Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Naproxen
Drug ID BADD_D01533
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 D00118
MeSH ID D009288
PubChem ID 156391
TTD Drug ID D0DJ1B
NDC Product Code 61919-376; 70518-0636; 65862-522; 68071-4995; 63629-8511; 55700-888; 45865-948; 50090-3041; 50090-0478; 77771-435; 63629-8513; 71335-0973; 50090-5645; 71335-0217; 71610-560; 80425-0175; 51552-0401; 71335-0345; 45865-581; 43353-201; 50228-436; 71610-489; 77771-434; 71205-597; 69097-855; 71610-597; 69543-426; 0093-1005; 43353-218; 69437-316; 63629-8515; 25000-140; 53746-188; 50228-434; 43063-344; 45865-914; 62331-029; 71610-591; 71205-469; 0363-9609; 50228-435; 63629-6657; 63187-461; 61919-204; 43353-216; 53746-189; 71335-0095; 68788-7946; 65162-190; 80425-0051; 70518-2428; 45865-610; 65841-676; 67296-1521; 73309-203; 68462-189; 77771-436; 49483-617; 68071-3092; 50090-3036; 51655-743; 0093-1006; 71511-701; 63629-8512; 50090-3055; 65162-189; 49999-049; 42291-628; 71335-0255; 50090-0481; 50090-4638; 25000-138; 63310-2080; 55700-316; 69097-851; 52423-0900; 49483-619; 76420-180; 42708-140; 76282-340; 68788-7711; 49483-618; 42708-043; 50090-0468; 43353-211; 42291-630; 60760-190; 68462-188; 63629-8107; 50090-1584; 53002-3240; 43063-920; 43063-650; 60687-491; 50090-1585; 67296-0406; 66267-807; 69238-1730; 49452-4815; 69097-853; 53746-190; 71610-436; 71335-0318; 68071-4006; 43063-937; 80425-0048; 65862-520; 80425-0049; 68071-2396; 76420-941; 0615-8094; 69097-852; 25000-139; 53002-3112; 68382-012; 67296-1609; 71205-060; 80425-0050; 71335-0386; 38779-0548; 72189-136; 68071-4510; 50090-4396; 42192-619; 71610-592; 55289-298; 53002-3100; 42291-629; 70518-1450; 70518-0208; 60760-140; 50090-4637; 53002-3110; 58118-0199; 76420-940; 68788-7090; 70934-803; 68382-013; 50090-4636; 62331-001; 71335-1869; 30007-828; 63187-535; 68071-2467; 66267-373; 63629-8514; 63629-1477; 63187-028; 69437-416; 70518-1516; 68382-014; 53002-3111; 65862-521; 50268-594; 68134-201; 68071-4381; 55111-003; 60760-561; 76420-042; 71297-200; 50090-4752; 63739-403; 66267-153; 50090-3524; 0054-3630; 69097-854; 50090-1583; 65841-677; 68462-190; 65862-958; 43063-600; 67296-1797; 61919-162; 65162-188; 50090-0472; 69543-425; 50090-3025; 50268-595; 76282-341; 50436-0618; 69437-415; 51655-363; 65841-678; 53002-3241; 63629-2484; 51927-2715; 63187-455; 67296-0561; 68071-2245; 71335-1850; 67046-546; 70934-746; 80425-0010; 76282-342; 72789-003; 61919-586
Synonyms Naproxen | Methoxypropiocin | Anaprox | Aleve | Proxen | Synflex | Naprosin | Naprosyn | Naproxen Sodium | Sodium, Naproxen | Sodium Naproxenate | Naproxenate, Sodium
Chemical Information
Molecular Formula C14H14O3
CAS Registry Number 22204-53-1
SMILES CC(C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)O
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)
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pollakiuria20.02.02.007--
Polyuria20.02.03.002--Not Available
Porphyria non-acute23.03.01.012; 14.14.01.004; 09.01.10.003; 03.08.01.004--Not Available
Prostatic disorder21.04.01.001--Not Available
Proteinuria20.02.01.011--
Pruritus23.03.12.0010.000734%
Pruritus genital21.10.01.002; 23.03.12.0080.000082%Not Available
Pseudoporphyria23.03.01.006--Not Available
Pulmonary embolism22.06.02.001; 24.01.06.0010.000285%Not Available
Pulmonary eosinophilia22.01.01.009; 01.02.04.006--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyelonephritis11.01.14.002; 20.01.09.001--Not Available
Pyrexia08.05.02.0030.000204%
Pyuria20.02.01.012; 11.01.08.043--Not Available
Rash23.03.13.0010.000653%Not Available
Rash erythematous23.03.06.0030.000122%Not Available
Rash generalised23.03.13.0020.000163%Not Available
Rash pruritic23.03.12.0020.000122%Not Available
Rash pustular23.03.10.003; 11.01.12.002--
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000082%
Renal failure20.01.03.005--Not Available
Renal pain20.02.03.003--Not Available
Renal papillary necrosis14.07.02.001; 20.01.07.002; 05.07.02.001--Not Available
Renal tubular necrosis20.01.07.003--Not Available
Respiratory depression22.02.01.010; 17.02.05.047--Not Available
Respiratory distress22.02.01.0120.000082%Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Scleritis10.02.01.025; 06.04.07.002--Not Available
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