diclofenac Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
anti-inflammatory agents, ibufenac derivatives	865	15307-86-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: diclofenac calcium diclofenac diethylamine diclofenac hydroxyethylpyrrolidine diclofenac diclofenamic acid diclofenac sodium diclofenac potassium diclofenac epolamine	A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt. Molecular weight: 296.15 Formula: C14H11Cl2NO2 CLOGP: 4.58 LIPINSKI: 0 HAC: 3 HDO: 2 TPSA: 49.33 ALOGS: -4.82 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	O
0.10	g	P
0.10	g	R
0.10	g	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	10.85 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
S (Water solubility)	0.14 mg/mL	Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine)	0.50 %	Hosey CM, Chan R, Benet LZ
BA (Bioavailability)	54 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.40 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 28, 1988	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Embolia cutis medicamentosa	708.95	9.63	167	150744	107	46535044
Pemphigus	618.22	9.63	747	150164	44527	46490624
Glossodynia	552.52	9.63	699	150212	43674	46491477
Rheumatoid arthritis	510.42	9.63	1820	149091	238395	46296756
Systemic lupus erythematosus	471.21	9.63	794	150117	64386	46470765
Hand deformity	461.39	9.63	564	150347	34010	46501141
Anti-cyclic citrullinated peptide antibody positive	444.68	9.63	419	150492	18726	46516425
Abdominal discomfort	400.59	9.63	1235	149676	149930	46385221
Pericarditis	382.00	9.63	428	150483	23499	46511652
Wound	350.74	9.63	552	150359	42250	46492901
Death	320.58	9.63	368	150543	335180	46199971
Arthropathy	284.38	9.63	754	150157	83946	46451205
Rheumatoid factor positive	274.87	9.63	335	150576	20126	46515025
Discomfort	264.95	9.63	512	150399	46158	46488993
Contraindicated product administered	257.60	9.63	701	150210	79246	46455905
Product use issue	232.73	9.63	754	150157	93890	46441261
Duodenal ulcer perforation	226.52	9.63	201	150710	8301	46526850
Deafness transitory	199.52	9.63	100	150811	1532	46533619
Pain	198.36	9.63	2382	148529	474566	46060585
Swelling	194.64	9.63	858	150053	123653	46411498
Treatment failure	191.59	9.63	699	150212	92388	46442763
Synovitis	181.38	9.63	520	150391	60555	46474596
Maternal exposure during pregnancy	179.11	9.63	731	150180	101818	46433333
Completed suicide	173.24	9.63	131	150780	145789	46389362
Alopecia	170.11	9.63	1000	149911	161414	46373737
Melaena	154.29	9.63	302	150609	27470	46507681
Gastric ulcer	148.18	9.63	259	150652	21604	46513547
Febrile neutropenia	146.73	9.63	61	150850	94566	46440585
Joint swelling	144.31	9.63	975	149936	165098	46370053
Neutropenia	144.20	9.63	150	150761	143054	46392097
Helicobacter infection	141.40	9.63	182	150729	11554	46523597
Infusion related reaction	136.40	9.63	668	150243	100540	46434611
Pharyngitis	134.68	9.63	220	150691	17363	46517788
Hypersensitivity	129.06	9.63	880	150031	149441	46385710
Sleep disorder	127.06	9.63	386	150525	46409	46488742
Gastrointestinal pain	121.76	9.63	135	150776	7320	46527831
Gastric ulcer perforation	119.70	9.63	63	150848	1074	46534077
Ear infection	114.43	9.63	239	150672	22774	46512377
Musculoskeletal stiffness	104.17	9.63	606	150305	97387	46437764
Ankylosing spondylitis	103.21	9.63	118	150793	6619	46528532
Pneumonia	99.19	9.63	761	150150	375559	46159592
Hip arthroplasty	98.23	9.63	195	150716	17917	46517234
Anaphylactic shock	94.39	9.63	205	150706	20069	46515082
Hepatic enzyme increased	88.36	9.63	508	150403	81279	46453872
Rash	86.59	9.63	1625	149286	354887	46180264
Cardiac failure congestive	85.84	9.63	102	150809	91648	46443503
Shoulder arthroplasty	85.83	9.63	75	150836	3033	46532118
Knee arthroplasty	81.68	9.63	213	150698	23452	46511699
Toxicity to various agents	79.42	9.63	383	150528	211383	46323768
Drug intolerance	78.51	9.63	773	150138	146276	46388875
Duodenal ulcer	76.29	9.63	105	150806	7113	46528038
Angioedema	72.24	9.63	285	150626	39057	46496094
Thrombocytopenia	70.55	9.63	194	150717	126387	46408764
International normalised ratio fluctuation	66.84	9.63	56	150855	2137	46533014
Anaphylactic reaction	65.47	9.63	342	150569	52770	46482381
Plasma cell myeloma	63.74	9.63	32	150879	44446	46490705
Electrocardiogram QT prolonged	63.56	9.63	44	150867	51281	46483870
Oligohydramnios	63.10	9.63	83	150828	5382	46529769
Tonsillar ulcer	63.03	9.63	26	150885	245	46534906
Seizure	62.48	9.63	197	150714	122857	46412294
Device expulsion	61.77	9.63	8	150903	27534	46507617
Large intestinal stenosis	61.26	9.63	49	150862	1750	46533401
Intestinal diaphragm disease	61.13	9.63	20	150891	89	46535062
Large intestinal ulcer	58.57	9.63	61	150850	3078	46532073
Small intestine ulcer	58.40	9.63	26	150885	300	46534851
Haematemesis	58.08	9.63	215	150696	28591	46506560
Type I hypersensitivity	57.64	9.63	53	150858	2293	46532858
Swollen joint count increased	54.70	9.63	52	150859	2348	46532803
Dyspnoea	54.46	9.63	1261	149650	514287	46020864
Arthralgia	53.38	9.63	1549	149362	363054	46172097
Renal failure neonatal	53	9.63	19	150892	117	46535034
Off label use	52.80	9.63	887	150024	378954	46156197
Osteoarthritis	51.88	9.63	361	150550	61664	46473487
Hospitalisation	50.65	9.63	79	150832	63306	46471845
Ileal ulcer	50.59	9.63	26	150885	421	46534730
Product dose omission issue	50.50	9.63	328	150583	168192	46366959
Foot operation	50.20	9.63	69	150842	4668	46530483
Drug hypersensitivity	49.62	9.63	1083	149828	242742	46292409
Ductus arteriosus stenosis foetal	48.51	9.63	17	150894	97	46535054
Hypotension	48.09	9.63	500	150411	232089	46303062
Diarrhoea	45.92	9.63	1419	149492	558183	45976968
Dehydration	45.56	9.63	315	150596	159225	46375926
Porphyria acute	45.50	9.63	23	150888	359	46534792
Gastritis erosive	45.37	9.63	70	150841	5260	46529891
Hypokalaemia	45.31	9.63	140	150771	87884	46447267
Injection site necrosis	44.05	9.63	36	150875	1326	46533825
Foetal methotrexate syndrome	43.98	9.63	14	150897	56	46535095
Rheumatic fever	43.89	9.63	50	150861	2793	46532358
Lower respiratory tract infection viral	43.82	9.63	25	150886	503	46534648
Cardio-respiratory arrest	43.79	9.63	79	150832	59790	46475361
Cardiac arrest	43.60	9.63	148	150763	90251	46444900
Ductus arteriosus premature closure	42.05	9.63	21	150890	319	46534832
Pulmonary mass	41.79	9.63	140	150771	17717	46517434
Duodenal ulcer haemorrhage	41.75	9.63	45	150866	2363	46532788
Pulmonary arterial hypertension	41.33	9.63	16	150895	25912	46509239
Tubulointerstitial nephritis	41.07	9.63	123	150788	14665	46520486
Feeding disorder	40.69	9.63	97	150814	10097	46525054
Atrial fibrillation	40.16	9.63	185	150726	103405	46431746
Pancytopenia	39.18	9.63	142	150769	84916	46450235
Endoscopy abnormal	38.68	9.63	9	150902	5	46535146
Jejunal ulcer	38.68	9.63	14	150897	89	46535062
Aspirin-exacerbated respiratory disease	38.18	9.63	26	150885	722	46534429
Bloody discharge	38.10	9.63	29	150882	962	46534189
