Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
antihyperlipidaemics, acyl CoA: cholesterol acyltransferase (ACAT) inhibitors	1125	163222-33-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: SCH58235 SCH-58235 ezetimib ezetimibe ezedoc ezentia ezetrol zetia	An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS. Molecular weight: 409.43 Formula: C24H21F2NO3 CLOGP: 3.96 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 60.77 ALOGS: -4.68 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

SCH58235
SCH-58235
ezetimib
ezetimibe
ezedoc
ezentia
ezetrol
zetia

An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.

Molecular weight: 409.43
Formula: C24H21F2NO3
CLOGP: 3.96
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 60.77
ALOGS: -4.68
ROTB: 6

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.35 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	4.047		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	2.089		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	58.884	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	28.119	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	1.160	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	2.060	%	High	1
herg	hERG pIC50	4.858	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	35.810	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	97.949	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	1.110	%	High	1
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,MAPK10,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PRKDC,TGFBR1	17
kinase-selectivity-class	ACVR2B,AXL,GRK2	3
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	4.710		High	1
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	4.786		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	96.383		High	1
mppb	Mouse plasma protein binding (% unbound)	1.260		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	19.724		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1		High	1
pppb	Pig plasma protein binding (% unbound)	2.370	%	High	1
rat-kpuu-brain	Rat brain Kpuu	0.133	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	209.411	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	10.540	%	High	1
rppb	Rat plasma protein binding (% unbound)	0.890	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	15.453	uM	High	1

Approvals:

Date	Agency	Company	Orphan
Oct. 25, 2002	FDA	MSD INTL GMBH
April 18, 2007	PMDA	Schering-Plough K.K

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
Myalgia	1843.72	10.21	1476	89918	173649	90363404
Rhabdomyolysis	794.16	10.21	546	90848	50710	90486343
Blood creatine phosphokinase increased	523.48	10.21	361	91033	33662	90503391
Angina pectoris	368.65	10.21	310	91084	38850	90498203
Low density lipoprotein increased	333.52	10.21	163	91231	7922	90529131
Pemphigus	300.16	10.21	6	91388	326858	90210195
Arterial occlusive disease	298.82	10.21	175	91219	12271	90524782
Hand deformity	282.54	10.21	3	91391	296359	90240694
Gangrene	275.23	10.21	168	91226	12708	90524345
Carotid artery thrombosis	259.09	10.21	143	91251	8949	90528104
Neurologic neglect syndrome	257.22	10.21	141	91253	8706	90528347
Maternal exposure during pregnancy	239.91	10.21	38	91356	360025	90177028
Synovitis	235.76	10.21	28	91366	329724	90207329
Adjustment disorder	235.24	10.21	137	91257	9505	90527548
Glossodynia	228.38	10.21	28	91366	321751	90215302
Pericarditis	226.50	10.21	11	91383	270140	90266913
Wound	226.10	10.21	22	91372	302958	90234095
Contraindicated product administered	222.03	10.21	30	91364	320109	90216944
Personality disorder	215.16	10.21	142	91252	12302	90524751
Sinus congestion	211.73	10.21	194	91200	27230	90509823
Sensory loss	210.26	10.21	162	91232	17913	90519140
Systemic lupus erythematosus	210.23	10.21	53	91341	361843	90175210
Infusion related reaction	206.56	10.21	81	91313	416699	90120354
Duodenal ulcer perforation	203.33	10.21	4	91390	221284	90315769
Hemiplegia	194.92	10.21	148	91246	16012	90521041
Skin haemorrhage	194.50	10.21	166	91228	21214	90515839
Coronary artery disease	194.35	10.21	203	91191	33420	90503633
Helicobacter infection	187.73	10.21	10	91384	226840	90310213
Folliculitis	186.54	10.21	4	91390	204349	90332704
Muscle spasms	186.21	10.21	618	90776	251265	90285788
Sneezing	182.87	10.21	186	91208	29683	90507370
Muscular weakness	180.27	10.21	537	90857	206129	90330924
Cerebrovascular accident	177.76	10.21	388	91006	123145	90413908
Motor dysfunction	176.35	10.21	150	91244	19080	90517973
Affect lability	176.18	10.21	146	91248	17917	90519136
Palpitations	172.91	10.21	408	90986	136320	90400733
Coordination abnormal	170.58	10.21	154	91240	21202	90515851
Myopathy	165.69	10.21	125	91269	13393	90523660
Off label use	163.84	10.21	568	90826	1101684	89435369
Sinus disorder	152.63	10.21	181	91213	34266	90502787
Hemiparesis	152.36	10.21	174	91220	31645	90505408
Muscle injury	148.65	10.21	7	91387	176647	90360406
Eating disorder	147.25	10.21	161	91233	27912	90509141
Myocardial infarction	146.96	10.21	328	91066	105644	90431409
Respiratory tract congestion	146.92	10.21	159	91235	27251	90509802
Cataract	146.78	10.21	262	91132	71830	90465223
Product use issue	133.42	10.21	84	91310	329835	90207218
Chest discomfort	130.65	10.21	370	91024	137995	90399058
Therapeutic product effect decreased	129.32	10.21	59	91335	277512	90259541
Irritable bowel syndrome	125.07	10.21	28	91366	207420	90329633
Influenza like illness	121.43	10.21	258	91136	80353	90456700
Skin exfoliation	119.70	10.21	232	91162	67681	90469372
Aphasia	118.84	10.21	179	91215	42633	90494420
Impaired healing	118.44	10.21	44	91350	234155	90302898
Psoriatic arthropathy	115.30	10.21	43	91351	228292	90308761
Drug ineffective	114.70	10.21	873	90521	1383425	89153628
Liver function test abnormal	114.21	10.21	193	91201	50652	90486401
Exposure during pregnancy	113.69	10.21	49	91345	238361	90298692
Treatment failure	112.75	10.21	85	91309	303843	90233210
Acute kidney injury	111.64	10.21	626	90768	319761	90217292
Infection	110.83	10.21	121	91273	361973	90175080
Pancreatitis acute	107.83	10.21	147	91247	31968	90505085
Swelling	107.58	10.21	160	91234	418898	90118155
C-reactive protein abnormal	107.36	10.21	5	91389	127424	90409629
Blood pressure increased	106.21	10.21	437	90957	196780	90340273
Rhinorrhoea	104.57	10.21	257	91137	88059	90448994
Fibromyalgia	103.88	10.21	39	91355	206230	90330823
Flatulence	102.31	10.21	164	91230	41203	90495850
Fall	102.05	10.21	832	90562	480978	90056075
Dysarthria	102.03	10.21	191	91203	54291	90482762
Pain in extremity	100.87	10.21	788	90606	449741	90087312
Coronary artery occlusion	100.20	10.21	77	91317	8477	90528576
Discomfort	97.61	10.21	80	91314	274255	90262798
Blister	96.26	10.21	70	91324	254928	90282125
Amyloid arthropathy	94.54	10.21	42	91352	1638	90535415
Immune-mediated myositis	94.46	10.21	47	91347	2374	90534679
Muscle spasticity	94.24	10.21	145	91249	35177	90501876
Stomatitis	94.19	10.21	83	91311	274615	90262438
Muscle rupture	93.90	10.21	51	91343	3090	90533963
Alopecia	93.75	10.21	227	91167	494844	90042209
Vascular stent stenosis	91.85	10.21	32	91362	644	90536409
Intentional product use issue	89.34	10.21	54	91340	216838	90320215
Dyslipidaemia	88.92	10.21	77	91317	10030	90527023
Pulmonary pain	87.54	10.21	58	91336	5056	90531997
Dysphagia	86.89	10.21	280	91114	111998	90425055
Facet joint syndrome	85.78	10.21	3	91391	98386	90438667
Joint swelling	84.49	10.21	245	91149	503055	90033998
Lip dry	81.79	10.21	5	91389	100950	90436103
Hyper IgE syndrome	80.72	10.21	27	91367	478	90536575
Crush syndrome	80.57	10.21	24	91370	285	90536768
Mobility decreased	78.67	10.21	82	91312	250652	90286401
