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
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)
Hypomania19.16.02.001--Not Available
Hyponatraemia14.05.04.002--
Hypotension24.06.03.002--
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Jaundice cholestatic09.01.01.005--Not Available
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.003--
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased21.03.02.007; 19.08.03.002--
Mania19.16.02.002--
Melaena24.07.02.013; 07.12.02.004--Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Menorrhagia21.01.03.002--
Micturition disorder20.02.02.005--Not Available
Movement disorder17.01.02.010--Not Available
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Myoclonus17.02.05.008--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Oesophageal ulcer07.04.05.002--
Optic neuritis10.04.10.002; 06.04.08.002; 17.04.05.001--Not Available
Palpitations02.01.02.003--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003--Not Available
Paranoia19.05.01.005--Not Available
Peptic ulcer07.04.07.001--Not Available
Personality disorder19.05.02.002--Not Available
Petechiae23.06.01.003; 01.01.03.002; 24.07.06.004--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Photosensitivity reaction23.03.09.003--
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