Leukopenia	37.86	9.63	105	150806	68238	46466913
Gastrointestinal disorder	37.72	9.63	325	150586	59251	46475900
Cerebrovascular accident	37.67	9.63	183	150728	100856	46434295
Psoriatic arthropathy	37.34	9.63	223	150688	36156	46498995
Sepsis	36.66	9.63	273	150638	135741	46399410
Infection	35.47	9.63	618	150293	132974	46402177
No adverse event	35.38	9.63	35	150876	34196	46500955
Gastrointestinal erosion	35.20	9.63	23	150888	595	46534556
Deafness	35.00	9.63	123	150788	15945	46519206
Cough	34.82	9.63	529	150382	229720	46305431
Intestinal ulcer	34.62	9.63	28	150883	1016	46534135
Blister	34.55	9.63	255	150656	44376	46490775
Large intestine perforation	34.54	9.63	76	150835	7504	46527647
Application site rash	34.22	9.63	42	150869	2540	46532611
Spinal pain	34.09	9.63	89	150822	9803	46525348
Blood lactate dehydrogenase increased	34.05	9.63	144	150767	20356	46514795
White blood cell count decreased	33.82	9.63	218	150693	112013	46423138
Rheumatoid lung	33.46	9.63	34	150877	1666	46533485
Urinary tract infection	32.30	9.63	509	150402	219757	46315394
Fat necrosis	31.88	9.63	21	150890	551	46534600
Constipation	31.72	9.63	385	150526	173712	46361439
Functional gastrointestinal disorder	31.58	9.63	45	150866	3149	46532002
Spinal stenosis	30.83	9.63	100	150811	12443	46522708
Neutrophil count decreased	30.26	9.63	59	150852	43367	46491784
Hypoxia	29.95	9.63	78	150833	51760	46483391
Hypoglycaemia	29.73	9.63	84	150827	54265	46480886
Fibromyalgia	29.18	9.63	210	150701	36253	46498898
Mental status changes	28.99	9.63	49	150862	38039	46497112
Anxiety	28.90	9.63	414	150497	181543	46353608
Gastric ulcer haemorrhage	28.33	9.63	54	150857	4814	46530337
Fluid retention	27.84	9.63	79	150832	50967	46484184
Corneal epithelium defect	27.56	9.63	16	150895	333	46534818
Soft tissue infection	27.53	9.63	33	150878	1947	46533204
Joint dislocation	27.33	9.63	89	150822	11097	46524054
Gastrointestinal haemorrhage	27.05	9.63	375	150536	76998	46458153
Orbital oedema	26.85	9.63	13	150898	184	46534967
Hyperglycaemia	26.80	9.63	45	150866	35026	46500125
Fall	26.76	9.63	835	150076	328262	46206889
Ejection fraction	26.53	9.63	19	150892	573	46534578
Posterior reversible encephalopathy syndrome	26.46	9.63	8	150903	15133	46520018
Acute myeloid leukaemia	26.40	9.63	9	150902	15769	46519382
Platelet count decreased	26.36	9.63	202	150709	99822	46435329
Neonatal respiratory acidosis	26.34	9.63	9	150902	47	46535104
Synostosis	26.18	9.63	9	150902	48	46535103
Disease progression	26.17	9.63	180	150731	91120	46444031
Periorbital oedema	25.85	9.63	53	150858	4982	46530169
Pyrexia	25.76	9.63	896	150015	347906	46187245
C-reactive protein abnormal	25.33	9.63	19	150892	21251	46513900
Grip strength decreased	25.25	9.63	73	150838	8533	46526618
Pulmonary toxicity	24.81	9.63	50	150861	4643	46530508
Lip ulceration	24.42	9.63	29	150882	1694	46533457
Respiratory distress	24.35	9.63	41	150870	31875	46503276
Drug ineffective	24.33	9.63	2523	148388	675315	45859836
Cardiac failure	24.23	9.63	155	150756	79793	46455358
Bradycardia	24.17	9.63	121	150790	66177	46468974
Keratopathy	24.09	9.63	14	150897	292	46534859
Joint stiffness	23.98	9.63	160	150751	26948	46508203
Coma	23.94	9.63	102	150809	58247	46476904
C-reactive protein increased	23.85	9.63	292	150619	58298	46476853
Complication associated with device	23.84	9.63	10	150901	15431	46519720
Abdominal rebound tenderness	23.78	9.63	7	150904	20	46535131
Gastritis	23.60	9.63	191	150720	34187	46500964
Lymphatic fistula	23.46	9.63	21	150890	877	46534274
Pulmonary embolism	23.40	9.63	231	150680	108354	46426797
Pancreatic steatosis	23.33	9.63	22	150889	983	46534168
Lymphocyte stimulation test positive	23.26	9.63	18	150893	612	46534539
Femoral hernia incarcerated	23.24	9.63	21	150890	888	46534263
Congenital pulmonary hypertension	23.21	9.63	9	150902	71	46535080
Neuroleptic malignant syndrome	23.17	9.63	4	150907	11118	46524033
Multiple sclerosis relapse	23.12	9.63	65	150846	42060	46493091
Lyme disease	22.93	9.63	33	150878	2330	46532821
Ovulation disorder	22.83	9.63	7	150904	24	46535127
Conjunctival hyperaemia	22.64	9.63	30	150881	1959	46533192
Gallbladder adenocarcinoma	22.47	9.63	9	150902	78	46535073
Nausea	22.45	9.63	1916	148995	685538	45849613
Live birth	22.43	9.63	79	150832	10251	46524900
Neuropathy peripheral	22.36	9.63	187	150724	90706	46444445
Clostridium difficile infection	22.31	9.63	29	150882	25074	46510077
Infective pulmonary exacerbation of cystic fibrosis	22.27	9.63	4	150907	10803	46524348
Tachycardia	21.86	9.63	211	150700	99411	46435740
Adactyly	21.80	9.63	7	150904	29	46535122
Wrong technique in product usage process	21.79	9.63	96	150815	54326	46480825
Punctate keratitis	21.77	9.63	17	150894	586	46534565
Necrotising fasciitis	21.70	9.63	34	150877	2589	46532562
Blood glucose increased	21.63	9.63	140	150771	71873	46463278
Injection site abscess	21.55	9.63	21	150890	978	46534173
Hypomagnesaemia	21.50	9.63	24	150887	22186	46512965
Pleural effusion	21.16	9.63	169	150742	82783	46452368
Product quality issue	21.08	9.63	53	150858	35595	46499556
Analgesic drug level increased	20.94	9.63	25	150886	1469	46533682
Cognitive disorder	20.92	9.63	56	150855	36827	46498324
Red blood cell sedimentation rate abnormal	20.82	9.63	9	150902	13640	46521511
Pancreatitis	20.64	9.63	72	150839	43555	46491596
Arteriovenous fistula occlusion	20.61	9.63	13	150898	316	46534835
Cytomegalovirus infection	20.60	9.63	17	150894	18127	46517024
Shock	20.58	9.63	131	150780	21714	46513437
Unresponsive to stimuli	20.49	9.63	46	150865	32128	46503023
Pneumonia aspiration	20.28	9.63	45	150866	31560	46503591
Diabetes mellitus	20.24	9.63	88	150823	49977	46485174
Torsade de pointes	20.22	9.63	7	150904	12147	46523004
Gastric haemorrhage	20.05	9.63	53	150858	5881	46529270
Vasoconstriction	20.04	9.63	15	150896	485	46534666
Cyanosis neonatal	19.98	9.63	11	150900	206	46534945
Blood potassium decreased	19.96	9.63	60	150851	38003	46497148
Pain in extremity	19.79	9.63	1024	149887	257656	46277495
Blue toe syndrome	19.70	9.63	13	150898	342	46534809
Paranoia	19.64	9.63	5	150906	10592	46524559
Urinoma	19.41	9.63	7	150904	44	46535107
Rotator cuff repair	19.40	9.63	24	150887	1463	46533688
Neuralgia	19.39	9.63	127	150784	21256	46513895
Iron deficiency anaemia	19.30	9.63	108	150803	17098	46518053
Gastrointestinal ulcer	19.26	9.63	28	150883	1995	46533156
Myocardial infarction	19.17	9.63	212	150699	97316	46437835
Colitis erosive	19.16	9.63	8	150903	78	46535073
Condition aggravated	19.14	9.63	972	149939	244080	46291071
Respiratory failure	19.08	9.63	205	150706	94611	46440540
Musculoskeletal disorder	19.08	9.63	100	150811	15445	46519706
Porphyria	19.00	9.63	9	150902	121	46535030
Urine porphobilinogen increased	18.95	9.63	4	150907	0	46535151
Abdominal pain upper	18.94	9.63	609	150302	144696	46390455
Neoplasm progression	18.81	9.63	36	150875	26647	46508504
Dry skin	18.53	9.63	69	150842	40947	46494204
Gamma-glutamyltransferase increased	18.46	9.63	170	150741	31570	46503581