Arthropathy	75.73	10.21	160	91234	366082	90170971
Injury	74.69	10.21	54	91340	197295	90339758
Joint range of motion decreased	74.66	10.21	22	91372	135621	90401432
Cystitis	74.61	10.21	190	91204	66528	90470525
Blood triglycerides increased	72.30	10.21	79	91315	13682	90523371
Toxicity to various agents	71.79	10.21	112	91282	287734	90249319
Wound infection	71.30	10.21	11	91383	106391	90430662
Wheezing	69.07	10.21	83	91311	237997	90299056
Muscle discomfort	68.28	10.21	21	91373	280	90536773
Grip strength decreased	68.27	10.21	7	91387	92569	90444484
Ill-defined disorder	68.15	10.21	52	91342	184839	90352214
Blood glucose increased	66.11	10.21	229	91165	95017	90442036
High density lipoprotein decreased	65.54	10.21	38	91356	2613	90534440
Asthenia	63.89	10.21	820	90574	532931	90004122
Acute coronary syndrome	63.75	10.21	66	91328	10747	90526306
Liver injury	62.83	10.21	48	91346	170519	90366534
Peripheral venous disease	60.22	10.21	7	91387	83914	90453139
Lung disorder	59.38	10.21	39	91355	149844	90387209
Hypersensitivity	57.73	10.21	249	91145	454428	90082625
Nausea	57.34	10.21	1494	89900	1108822	89428231
Influenza	55.14	10.21	282	91112	138982	90398071
Lipoprotein (a) increased	54.69	10.21	13	91381	58	90536995
Inhibitory drug interaction	54.45	10.21	36	91358	3127	90533926
Coronary artery stenosis	54.36	10.21	44	91350	5222	90531831
Carotid arteriosclerosis	54.15	10.21	26	91368	1214	90535839
Hyperlipidaemia	54.14	10.21	89	91305	22827	90514226
Body tinea	53.66	10.21	31	91363	2117	90534936
Neutropenia	52.80	10.21	91	91303	224813	90312240
Acute myocardial infarction	51.75	10.21	111	91283	34779	90502274
Autoimmune disorder	51.26	10.21	8	91386	76736	90460317
Truncus arteriosus persistent	50.73	10.21	18	91376	383	90536670
Lower respiratory tract infection	50.54	10.21	111	91283	250548	90286505
Type 2 diabetes mellitus	49.78	10.21	80	91314	203164	90333889
Glucose tolerance impaired	49.36	10.21	50	91344	7935	90529118
Cough	48.90	10.21	578	90816	368384	90168669
Pancreatitis	48.55	10.21	168	91226	69658	90467395
Antinuclear antibody negative	48.55	10.21	16	91378	270	90536783
Cone-rod dystrophy	48.51	10.21	9	91385	6	90537047
Alanine aminotransferase increased	48.51	10.21	242	91152	118096	90418957
Restrictive pulmonary disease	48.38	10.21	30	91364	2332	90534721
Prescribed overdose	48.23	10.21	19	91375	97606	90439447
C-reactive protein increased	47.70	10.21	68	91326	181321	90355732
Coombs positive haemolytic anaemia	47.21	10.21	18	91376	472	90536581
Febrile neutropenia	47.20	10.21	54	91340	158295	90378758
Cardiac failure congestive	46.40	10.21	210	91184	98484	90438569
Dizziness	46.36	10.21	843	90551	588441	89948612
Polymyositis	45.46	10.21	28	91366	2151	90534902
Pulmonary fibrosis	45.33	10.21	26	91368	107477	90429576
Arthritis	44.99	10.21	306	91088	167009	90370044
Pregnancy	44.96	10.21	5	91389	62042	90475011
Bursitis	44.83	10.21	40	91354	131614	90405439
Aspartate aminotransferase increased	43.97	10.21	213	91181	102724	90434329
Congenital cardiovascular anomaly	43.38	10.21	17	91377	481	90536572
Myopathy toxic	43.28	10.21	18	91376	596	90536457
C3 glomerulopathy	42.93	10.21	13	91381	164	90536889
Drug interaction	42.03	10.21	445	90949	276008	90261045
Rhinalgia	41.75	10.21	28	91366	2490	90534563
Back pain	41.63	10.21	496	90898	316679	90220374
Completed suicide	41.59	10.21	51	91343	145007	90392046
Skin disorder	41.52	10.21	105	91289	36601	90500452
Hepatic enzyme increased	41.34	10.21	205	91189	360531	90176522
Necrotising myositis	41.14	10.21	19	91375	812	90536241
Death	40.35	10.21	282	91112	456269	90080784
Condition aggravated	40.30	10.21	395	90999	595150	89941903
Musculoskeletal stiffness	39.71	10.21	159	91235	296373	90240680
Disease progression	38.96	10.21	61	91333	156554	90380499
Infection susceptibility increased	38.83	10.21	32	91362	3894	90533159
Euglycaemic diabetic ketoacidosis	38.65	10.21	39	91355	6162	90530891
Urine protein/creatinine ratio increased	37.58	10.21	19	91375	993	90536060
Epilepsy	37.43	10.21	18	91376	82188	90454865
Night sweats	37.21	10.21	45	91349	128721	90408332
Therapy non-responder	37.19	10.21	50	91344	136654	90400399
Arterial stenosis	36.87	10.21	17	91377	724	90536329
International normalised ratio increased	36.58	10.21	118	91276	47198	90489855
Milk-alkali syndrome	36.21	10.21	20	91374	1253	90535800
Chromaturia	35.58	10.21	67	91327	19120	90517933
Myelosuppression	34.87	10.21	6	91388	53585	90483468
Hypoglycaemia	34.62	10.21	151	91243	69697	90467356
Blepharospasm	34.38	10.21	7	91387	55438	90481615
Endocarditis enterococcal	34.19	10.21	12	91382	247	90536806
Hepatic steatosis	34.06	10.21	98	91296	36847	90500206
Musculoskeletal discomfort	33.71	10.21	69	91325	20922	90516131
Prescribed underdose	33.29	10.21	17	91377	75002	90462051
Cardiac septal defect	32.89	10.21	16	91378	769	90536284
Road traffic accident	32.84	10.21	36	91358	107590	90429463
Peripheral swelling	32.76	10.21	263	91131	412843	90124210
Scleroedema	32.75	10.21	10	91384	130	90536923
Hip arthroplasty	32.74	10.21	18	91376	76190	90460863
Psoriasis	32.71	10.21	258	91136	147496	90389557
Myoglobin blood increased	32.52	10.21	20	91374	1532	90535521
Arteriosclerosis	32.45	10.21	47	91347	10806	90526247
Gastritis haemorrhagic	32.23	10.21	21	91373	1779	90535274
Cardiac myxoma	31.75	10.21	12	91382	307	90536746
General physical health deterioration	31.52	10.21	219	91175	354896	90182157
Toxic shock syndrome	31.34	10.21	17	91377	1027	90536026
Endocrine ophthalmopathy	30.89	10.21	17	91377	1057	90535996
Angina unstable	30.75	10.21	37	91357	7106	90529947
Product use in unapproved indication	30.51	10.21	206	91188	336030	90201023
Sensorimotor disorder	30.47	10.21	15	91379	740	90536313
Vulvovaginal pruritus	30.33	10.21	28	91366	3965	90533088
Respiratory disorder	29.81	10.21	14	91380	64802	90472251
Muscle disorder	29.73	10.21	32	91362	5447	90531606
Drug ineffective for unapproved indication	29.73	10.21	15	91379	66629	90470424
Malaise	29.64	10.21	787	90607	585199	89951854
Vulvovaginal burning sensation	29.61	10.21	23	91371	2572	90534481
Nasal discomfort	29.40	10.21	32	91362	5516	90531537
Mitral valve replacement	29.38	10.21	13	91381	502	90536551
Nasal dryness	29.24	10.21	32	91362	5551	90531502
Aortic stenosis	29.23	10.21	34	91360	6302	90530751
Renal impairment	29.04	10.21	194	91200	105227	90431826
Lupus-like syndrome	28.61	10.21	7	91387	48839	90488214
Poor quality sleep	28.30	10.21	71	91323	24622	90512431
Intervertebral disc degeneration	28.00	10.21	57	91337	17217	90519836
Low density lipoprotein abnormal	27.88	10.21	11	91383	317	90536736
Delirium	27.55	10.21	39	91355	104320	90432733
Oral herpes	27.19	10.21	85	91309	33439	90503614
Carotid artery stenosis	26.94	10.21	30	91364	5304	90531749
Transient ischaemic attack	26.71	10.21	100	91294	43076	90493977
Heart disease congenital	26.54	10.21	18	91376	1631	90535422
Herpes simplex reactivation	26.24	10.21	15	91379	1004	90536049
Sedation	26.16	10.21	8	91386	48163	90488890
Onychomadesis	26.16	10.21	7	91387	45991	90491062
Low density lipoprotein decreased	26.13	10.21	10	91384	265	90536788
Purpura	25.43	10.21	50	91344	14728	90522325
Lower limb fracture	25.32	10.21	29	91365	84984	90452069
Restless legs syndrome	25.12	10.21	64	91330	22406	90514647
Peripheral arterial occlusive disease	25.10	10.21	27	91367	4594	90532459
Coma acidotic	25.02	10.21	8	91386	122	90536931
Inflammation	25.02	10.21	94	91300	178498	90358555
Lipids increased	24.98	10.21	16	91378	1316	90535737
Coeliac disease	24.97	10.21	7	91387	44603	90492450
Vision blurred	24.63	10.21	193	91201	110100	90426953
Aortic valve replacement	24.52	10.21	14	91380	935	90536118
Pancytopenia	24.43	10.21	53	91341	120210	90416843
