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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Fixed drug eruption08.01.06.017; 10.01.01.022; 23.03.05.006--Not Available
Flatulence07.01.04.0020.000122%
Flushing08.01.03.025; 23.06.05.003; 24.03.01.0020.000122%
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.0030.000082%
Gastroenteritis07.19.03.001; 11.01.07.0040.000082%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.0090.000245%Not Available
Gastrointestinal pain07.01.05.005--
Gastrointestinal perforation07.04.04.001--Not Available
Glomerulonephritis10.02.01.006; 20.05.01.001--Not Available
Glossitis07.14.01.001--Not Available
Glycosuria20.02.01.005--
Granulocytopenia01.02.03.003--Not Available
Haematemesis07.12.02.002; 24.07.02.011--Not Available
Haematochezia07.12.02.003; 24.07.02.0120.000122%Not Available
Haematuria20.02.01.006; 24.07.01.0470.000245%
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.0030.000122%Not Available
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.02.0020.000021%
Headache17.14.01.0010.000489%
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hepatosplenomegaly01.09.03.001; 09.01.05.002--Not Available
Herpes simplex11.05.02.001; 23.09.03.001--Not Available
Herpes zoster11.05.02.003; 23.09.03.002--
Hypercholesterolaemia14.08.01.001--Not Available
Hyperglycaemia05.06.02.002; 14.06.02.002--
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