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)
Epigastric discomfort07.01.02.0040.000019%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
Infusion site swelling12.07.05.003; 08.02.05.002--Not Available
Affect lability19.04.01.001--Not Available
Haemorrhage24.07.01.002--Not Available
Pulmonary mass22.02.07.004--Not Available
Gastrointestinal ulcer haemorrhage24.07.02.023; 07.04.04.006--Not Available
Weight abnormal13.15.01.016--Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Paraesthesia oral17.02.06.008; 07.05.05.0350.000029%Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Vasodilation procedure25.03.01.001--Not Available
Injection site scar23.03.11.016; 12.07.03.050; 08.02.03.0500.000042%Not Available
Juvenile idiopathic arthritis15.01.03.004; 10.04.06.004--Not Available
Angiopathy24.03.02.007--Not Available
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush08.01.03.027; 24.03.01.005; 21.02.02.0010.000042%
Appetite disorder19.09.01.002; 14.03.01.0040.000019%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder15.06.01.006; 10.04.04.026--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Limb discomfort15.03.04.0140.000052%Not Available
Intervertebral disc degeneration15.10.01.0020.000019%Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
The 16th Page    First    Pre   16 17 18 19    Next   Last    Total 19 Pages