Microscopic polyangiitis	24.12	10.21	9	91385	222	90536831
Eyelid disorder	24.00	10.21	19	91375	2184	90534869
Polycystic ovaries	23.87	10.21	29	91365	5625	90531428
Device expulsion	23.67	10.21	6	91388	40880	90496173
Cerebrovascular arteriovenous malformation	23.66	10.21	7	91387	81	90536972
Sleep apnoea syndrome	23.49	10.21	78	91316	31669	90505384
Blood pressure systolic abnormal	23.38	10.21	57	91337	19421	90517632
Hip fracture	23.35	10.21	80	91314	32997	90504056
Paranasal sinus discomfort	23.26	10.21	30	91364	6180	90530873
Suicide attempt	23.24	10.21	25	91369	75374	90461679
Tubulointerstitial nephritis	23.14	10.21	67	91327	25276	90511777
Muscle atrophy	23.13	10.21	35	91359	8366	90528687
Respiratory syncytial virus test positive	23.11	10.21	14	91380	1044	90536009
Taste disorder	23.06	10.21	17	91377	61529	90475524
Finger deformity	22.97	10.21	3	91391	32894	90504159
Myocardial ischaemia	22.89	10.21	46	91348	13768	90523285
Apolipoprotein B increased	22.84	10.21	5	91389	14	90537039
Nasal ulcer	22.83	10.21	20	91374	2646	90534407
Impaired work ability	22.60	10.21	56	91338	19270	90517783
Hypercholesterolaemia	22.60	10.21	42	91352	100850	90436203
Migraine	22.48	10.21	107	91287	190285	90346768
Sleep disorder	22.40	10.21	113	91281	197917	90339136
Reaction to colouring	22.38	10.21	6	91388	47	90537006
Drug tolerance decreased	22.27	10.21	3	91391	32127	90504926
Encephalopathy	21.40	10.21	10	91384	46434	90490619
Hypoaesthesia	21.38	10.21	208	91186	314002	90223051
Glycosylated haemoglobin increased	21.36	10.21	48	91346	15514	90521539
Non-high-density lipoprotein cholesterol increased	21.23	10.21	8	91386	203	90536850
Vascular purpura	21.14	10.21	16	91378	1722	90535331
Renovascular hypertension	21.09	10.21	5	91389	22	90537031
Intentional overdose	21.08	10.21	39	91355	93795	90443258
Impaired quality of life	20.95	10.21	61	91333	23083	90513970
Abdominal discomfort	20.89	10.21	347	91047	476981	90060072
Complex regional pain syndrome	20.89	10.21	19	91375	2640	90534413
Copper metabolism disorder	20.83	10.21	4	91390	4	90537049
Cardiac failure chronic	20.72	10.21	27	91367	5619	90531434
Therapeutic product effect incomplete	20.61	10.21	113	91281	193783	90343270
Ear infection	20.56	10.21	24	91370	69751	90467302
Urinary tract infection	20.49	10.21	427	90967	305205	90231848
Drug hypersensitivity	20.30	10.21	337	91057	463272	90073781
Foetal exposure during pregnancy	20.20	10.21	9	91385	42966	90494087
Faeces discoloured	20.08	10.21	57	91337	21263	90515790
Hyperkalaemia	20.01	10.21	123	91271	64841	90472212
Gout	19.88	10.21	49	91345	16810	90520243
Palmar erythema	19.79	10.21	16	91378	1895	90535158
Aortic arteriosclerosis	19.73	10.21	31	91363	7653	90529400
Coronary artery thrombosis	19.66	10.21	13	91381	1129	90535924
Carotid artery disease	19.59	10.21	15	91379	1642	90535411
Biliary fibrosis	19.56	10.21	4	91390	7	90537046
Blood glucose decreased	19.55	10.21	60	91334	23369	90513684
Sciatica	19.52	10.21	46	91348	101336	90435717
Atrial fibrillation	19.32	10.21	213	91181	133398	90403655
Abnormal dreams	19.27	10.21	38	91356	11219	90525834
Oedema	19.02	10.21	121	91273	200174	90336879
Pyrexia	18.98	10.21	514	90880	659971	89877082
Gastric disorder	18.75	10.21	75	91319	33309	90503744
Platelet count decreased	18.60	10.21	73	91321	136896	90400157
Diabetic neuropathy	18.57	10.21	23	91371	4551	90532502
Cholestasis	18.39	10.21	79	91315	36220	90500833
Swelling of eyelid	18.36	10.21	25	91369	5429	90531624
Chronic spontaneous urticaria	18.35	10.21	15	91379	1805	90535248
Spleen congestion	18.06	10.21	6	91388	104	90536949
Lipids abnormal	18.01	10.21	8	91386	312	90536741
Gastrooesophageal reflux disease	17.94	10.21	251	91143	166086	90370967
Urticaria	17.68	10.21	216	91178	312518	90224535
Total cholesterol/HDL ratio decreased	17.60	10.21	4	91390	14	90537039
Hospitalisation	17.57	10.21	68	91326	128032	90409021
Oesophageal irritation	17.52	10.21	8	91386	333	90536720
Antiphospholipid syndrome	17.38	10.21	16	91378	2258	90534795
Ischaemic cardiomyopathy	17.33	10.21	17	91377	2596	90534457
Back injury	17.31	10.21	13	91381	46609	90490444
Autoimmune myositis	17.26	10.21	8	91386	345	90536708
Anxiety disorder	17.23	10.21	23	91371	4899	90532154
Chest pain	17.20	10.21	433	90961	319212	90217841
Arteriosclerosis coronary artery	17.15	10.21	33	91361	9570	90527483
Spontaneous haematoma	17.13	10.21	12	91382	1146	90535907
Language disorder	17.12	10.21	17	91377	2635	90534418
Polymyalgia rheumatica	17.03	10.21	23	91371	4954	90532099
Osteoarthropathy	16.94	10.21	8	91386	360	90536693
Photopsia	16.86	10.21	23	91371	5001	90532052
Swollen tongue	16.76	10.21	91	91303	45865	90491188
Cardiac valve disease	16.75	10.21	22	91372	4613	90532440
Nail disorder	16.68	10.21	21	91373	59046	90478007
Heliotrope rash	16.66	10.21	7	91387	238	90536815
Hyperhidrosis	16.48	10.21	210	91184	136095	90400958
Hyperparathyroidism secondary	16.41	10.21	14	91380	1787	90535266
Lichen planus	16.39	10.21	17	91377	2774	90534279
Transferrin decreased	16.34	10.21	8	91386	390	90536663
Frequent bowel movements	16.33	10.21	20	91374	56915	90480138
Mononeuropathy multiplex	16.23	10.21	8	91386	396	90536657
Anxiety	16.19	10.21	418	90976	309354	90227699
Product administration error	16.18	10.21	61	91333	26362	90510691
Immunodeficiency	16.12	10.21	12	91382	43222	90493831
Reaction to excipient	16.02	10.21	14	91380	1846	90535207
Anembryonic gestation	16.02	10.21	9	91385	583	90536470
Palatal swelling	16.01	10.21	6	91388	150	90536903
Exostosis	15.95	10.21	18	91376	53116	90483937
Gastric ulcer haemorrhage	15.88	10.21	23	91371	5288	90531765
Skin laceration	15.85	10.21	60	91334	25975	90511078
Blood uric acid abnormal	15.79	10.21	6	91388	156	90536897
Glomerular filtration rate decreased	15.69	10.21	45	91349	16887	90520166
Gastrointestinal haemorrhage	15.48	10.21	149	91245	90099	90446954
Blood lactic acid increased	15.47	10.21	30	91364	8748	90528305
Iron binding capacity total decreased	15.15	10.21	8	91386	458	90536595
Aphthous ulcer	15.11	10.21	45	91349	17242	90519811
Helicobacter gastritis	15.05	10.21	13	91381	1687	90535366
Bone density decreased	15.02	10.21	45	91349	17300	90519753
Poikiloderma	14.90	10.21	7	91387	311	90536742
General physical condition	14.85	10.21	4	91390	32	90537021
Obstructive pancreatitis	14.84	10.21	9	91385	672	90536381
Hepatic cyst	14.83	10.21	25	91369	6543	90530510
Gingival oedema	14.77	10.21	5	91389	92	90536961
Sleep disorder due to a general medical condition	14.74	10.21	14	91380	44724	90492329
Bradycardia	14.66	10.21	139	91255	83708	90453345
Cognitive disorder	14.59	10.21	30	91364	69377	90467676
Acute on chronic liver failure	14.46	10.21	7	91387	333	90536720
Lip swelling	14.45	10.21	77	91317	38533	90498520
Adverse reaction	14.32	10.21	6	91388	29706	90507347
Blood creatine phosphokinase MM increased	14.23	10.21	4	91390	38	90537015
Vertebral lateral recess stenosis	14.23	10.21	7	91387	345	90536708
Acquired epidermolysis bullosa	14.14	10.21	4	91390	39	90537014
Haematoma muscle	14.10	10.21	13	91381	1837	90535216
Nephrogenic systemic fibrosis	14.08	10.21	19	91375	4089	90532964
Muscle fatigue	14.01	10.21	16	91378	2908	90534145
Osteoarthritis	13.97	10.21	128	91266	195602	90341451
Nasal cyst	13.87	10.21	4	91390	42	90537011
Hot flush	13.78	10.21	105	91289	59383	90477670
Hypoglycaemic seizure	13.77	10.21	8	91386	552	90536501
Ligamentum flavum hypertrophy	13.77	10.21	7	91387	370	90536683
Gait disturbance	13.75	10.21	352	91042	260144	90276909
Stent placement	13.74	10.21	19	91375	4184	90532869
Product quality issue	13.72	10.21	38	91356	79287	90457766
Headache	13.68	10.21	1028	90366	861718	89675335
Increased appetite	13.66	10.21	34	91360	11731	90525322
