.02.02.002--Not Available
Blood lactic acid increased13.02.01.0150.000182%Not Available
Blood magnesium decreased13.11.01.0080.000091%Not Available
Blood osmolarity decreased13.11.02.0050.000136%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Blood sodium decreased13.11.01.0120.000227%Not Available
Blood testosterone decreased13.10.05.0040.000136%Not Available
Blood thyroid stimulating hormone increased13.10.03.0060.000091%
Blood triglycerides increased13.12.03.0010.000182%Not Available
Blood urea increased13.13.01.006--Not Available
Blood uric acid increased13.02.04.001--Not Available
Blunted affect19.04.01.0030.000091%Not Available
Body temperature decreased13.15.01.010--Not Available
Body temperature increased13.15.01.0010.000136%Not Available
Bone development abnormal15.02.04.0030.000091%Not Available
Bone pain15.02.01.001--
Bradycardia02.03.02.0020.001180%Not Available
Bradycardia foetal18.03.02.006; 02.03.02.0180.000182%Not Available
Bradykinesia17.01.02.0040.000136%Not Available
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