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 Naproxen is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea, and for the relief of mild to moderate pain.[L6582][L6583][A178975] Further, it is first-line therapy for osteoarthritis, acute gouty arthritis, dysmenorrhea, and musculoskeletal inflammation and pain.[A178975]
Marketing Status approved; vet_approved
ATC Code G02CC02; M02AA12; M01AE02
DrugBank ID DB00788
KEGG ID D00970
MeSH ID D009288
PubChem ID 23681059
TTD Drug ID D0DJ1B
NDC Product Code 49452-4817; 51927-2771; 62207-762; 11673-748; 21130-748; 0113-0901; 41250-313; 42961-122; 46122-562; 47682-488; 49348-306; 50228-432; 50228-433; 50844-271; 53185-604; 53746-191; 55315-168; 55315-169; 0280-0041; 0280-6070; 59428-068; 65862-516; 68998-144; 71205-479; 80267-001; 81522-045; 10888-8127; 62331-002; 11822-4171; 21130-608; 27854-165; 30142-954; 47682-037; 49035-382; 55315-844; 55758-320; 55910-481; 55910-729; 55910-748; 0280-6080; 59779-797; 62011-0396; 62207-761; 0363-0844; 63187-794; 63868-466; 66715-9702; 67751-125; 68071-5039; 68071-5287; 68998-145; 0480-0951; 0480-0952; 69842-010; 70000-0171; 71205-595; 79903-005; 82501-1576; 10888-8130; 49588-0004; 52423-0903; 59651-191; 11822-0788; 27854-701; 33992-0169; 36800-748; 37808-049; 37808-068; 41520-702; 43598-059; 43598-072; 43598-073; 43598-494; 45802-490; 45865-666; 46994-661; 50090-3352; 50844-261; 50844-604; 53329-688; 53746-194; 53943-144; 53943-728; 55700-625; 56062-748; 0280-6000; 0280-6050; 58602-736; 59726-169; 59726-748; 0363-0368; 63941-144; 67091-138; 68210-0040; 68210-4137; 69420-1375; 69437-203; 69452-179; 70010-138; 0536-1093; 71335-1650; 72036-145; 72189-332; 72288-489; 53746-192; 55301-368; 55319-255; 57344-144; 58602-737; 58602-845; 59726-751; 62011-0017; 62207-328; 63187-596; 66715-6502; 68391-368; 70000-0201; 71335-9663; 72288-331; 62331-030; 65862-515; 11822-0140; 11822-0507; 21130-802; 27854-700; 0113-7368; 0113-7901; 42291-517; 57344-145; 0280-6092; 62207-327; 62207-729; 0363-0748; 63187-986; 63981-368; 68788-7800; 69230-329; 69842-748; 69842-975; 71335-1061; 72036-144; 0924-6000; 49588-0003; 68554-0129; 11822-0490; 11822-4170; 11822-6040; 0113-4368; 0113-7033; 37808-713; 41163-511; 41250-680; 41250-818; 43063-909; 43598-071; 47682-237; 47781-155; 50090-0685; 50268-592; 50594-024; 50594-140; 53943-145; 55111-273; 55910-500; 56062-490; 0280-6010; 0280-6020; 0280-6091; 58602-819; 59779-353; 0363-0102; 63629-8516; 63868-465; 63941-245; 68788-8443; 0480-0953; 69729-032; 69842-811; 69848-009; 70677-1148; 79903-098; 0280-0048; 10888-5015; 72121-007; 11673-909; 21130-187; 27854-505; 27854-555; 30142-748; 36800-490; 41163-079; 43598-060; 47682-737; 47781-153; 49035-754; 49035-767; 49483-608; 50844-417; 50844-714; 51013-137; 51316-417; 51824-030; 62207-747; 0363-0938; 63187-121; 63868-411; 63868-830; 66715-9740; 68016-056; 68788-7572; 68788-8447; 69848-010; 70518-0724; 0536-1094; 72288-368; 72476-748; 81522-490; 30007-815; 11673-368; 11822-1330; 37808-175; 37808-631; 41226-609; 41520-349; 43598-058; 46122-564; 49035-075; 51316-714; 51316-817; 52427-273; 52904-832; 53002-5330; 55289-367; 55301-748; 59726-168; 59779-914; 61010-4410; 62207-728; 0363-6099; 63629-1260; 63629-8517; 67091-140; 67751-144; 69230-305; 69452-259; 70518-2863; 71141-245; 71309-109; 71335-0822; 65862-785; 30142-174; 36800-204; 36800-368; 36800-696; 41250-073; 41250-225; 41250-477; 42291-516; 42507-174; 43598-074; 46122-534; 46994-665; 49035-748; 49035-974; 49483-609; 50268-593; 52427-272; 52427-274; 53002-1307; 53345-042; 53746-193; 53943-179; 55319-168; 55319-748; 55910-490; 57896-954; 59726-256; 61919-388; 0363-9608; 68462-179; 69784-550; 69842-417; 70677-0064; 72189-272; 10888-8115; 10888-8129; 55111-004; 63310-2070; 65862-507; 21130-180; 21130-690; 27854-160; 30142-285; 0113-1412; 37808-652; 43598-495; 47781-154; 51655-457; 51824-072; 55315-748; 55758-048; 55910-075; 55910-851; 55910-854; 56062-368; 0363-0140; 0363-0177; 62011-0369; 62207-745; 62207-746; 0363-7510; 68016-676; 68196-255; 68196-368; 68210-4096; 68462-178; 69452-284; 70010-137; 70010-139; 70264-011; 70518-3726; 70518-3748; 71205-631; 71335-1282; 71335-1925; 81522-368; 62991-2904; 27854-170; 36800-140; 41163-707; 41520-507; 41520-533; 41520-748; 45865-519; 48201-007; 50090-5238; 50844-471; 55111-272; 55319-256; 0280-6060; 58602-735; 58602-738; 58602-739; 59726-174
UNII 9TN87S3A3C
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Abnormal dreams19.02.03.001; 17.15.02.001---
Agranulocytosis01.02.03.001---
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003---
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009---
Anxiety19.06.02.002--
Aplastic anaemia01.03.03.002---
Arrhythmia02.03.02.001---
Asthenia08.01.01.001---
Asthma22.03.01.002; 10.01.03.010---
Bleeding time prolonged13.01.02.002---
Blood creatinine increased13.13.01.004--
Cardiac failure congestive02.05.01.002---
Colitis07.08.01.001--
Colitis ulcerative10.02.01.004; 07.08.01.005---
Coma17.02.09.001---
Confusional state19.13.01.001; 17.02.03.005--
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Corneal opacity06.06.03.005---
Crohn's disease07.08.01.015; 10.02.01.005---
Cystitis20.03.02.002; 11.01.14.001--
Death08.04.01.001--
Depression19.15.01.001--
Dermatitis bullous23.03.01.002--
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Diarrhoea07.02.01.001--
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