Asthenia	18.39	9.63	820	150091	310255	46224896
Kounis syndrome	18.32	9.63	21	150890	1181	46533970
Lethargy	18.30	9.63	94	150817	51077	46484074
Wound infection pseudomonas	18.21	9.63	23	150888	1432	46533719
Anterior chamber cell	18.18	9.63	15	150896	560	46534591
Arterial haemorrhage	18.17	9.63	25	150886	1693	46533458
Laparotomy	18.12	9.63	9	150902	135	46535016
Fluid overload	18.03	9.63	38	150873	27147	46508004
Neurotoxicity	18.01	9.63	11	150900	13706	46521445
Libido disorder	17.86	9.63	7	150904	57	46535094
Bone marrow failure	17.63	9.63	44	150867	29625	46505526
Device dislocation	17.58	9.63	27	150884	21775	46513376
Palatal oedema	17.57	9.63	14	150897	497	46534654
Status epilepticus	17.28	9.63	12	150899	13967	46521184
Anuria	17.23	9.63	78	150833	11353	46523798
Premature delivery	17.16	9.63	28	150883	22041	46513110
Weight increased	17.06	9.63	403	150508	164070	46371081
Homicide	17.03	9.63	13	150898	433	46534718
Tenderness	17.01	9.63	103	150808	16778	46518373
Transfusion	16.84	9.63	11	150900	13220	46521931
Device issue	16.83	9.63	24	150887	19956	46515195
Lipoedema	16.81	9.63	9	150902	159	46534992
Pyoderma streptococcal	16.72	9.63	4	150907	3	46535148
Synovial cyst	16.66	9.63	57	150854	7289	46527862
Self-medication	16.58	9.63	27	150884	2125	46533026
Progressive multifocal leukoencephalopathy	16.50	9.63	8	150903	11338	46523813
Depression	16.49	9.63	421	150490	169683	46365468
Viral upper respiratory tract infection	16.40	9.63	55	150856	6963	46528188
Femur-fibula-ulna complex	16.34	9.63	5	150906	17	46535134
Mucosal inflammation	16.07	9.63	68	150843	38908	46496243
Adverse reaction	15.98	9.63	60	150851	8030	46527121
Haemarthrosis	15.96	9.63	32	150879	2961	46532190
Renal tubular necrosis	15.91	9.63	73	150838	10686	46524465
Liver function test increased	15.91	9.63	31	150880	22795	46512356
Congenital tricuspid valve atresia	15.85	9.63	6	150905	44	46535107
Product administered at inappropriate site	15.84	9.63	28	150883	2355	46532796
Peritonitis	15.83	9.63	118	150793	20596	46514555
Aggression	15.76	9.63	31	150880	22713	46512438
Face oedema	15.72	9.63	111	150800	19042	46516109
Emotional distress	15.68	9.63	49	150862	30658	46504493
Therapy non-responder	15.64	9.63	74	150837	41078	46494073
Akathisia	15.58	9.63	3	150908	7711	46527440
Anal erosion	15.51	9.63	5	150906	21	46535130
Asthma	15.33	9.63	206	150705	91336	46443815
Ulcerative keratitis	15.32	9.63	27	150884	2266	46532885
Unevaluable event	15.31	9.63	87	150824	46088	46489063
Tachyarrhythmia	15.28	9.63	41	150870	4591	46530560
Mouth ulceration	15.25	9.63	143	150768	26689	46508462
Abnormal behaviour	15.20	9.63	28	150883	21030	46514121
Porphyrins urine increased	15.15	9.63	5	150906	23	46535128
Acquired porphyria	15.15	9.63	5	150906	23	46535128
Laboratory test abnormal	15.10	9.63	32	150879	22815	46512336
Hypophagia	15.09	9.63	153	150758	29153	46505998
Metastases to liver	15.08	9.63	25	150886	19560	46515591
Extradural abscess	15.05	9.63	15	150896	718	46534433
Bone density decreased	15.04	9.63	67	150844	9685	46525466
Hypocalcaemia	14.94	9.63	41	150870	26744	46508407
Complications of intestinal transplant	14.93	9.63	4	150907	7	46535144
Oesophagitis ulcerative	14.89	9.63	13	150898	525	46534626
Diverticulum intestinal	14.70	9.63	48	150863	5993	46529158
Application site pain	14.70	9.63	37	150874	3986	46531165
Linear IgA disease	14.69	9.63	20	150891	1341	46533810
Tonsillitis	14.46	9.63	42	150869	4922	46530229
Central pain syndrome	14.41	9.63	9	150902	215	46534936
Abnormal loss of weight	14.40	9.63	42	150869	4933	46530218
Muscle tone disorder	14.40	9.63	7	150904	100	46535051
Oesophageal carcinoma recurrent	14.34	9.63	5	150906	28	46535123
Sciatic nerve palsy	14.34	9.63	5	150906	28	46535123
Seroma	14.32	9.63	25	150886	2082	46533069
Asthenopia	14.25	9.63	24	150887	1942	46533209
Injection site pain	14.24	9.63	252	150659	106900	46428251
Application site eczema	14.21	9.63	3	150908	0	46535151
Pseudodiverticular disease	14.21	9.63	3	150908	0	46535151
Injection site hyperaesthesia	14.20	9.63	5	150906	29	46535122
Epistaxis	14.19	9.63	136	150775	64169	46470982
Injection site bruising	14.18	9.63	63	150848	35573	46499578
Schizophrenia	14.14	9.63	5	150906	8563	46526588
Juvenile idiopathic arthritis	14.06	9.63	37	150874	4095	46531056
Porphyrins stool increased	14.06	9.63	5	150906	30	46535121
Therapeutic product effect decreased	14.02	9.63	358	150553	82243	46452908
Nail bed inflammation	13.94	9.63	11	150900	385	46534766
Reticulocytosis	13.92	9.63	7	150904	108	46535043
Hypochromic anaemia	13.87	9.63	20	150891	1415	46533736
Sacroiliitis	13.80	9.63	25	150886	2144	46533007
Alpha tumour necrosis factor increased	13.79	9.63	5	150906	32	46535119
Upper gastrointestinal haemorrhage	13.74	9.63	97	150814	16641	46518510
Ejection fraction decreased	13.72	9.63	23	150888	17914	46517237
Axial spondyloarthritis	13.69	9.63	7	150904	112	46535039
Pneumonitis chemical	13.68	9.63	8	150903	169	46534982
Blood cholesterol increased	13.60	9.63	193	150718	39820	46495331
Balance disorder	13.59	9.63	138	150773	64383	46470768
Deep vein thrombosis	13.54	9.63	179	150732	79594	46455557
Oesophageal adenocarcinoma	13.51	9.63	8	150903	173	46534978
Extrapyramidal disorder	13.50	9.63	10	150901	11258	46523893
Erythematotelangiectatic rosacea	13.45	9.63	4	150907	12	46535139
Neurological procedural complication	13.45	9.63	4	150907	12	46535139
Meteoropathy	13.45	9.63	4	150907	12	46535139
Treatment noncompliance	13.44	9.63	50	150861	29681	46505470
Extravascular haemolysis	13.41	9.63	5	150906	35	46535116
Haematotoxicity	13.38	9.63	3	150908	6930	46528221
Urosepsis	13.38	9.63	18	150893	15335	46519816
Generalised tonic-clonic seizure	13.34	9.63	44	150867	27078	46508073
Diabetic ketoacidosis	13.34	9.63	24	150887	18186	46516965
Joint range of motion decreased	13.21	9.63	89	150822	15035	46520116
Cardiac massage	13.21	9.63	4	150907	13	46535138
Warm type haemolytic anaemia	13.21	9.63	4	150907	13	46535138
Hallucination	13.09	9.63	101	150810	49850	46485301
Muscle injury	13.07	9.63	40	150871	4826	46530325
Application site ulcer	13.06	9.63	7	150904	124	46535027
Peptic ulcer	13.02	9.63	35	150876	3923	46531228
Pharyngo-oesophageal diverticulum	12.98	9.63	4	150907	14	46535137
Eyelid oedema	12.97	9.63	67	150844	10290	46524861
Small intestinal perforation	12.96	9.63	18	150893	1230	46533921
Sopor	12.91	9.63	28	150883	19800	46515351
Perforation bile duct	12.77	9.63	4	150907	15	46535136
Insomnia	12.76	9.63	421	150490	164503	46370648
Chest pain	12.73	9.63	454	150457	175870	46359281
Jaundice	12.72	9.63	146	150765	28699	46506452
Blood count abnormal	12.70	9.63	24	150887	17854	46517297
Tenosynovitis	12.64	9.63	53	150858	7462	46527689
Subdural haematoma	12.63	9.63	14	150897	12983	46522168
Failure to thrive	12.63	9.63	3	150908	6661	46528490
Abortion spontaneous	12.52	9.63	86	150825	43560	46491591
Mania	12.52	9.63	10	150901	10836	46524315
Underdose	12.42	9.63	28	150883	19530	46515621