Abortion spontaneous	13.49	10.21	21	91373	54035	90483018
Cerebellar syndrome	13.41	10.21	18	91376	3854	90533199
Myositis	13.39	10.21	54	91340	24074	90512979
Drug resistance	13.36	10.21	7	91387	30442	90506611
Mean cell haemoglobin increased	13.29	10.21	18	91376	3887	90533166
Therapy cessation	13.26	10.21	72	91322	36289	90500764
Malignant neoplasm progression	13.24	10.21	59	91335	106811	90430242
Cholangitis	13.22	10.21	25	91369	7157	90529896
Cystitis noninfective	13.21	10.21	11	91383	1358	90535695
Autoimmune hepatitis	13.18	10.21	31	91363	10320	90526733
Liver function test increased	12.99	10.21	43	91351	84812	90452241
Aneurysm	12.88	10.21	17	91377	3583	90533470
Hyperchylomicronaemia	12.83	10.21	4	91390	56	90536997
Radius fracture	12.80	10.21	18	91376	4026	90533027
Arcus lipoides	12.69	10.21	3	91391	13	90537040
Renal failure	12.67	10.21	194	91200	130813	90406240
Tremor	12.65	10.21	221	91173	152952	90384101
Paranoia	12.64	10.21	35	91359	12873	90524180
Injection site extravasation	12.58	10.21	28	91366	8991	90528062
Throat tightness	12.57	10.21	61	91333	29423	90507630
Toe operation	12.57	10.21	10	91384	1158	90535895
Red blood cell sedimentation rate increased	12.55	10.21	42	91352	82553	90454500
Food allergy	12.51	10.21	5	91389	25473	90511580
Blood cholesterol abnormal	12.49	10.21	15	91379	2875	90534178
Hallucination, auditory	12.49	10.21	40	91354	15935	90521118
Catheter site thrombosis	12.43	10.21	7	91387	455	90536598
Laryngitis	12.39	10.21	20	91374	50733	90486320
Vascular stent occlusion	12.39	10.21	4	91390	63	90536990
Product substitution issue	12.23	10.21	43	91351	17965	90519088
Aortic valve stenosis	12.15	10.21	18	91376	4222	90532831
Haematochezia	12.12	10.21	117	91277	70796	90466257
Xanthoma	12.00	10.21	4	91390	70	90536983
Septic shock	11.98	10.21	44	91350	84116	90452937
Feeling abnormal	11.97	10.21	236	91158	166999	90370054
Bone marrow failure	11.94	10.21	9	91385	32212	90504841
Abscess	11.89	10.21	44	91350	18847	90518206
Low density lipoprotein	11.88	10.21	3	91391	18	90537035
Renal pain	11.87	10.21	25	91369	7734	90529319
Small intestinal haemorrhage	11.86	10.21	13	91381	2258	90534795
Vascular access site pain	11.84	10.21	7	91387	499	90536554
Neutrophil count decreased	11.83	10.21	35	91359	71497	90465556
Sepsis	11.81	10.21	120	91274	179694	90357359
Duodenitis	11.76	10.21	18	91376	4345	90532708
Pancreatic neoplasm	11.66	10.21	9	91385	997	90536056
Peritonitis	11.66	10.21	45	91349	19660	90517393
Joint space narrowing	11.66	10.21	8	91386	739	90536314
Xanthelasma	11.60	10.21	4	91390	78	90536975
Paresis	11.59	10.21	14	91380	2700	90534353
Electrocardiogram Q wave abnormal	11.53	10.21	5	91389	184	90536869
Eye infection	11.43	10.21	36	91358	14218	90522835
Blood pressure systolic increased	11.36	10.21	99	91295	58246	90478807
Hypothyroidism	11.33	10.21	92	91302	53035	90484018
Renal disorder	11.23	10.21	71	91323	37788	90499265
Syncope	11.17	10.21	192	91202	132471	90404582
Hepatic cirrhosis	11.16	10.21	30	91364	63223	90473830
Liver disorder	11.13	10.21	74	91320	121195	90415858
Coronary arterial stent insertion	11.08	10.21	14	91380	2826	90534227
Skin induration	11.05	10.21	15	91379	3247	90533806
Vaginal discharge	11.00	10.21	3	91391	19461	90517592
Hyperphosphataemia	10.99	10.21	16	91378	3695	90533358
MELAS syndrome	10.89	10.21	5	91389	211	90536842
Memory impairment	10.85	10.21	137	91257	197107	90339946
Normal newborn	10.81	10.21	5	91389	23357	90513696
Chronic obstructive pulmonary disease	10.81	10.21	118	91276	73711	90463342
Granuloma annulare	10.78	10.21	8	91386	836	90536217
Hypotrichosis	10.69	10.21	5	91389	220	90536833
Multiple sclerosis relapse	10.66	10.21	23	91371	52282	90484771
Right atrial enlargement	10.65	10.21	5	91389	222	90536831
Mitral valve incompetence	10.63	10.21	48	91346	22476	90514577
Abdominal distension	10.63	10.21	188	91206	130413	90406640
Ascites	10.58	10.21	20	91374	47720	90489333
Myoglobinuria	10.46	10.21	6	91388	404	90536649
Hypertriglyceridaemia	10.46	10.21	24	91370	7865	90529188
Pancreatic cyst	10.43	10.21	12	91382	2198	90534855
Seizure	10.38	10.21	101	91293	152528	90384525
Disease risk factor	10.36	10.21	5	91389	236	90536817
Eye irritation	10.25	10.21	64	91330	33914	90503139
Pustular psoriasis	10.22	10.21	3	91391	18553	90518500

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
Myalgia	1629.99	11.04	1348	73586	94732	42451669
Rhabdomyolysis	724.40	11.04	785	74149	77234	42469167
Blood creatine phosphokinase increased	671.23	11.04	606	74328	47732	42498669
Myopathy	401.10	11.04	268	74666	13493	42532908
Low density lipoprotein increased	291.54	11.04	156	74778	5199	42541202
Myocardial infarction	221.33	11.04	595	74339	123414	42422987
Angina pectoris	199.54	11.04	267	74667	32629	42513772
Off label use	183.68	11.04	548	74386	637787	41908614
Muscular weakness	166.69	11.04	418	74516	83080	42463321
Muscle spasms	143.57	11.04	403	74531	85641	42460760
Coronary artery disease	140.30	11.04	299	74635	53421	42492980
High density lipoprotein decreased	125.96	11.04	81	74853	3816	42542585
Death	114.24	11.04	435	74499	470750	42075651
Neutropenia	113.50	11.04	110	74824	199321	42347080
Low density lipoprotein decreased	112.63	11.04	52	74882	1252	42545149
Myositis	104.76	11.04	130	74804	14736	42531665
Dizziness	102.98	11.04	770	74164	248484	42297917
Toxicity to various agents	100.22	11.04	155	74779	228981	42317420
Blood triglycerides increased	99.40	11.04	131	74803	15765	42530636
Muscle discomfort	96.20	11.04	29	74905	194	42546207
Low density lipoprotein abnormal	90.03	11.04	32	74902	379	42546022
Angina unstable	86.98	11.04	104	74830	11344	42535057
Drug interaction	85.64	11.04	779	74155	266220	42280181
Immune-mediated myositis	85.17	11.04	63	74871	3730	42542671
Hepatic enzyme increased	84.86	11.04	223	74711	45561	42500840
Drug abuse	65.29	11.04	53	74881	104718	42441683
Blood cholesterol increased	64.27	11.04	144	74790	26597	42519804
Pancreatitis	63.79	11.04	194	74740	43074	42503327
Malignant neoplasm progression	62.52	11.04	59	74875	108341	42438060
Febrile neutropenia	61.61	11.04	148	74786	185555	42360846
Venous pressure jugular increased	61.16	11.04	29	74905	743	42545658
Pancreatitis acute	59.68	11.04	161	74773	33403	42512998
Sepsis	59.15	11.04	168	74766	199166	42347235
Acute kidney injury	55.13	11.04	929	74005	366408	42179993
Disease progression	54.68	11.04	106	74828	143550	42402851
Erectile dysfunction	54.19	11.04	129	74805	24784	42521617
Asthenia	53.62	11.04	740	74194	280053	42266348
Coronary artery occlusion	52.97	11.04	80	74854	10917	42535484
Acute myocardial infarction	52.44	11.04	222	74712	57943	42488458
Pneumonia	52.15	11.04	483	74451	421666	42124735
Muscle rupture	51.38	11.04	39	74895	2401	42544000
Chest pain	50.82	11.04	419	74515	139111	42407290
Product use in unapproved indication	50.74	11.04	161	74773	184295	42362106
Pyrexia	50.33	11.04	447	74487	393595	42152806
Treatment failure	49.59	11.04	24	74910	62600	42483801
Necrotising myositis	47.82	11.04	28	74906	1113	42545288
Hyperthyroidism	47.24	11.04	88	74846	14253	42532148
Coronary artery stenosis	46.48	11.04	73	74861	10306	42536095
Drug ineffective for unapproved indication	46.25	11.04	12	74922	46151	42500250
Dyslipidaemia	46.06	11.04	69	74865	9349	42537052
Foetal exposure during pregnancy	44.26	11.04	14	74920	47297	42499104
Infection	44.12	11.04	81	74853	111987	42434414
Type V hyperlipidaemia	44.08	11.04	25	74909	935	42545466
Liver function test abnormal	43.83	11.04	141	74793	32250	42514151
Muscle disorder	43.60	11.04	39	74895	3025	42543376
Dyspnoea exertional	42.59	11.04	188	74746	49960	42496441
Radiation inflammation	42.04	11.04	25	74909	1023	42545378
Septic shock	41.95	11.04	60	74874	91612	42454789
