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 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; M01AE02; M02AA12
DrugBank ID DB00788
KEGG ID D00118
MeSH ID D009288
PubChem ID 156391
TTD Drug ID D0DJ1B
NDC Product Code 72789-003; 72789-321; 80425-0050; 80425-0175; 68554-0143; 25000-138; 49483-618; 50090-3055; 50090-4636; 50090-5645; 51655-743; 53002-3240; 61919-376; 63187-028; 63187-455; 63187-461; 63629-2484; 65862-522; 68071-2245; 68071-2793; 68788-7711; 69097-855; 69437-415; 70518-3514; 71335-1869; 71610-591; 77771-434; 80425-0051; 51927-2715; 62331-029; 76420-940; 43353-201; 43353-211; 43353-216; 50090-0482; 50090-3036; 50228-436; 51655-657; 53746-190; 63629-8512; 67296-1609; 68071-3092; 68462-188; 69238-1730; 69784-500; 71205-469; 71335-0255; 71610-597; 65862-521; 65862-958; 25000-139; 25000-140; 43063-650; 50090-0481; 50090-0483; 50090-4638; 50268-594; 52959-193; 55700-987; 60760-564; 63739-403; 68382-014; 71335-0973; 63629-8514; 65162-188; 67296-0406; 68382-013; 69097-853; 69543-426; 80425-0048; 62331-001; 63310-2080; 72046-416; 73309-203; 76420-941; 50268-595; 53002-3112; 53002-3113; 61919-162; 63629-1477; 70934-746; 0615-8094; 72162-1935; 76282-342; 77771-436; 80425-0010; 42708-043; 53746-189; 67296-0561; 68071-2396; 68071-2467; 68382-012; 68462-190; 70518-3610; 71205-060; 71335-0345; 72189-425; 76282-341; 82982-013; 49483-617; 50228-435; 53002-3100; 53002-3110; 60760-644; 61919-204; 63187-535; 65162-190; 65862-520; 68071-2769; 68462-189; 69097-851; 69097-852; 69543-425; 70518-1516; 71335-0217; 72189-136; 42192-619; 45865-610; 50090-1583; 50090-3041; 50090-4637; 63629-8511; 63629-8515; 0363-9609; 65162-189; 69097-854; 70518-1450; 70518-3486; 71335-0095; 76282-340; 77771-435; 30007-828; 51552-0401; 52423-0900; 0093-1005; 31722-682; 42291-628; 42708-140; 50090-4752; 50228-434; 51655-363; 53002-3111; 53002-3241; 55700-316; 55700-888; 60687-491; 60760-140; 60760-561; 63629-8513; 65841-677; 65841-678; 68788-7090; 68788-7946; 69784-501; 69784-505; 71335-1850; 71610-436; 76420-042; 76420-264; 38779-0548; 49452-4815; 0093-1006; 43063-600; 43063-937; 49999-049; 51655-621; 60760-190; 65841-676; 69437-316; 69437-416; 70518-0208; 70934-073; 0054-3630; 71205-597; 71511-701; 71610-489; 71610-592; 80425-0049; 55111-003; 76420-180; 43063-920; 43353-218; 45865-581; 45865-948; 49483-619; 53746-188; 58118-0199
UNII 57Y76R9ATQ
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
*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)
Menstrual disorder21.01.01.004--Not Available
Mental disability26.01.01.001--Not Available
Mental impairment19.21.02.003; 17.03.03.002--Not Available
Metabolic acidosis14.01.01.0030.000086%Not Available
Middle insomnia19.02.01.003; 17.15.03.003--Not Available
Migraine17.14.02.001; 24.03.05.0030.000019%Not Available
Migraine with aura24.03.05.005; 17.14.02.0020.000019%Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.0040.000019%Not Available
Movement disorder17.01.02.010--Not Available
Muscle spasms15.05.03.0040.000090%
Muscular weakness17.05.03.005; 15.05.06.0010.000061%
Myalgia15.05.02.0010.000057%
Myocardial infarction24.04.04.009; 02.02.02.007--
Nail disorder23.02.05.002--
Nasal congestion22.04.04.0010.000019%
Nasal polyps22.04.03.010; 16.38.01.001--Not Available
Nausea07.01.07.0010.000449%
Neck pain15.03.04.0090.000052%
Necrosis24.04.02.006; 08.03.03.001--Not Available
Neoplasm malignant16.16.01.001--Not Available
Neoplasm skin23.08.02.003; 16.03.02.003--Not Available
Nephritis20.05.02.001--Not Available
Nephrolithiasis20.04.01.0020.000019%
Nephropathy20.05.03.001--Not Available
Nephropathy toxic20.05.03.002; 12.03.01.0100.000019%Not Available
Nephrosclerosis20.05.03.007--Not Available
Nephrotic syndrome20.05.01.002--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
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