Injection site ulcer	12.42	9.63	12	150899	553	46534598
Palmar-plantar erythrodysaesthesia syndrome	12.41	9.63	30	150881	20421	46514730
Second primary malignancy	12.41	9.63	3	150908	6581	46528570
Multiple sclerosis	12.35	9.63	40	150871	24751	46510400
Application site injury	12.32	9.63	5	150906	45	46535106
Parotid gland enlargement	12.32	9.63	14	150897	780	46534371
Acute kidney injury	12.30	9.63	903	150008	234952	46300199
Gestational diabetes	12.28	9.63	4	150907	7215	46527936
Central nervous system lesion	12.23	9.63	8	150903	9607	46525544
Papulopustular rosacea	12.19	9.63	4	150907	18	46535133
Fistula discharge	12.18	9.63	15	150896	910	46534241
Craniosynostosis	12.17	9.63	7	150904	143	46535008
Bacteraemia	11.98	9.63	17	150894	14162	46520989
Right ventricular failure	11.97	9.63	21	150890	16072	46519079
Myocarditis	11.97	9.63	5	150906	7734	46527417
Ventricular hypoplasia	11.92	9.63	7	150904	149	46535002
Drug-induced liver injury	11.91	9.63	130	150781	25238	46509913
Atrioventricular dissociation	11.91	9.63	8	150903	217	46534934
Urticaria	11.89	9.63	480	150431	117412	46417739
Blood alkaline phosphatase increased	11.88	9.63	187	150724	39422	46495729
Amenorrhoea	11.87	9.63	7	150904	8888	46526263
Thrombotic microangiopathy	11.86	9.63	6	150905	8300	46526851
Atelectasis	11.85	9.63	27	150884	18763	46516388
Nasal polypectomy	11.85	9.63	4	150907	20	46535131
Tongue oedema	11.77	9.63	34	150877	3972	46531179
Movement disorder	11.77	9.63	94	150817	16755	46518396
Pulmonary oedema	11.74	9.63	107	150804	50998	46484153
Arthritis bacterial	11.72	9.63	43	150868	5693	46529458
Confusional state	11.70	9.63	411	150500	159481	46375670
Enterococcal infection	11.66	9.63	4	150907	6983	46528168
Haematochezia	11.63	9.63	178	150733	37315	46497836
Iris transillumination defect	11.61	9.63	5	150906	53	46535098
Ascites	11.56	9.63	70	150841	36514	46498637
pH body fluid decreased	11.54	9.63	4	150907	22	46535129
Pallor	11.48	9.63	120	150791	23046	46512105
Ataxia	11.47	9.63	17	150894	13913	46521238
Chest discomfort	11.46	9.63	214	150697	90055	46445096
Chronic obstructive pulmonary disease	11.43	9.63	125	150786	57508	46477643
Hypoproteinaemia	11.42	9.63	21	150890	1822	46533329
Mucosal erosion	11.40	9.63	18	150893	1380	46533771
Small intestinal stenosis	11.35	9.63	11	150900	509	46534642
Lip oedema	11.32	9.63	30	150881	3334	46531817
Peritonitis bacterial	11.28	9.63	7	150904	8646	46526505
Fear	11.24	9.63	22	150889	16150	46519001
Intervertebral discitis	11.06	9.63	25	150886	2514	46532637
Gastroduodenal ulcer	11.03	9.63	7	150904	172	46534979
Head titubation	11.00	9.63	12	150899	639	46534512
Anaemia	11.00	9.63	696	150215	255083	46280068
Libido increased	10.95	9.63	13	150898	759	46534392
Psychotic disorder	10.92	9.63	37	150874	22584	46512567
Stress ulcer	10.91	9.63	5	150906	62	46535089
Microcytic anaemia	10.81	9.63	28	150883	3070	46532081
Peritoneal tuberculosis	10.78	9.63	11	150900	542	46534609
Small intestinal haemorrhage	10.76	9.63	21	150890	1905	46533246
Uterine perforation	10.76	9.63	5	150906	7262	46527889
Sebaceous gland infection	10.73	9.63	6	150905	116	46535035
Agonal rhythm	10.72	9.63	4	150907	28	46535123
Dermatitis bullous	10.67	9.63	51	150860	7592	46527559
Heart rate increased	10.55	9.63	174	150737	74617	46460534
Hepatic failure	10.53	9.63	64	150847	33352	46501799
Acute generalised exanthematous pustulosis	10.52	9.63	59	150852	9346	46525805
Blood glucose decreased	10.48	9.63	29	150882	18863	46516288
Gastrointestinal hypermotility	10.46	9.63	6	150905	122	46535029
Intestinal obstruction	10.44	9.63	46	150865	26029	46509122
Small intestine carcinoma	10.42	9.63	8	150903	269	46534882
Dyspnoea exertional	10.41	9.63	108	150803	50181	46484970
Inclusion body myositis	10.34	9.63	3	150908	8	46535143
Agitation	10.28	9.63	122	150789	55293	46479858
Documented hypersensitivity to administered product	10.26	9.63	11	150900	574	46534577
Erosive duodenitis	10.26	9.63	10	150901	466	46534685
Salivary hypersecretion	10.23	9.63	4	150907	6441	46528710
Application site erythema	10.22	9.63	37	150874	4867	46530284
Endoscopy	10.21	9.63	8	150903	277	46534874
Ventricular tachycardia	10.21	9.63	25	150886	16942	46518209
Neutropenic sepsis	10.19	9.63	15	150896	12309	46522842
Drug abuse	10.14	9.63	144	150767	63264	46471887
Lordosis	10.12	9.63	8	150903	281	46534870
Autoimmune hepatitis	10.10	9.63	51	150860	7763	46527388
Osteochondrosis	10.08	9.63	14	150897	956	46534195
Necrolytic migratory erythema	10.08	9.63	3	150908	9	46535142
Laryngeal dyspnoea	10.08	9.63	6	150905	131	46535020
Oxygen saturation decreased	10.06	9.63	160	150751	69004	46466147
Breast cancer metastatic	10.04	9.63	18	150893	13660	46521491
Lividity	9.98	9.63	7	150904	204	46534947
Gastrointestinal amyloidosis	9.95	9.63	5	150906	77	46535074
Metastases to central nervous system	9.93	9.63	13	150898	11208	46523943
Radial nerve palsy	9.93	9.63	9	150902	382	46534769
Dysphagia	9.90	9.63	183	150728	77129	46458022
Nasal disorder	9.86	9.63	22	150889	2192	46532959
Faeces discoloured	9.80	9.63	90	150821	16697	46518454
Mucosa vesicle	9.76	9.63	4	150907	37	46535114
Intestinal haemorrhage	9.74	9.63	27	150884	3081	46532070
Psychomotor hyperactivity	9.74	9.63	10	150901	9603	46525548
Hyperchromic anaemia	9.67	9.63	4	150907	38	46535113
Hiatus hernia	9.64	9.63	96	150815	18206	46516945

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	250.46	10.12	275	68934	357008	29526261
Embolia cutis medicamentosa	245.90	10.12	63	69146	141	29883128
Melaena	202.63	10.12	308	68901	32129	29851140
Gastric ulcer	198.21	10.12	208	69001	14913	29868356
Ankylosing spondylitis	138.40	10.12	101	69108	4433	29878836
Duodenal ulcer	131.18	10.12	137	69072	9764	29873505
Onychoclasis	128.55	10.12	67	69142	1592	29881677
Arthralgia	103.33	10.12	600	68609	135191	29748078
Kounis syndrome	102.97	10.12	58	69151	1615	29881654
Large intestinal stenosis	101.22	10.12	52	69157	1198	29882071
Inflammation	94.62	10.12	177	69032	21849	29861420
Febrile neutropenia	89.89	10.12	69	69140	106624	29776645
Gastric ulcer haemorrhage	89.84	10.12	84	69125	5230	29878039
Large intestinal ulcer	81.52	10.12	50	69159	1636	29881633
Anaphylactic shock	79.15	10.12	127	69082	13866	29869403
Gastritis erosive	78.56	10.12	80	69129	5533	29877736
Angioedema	75.65	10.12	212	68997	34172	29849097
Tooth loss	75.44	10.12	67	69142	3902	29879367
Neutropenia	73.13	10.12	115	69094	128425	29754844
Lymphoma	71.66	10.12	102	69107	10019	29873250
Urticaria	67.95	10.12	278	68931	54328	29828941
Gastric haemorrhage	67.90	10.12	96	69113	9371	29873898
Cardiac failure congestive	65.63	10.12	59	69150	84348	29798921
Pain	65.25	10.12	647	68562	171994	29711275
Intestinal diaphragm disease	65.20	10.12	24	69185	235	29883034
Psoriatic arthropathy	64.40	10.12	124	69085	15637	29867632
Off label use	63.19	10.12	329	68880	248961	29634308
Anaphylactic reaction	63.00	10.12	174	69035	27808	29855461
Pruritus	59.62	10.12	472	68737	117732	29765537