Myelosuppression	41.54	11.04	10	74924	40451	42505950
Amyotrophic lateral sclerosis	40.67	11.04	25	74909	1087	42545314
Blood cholesterol decreased	40.65	11.04	25	74909	1088	42545313
Pulmonary pain	39.51	11.04	28	74906	1550	42544851
Suicide attempt	39.12	11.04	16	74918	46084	42500317
Cytokine release syndrome	38.53	11.04	15	74919	44512	42501889
Drug resistance	38.17	11.04	7	74927	34241	42512160
Alanine aminotransferase increased	38.01	11.04	276	74658	88130	42458271
Aspartate aminotransferase increased	37.36	11.04	248	74686	76915	42469486
Chromaturia	37.19	11.04	85	74849	15904	42530497
Intentional product use issue	37.01	11.04	43	74891	71790	42474611
Hyperuricaemia	36.40	11.04	62	74872	9362	42537039
Left atrial dilatation	35.02	11.04	31	74903	2371	42544030
Completed suicide	34.29	11.04	74	74860	96391	42450010
Oedema peripheral	34.28	11.04	378	74556	135698	42410703
Total cholesterol/HDL ratio increased	34.16	11.04	13	74921	189	42546212
Restrictive pulmonary disease	33.70	11.04	24	74910	1339	42545062
Inspiratory capacity abnormal	33.64	11.04	11	74923	99	42546302
Muscle atrophy	33.61	11.04	56	74878	8305	42538096
Left ventricular dysfunction	33.50	11.04	67	74867	11434	42534967
Autoimmune hepatitis	32.96	11.04	45	74889	5600	42540801
Lipoprotein (a) increased	32.96	11.04	15	74919	349	42546052
Pulmonary embolism	32.44	11.04	105	74829	119507	42426894
Sedation	32.35	11.04	7	74927	30468	42515933
Drug dependence	32.31	11.04	6	74928	29088	42517313
Crush syndrome	32.30	11.04	10	74924	74	42546327
Ischaemic cardiomyopathy	32.20	11.04	48	74886	6474	42539927
Urticarial dermatitis	32.07	11.04	6	74928	0	42546401
Ascites	31.33	11.04	32	74902	56646	42489755
Cutaneous lupus erythematosus	30.89	11.04	19	74915	827	42545574
Pain in extremity	30.76	11.04	402	74532	150202	42396199
Erythromelalgia	30.69	11.04	9	74925	54	42546347
Bone marrow failure	30.59	11.04	10	74924	33083	42513318
Cardiac failure congestive	30.57	11.04	256	74678	85346	42461055
Vascular stent stenosis	30.14	11.04	21	74913	1131	42545270
Arthralgia	29.92	11.04	517	74417	204721	42341680
Premature baby	29.89	11.04	3	74931	23150	42523251
Haematocrit increased	29.47	11.04	29	74905	2538	42543863
Leukopenia	29.43	11.04	54	74880	74692	42471709
Acquired haemophilia	29.30	11.04	24	74910	1651	42544750
Glycogen storage disease type V	29.19	11.04	8	74926	36	42546365
Stent placement	28.72	11.04	41	74893	5319	42541082
Multiple organ dysfunction syndrome	28.58	11.04	82	74852	96953	42449448
Intentional overdose	28.50	11.04	29	74905	51427	42494974
Myocardial ischaemia	28.41	11.04	82	74852	17680	42528721
Exercise lack of	28.17	11.04	10	74924	118	42546283
Atrial fibrillation	27.83	11.04	371	74563	139222	42407179
Neutrophil count decreased	27.56	11.04	43	74891	63372	42483029
Hospitalisation	27.26	11.04	56	74878	74274	42472127
Mean cell haemoglobin concentration abnormal	27.14	11.04	8	74926	49	42546352
Tendon rupture	27.12	11.04	50	74884	8033	42538368
Diaphragmatic disorder	26.52	11.04	20	74914	1219	42545182
Pancytopenia	26.27	11.04	112	74822	117631	42428770
Prohormone brain natriuretic peptide increased	26.25	11.04	9	74925	95	42546306
Glycosylated haemoglobin increased	26.05	11.04	65	74869	12859	42533542
Arteriosclerosis	25.88	11.04	80	74854	17909	42528492
Respiratory failure	25.55	11.04	127	74807	128005	42418396
Renal impairment	25.41	11.04	301	74633	109927	42436474
Mucosal dryness	25.16	11.04	22	74912	1656	42544745
Xanthoma	25.06	11.04	9	74925	110	42546291
Autoimmune myositis	24.74	11.04	15	74919	636	42545765
Cytomegalovirus infection	24.64	11.04	13	74921	32293	42514108
C-reactive protein increased	24.07	11.04	47	74887	63513	42482888
Troponin increased	24.01	11.04	81	74853	18981	42527420
Platelet count decreased	23.98	11.04	144	74790	138437	42407964
Myasthenic syndrome	23.93	11.04	16	74918	805	42545596
Miller Fisher syndrome	23.45	11.04	9	74925	134	42546267
Toxic epidermal necrolysis	23.16	11.04	9	74925	26741	42519660
Incorrect route of product administration	23.08	11.04	7	74927	24298	42522103
Thrombocytopenia	22.84	11.04	219	74715	190060	42356341
Therapy partial responder	22.51	11.04	4	74930	20017	42526384
Hypovolaemia	22.35	11.04	57	74877	11428	42534973
Spinal osteoarthritis	22.25	11.04	48	74886	8638	42537763
Serotonin syndrome	21.88	11.04	9	74925	25836	42520565
Allergy to animal	21.75	11.04	13	74921	537	42545864
White blood cell count decreased	21.68	11.04	110	74824	110286	42436115
Bronchopulmonary aspergillosis	21.59	11.04	4	74930	19425	42526976
Lymphocyte count decreased	21.49	11.04	11	74923	27798	42518603
Drug intolerance	21.43	11.04	226	74708	80198	42466203
Acute coronary syndrome	21.29	11.04	66	74868	14799	42531602
Mucosal inflammation	20.96	11.04	34	74900	49340	42497061
Phaeochromocytoma malignant	20.94	11.04	7	74927	68	42546333
Candida infection	20.93	11.04	6	74928	21604	42524797
Coma	20.80	11.04	39	74895	53515	42492886
Overdose	20.60	11.04	105	74829	105159	42441242
Dyspnoea at rest	20.59	11.04	31	74903	4218	42542183
Heart valve stenosis	20.58	11.04	7	74927	72	42546329
Neurotoxicity	20.40	11.04	8	74926	23643	42522758
Polymyositis	20.30	11.04	20	74914	1753	42544648
Pericardial haemorrhage	20.16	11.04	28	74906	3541	42542860
BRASH syndrome	19.81	11.04	20	74914	1805	42544596
Food aversion	19.79	11.04	12	74922	509	42545892
Self esteem decreased	19.77	11.04	12	74922	510	42545891
Orthostatic hypotension	19.76	11.04	106	74828	30464	42515937
Syncope	19.72	11.04	264	74670	99142	42447259
Exercise tolerance decreased	19.70	11.04	37	74897	6029	42540372
Drug ineffective	19.51	11.04	908	74026	629289	41917112
Feeling abnormal	18.54	11.04	196	74738	69590	42476811
Drug effect less than expected	18.49	11.04	28	74906	3829	42542572
Muscle fatigue	18.48	11.04	19	74915	1752	42544649
Back pain	18.47	11.04	351	74583	141425	42404976
Product use issue	18.37	11.04	71	74863	76680	42469721
Muscle necrosis	18.34	11.04	15	74919	1030	42545371
Haemorrhagic transformation stroke	18.30	11.04	19	74915	1772	42544629
Hypophosphataemia	18.21	11.04	7	74927	20938	42525463
Flatulence	18.19	11.04	90	74844	25062	42521339
Aldolase increased	18.16	11.04	6	74928	56	42546345
Testicular swelling	18.13	11.04	20	74914	1999	42544402
Lipase increased	18.09	11.04	50	74884	10516	42535885
Accidental overdose	18.05	11.04	14	74920	28316	42518085
Potentiating drug interaction	18.03	11.04	37	74897	6431	42539970
Paraesthesia	17.99	11.04	203	74731	73256	42473145
Heliotrope rash	17.98	11.04	5	74929	24	42546377
Hyperkalaemia	17.78	11.04	218	74716	80240	42466161
Dyspepsia	17.70	11.04	129	74805	41223	42505178
Cardio-respiratory arrest	17.66	11.04	49	74885	58587	42487814
Somnolence	17.52	11.04	161	74773	140944	42405457
Blood creatine phosphokinase abnormal	17.49	11.04	10	74924	380	42546021
Cardiac disorder	17.28	11.04	146	74788	48786	42497615
ECG signs of myocardial ischaemia	17.16	11.04	8	74926	197	42546204
Type IIa hyperlipidaemia	16.57	11.04	9	74925	309	42546092
Hypercholesterolaemia	16.54	11.04	55	74879	12794	42533607
Neoplasm progression	16.45	11.04	16	74918	28984	42517417
Anion gap abnormal	16.43	11.04	10	74924	427	42545974
Agitation	16.37	11.04	58	74876	64256	42482145
Loss of personal independence in daily activities	16.25	11.04	40	74894	49776	42496625
Fatigue	16.23	11.04	928	74006	434713	42111688
Tendon injury	16.21	11.04	14	74920	1036	42545365
Melaena	16.08	11.04	120	74814	38626	42507775
Haemoglobin increased	15.97	11.04	31	74903	5175	42541226
Ventricular tachycardia	15.85	11.04	99	74835	30061	42516340
Genital pain	15.84	11.04	13	74921	897	42545504
Sclerodactylia	15.81	11.04	5	74929	40	42546361
Laryngeal discomfort	15.77	11.04	8	74926	238	42546163
