Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fluoxetine hydrochloride
Drug ID BADD_D00933
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 D00823
MeSH ID D005473
PubChem ID 62857
TTD Drug ID D0TR5X
NDC Product Code 43063-712; 69367-237; 55111-007; 60760-282; 68788-7356; 16714-721; 51407-196; 43063-570; 68071-4314; 50090-5678; 16714-722; 55289-610; 42543-726; 67296-1690; 53002-3671; 71205-125; 71335-1548; 63629-6855; 68071-3284; 68084-605; 50228-115; 50228-422; 0395-8144; 0121-4721; 68001-400; 68071-4542; 68071-5276; 16714-720; 12780-2945; 53002-1305; 71335-1588; 49483-701; 49452-3176; 63187-361; 65862-347; 49483-703; 51655-314; 63629-8990; 70518-1174; 71335-2020; 69367-236; 68084-101; 65862-192; 46708-242; 68788-7909; 0777-3105; 38779-0013; 68071-4671; 51927-0117; 0110-3105; 69367-235; 68071-3133; 65862-193; 63629-1609; 17337-0020; 63629-2197; 68001-401; 0110-3107; 65862-194; 53002-1671; 46708-243; 46708-855; 47781-600; 0781-2824; 71335-1145; 70934-710; 70120-080; 68981-044; 43353-637; 70934-141; 53002-1016; 63187-218; 43598-632; 16714-114; 63629-1610; 68071-2275; 51672-5306; 49884-335; 17337-0517; 43063-993; 50090-0745; 68180-997; 70518-3083; 63629-2198; 62991-2866; 70120-081; 63187-069; 71205-979; 25000-148; 71335-0827; 68071-2375; 0781-2823; 0110-3104; 70518-0417; 0121-0721; 0777-3104; 60687-244; 71205-393; 53069-0220; 52483-0600; 72189-067; 51655-274; 65691-0028; 70518-2134; 35356-728; 70934-394; 63415-0013; 75834-148; 25000-147; 42543-727; 50228-113; 42543-725; 68001-399; 0777-3107; 70934-077; 71335-1033; 25000-149; 70518-0369; 68071-5240; 70518-2754; 70934-714; 0832-0402; 60760-311; 68180-998; 0832-0403; 50090-2589; 71205-974; 0781-2822; 63187-081; 50228-114; 49483-702; 55111-284; 70518-3322; 68788-7817; 68180-999; 49711-1500; 49884-336; 55700-866; 67296-1568; 71335-1482; 71205-975; 68788-9222; 63629-2199; 50090-0749; 54838-523; 51927-3409; 63629-2200; 71335-0923; 70934-833; 68788-9223; 63629-8989; 70518-1359; 0615-8183; 49706-0785
Synonyms Fluoxetine | Fluoxetin | N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine | Lilly-110140 | Lilly 110140 | Lilly110140 | Sarafem | Fluoxetine Hydrochloride | Prozac
Chemical Information
Molecular Formula C17H19ClF3NO
CAS Registry Number 56296-78-7
SMILES CNCCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F.Cl
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Acute abdomen07.01.06.015--Not Available
Aggression19.05.01.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Akathisia17.01.02.002; 19.06.02.006--
Alopecia23.02.02.001--
Angle closure glaucoma06.03.01.001--Not Available
Anxiety19.06.02.002--
Aplastic anaemia01.03.03.002--Not Available
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Ataxia08.01.02.004; 17.02.02.001--
Atrial fibrillation02.03.03.002--
Bruxism07.01.06.008; 19.11.03.001--Not Available
Buccoglossal syndrome07.14.02.010; 17.01.02.013--Not Available
Cardiac arrest02.03.04.001--
Cataract06.06.01.001--
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Delusion19.10.01.001--
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.004--Not Available
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Duodenal ulcer07.04.02.002--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
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