Plasma cell myeloma	58.66	10.12	25	69184	53437	29829832
Macrocephaly	58.38	10.12	24	69185	323	29882946
Joint swelling	56.04	10.12	236	68973	46710	29836559
Type I hypersensitivity	56.01	10.12	32	69177	916	29882353
Pyloric stenosis	55.34	10.12	27	69182	555	29882714
Arthritis	55.19	10.12	152	69057	24249	29859020
Gastric ulcer perforation	52.59	10.12	30	69179	856	29882413
Acute kidney injury	51.43	10.12	903	68306	272939	29610330
Metastases to stomach	50.77	10.12	15	69194	67	29883202
Thrombocytopenia	50.40	10.12	156	69053	136888	29746381
Application site rash	49.02	10.12	28	69181	801	29882468
Toxicity to various agents	48.18	10.12	228	68981	176955	29706314
Duodenal ulcer perforation	47.84	10.12	36	69173	1656	29881613
Atrial fibrillation	47.32	10.12	113	69096	108011	29775258
Cerebrovascular accident	45.27	10.12	77	69132	83400	29799869
Abdominal pain upper	44.64	10.12	272	68937	62279	29820990
C-reactive protein increased	43.93	10.12	208	69001	43265	29840004
Erythema	42.77	10.12	316	68893	77135	29806134
Alopecia	41.55	10.12	118	69091	19157	29864112
Muscle swelling	40.54	10.12	19	69190	356	29882913
Haematemesis	39.64	10.12	142	69067	26061	29857208
Mucosal erosion	39.58	10.12	24	69185	769	29882500
Product dose omission issue	38.33	10.12	98	69111	91533	29791736
Gastrointestinal erosion	38.08	10.12	18	69191	344	29882925
Nephrotic syndrome	36.91	10.12	61	69148	6824	29876445
Seronegative arthritis	36.50	10.12	23	69186	790	29882479
Neoplasm malignant	36.41	10.12	107	69102	17707	29865562
Drug tolerance decreased	36.25	10.12	26	69183	1110	29882159
Glomerulonephritis minimal lesion	35.78	10.12	18	69191	396	29882873
Musculoskeletal stiffness	35.76	10.12	171	69038	35710	29847559
Hospitalisation	35.61	10.12	30	69179	44289	29838980
Sacroiliitis	35.31	10.12	23	69186	837	29882432
Injection site necrosis	33.51	10.12	17	69192	381	29882888
Antidepressant drug level above therapeutic	33.19	10.12	13	69196	153	29883116
Disease progression	32.96	10.12	86	69123	79788	29803481
Toxic epidermal necrolysis	32.23	10.12	103	69106	17837	29865432
Pneumonia	32.02	10.12	562	68647	333744	29549525
Ulcerative keratitis	31.61	10.12	26	69183	1363	29881906
Neck pain	31.25	10.12	113	69096	20831	29862438
Haematochezia	31.19	10.12	159	69050	34063	29849206
Corneal thinning	31.04	10.12	12	69197	136	29883133
Peptic ulcer	30.89	10.12	35	69174	2733	29880536
Mastoid abscess	30.44	10.12	6	69203	0	29883269
Blood pressure measurement	30.28	10.12	12	69197	146	29883123
Swelling	29.94	10.12	163	69046	35812	29847457
Erosive duodenitis	29.16	10.12	25	69184	1388	29881881
Aspirin-exacerbated respiratory disease	28.94	10.12	15	69194	352	29882917
Periorbital oedema	28.84	10.12	37	69172	3289	29879980
Duodenal ulcer haemorrhage	28.63	10.12	44	69165	4628	29878641
Analgesic drug level above therapeutic	28.31	10.12	13	69196	232	29883037
Ligament calcification	28.27	10.12	9	69200	54	29883215
Bronchospasm	28.09	10.12	69	69140	10269	29873000
Platelet dysfunction	27.78	10.12	12	69197	184	29883085
Cardiac septal defect	27.72	10.12	12	69197	185	29883084
Conjunctival hyperaemia	27.60	10.12	30	69179	2237	29881032
Faeces discoloured	26.83	10.12	82	69127	13864	29869405
Microcytic anaemia	26.83	10.12	29	69180	2149	29881120
Sciatic nerve palsy	26.29	10.12	6	69203	6	29883263
Tubulointerstitial nephritis	26.24	10.12	96	69113	17795	29865474
Malignant mesenteric neoplasm	25.71	10.12	8	69201	44	29883225
Weight bearing difficulty	25.59	10.12	19	69190	856	29882413
Renal failure neonatal	25.52	10.12	9	69200	77	29883192
Sepsis	25.49	10.12	216	68993	146179	29737090
Hypotension	25.45	10.12	319	68890	200246	29683023
Lymphocyte stimulation test positive	25.44	10.12	19	69190	864	29882405
Cerebral atrophy congenital	25.41	10.12	8	69201	46	29883223
Nerve stimulation test abnormal	25.36	10.12	5	69204	0	29883269
Hypomagnesaemia	25.32	10.12	4	69205	16594	29866675
Body mass index abnormal	25.32	10.12	9	69200	79	29883190
Grip strength decreased	25.20	10.12	28	69181	2140	29881129
Completed suicide	24.73	10.12	132	69077	99360	29783909
Erythema multiforme	24.64	10.12	56	69153	7929	29875340
Gingivitis ulcerative	24.58	10.12	8	69201	52	29883217
Corneal epithelium defect	24.45	10.12	13	69196	322	29882947
Back pain	24.31	10.12	352	68857	102244	29781025
Mental status changes	24.22	10.12	30	69179	37049	29846220
Blood lactate dehydrogenase increased	24.13	10.12	103	69106	20498	29862771
Keratopathy	24.12	10.12	11	69198	193	29883076
Blister	23.91	10.12	103	69106	20580	29862689
Sciatic nerve injury	23.85	10.12	9	69200	95	29883174
Fatigue	23.83	10.12	562	68647	320111	29563158
Mast cell activation syndrome	23.68	10.12	9	69200	97	29883172
Application site swelling	23.57	10.12	12	69197	271	29882998
Shock	23.54	10.12	110	69099	22749	29860520
Duodenal stenosis	23.47	10.12	11	69198	206	29883063
Electrocardiogram QT prolonged	23.40	10.12	29	69180	35806	29847463
Spinal pain	23.19	10.12	39	69170	4425	29878844
Cytomegalovirus infection	23.03	10.12	13	69196	23661	29859608
Factor VIII deficiency	22.82	10.12	9	69200	108	29883161
Psoriasis	22.63	10.12	172	69037	42334	29840935
Jejunal ulcer perforation	22.52	10.12	8	69201	70	29883199
Product administered at inappropriate site	22.33	10.12	23	69186	1612	29881657
Pancytopenia	22.17	10.12	111	69098	84941	29798328
Disability	22.16	10.12	38	69171	4380	29878889
Pulmonary embolism	22.11	10.12	99	69110	78036	29805233
Blood urea increased	22.07	10.12	136	69073	31245	29852024
Hypoaldosteronism	21.95	10.12	10	69199	175	29883094
Tachycardia	21.73	10.12	92	69117	73647	29809622
Rheumatoid arthritis	21.54	10.12	166	69043	41031	29842238
Oral pruritus	21.43	10.12	11	69198	253	29883016
Incorrect product administration duration	21.36	10.12	35	69174	3887	29879382
Uveitis	21.04	10.12	42	69167	5435	29877834
Kidney duplex	20.99	10.12	12	69197	344	29882925
Gastrointestinal haemorrhage	20.84	10.12	289	68920	83157	29800112
Fluid overload	20.82	10.12	9	69200	19083	29864186
Deep vein thrombosis	20.73	10.12	71	69138	60430	29822839
Subacute endocarditis	20.71	10.12	7	69202	52	29883217
Joint space narrowing	20.59	10.12	7	69202	53	29883216
Corneal perforation	20.54	10.12	9	69200	143	29883126
Gastritis haemorrhagic	20.53	10.12	19	69190	1167	29882102
Upper gastrointestinal haemorrhage	20.52	10.12	103	69106	21925	29861344
Cardio-respiratory arrest	20.49	10.12	66	69143	57240	29826029
Necrotising fasciitis	20.46	10.12	32	69177	3417	29879852
Physical examination abnormal	20.43	10.12	8	69201	94	29883175
Drug interaction	20.30	10.12	604	68605	198964	29684305
Secondary amyloidosis	20.26	10.12	7	69202	56	29883213
Intervertebral disc compression	20.14	10.12	11	69198	288	29882981
Oropharyngeal discomfort	19.99	10.12	21	69188	1506	29881763
Eastern Cooperative Oncology Group performance status	19.75	10.12	6	69203	30	29883239
Omental necrosis	19.75	10.12	6	69203	30	29883239
Platelet function test abnormal	19.44	10.12	8	69201	108	29883161
Mesenteric neoplasm	19.44	10.12	6	69203	32	29883237