Irritable bowel syndrome	15.76	11.04	29	74905	4652	42541749
Respiratory arrest	15.76	11.04	16	74918	28408	42517993
Psychotic disorder	15.57	11.04	17	74917	29191	42517210
Hypotony of eye	15.39	11.04	8	74926	251	42546150
Dyspnoea	15.37	11.04	937	73997	441684	42104717
Cerebrovascular accident	15.32	11.04	248	74686	96912	42449489
Cardiovascular disorder	15.28	11.04	55	74879	13310	42533091
Stomatitis	15.20	11.04	42	74892	50287	42496114
Serum ferritin abnormal	14.91	11.04	8	74926	268	42546133
Aggression	14.77	11.04	35	74899	44128	42502273
Dissociation	14.68	11.04	25	74909	3773	42542628
Blood creatine phosphokinase	14.65	11.04	6	74928	107	42546294
Influenza like illness	14.60	11.04	101	74833	31739	42514662
Drug withdrawal syndrome	14.57	11.04	10	74924	21539	42524862
Anuria	14.52	11.04	49	74885	11483	42534918
Faeces pale	14.51	11.04	16	74918	1598	42544803
Electrocardiogram abnormal	14.49	11.04	45	74889	10100	42536301
Neuroleptic malignant syndrome	14.47	11.04	10	74924	21462	42524939
Gastrointestinal pain	14.42	11.04	27	74907	4388	42542013
Duplicate therapy error	14.38	11.04	8	74926	288	42546113
Pancreatic carcinoma	14.35	11.04	43	74891	9463	42536938
Delirium	14.30	11.04	46	74888	52473	42493928
Tumour lysis syndrome	14.14	11.04	11	74923	22220	42524181
Muscle injury	14.05	11.04	16	74918	1656	42544745
Genital ulceration	14	11.04	12	74922	879	42545522
Coronary artery bypass	13.98	11.04	28	74906	4782	42541619
Lichenoid keratosis	13.97	11.04	25	74909	3925	42542476
Apolipoprotein increased	13.96	11.04	3	74931	3	42546398
Inappropriate schedule of product administration	13.91	11.04	105	74829	95797	42450604
Transaminases abnormal	13.89	11.04	8	74926	308	42546093
High density lipoprotein abnormal	13.86	11.04	5	74929	62	42546339
Electrocardiogram QT prolonged	13.76	11.04	41	74893	47904	42498497
Posterior reversible encephalopathy syndrome	13.49	11.04	3	74931	12818	42533583
Dystonia	13.45	11.04	3	74931	12787	42533614
Total cholesterol/HDL ratio decreased	13.44	11.04	5	74929	68	42546333
Peripheral arterial occlusive disease	13.37	11.04	34	74900	6804	42539597
Abdominal discomfort	13.36	11.04	196	74738	75059	42471342
Pneumothorax	13.34	11.04	13	74921	23530	42522871
Hepatic function abnormal	13.31	11.04	144	74790	51423	42494978
Adrenal insufficiency	13.18	11.04	67	74867	18857	42527544
Tachycardia	13.13	11.04	114	74820	100973	42445428
Aortic bruit	13.08	11.04	7	74927	233	42546168
Pancreatic neoplasm	13.08	11.04	12	74922	962	42545439
Euglycaemic diabetic ketoacidosis	13.06	11.04	30	74904	5630	42540771
Thrombosis	13.03	11.04	69	74865	68442	42477959
Arteriosclerosis coronary artery	12.92	11.04	66	74868	18611	42527790
Glomerular filtration rate decreased	12.90	11.04	60	74874	16291	42530110
Ureteric cancer recurrent	12.87	11.04	4	74930	30	42546371
Red blood cell count abnormal	12.84	11.04	11	74923	805	42545596
Injury	12.84	11.04	75	74859	22241	42524160
Lipoprotein increased	12.75	11.04	3	74931	6	42546395
Aortic embolus	12.75	11.04	3	74931	6	42546395
Carotid artery stenosis	12.75	11.04	29	74905	5407	42540994
Plasma cell myeloma	12.72	11.04	42	74892	47536	42498865
Delusion	12.68	11.04	5	74929	14729	42531672
Iron binding capacity total increased	12.65	11.04	4	74930	32	42546369
Vein disorder	12.64	11.04	17	74917	2085	42544316
Aspergillus infection	12.64	11.04	6	74928	15831	42530570
Hepatitis cholestatic	12.60	11.04	42	74892	9782	42536619
Ventricular fibrillation	12.54	11.04	21	74913	30102	42516299
Blood creatinine increased	12.54	11.04	267	74667	109736	42436665
Intentional product misuse	12.53	11.04	61	74873	61839	42484562
Systemic infection	12.47	11.04	28	74906	5177	42541224
Abnormal behaviour	12.40	11.04	17	74917	26434	42519967
Gait disturbance	12.20	11.04	241	74693	97759	42448642
Microalbuminuria	12.19	11.04	11	74923	863	42545538
Hepatic failure	12.11	11.04	31	74903	38069	42508332
Bacterial infection	12.02	11.04	19	74915	27860	42518541
Cytopenia	11.99	11.04	8	74926	17489	42528912
Muscle strength abnormal	11.98	11.04	7	74927	277	42546124
Blood glucose increased	11.95	11.04	189	74745	73510	42472891
Hyperphosphataemia	11.89	11.04	4	74930	13000	42533401
Bacteraemia	11.84	11.04	16	74918	25024	42521377
Hypotension	11.83	11.04	560	74374	257071	42289330
Hypercapnic coma	11.78	11.04	6	74928	180	42546221
Urogenital haemorrhage	11.77	11.04	10	74924	724	42545677
Dermatitis atopic	11.68	11.04	48	74886	12356	42534045
Knee arthroplasty	11.67	11.04	38	74896	8743	42537658
Acute phosphate nephropathy	11.65	11.04	3	74931	10	42546391
Progressive multifocal leukoencephalopathy	11.55	11.04	3	74931	11533	42534868
Arrhythmia	11.55	11.04	115	74819	40202	42506199
Pancreatitis necrotising	11.53	11.04	22	74912	3627	42542774
Blood pressure increased	11.49	11.04	247	74687	101681	42444720
Condition aggravated	11.48	11.04	360	74574	260394	42286007
Nasal neoplasm	11.37	11.04	5	74929	107	42546294
Impetigo	11.36	11.04	13	74921	1353	42545048
Escherichia infection	11.34	11.04	3	74931	11393	42535008
Polymyalgia rheumatica	11.33	11.04	17	74917	2306	42544095
Weight decreased	11.32	11.04	460	74474	207488	42338913
Pseudomonas infection	11.30	11.04	7	74927	15916	42530485
Cholestatic liver injury	11.28	11.04	22	74912	3687	42542714
COVID-19	11.27	11.04	140	74794	115808	42430593
Tricuspid valve incompetence	11.26	11.04	44	74890	11069	42535332
Dyskinesia oesophageal	11.13	11.04	4	74930	49	42546352
Therapeutic drug monitoring analysis incorrectly performed	11.11	11.04	7	74927	318	42546083
Diabetes mellitus inadequate control	11.08	11.04	55	74879	15335	42531066
Hand fracture	11.07	11.04	19	74915	2887	42543514
Burning sensation	11.06	11.04	69	74865	20944	42525457

FDA Adverse Event Reporting System (Geriatric)

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
Myalgia	2676.34	10.23	2221	136724	220160	110230194
Rhabdomyolysis	1374.36	10.23	1168	137777	119233	110331121
Blood creatine phosphokinase increased	952.46	10.23	766	138179	72311	110378043
Angina pectoris	487.67	10.23	490	138455	61805	110388549
Myopathy	483.07	10.23	332	138613	24628	110425726
Low density lipoprotein increased	409.18	10.23	220	138725	10446	110439908
Myocardial infarction	330.25	10.23	739	138206	191344	110259010
Off label use	293.41	10.23	941	138004	1499244	108951110
Muscular weakness	288.90	10.23	824	138121	247644	110202710
Coronary artery disease	276.37	10.23	393	138552	71297	110379057
Arterial occlusive disease	255.39	10.23	186	138759	15122	110435232
Hand deformity	253.88	10.23	4	138941	218502	110231852
Carotid artery thrombosis	234.66	10.23	148	138797	9490	110440864
Neurologic neglect syndrome	231.96	10.23	145	138800	9153	110441201
Synovitis	220.76	10.23	39	138906	274053	110176301
Gangrene	216.34	10.23	173	138772	16168	110434186
Pemphigus	211.49	10.23	15	138930	214555	110235799
Acute kidney injury	210.41	10.23	1442	137503	633988	109816366
Maternal exposure during pregnancy	208.05	10.23	35	138910	254848	110195506
Pericarditis	205.74	10.23	19	138926	219095	110231259
Adjustment disorder	200.42	10.23	140	138805	10655	110439699
Muscle spasms	195.57	10.23	779	138166	277378	110172976
Personality disorder	191.83	10.23	146	138799	12691	110437663
Systemic lupus erythematosus	188.59	10.23	44	138901	254294	110196060
Folliculitis	183.44	10.23	6	138939	167647	110282707
Immune-mediated myositis	181.39	10.23	107	138838	6079	110444275
Sensory loss	179.37	10.23	175	138770	21282	110429072
Contraindicated product administered	178.13	10.23	46	138899	248221	110202133
Sinus congestion	177.44	10.23	205	138740	30254	110420100
Duodenal ulcer perforation	176.34	10.23	12	138933	177688	110272666
Infusion related reaction	175.94	10.23	133	138812	381029	110069325
