Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Diclofenac sodium
Drug ID BADD_D00656
Description Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID).[label] NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes. Diclofenac was the product of rational drug design based on the structures of [phenylbutazone], [mefenamic acid], and [indomethacin].[A180796] The addition of two chlorine groups in the ortho position of the phenyl ring locks the ring in maximal torsion which appears to be related to increased potency. It is often used in combination with [misoprostol] to prevent NSAID-induced gastric ulcers. Diclofenac was first approved by the FDA in July 1988 under the trade name Voltaren, marketed by Novartis (previously Ciba-Geigy).[L7360]
Indications and Usage Diclofenac is indicated for use in the treatment of pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and akylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma. It is often used in combination with [misoprostol] as a gastro-protective agent in patients with high risk of developing NSAID-induced ulcers.
Marketing Status approved; vet_approved
ATC Code D11AX18; M02AA15; S01BC03; M01AB05
DrugBank ID DB00586
KEGG ID D00904
MeSH ID D004008
PubChem ID 5018304
TTD Drug ID D0TG1H
NDC Product Code 80425-0337; 0067-8152; 46438-0629; 50335-0060; 51552-0482; 60592-204; 68981-003; 16571-101; 21130-028; 21130-313; 40032-016; 42291-230; 42291-231; 50383-528; 50742-278; 51316-012; 52565-002; 53002-1792; 55700-511; 59088-365; 63187-753; 63629-1012; 63981-112; 68788-6388; 68788-8236; 68788-9806; 70748-335; 70771-1415; 71205-752; 71205-789; 72888-110; 80425-0238; 62991-2024; 76420-013; 13107-269; 36800-526; 51655-176; 51655-280; 51672-1358; 55700-591; 60429-422; 61442-101; 0363-1210; 63187-522; 63629-1011; 63629-2526; 67296-1064; 68071-4859; 70518-2944; 70934-165; 0574-0167; 71335-0481; 80425-0189; 80425-0237; 45802-111; 45865-878; 45865-964; 50580-574; 51672-1369; 55700-980; 56062-878; 0280-0039; 58602-606; 59390-149; 60760-058; 63187-222; 0363-1871; 63629-8644; 63981-211; 68682-103; 68788-8193; 0472-1783; 70518-2811; 71085-002; 71205-538; 71205-991; 71205-995; 72162-1733; 59088-435; 60687-606; 60760-090; 63187-761; 63187-822; 63187-994; 66267-071; 68001-280; 68071-2239; 69256-012; 69842-729; 70518-2673; 70518-3464; 71205-821; 72888-109; 76420-275; 80425-0102; 80425-0197; 80425-0235; 80425-0236; 80425-0240; 82649-012; 71052-112; 11822-7300; 16571-202; 24208-457; 41163-087; 45865-118; 45865-983; 50090-3568; 50436-0356; 0228-2551; 55319-969; 55328-801; 55700-966; 55910-424; 60505-0406; 60760-095; 63187-012; 63629-9603; 68001-281; 68071-1653; 68084-333; 68391-205; 68788-7715; 0527-2170; 70512-810; 70518-2707; 72162-1086; 72162-1734; 72578-092; 48589-0005; 52935-0006; 53873-080; 62512-0012; 45802-953; 50090-4020; 51021-250; 51672-1363; 55700-588; 60687-658; 60760-264; 61314-014; 61442-103; 61919-608; 62011-0450; 63187-791; 67296-1225; 68001-279; 68016-171; 68071-2223; 68196-870; 68788-8415; 70518-1903; 70518-3315; 70677-0108; 71085-003; 72559-020; 73516-450; 75987-040; 80425-0055; 80425-0210; 80425-0234; 80425-0336; 46438-0640; 76420-985; 11822-0870; 11822-8120; 0113-1189; 41167-0573; 41250-674; 42799-953; 46122-752; 49035-262; 49035-269; 50090-0545; 50090-4172; 53002-5360; 58602-604; 59726-012; 60760-112; 61145-101; 61145-102; 61442-102; 63629-2012; 63941-812; 68788-8237; 69097-524; 70000-0555; 70518-0627; 71205-062; 71205-450; 71335-0648; 72189-319; 76420-132; 17337-0409; 51927-0005; 54871-1084; 79572-014; 35356-714; 50436-0357; 0228-2550; 63629-2077; 63981-599; 69842-974; 71205-494; 71335-0456; 71610-068; 72189-075; 76420-261; 38779-2683; 46438-0046; 50335-0030; 58747-0406; 76420-986; 11673-569; 16571-203; 37808-087; 41250-973; 45865-436; 50090-0541; 55289-150; 60429-421; 62332-487; 63187-582; 63629-2013; 63981-870; 67296-1480; 68071-3456; 68180-538; 68788-8952; 70882-128; 71205-579; 71205-618; 71335-1238; 72189-273; 72189-454; 72888-111; 80425-0233; 0067-8153; 83008-017; 38779-2705; 49452-2581; 73377-145; 16571-201; 35356-725; 43063-467; 50090-0542; 50436-1003; 51316-073; 53002-5370; 60760-153; 63187-714; 0363-5123; 63629-2010; 63629-2011; 67296-1197; 68462-355; 68788-9435; 70934-122; 70934-678; 71205-670; 71205-692; 71335-0357; 71335-9665; 72288-870; 76420-025; 76420-134; 57572-0410; 0115-1483; 41520-788; 45802-160; 45865-999; 46122-646; 50436-2201; 50436-3339; 59088-372
UNII QTG126297Q
Synonyms Diclofenac | Diclophenac | Dicrofenac | Dichlofenal | Diclofenac Sodium | Sodium Diclofenac | Diclofenac, Sodium | Diclonate P | Feloran | Voltarol | Novapirina | Orthofen | Ortofen | Orthophen | SR-38 | SR 38 | SR38 | Voltaren | Diclofenac Potassium | GP-45,840 | GP 45,840 | GP45,840
Chemical Information
Molecular Formula C14H10Cl2NNaO2
CAS Registry Number 15307-79-6
SMILES C1=CC=C(C(=C1)CC(=O)[O-])NC2=C(C=CC=C2Cl)Cl.[Na+]
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)
Nervousness19.06.02.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oesophagitis07.08.05.001--
Oliguria20.01.03.004--Not Available
Palpitations02.11.04.012--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Peptic ulcer07.04.07.001--Not Available
Photosensitivity reaction23.03.09.003--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Polyuria20.02.03.002--Not Available
Proteinuria20.02.01.011--
Pruritus23.03.12.001--
Purpura01.01.04.003; 24.07.06.005; 23.06.01.004--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal failure20.01.03.005--Not Available
Respiratory depression17.02.05.047; 22.02.01.010--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.01.045--
Stomatitis07.05.06.005--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus04.04.01.002; 17.04.07.004--
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
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