Pupils unequal	19.28	10.12	19	69190	1263	29882006
Tissue infiltration	19.25	10.12	7	69202	66	29883203
Hypoglycaemia	18.73	10.12	58	69151	50923	29832346
Suicide attempt	18.70	10.12	147	69062	36550	29846719
Metastases to lung	18.66	10.12	50	69159	7845	29875424
Contraindicated product administered	18.54	10.12	84	69125	17147	29866122
Leukopenia	18.50	10.12	67	69142	56092	29827177
Anuria	18.32	10.12	59	69150	10257	29873012
Hypoosmolar state	18.29	10.12	7	69202	77	29883192
Palmoplantar pustulosis	18.21	10.12	7	69202	78	29883191
Seizure	18.17	10.12	143	69066	98332	29784937
Intestinal ulcer	18.11	10.12	15	69194	794	29882475
Musculoskeletal pain	18.07	10.12	128	69081	30812	29852457
Fibromyalgia	17.96	10.12	26	69183	2592	29880677
Leptotrichia infection	17.90	10.12	7	69202	82	29883187
Deafness congenital	17.82	10.12	6	69203	44	29883225
Cryopyrin associated periodic syndrome	17.82	10.12	6	69203	44	29883225
Nasopharyngitis	17.73	10.12	211	68998	58638	29824631
Eschar	17.62	10.12	13	69196	580	29882689
Persistent corneal epithelial defect	17.36	10.12	5	69204	20	29883249
Acute myeloid leukaemia	17.36	10.12	10	69199	17996	29865273
Tonsil cancer	16.69	10.12	14	69195	754	29882515
Skin necrosis	16.69	10.12	35	69174	4692	29878577
Bacteroides infection	16.65	10.12	7	69202	100	29883169
Oligoarthritis	16.65	10.12	6	69203	55	29883214
Twin pregnancy	16.64	10.12	4	69205	6	29883263
Abdominal pain	16.43	10.12	420	68789	135234	29748035
Neurotoxicity	16.43	10.12	5	69204	13177	29870092
Double stranded DNULL antibody positive	16.40	10.12	7	69202	104	29883165
Respiratory failure	16.39	10.12	151	69058	100491	29782778
Ductus arteriosus premature closure	16.34	10.12	7	69202	105	29883164
Gastric mucosal lesion	16.29	10.12	12	69197	534	29882735
Rash erythematous	16.23	10.12	98	69111	22354	29860915
Full blood count decreased	16.22	10.12	8	69201	15709	29867560
Gastrointestinal ulcer	16.18	10.12	20	69189	1712	29881557
Gastric mucosa erythema	16.16	10.12	9	69200	245	29883024
Iris hypopigmentation	16.14	10.12	5	69204	27	29883242
Medium-chain acyl-coenzyme A dehydrogenase deficiency	16.14	10.12	5	69204	27	29883242
Application site reaction	16.12	10.12	11	69198	433	29882836
Pain in extremity	16.02	10.12	350	68859	109871	29773398
Fragile X syndrome	15.99	10.12	5	69204	28	29883241
Application site erythema	15.99	10.12	23	69186	2280	29880989
Myelodysplastic syndrome	15.97	10.12	12	69197	18766	29864503
Lentigo maligna	15.96	10.12	9	69200	251	29883018
Ureteral disorder	15.95	10.12	8	69201	175	29883094
Melanaemia	15.91	10.12	4	69205	8	29883261
Spondyloarthropathy	15.86	10.12	11	69198	445	29882824
Gastritis	15.79	10.12	90	69119	20108	29863161
Neuroleptic malignant syndrome	15.78	10.12	9	69200	16286	29866983
Soft tissue infection	15.75	10.12	19	69190	1586	29881683
Energy increased	15.73	10.12	17	69192	1259	29882010
Endoscopy abnormal	15.60	10.12	4	69205	9	29883260
Ciliary hyperaemia	15.56	10.12	5	69204	31	29883238
Gout	15.46	10.12	80	69129	17235	29866034
Inflammatory marker increased	15.44	10.12	27	69182	3161	29880108
Renal tubular necrosis	15.42	10.12	73	69136	15178	29868091
Application site vesicles	15.41	10.12	12	69197	581	29882688
Application site eczema	15.30	10.12	4	69205	10	29883259
Pallor	15.29	10.12	92	69117	20957	29862312
Internal limiting membrane peeling	15.22	10.12	3	69206	0	29883269
Leucine aminopeptidase increased	15.22	10.12	3	69206	0	29883269
Urinary tract infection	15.00	10.12	104	69105	73555	29809714
Ultrasound skull abnormal	14.85	10.12	6	69203	77	29883192
CADASIL	14.85	10.12	6	69203	77	29883192
Retroperitoneal fibrosis	14.77	10.12	9	69200	291	29882978
Retinal toxicity	14.76	10.12	10	69199	389	29882880
Mallory-Weiss syndrome	14.68	10.12	17	69192	1359	29881910
Inflammatory bowel disease	14.62	10.12	22	69187	2271	29880998
Magnetic resonance imaging spinal abnormal	14.58	10.12	6	69203	81	29883188
Gastrointestinal wall thickening	14.50	10.12	14	69195	907	29882362
Wound secretion	14.50	10.12	23	69186	2485	29880784
Oligohydramnios	14.50	10.12	9	69200	301	29882968
Tubulointerstitial nephritis and uveitis syndrome	14.47	10.12	5	69204	40	29883229
Oropharyngeal pain	14.44	10.12	114	69095	28382	29854887
Microcephaly	14.41	10.12	12	69197	640	29882629
Acquired haemophilia	14.39	10.12	13	69196	774	29882495
Axillary pain	14.32	10.12	8	69201	219	29883050
Neisseria infection	14.31	10.12	4	69205	14	29883255
Visual evoked potentials abnormal	14.25	10.12	6	69203	86	29883183
Nikolsky's sign	14.23	10.12	8	69201	222	29883047
Skin ulcer	14.09	10.12	83	69126	18766	29864503
Ulcer	14.08	10.12	41	69168	6750	29876519
Procalcitonin increased	13.97	10.12	15	69194	1103	29882166
Oral mucosa erosion	13.96	10.12	13	69196	805	29882464
Intestinal metastasis	13.92	10.12	7	69202	154	29883115
Xanthelasma	13.72	10.12	6	69203	95	29883174
Tumour invasion	13.66	10.12	9	69200	334	29882935
Dehydration	13.65	10.12	202	69007	123337	29759932
White blood cell count decreased	13.64	10.12	126	69083	83821	29799448
Trisomy 8	13.58	10.12	5	69204	49	29883220
Corneal opacity	13.51	10.12	11	69198	568	29882701
Ecthyma	13.45	10.12	9	69200	343	29882926
Ductus arteriosus stenosis foetal	13.44	10.12	6	69203	100	29883169
Desmoid tumour	13.44	10.12	6	69203	100	29883169
Arthritis bacterial	13.43	10.12	31	69178	4433	29878836
Central nervous system inflammation	13.33	10.12	6	69203	102	29883167
Lipid metabolism disorder	13.26	10.12	8	69201	254	29883015
Oculomucocutaneous syndrome	13.25	10.12	7	69202	171	29883098
Thrombosis mesenteric vessel	13.23	10.12	5	69204	53	29883216
Dermatosis	13.20	10.12	8	69201	256	29883013
Neuropathy peripheral	13.15	10.12	102	69107	70373	29812896
Peritonsillitis	13.15	10.12	3	69206	3	29883266
Myofascial pain syndrome	13.13	10.12	9	69200	357	29882912
Duodenal perforation	13.06	10.12	15	69194	1189	29882080
Musculoskeletal discomfort	13.02	10.12	38	69171	6262	29877007
Pharyngitis	12.95	10.12	40	69169	6802	29876467
Large intestine perforation	12.90	10.12	43	69166	7608	29875661
Skin erosion	12.90	10.12	18	69191	1735	29881534
Diarrhoea	12.89	10.12	636	68573	333467	29549802
Drug reaction with eosinophilia and systemic symptoms	12.84	10.12	111	69098	28377	29854892
Noninfective gingivitis	12.77	10.12	8	69201	272	29882997
Gastric bypass	12.77	10.12	8	69201	272	29882997
Duodenal obstruction	12.73	10.12	6	69203	114	29883155
Hypoxia	12.72	10.12	62	69147	47792	29835477
Angiocardiogram	12.72	10.12	7	69202	186	29883083
Application site exfoliation	12.68	10.12	6	69203	115	29883154
Rash	12.64	10.12	553	68656	191336	29691933
Bradycardia	12.62	10.12	94	69115	65432	29817837
Linear IgA disease	12.62	10.12	17	69192	1585	29881684
Discoloured vomit	12.61	10.12	9	69200	381	29882888
Poisoning deliberate	12.58	10.12	36	69173	5868	29877401
Unevaluable event	12.51	10.12	35	69174	31750	29851519
Ejection fraction	12.46	10.12	5	69204	63	29883206
Application site oedema	12.42	10.12	4	69205	25	29883244
Eye pain	12.33	10.12	57	69152	11732	29871537