Drug interaction	174.35	10.23	1150	137795	499033	109951321
Glossodynia	169.43	10.23	36	138909	221968	110228386
Helicobacter infection	167.50	10.23	17	138928	181860	110268494
Skin haemorrhage	165.02	10.23	179	138766	24648	110425706
Sneezing	156.45	10.23	197	138748	31787	110418567
Hemiplegia	156.24	10.23	167	138778	22615	110427739
Affect lability	153.92	10.23	151	138794	18486	110431868
Infection	145.73	10.23	144	138801	362056	110088298
Cerebrovascular accident	142.34	10.23	526	138419	180758	110269596
Treatment failure	142.27	10.23	86	138859	277148	110173206
Pancreatitis acute	139.05	10.23	262	138683	60012	110390342
Coordination abnormal	138.97	10.23	165	138780	25063	110425291
Palpitations	138.71	10.23	478	138467	158734	110291620
Motor dysfunction	138.38	10.23	162	138783	24244	110426110
High density lipoprotein decreased	136.98	10.23	87	138858	5646	110444708
Therapeutic product effect decreased	136.68	10.23	68	138877	244248	110206106
Toxicity to various agents	132.03	10.23	252	138693	480303	109970051
Low density lipoprotein decreased	131.86	10.23	54	138891	1368	110448986
Wound	128.52	10.23	67	138878	234370	110215984
Angina unstable	126.23	10.23	128	138817	16304	110434050
Fibromyalgia	125.81	10.23	30	138915	170879	110279475
Pulmonary pain	124.80	10.23	85	138860	6208	110444146
Acute myocardial infarction	123.83	10.23	304	138641	83473	110366881
Muscle rupture	122.59	10.23	74	138871	4386	110445968
Stomatitis	122.48	10.23	96	138849	270146	110180208
Sinus disorder	121.09	10.23	176	138769	32552	110417802
Neutropenia	120.88	10.23	177	138768	374443	110075911
Muscle discomfort	120.52	10.23	38	138907	436	110449918
Muscle injury	117.87	10.23	18	138927	140789	110309565
Influenza like illness	117.33	10.23	308	138637	88104	110362250
Intentional product use issue	116.27	10.23	85	138860	247821	110202533
Drug ineffective	115.26	10.23	1290	137655	1519250	108931104
Sleep disorder due to general medical condition, insomnia type	114.78	10.23	4	138941	105639	110344715
Chest discomfort	114.24	10.23	477	138468	173371	110276983
Eating disorder	112.80	10.23	165	138780	30693	110419661
Product use issue	112.01	10.23	136	138809	311559	110138795
Dizziness	111.77	10.23	1354	137591	696839	109753515
Respiratory tract congestion	109.91	10.23	163	138782	30694	110419660
Cataract	109.69	10.23	281	138664	79204	110371150
Asthenia	108.90	10.23	1333	137612	687666	109762688
Myositis	108.88	10.23	163	138782	30953	110419401
Blood triglycerides increased	108.58	10.23	142	138803	23784	110426570
Liver function test abnormal	108.12	10.23	256	138689	68694	110381660
Facet joint syndrome	107.60	10.23	3	138942	96825	110353529
Flatulence	107.27	10.23	216	138729	51933	110398421
Swelling	106.40	10.23	173	138772	350868	110099486
Crush syndrome	106.01	10.23	33	138912	362	110449992
Dyslipidaemia	105.91	10.23	115	138830	15850	110434504
Coronary artery occlusion	105.32	10.23	114	138831	15658	110434696
Lip dry	104.67	10.23	5	138940	100078	110350276
Psoriatic arthropathy	103.81	10.23	59	138886	196702	110253652
Blood pressure increased	100.97	10.23	612	138333	257761	110192593
Exposure during pregnancy	100.79	10.23	42	138903	167382	110282972
Alopecia	100.37	10.23	191	138754	364562	110085792
Irritable bowel syndrome	99.17	10.23	41	138904	164174	110286180
Impaired healing	98.17	10.23	63	138882	196654	110253700
Hemiparesis	97.75	10.23	188	138757	43715	110406639
Product use in unapproved indication	96.64	10.23	267	138678	447110	110003244
Restrictive pulmonary disease	86.82	10.23	53	138892	3206	110447148
Skin exfoliation	85.98	10.23	274	138671	87377	110362977
Joint swelling	85.78	10.23	278	138667	442567	110007787
Amyloid arthropathy	85.72	10.23	42	138903	1638	110448716
Aphasia	84.97	10.23	212	138733	58785	110391569
Vascular stent stenosis	83.37	10.23	40	138905	1489	110448865
Necrotising myositis	81.59	10.23	43	138902	1959	110448395
Blister	80.83	10.23	100	138845	227276	110223078
Coronary artery stenosis	80.80	10.23	93	138852	13665	110436689
Muscle spasticity	80.21	10.23	154	138791	35761	110414593
Drug ineffective for unapproved indication	79.83	10.23	16	138929	102822	110347532
Death	76.94	10.23	538	138407	698331	109752023
Low density lipoprotein abnormal	75.61	10.23	28	138917	537	110449817
Erectile dysfunction	74.85	10.23	104	138841	18452	110431902
Alanine aminotransferase increased	74.77	10.23	440	138505	183333	110267021
Peripheral venous disease	74.55	10.23	9	138936	84108	110366246
Aspartate aminotransferase increased	74.40	10.23	397	138548	159539	110290815
Rhinorrhoea	74.03	10.23	290	138655	102376	110347978
Lipoprotein (a) increased	72.43	10.23	19	138926	105	110450249
Completed suicide	71.05	10.23	122	138823	242259	110208095
Cardiac failure congestive	71.05	10.23	376	138569	150624	110299730
Hypersensitivity	70.57	10.23	265	138680	403733	110046621
C-reactive protein increased	70.20	10.23	103	138842	217816	110232538
Grip strength decreased	70.02	10.23	9	138936	80165	110370189
Joint range of motion decreased	69.49	10.23	33	138912	121799	110328555
Pain in extremity	69.43	10.23	925	138020	486193	109964161
Febrile neutropenia	68.40	10.23	189	138756	316578	110133776
Ill-defined disorder	68.20	10.23	58	138887	156795	110293559
Hyper IgE syndrome	67.06	10.23	27	138918	654	110449700
Renal impairment	65.90	10.23	434	138511	188011	110262343
Bursitis	65.64	10.23	41	138904	129877	110320477
Mobility decreased	65.56	10.23	124	138821	237298	110213056
Myelosuppression	62.98	10.23	20	138925	94320	110356034
Dysarthria	62.59	10.23	240	138705	83881	110366473
Disease progression	61.80	10.23	134	138811	243900	110206454
Dysphagia	60.06	10.23	364	138581	153236	110297118
Chromaturia	59.65	10.23	121	138824	29239	110421115
Polymyositis	59.46	10.23	44	138901	3664	110446690
Sedation	58.10	10.23	9	138936	69674	110380680
Atrial fibrillation	57.66	10.23	489	138456	229153	110221201
Lung disorder	56.15	10.23	87	138858	179960	110270394
Arthropathy	55.98	10.23	180	138765	287342	110163012
Suicide attempt	55.97	10.23	30	138915	103364	110346990
Fall	55.75	10.23	1066	137879	602416	109847938
Venous pressure jugular increased	54.99	10.23	29	138916	1323	110449031
Dyspnoea exertional	54.45	10.23	267	138678	103793	110346561
Muscle atrophy	53.04	10.23	74	138871	13180	110437174
Euglycaemic diabetic ketoacidosis	52.76	10.23	69	138876	11554	110438800
Acute coronary syndrome	52.71	10.23	100	138845	23012	110427342
Wound infection	52.20	10.23	28	138917	96437	110353917
Cystitis	52.11	10.23	192	138753	65844	110384510
Ischaemic cardiomyopathy	51.91	10.23	57	138888	7954	110442400
International normalised ratio increased	51.53	10.23	231	138714	86541	110363813
Cone-rod dystrophy	51.51	10.23	10	138935	7	110450347
Lower respiratory tract infection	51.03	10.23	147	138798	242959	110207395
Drug hypersensitivity	50.17	10.23	349	138596	453741	109996613
Radiation inflammation	49.91	10.23	25	138920	1023	110449331
Wheezing	49.53	10.23	160	138785	255070	110195284
Hyperuricaemia	49.24	10.23	75	138870	14456	110435898
Lower limb fracture	48.50	10.23	17	138928	75331	110375023
Discomfort	47.16	10.23	127	138818	214580	110235774
Type V hyperlipidaemia	47.07	10.23	27	138918	1455	110448899
Autoimmune hepatitis	46.80	10.23	74	138871	14730	110435624
Night sweats	46.48	10.23	60	138885	133923	110316431
Pregnancy	46.41	10.23	5	138940	51062	110399292
Epilepsy	46.13	10.23	35	138910	100174	110350180
Amyotrophic lateral sclerosis	45.69	10.23	30	138915	2061	110448293
Body tinea	45.38	10.23	30	138915	2085	110448269
Chest pain	45.30	10.23	694	138251	375681	110074673
Hyperkalaemia	45.21	10.23	309	138636	135487	110314867
Autoimmune myositis	45.10	10.23	23	138922	978	110449376
Injury	44.32	10.23	98	138847	177167	110273187
