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)
Skin mass23.07.04.014---
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.000029%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.000084%
Acute kidney injury20.01.03.0160.000181%
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000019%-
Lacrimal structural disorder06.06.04.013---
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.000019%-
Vascular malformation03.07.03.004; 24.03.03.014---
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.000019%-
Perforation08.01.03.058---
Anal incontinence07.01.06.029; 17.05.01.021--
Alcohol interaction08.06.03.003---
Enthesopathy15.07.01.011---
IgA nephropathy10.02.01.063; 20.05.01.0160.000019%-
Palatal oedema07.05.04.0080.000029%-
Skin plaque23.03.03.044---
Sensitivity to weather change08.01.03.077---
Internal haemorrhage24.07.01.0720.000019%-
Bell's palsy17.04.03.011---
Blood loss anaemia01.03.02.018; 24.07.01.0880.000029%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.000065%-
Fixed eruption08.01.06.025; 10.01.01.037; 23.03.05.0080.000042%-
Gait inability08.01.02.011; 17.02.05.0690.000042%-
Heavy menstrual bleeding21.01.03.005---
Illness08.01.03.091---
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.000019%-
Inadequate analgesia08.06.01.040; 12.02.20.006---
Intermenstrual bleeding21.01.01.015---
Mucosal disorder08.01.06.029---
Periorbital swelling06.08.03.032; 10.01.05.025; 23.04.01.0250.000071%-
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