Intentional product use issue	12.32	10.12	43	69166	36397	29846872
Laryngeal oedema	12.24	10.12	25	69184	3289	29879980
Peritonitis	12.23	10.12	88	69121	21287	29861982
Application site hypersensitivity	12.22	10.12	6	69203	125	29883144
Tension headache	12.19	10.12	15	69194	1278	29881991
Chronic obstructive pulmonary disease	12.12	10.12	60	69149	46066	29837203
Mobility decreased	12.09	10.12	102	69107	25897	29857372
Lipoma	12.08	10.12	16	69193	1467	29881802
Abdominal lymphadenopathy	12.08	10.12	10	69199	529	29882740
Hyperkalaemia	12.06	10.12	217	68992	65793	29817476
Exposure to communicable disease	12.05	10.12	6	69203	129	29883140
Saccadic eye movement	11.97	10.12	6	69203	131	29883138
Metastases to bone	11.86	10.12	49	69160	9609	29873660
Pulmonary hypertension	11.81	10.12	16	69193	19020	29864249
Gastric disorder	11.80	10.12	52	69157	10491	29872778
Slow speech	11.79	10.12	13	69196	985	29882284
Drug hypersensitivity	11.74	10.12	223	68986	68296	29814973
Postictal paralysis	11.69	10.12	6	69203	138	29883131
Corneal transplant	11.69	10.12	4	69205	31	29883238
Skin lesion	11.68	10.12	78	69131	18416	29864853
Stevens-Johnson syndrome	11.67	10.12	75	69134	17481	29865788
Intestinal transit time decreased	11.62	10.12	3	69206	7	29883262
Skin graft	11.59	10.12	10	69199	560	29882709
Tongue oedema	11.51	10.12	22	69187	2758	29880511
Laboratory test abnormal	11.50	10.12	14	69195	17428	29865841
Metastases to heart	11.49	10.12	6	69203	143	29883126
Metastases to peritoneum	11.48	10.12	16	69193	1541	29881728
Pyomyositis	11.46	10.12	6	69203	144	29883125
Small intestine ulcer	11.45	10.12	9	69200	442	29882827
Small intestine carcinoma	11.38	10.12	9	69200	446	29882823
Bicytopenia	11.37	10.12	17	69192	1745	29881524
Osteoarthritis	11.35	10.12	77	69132	18272	29864997
Oral herpes	11.33	10.12	29	69180	4426	29878843
Blood pressure decreased	11.32	10.12	162	69047	46913	29836356
Prurigo	11.31	10.12	11	69198	719	29882550
Face oedema	11.27	10.12	54	69155	11280	29871989
Diabetes mellitus	11.27	10.12	54	69155	41811	29841458
Ileal perforation	11.23	10.12	11	69198	726	29882543
Tenderness	11.22	10.12	34	69175	5721	29877548
Ocular hyperaemia	11.20	10.12	46	69163	8997	29874272
Gouty arthritis	11.20	10.12	13	69196	1042	29882227
Ventricular tachycardia	11.18	10.12	24	69185	23838	29859431
Delirium	11.17	10.12	52	69157	40579	29842690
Intervertebral disc degeneration	11.17	10.12	32	69177	5219	29878050
Scrotal ulcer	11.12	10.12	8	69201	343	29882926
Hypoproteinaemia	10.98	10.12	17	69192	1799	29881470
Pneumonitis	10.98	10.12	30	69179	27424	29855845
Hypermetropia	10.96	10.12	7	69202	246	29883023
Cognitive disorder	10.96	10.12	24	69185	23666	29859603
Visual impairment	10.93	10.12	113	69096	30325	29852944
Platelet count decreased	10.88	10.12	176	69033	105953	29777316
Duodenal ulcer repair	10.84	10.12	3	69206	10	29883259
Lip swelling	10.77	10.12	58	69151	12686	29870583
Coronary artery disease	10.72	10.12	69	69140	49643	29833626
Steroid diabetes	10.72	10.12	14	69195	1267	29882002
Obstruction gastric	10.71	10.12	12	69197	926	29882343
Intestinal angioedema	10.69	10.12	6	69203	166	29883103
Stomatitis	10.68	10.12	47	69162	37232	29846037
Eye swelling	10.63	10.12	45	69164	8919	29874350
Pseudoporphyria	10.60	10.12	7	69202	261	29883008
Helicobacter test positive	10.57	10.12	9	69200	495	29882774
Application site dermatitis	10.53	10.12	4	69205	43	29883226
Cytopenia	10.53	10.12	3	69206	8253	29875016
Hepatitis C	10.53	10.12	9	69200	13196	29870073
Orthostatic hypotension	10.52	10.12	25	69184	23954	29859315
Drug resistance	10.51	10.12	19	69190	20114	29863155
Renal infarct	10.49	10.12	13	69196	1116	29882153
Product quality issue	10.46	10.12	17	69192	18757	29864512
Exostosis	10.40	10.12	24	69185	3431	29879838
Nail bed inflammation	10.31	10.12	6	69203	178	29883091
Schizophrenia	10.29	10.12	4	69205	9044	29874225
Encephalopathy	10.23	10.12	39	69170	32166	29851103
Febrile bone marrow aplasia	10.22	10.12	3	69206	8094	29875175
Bone marrow failure	10.16	10.12	35	69174	29750	29853519

Pharmacologic Action:

Source	Code	Description
ATC	D11AX18	DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Other dermatologicals
ATC	M01AB05	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
ATC	M02AA15	MUSCULO-SKELETAL SYSTEM TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN Antiinflammatory preparations, non-steroids for topical use
ATC	S01BC03	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Antiinflammatory agents, non-steroids
ATC	M01AB55	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
ATC	S01CC01	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Antiinflammatory agents, non-steroids and antiinfectives in combination
FDA CS	M0001335	Anti-Inflammatory Agents, Non-Steroidal
FDA MoA	N0000000160	Cyclooxygenase Inhibitors
FDA PE	N0000008836	Decreased Prostaglandin Production
FDA EPC	N0000175722	Nonsteroidal Anti-inflammatory Drug
MeSH PA	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D000894	Anti-Inflammatory Agents, Non-Steroidal
MeSH PA	D018501	Antirheumatic Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
MeSH PA	D016861	Cyclooxygenase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory drugs
CHEBI has role	CHEBI:35493	anti-pyretic
CHEBI has role	CHEBI:35544	cyclooxygenase inhibitors
CHEBI has role	CHEBI:35703	xenobiotic
CHEBI has role	CHEBI:78298	environmental contaminants
CHEBI has role	CHEBI:88188	allergenic drug

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Ankylosing spondylitis	indication	9631008	DOID:7147
Pain	indication	22253000
Rheumatoid arthritis	indication	69896004	DOID:7148
Actinic keratosis	indication	201101007	DOID:8866
Dysmenorrhea	indication	266599000
Osteoarthritis	indication	396275006
Rheumatoid Arthritis in Patient at High Ulcer Risk	indication
Sprains and Strains	indication
Postoperative Ocular Pain	indication
Post-Op Ocular Inflammation	indication
Post-Op Photophobia	indication
Osteoarthrosis of the Knee	indication
Osteoarthritis in Patients at High Ulcer Risk	indication
Renal colic	off-label use	7093002
Tendinitis	off-label use	34840004	DOID:971
Bursitis	off-label use	84017003	DOID:2965
Cystoid macular edema	off-label use	193387007	DOID:4447
Prevention of Ocular Surgery-Induced Miosis	off-label use
Keratitis	contraindication	5888003	DOID:4677
Alcoholism	contraindication	7200002
Peptic ulcer	contraindication	13200003	DOID:750
Asthenia	contraindication	13791008
Infection of skin AND/OR subcutaneous tissue	contraindication	19824006
Myocardial infarction	contraindication	22298006	DOID:5844
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Dehydration	contraindication	34095006
Hypertensive disorder	contraindication	38341003	DOID:10763
Gastrointestinal ulcer	contraindication	40845000
Body fluid retention	contraindication	43498006
Skin ulcer	contraindication	46742003
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Corneal erosion	contraindication	50792001
