Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Naproxen sodium
Drug ID BADD_D01534
Description Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994.[A178975] It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile.[A179098] Given its overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia.[A179098] Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.[L6582][L6583][L7309][L7312]
Indications and Usage For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and acute gout. Also for the relief of mild to moderate pain and the treatment of primary dysmenorrhea.
Marketing Status Prescription; Discontinued; OTC
ATC Code G02CC02; M01AE02; M02AA12
DrugBank ID DB00788
KEGG ID D00970
MeSH ID D009288
PubChem ID 23681059
TTD Drug ID D0DJ1B
NDC Product Code 0363-0169; 70010-137; 52427-274; 65862-507; 70934-936; 72288-489; 43063-909; 68071-2333; 0363-0938; 55315-844; 65862-516; 0363-0490; 56062-490; 71141-245; 50228-432; 68016-661; 45865-666; 0536-1094; 62331-030; 63940-761; 63629-3638; 27854-700; 50844-271; 67060-000; 49035-748; 36800-204; 0280-0041; 62207-745; 36800-368; 55758-047; 51316-417; 10888-8129; 63310-2070; 62037-825; 62207-761; 72090-003; 70934-247; 50268-592; 68071-4901; 50090-0685; 53943-179; 70677-0064; 41520-533; 55319-761; 0363-6099; 0280-6000; 59779-353; 69842-417; 68554-0129; 53746-194; 49035-382; 58602-736; 0113-0901; 30142-174; 11673-909; 51013-137; 70010-138; 81522-490; 68210-0040; 69842-811; 61919-173; 55910-481; 68391-368; 69842-975; 11673-748; 10888-5015; 30142-617; 11673-368; 69842-010; 58602-739; 0280-6010; 43598-071; 41163-079; 80267-001; 11822-0788; 21130-174; 68210-4096; 55289-367; 72288-331; 63868-465; 63187-986; 71335-1925; 50844-417; 71205-631; 55910-748; 62011-0017; 68196-368; 68788-7800; 49035-974; 0363-0140; 42961-108; 0536-1093; 66715-9740; 59726-748; 51824-030; 27854-505; 11822-0507; 69437-203; 55111-272; 68210-0030; 55758-320; 65862-515; 58602-738; 67091-138; 58602-735; 62207-327; 62207-762; 50090-3369; 37808-175; 55758-048; 68998-145; 71335-1282; 41163-707; 43598-060; 67751-154; 41250-680; 55111-004; 68210-4121; 0113-1412; 57896-954; 53943-144; 56062-174; 42291-516; 47781-155; 68016-056; 37012-748; 59428-068; 27854-160; 0280-6050; 11822-1330; 27854-701; 49348-306; 21130-748; 63941-144; 63187-794; 55301-368; 55319-417; 33992-0169; 11673-175; 71205-479; 59651-191; 43598-072; 41163-511; 21130-802; 69848-009; 69420-1375; 53746-193; 42507-174; 49588-0003; 37808-068; 63629-8516; 68462-178; 50268-593; 47682-237; 62991-2904; 36800-140; 61919-165; 52423-0903; 68998-144; 69848-010; 67091-140; 0363-9608; 63940-763; 27854-103; 53943-728; 36800-696; 62011-0396; 56062-748; 63187-121; 10888-8127; 46122-564; 45865-519; 68071-5287; 53746-192; 30142-177; 0280-6020; 50844-261; 55319-762; 56062-368; 58602-845; 46122-534; 48201-007; 42291-517; 0363-7510; 70000-0171; 49035-075; 43598-494; 37012-368; 53329-688; 50090-4704; 55319-255; 63868-411; 0113-7033; 50844-714; 81522-368; 0363-0844; 43598-058; 63629-1260; 62207-729; 62011-0369; 68210-4120; 49781-145; 27854-170; 52427-273; 59726-256; 58602-819; 15127-168; 0280-6092; 41520-702; 79903-005; 47781-154; 37808-652; 47682-488; 50090-5538; 0363-0177; 69230-305; 45802-490; 49483-609; 62207-728; 49035-767; 63629-8517; 0363-0168; 70000-0201; 0363-0102; 46122-562; 43598-074; 70518-2863; 0280-6060; 41226-609; 65862-785; 67751-144; 49035-903; 53329-678; 63941-245; 50090-5238; 0280-6070; 55319-714; 0113-7368; 55315-748; 72189-332; 57344-144; 68210-0400; 55301-748; 53746-191; 50594-140; 0280-0270; 62207-328; 61919-183; 55910-075; 55315-169; 43598-059; 50228-433; 50090-2388; 0113-7901; 47682-737; 55700-883; 37808-713; 0280-6091; 72288-368; 57344-145; 0113-4368; 55910-854; 72189-272; 59779-914; 63868-466; 55910-851; 63868-830; 49035-754; 70010-139; 0280-0048; 72476-748; 41250-313; 10888-8115; 55700-625; 53943-145; 62331-002; 71335-1650; 21130-187; 51927-2771; 0363-0748; 43598-495; 50844-471; 69452-284; 30142-954; 55910-729; 68462-179; 62207-746; 11822-0490; 70518-0724; 36800-490; 59779-797; 36800-748; 10888-8130; 43598-073; 71205-595; 41520-507; 68788-7572; 27854-555; 58602-737; 55111-273; 53002-5330; 62037-826; 69452-179; 41250-818; 41250-073; 55910-500; 47781-153; 0363-0368; 21130-180; 68016-660; 62207-016; 59726-169; 72036-145; 50594-024; 41250-225; 62207-747; 0280-6080; 79903-098; 49483-608; 51824-072; 66715-9702; 55315-168; 41520-748; 59726-751; 50090-3352; 63981-368; 63187-596; 53185-604; 41250-477; 68016-676; 41520-349; 55319-174; 69452-259; 71335-1061; 55319-604; 49452-4817; 37808-049; 30142-285; 53345-042; 59726-174; 53002-1307; 30007-815; 27854-165; 11822-0140; 68210-4137; 55910-490; 52427-272; 50844-604; 72036-144; 71335-0822; 0113-1773; 61010-4410; 69842-748; 55319-256; 37808-631; 30142-748
Synonyms Naproxen | Methoxypropiocin | Anaprox | Aleve | Proxen | Synflex | Naprosin | Naprosyn | Naproxen Sodium | Sodium, Naproxen | Sodium Naproxenate | Naproxenate, Sodium
Chemical Information
Molecular Formula C14H13NaO3
CAS Registry Number 26159-34-2
SMILES CC(C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)[O-].[Na+]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Disturbance in attention19.21.02.002; 17.03.03.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Duodenal ulcer07.04.02.002--
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.002--
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.001--Not Available
Eosinophilia01.02.04.001--
Eosinophilic pneumonia22.01.01.004; 01.02.04.003--Not Available
Epidermolysis bullosa23.03.01.010; 03.05.01.001--Not Available
Eructation07.01.02.003--
Erythema multiforme23.03.01.003; 10.01.03.015--
Erythema nodosum23.07.02.001; 10.02.01.020--Not Available
Fixed drug eruption08.01.06.017; 23.03.05.006; 10.01.01.022--Not Available
Flatulence07.01.04.002--
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal perforation07.04.04.001--Not Available
Glomerulonephritis20.05.01.001; 10.02.01.006--Not Available
Glossitis07.14.01.001--Not Available
Granulocytopenia01.02.03.003--Not Available
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematuria24.07.01.047; 20.02.01.006--
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.02.002--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
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