Duodenal ulcer disease	contraindication	51868009	DOID:1724
Gastrointestinal perforation	contraindication	51875005
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Blood coagulation disorder	contraindication	64779008	DOID:1247
Diabetes mellitus	contraindication	73211009	DOID:9351
Gastrointestinal hemorrhage	contraindication	74474003
Perforation of cornea	contraindication	74895004
Corneal ulcer	contraindication	91514001	DOID:8463
Corneal degeneration	contraindication	111521006	DOID:1237
Open wound	contraindication	125643001
Liver function tests abnormal	contraindication	166603001
Asthma	contraindication	195967001	DOID:2841
Deliveries by cesarean	contraindication	200144004
Cerebrovascular accident	contraindication	230690007
Coronary artery bypass graft	contraindication	232717009
Disease of liver	contraindication	235856003	DOID:409
Drug-induced hepatitis	contraindication	235876009
Edema	contraindication	267038008
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thromboembolic disorder	contraindication	371039008
Cardiovascular event risk	contraindication	395112001
Smokes tobacco daily	contraindication	449868002
Uterine Rupture in Pregnancy	contraindication
Bloody Vomit	contraindication
Gynecological Surgery	contraindication
Corneal Infiltrates	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.22	acidic
pKa2	0.55	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
1.3%	LICART	IBSA INST BIO	N206976	Dec. 19, 2018	RX	SYSTEM	TOPICAL	Dec. 19, 2021	NEW PRODUCT

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR	IC50	7.70		WOMBAT-PK	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN	INHIBITOR	IC50	7.52		WOMBAT-PK	CHEMBL
UDP-glucuronosyltransferase 1-10	Enzyme	Q9HAW8	UD110_HUMAN		Ki	4.55		CHEMBL
Interleukin-8	Cytokine	P10145	IL8_HUMAN		IC50	8.10		CHEMBL
UDP-glucuronosyltransferase 1-6	Enzyme	P19224	UD16_HUMAN		Ki	4.64		CHEMBL
UDP-glucuronosyltransferase 1-7	Enzyme	Q9HAW7	UD17_HUMAN		Ki	4.72		CHEMBL
UDP-glucuronosyltransferase 1-9	Enzyme	O60656	UD19_HUMAN		Ki	4.96		CHEMBL
C-X-C chemokine receptor type 1	GPCR	P25024	CXCR1_HUMAN		IC50	7.92		CHEMBL
UDP-glucuronosyltransferase 1-1	Enzyme	P22309	UD11_HUMAN		Ki	4.28		CHEMBL
Acid-sensing ion channel 3	Ion channel	Q9UHC3	ASIC3_HUMAN	BLOCKER	IC50	4		IUPHAR
Aldo-keto reductase family 1 member B10	Enzyme	O60218	AK1BA_HUMAN		IC50	5.72		CHEMBL
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN	ANTAGONIST	Ki	6.20		IUPHAR
Transthyretin	Secreted	P02766	TTHY_HUMAN		Kd	6		CHEMBL
Aldo-keto reductase family 1 member C3	Enzyme	P42330	AK1C3_HUMAN		IC50	5.59		CHEMBL
Prostaglandin G/H synthase 2	Enzyme		PGH2_MOUSE		IC50	7.66		CHEMBL
Fatty acid-binding protein, liver	Unclassified		FABPL_RAT		Ki	5.49		CHEMBL
Prostaglandin G/H synthase 1	Enzyme		PGH1_BOVIN		IC50	8.52		CHEMBL
Prostaglandin G/H synthase 2	Enzyme		PGH2_SHEEP		IC50	7.22		CHEMBL
Prostaglandin G/H synthase 1	Enzyme		PGH1_SHEEP		IC50	7.17		CHEMBL

External reference:

ID	Source
4019714	VUID
N0000147806	NUI
D00903	KEGG_DRUG
88170-10-9	SECONDARY_CAS_RN
4019378	VANDF
4019714	VANDF
4020829	VANDF
4027248	VANDF
C0012091	UMLSCUI
CHEBI:47381	CHEBI
DIF	PDB_CHEM_ID
CHEMBL139	ChEMBL_ID
CHEMBL1201180	ChEMBL_ID
CHEMBL1200804	ChEMBL_ID
CHEMBL1034	ChEMBL_ID
DB00586	DRUGBANK_ID
D004008	MESH_DESCRIPTOR_UI
C000614065	MESH_SUPPLEMENTAL_RECORD_UI
C064142	MESH_SUPPLEMENTAL_RECORD_UI
3033	PUBCHEM_CID
2714	IUPHAR_LIGAND_ID
3270	INN_ID
144O8QL0L1	UNII
203214	RXNORM
11838	MMSL
23373	MMSL
3184	MMSL
340620	MMSL
37364	MMSL
4582	MMSL
4583	MMSL
4584	MMSL
d00848	MMSL
002391	NDDF
004409	NDDF
004410	NDDF
005170	NDDF
006237	NDDF
108515008	SNOMEDCT_US
363598004	SNOMEDCT_US
425650004	SNOMEDCT_US
426714006	SNOMEDCT_US
62039007	SNOMEDCT_US
7034005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1411	TABLET, FILM COATED	50 mg	ORAL	NDA	30 sections
ARTHROTEC	HUMAN PRESCRIPTION DRUG LABEL	2	0025-1421	TABLET, FILM COATED	75 mg	ORAL	NDA	30 sections
VoltarenArthritis Pain	HUMAN OTC DRUG LABEL	1	0067-8152	GEL	10 mg	TOPICAL	NDA	18 sections
VOLTAREN	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0478	SOLUTION	1 mg	OPHTHALMIC	NDA	16 sections
Diclofenac Potassium	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0948	TABLET, FILM COATED	50 mg	ORAL	ANDA	14 sections
diclofenac epolamine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3225	PATCH	0.01 g	TOPICAL	NDA authorized generic	30 sections
diclofenac epolamine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3727	SYSTEM	0.01 g	TOPICAL	NDA AUTHORIZED GENERIC	31 sections
good sense arthritis pain	HUMAN OTC DRUG LABEL	1	0113-1189	GEL	10 mg	TOPICAL	ANDA	17 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1483	GEL	30 mg	TOPICAL	ANDA	15 sections
DICLOFENULLC SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0803	GEL	30 mg	TOPICAL	NDA authorized generic	27 sections
DICLOFENULLC SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0844	GEL	30 mg	TOPICAL	NDA authorized generic	27 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2550	TABLET, DELAYED RELEASE	50 mg	ORAL	ANDA	26 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2551	TABLET, DELAYED RELEASE	75 mg	ORAL	ANDA	26 sections
Aleve Arthritis Pain Gel	HUMAN OTC DRUG LABEL	1	0280-0039	GEL	1 mg	TOPICAL	ANDA	17 sections
Diclofenac sodium	HUMAN OTC DRUG LABEL	1	0363-1210	GEL	10 mg	TOPICAL	ANDA	17 sections
diclofenac sodium	HUMAN OTC DRUG LABEL	1	0363-1871	GEL	10 mg	TOPICAL	ANDA	17 sections
Diclofenac Sodium Topical Gel 1%	Human OTC Drug Label	1	0363-7065	GEL	10 mg	TOPICAL	ANDA	15 sections
Diclofenac Potassium	HUMAN PRESCRIPTION DRUG LABEL	1	0378-2474	TABLET, FILM COATED	50 mg	ORAL	ANDA	26 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8750	GEL	10 mg	TOPICAL	ANDA	28 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0472-1783	GEL	30 mg	TOPICAL	ANDA	25 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0527-2170	TABLET, EXTENDED RELEASE	100 mg	ORAL	ANDA	13 sections
Diclofenac sodium	HUMAN OTC DRUG LABEL	1	0536-1294	GEL	10 mg	TOPICAL	ANDA	16 sections
Diclofenac Sodium and Misoprostol	HUMAN PRESCRIPTION DRUG LABEL	2	0591-0397	TABLET, DELAYED RELEASE	50 mg	ORAL	ANDA	28 sections
Diclofenac Sodium and Misoprostol	HUMAN PRESCRIPTION DRUG LABEL	2	0591-0398	TABLET, DELAYED RELEASE	75 mg	ORAL	ANDA	28 sections
Solaraze	HUMAN PRESCRIPTION DRUG LABEL	1	10337-803	GEL	30 mg	TOPICAL	NDA	27 sections
Solaraze	HUMAN PRESCRIPTION DRUG LABEL	1	10337-844	GEL	30 mg	TOPICAL	NDA	26 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	10544-114	TABLET, DELAYED RELEASE	50 mg	ORAL	ANDA	24 sections
Diclofenac SodiumDelayed Release	HUMAN PRESCRIPTION DRUG LABEL	1	10544-188	TABLET, DELAYED RELEASE	50 mg	ORAL	ANDA	28 sections
Diclofenac SodiumDelayed Release	HUMAN PRESCRIPTION DRUG LABEL	1	10544-189	TABLET, DELAYED RELEASE	75 mg	ORAL	ANDA	28 sections
Diclofenac Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	10544-921	TABLET, DELAYED RELEASE	75 mg	ORAL	ANDA	24 sections