Syncope	44.02	10.23	418	138527	202118	110248236
Blepharospasm	43.70	10.23	8	138937	54843	110395511
Intentional overdose	43.28	10.23	62	138883	132439	110317915
Malignant neoplasm progression	43.24	10.23	97	138848	174470	110275884
Total cholesterol/HDL ratio increased	42.56	10.23	17	138928	403	110449951
Inspiratory capacity abnormal	41.39	10.23	12	138933	101	110450253
Delirium	41.38	10.23	66	138879	134959	110315395
Pancreatitis	41.34	10.23	229	138716	93304	110357050
Back pain	41.21	10.23	675	138270	370321	110080033
Glycosylated haemoglobin increased	40.66	10.23	91	138854	23528	110426826
Blood glucose increased	40.32	10.23	295	138650	132201	110318153
Hyperthyroidism	39.89	10.23	103	138842	29158	110421196
Xanthoma	39.81	10.23	14	138931	230	110450124
Carotid arteriosclerosis	39.69	10.23	32	138913	3025	110447329
Myopathy toxic	39.06	10.23	23	138922	1302	110449052
Muscle disorder	39.01	10.23	45	138900	6627	110443727
Myocardial ischaemia	38.54	10.23	96	138849	26588	110423766
Sleep disorder	38.20	10.23	125	138820	198519	110251835
Myoglobin blood increased	38.17	10.23	36	138909	4196	110446158
Onychomadesis	37.83	10.23	6	138939	45657	110404697
Carotid artery stenosis	37.49	10.23	52	138893	9211	110441143
Skin disorder	37.47	10.23	129	138816	42784	110407570
Cough	37.44	10.23	800	138145	460841	109989513
Troponin increased	36.76	10.23	101	138844	29665	110420689
Blood cholesterol decreased	36.47	10.23	29	138916	2687	110447667
Sepsis	36.42	10.23	251	138694	327095	110123259
Drug resistance	35.80	10.23	13	138932	56361	110393993
Left atrial dilatation	35.44	10.23	32	138913	3528	110446826
Infection susceptibility increased	35.14	10.23	35	138910	4363	110445991
Coeliac disease	35.06	10.23	6	138939	43181	110407173
Prescribed overdose	34.97	10.23	35	138910	87546	110362808
Urticarial dermatitis	34.09	10.23	6	138939	0	110450354
Pyrexia	33.76	10.23	865	138080	897400	109552954
Migraine	33.71	10.23	107	138838	171545	110278809
Tendon rupture	33.46	10.23	62	138883	14016	110436338
Inhibitory drug interaction	33.45	10.23	36	138909	4911	110445443
Condition aggravated	33.40	10.23	687	138258	734149	109716205
Faeces discoloured	33.16	10.23	106	138839	33842	110416512
Cytokine release syndrome	33.07	10.23	24	138921	70282	110380072
Pulmonary fibrosis	33.07	10.23	48	138897	101994	110348360
Cardiac myxoma	33.06	10.23	12	138933	217	110450137
Autoimmune disorder	32.61	10.23	21	138924	65462	110384892
Bone marrow failure	32.48	10.23	16	138929	57832	110392522
Psoriasis	32.46	10.23	293	138652	139700	110310654
Road traffic accident	32.43	10.23	53	138892	107345	110343009
Hyperlipidaemia	32.39	10.23	109	138836	35739	110414615
Liver injury	32.25	10.23	90	138855	150323	110300031
Glucose tolerance impaired	32.25	10.23	50	138895	9787	110440567
ECG signs of myocardial ischaemia	32.17	10.23	14	138931	414	110449940
Hepatic function abnormal	32.01	10.23	207	138738	89088	110361266
Drug abuse	31.84	10.23	115	138830	177296	110273058
Arthritis	31.65	10.23	336	138609	167250	110283104
Therapy non-responder	31.64	10.23	97	138848	157210	110293144
Melaena	31.50	10.23	170	138775	68587	110381767
Sciatica	31.41	10.23	42	138903	92357	110357997
Inflammation	31.01	10.23	131	138814	193107	110257247
Hospitalisation	30.75	10.23	85	138860	142408	110307946
Cytomegalovirus infection	30.65	10.23	15	138930	54429	110395925
Hepatic steatosis	30.51	10.23	132	138813	48699	110401655
Septic shock	30.37	10.23	99	138846	157429	110292925
Muscle necrosis	30.35	10.23	22	138923	1775	110448579
Lupus-like syndrome	30.32	10.23	7	138938	40785	110409569
Cholestasis	29.88	10.23	160	138785	64358	110385996
Type 2 diabetes mellitus	29.78	10.23	118	138827	177114	110273240
Glomerular filtration rate decreased	29.75	10.23	92	138853	28864	110421490
Pancytopenia	29.54	10.23	149	138796	209464	110240890
Acquired haemophilia	28.89	10.23	25	138920	2606	110447748
Scleroedema	28.85	10.23	10	138935	157	110450197
Neutrophil count decreased	28.50	10.23	69	138876	120872	110329482
Renal failure	28.48	10.23	421	138524	226153	110224201
Prescribed underdose	28.44	10.23	24	138921	65150	110385204
Peripheral swelling	28.34	10.23	348	138597	403686	110046668
Left ventricular dysfunction	28.30	10.23	79	138866	23414	110426940
Haematocrit increased	28.25	10.23	33	138912	4926	110445428
Finger deformity	28.22	10.23	4	138941	33088	110417266
Nausea	27.69	10.23	1853	137092	1233837	109216517
Aortic valve replacement	27.67	10.23	20	138925	1606	110448748
Vulvovaginal pruritus	27.52	10.23	27	138918	3304	110447050
Ear infection	27.50	10.23	23	138922	62709	110387645
Taste disorder	27.42	10.23	25	138920	65362	110384992
Endocarditis enterococcal	27.26	10.23	12	138933	365	110449989
Diaphragmatic disorder	27.19	10.23	21	138924	1865	110448489
Blood creatinine increased	27.11	10.23	350	138595	182539	110267815
Stent placement	26.90	10.23	39	138906	7195	110443159
Nasal dryness	26.10	10.23	34	138911	5672	110444682
Onychomycosis	26.01	10.23	8	138937	38523	110411831
Arteriosclerosis coronary artery	25.98	10.23	80	138865	25038	110425316
Endocrine ophthalmopathy	25.94	10.23	18	138927	1355	110448999
Arteriosclerosis	25.73	10.23	79	138866	24688	110425666
Nail disorder	25.70	10.23	21	138924	57914	110392440
Rhinalgia	25.53	10.23	28	138917	3901	110446453
Vulvovaginal burning sensation	25.47	10.23	21	138924	2048	110448306
Pericardial haemorrhage	25.30	10.23	32	138913	5185	110445169
Heliotrope rash	25.16	10.23	10	138935	234	110450120
Platelet count decreased	24.98	10.23	178	138767	230265	110220089
Hypoglycaemia	24.91	10.23	239	138706	115865	110334489
Testicular swelling	24.90	10.23	19	138926	1657	110448697
Influenza	24.81	10.23	323	138622	168778	110281576
Electrocardiogram abnormal	24.63	10.23	65	138880	18644	110431710
Purpura	24.60	10.23	77	138868	24311	110426043
Toxic shock syndrome	24.29	10.23	18	138927	1502	110448852
Mitral valve replacement	24.25	10.23	13	138932	613	110449741
Lipids increased	24.24	10.23	20	138925	1953	110448401
Heart valve stenosis	24.14	10.23	9	138936	176	110450178
Milk-alkali syndrome	23.96	10.23	20	138925	1985	110448369
Hip arthroplasty	23.81	10.23	21	138924	55792	110394562
Anuria	23.77	10.23	76	138869	24265	110426089
Thrombotic microangiopathy	23.77	10.23	4	138941	29145	110421209
Total cholesterol/HDL ratio decreased	23.73	10.23	7	138938	63	110450291
Hypotension	23.69	10.23	842	138103	523007	109927347
Potentiating drug interaction	23.67	10.23	48	138897	11595	110438759
Haemorrhagic stroke	23.59	10.23	53	138892	13736	110436618
Device expulsion	23.57	10.23	5	138940	30886	110419468
Encephalopathy	23.55	10.23	41	138904	81014	110369340
Fatigue	23.54	10.23	1802	137143	1214156	109236198
Toxic epidermal necrolysis	23.42	10.23	22	138923	56705	110393649
Phaeochromocytoma malignant	23.25	10.23	7	138938	68	110450286
Musculoskeletal stiffness	23.19	10.23	232	138713	279590	110170764
Prohormone brain natriuretic peptide increased	23.16	10.23	11	138934	400	110449954
Polymyalgia rheumatica	22.90	10.23	34	138911	6408	110443946
Glycogen storage disease type V	22.90	10.23	6	138939	33	110450321
Obstructive pancreatitis	22.82	10.23	16	138929	1225	110449129
Polycystic ovaries	22.59	10.23	29	138916	4767	110445587
Haematuria	22.55	10.23	180	138765	82825	110367529
Product quality issue	22.55	10.23	39	138906	77260	110373094
Exostosis	22.53	10.23	15	138930	45941	110404413
Nasal discomfort	22.51	10.23	33	138912	6148	110444206
Myasthenic syndrome	22.41	10.23	16	138929	1260	110449094
Carotid artery disease	22.17	10.23	20	138925	2203	110448151
Gait disturbance	22.16	10.23	481	138464	277727	110172627
Coma acidotic	22.02	10.23	8	138937	145	110450209
Oedema peripheral	21.82	10.23	554	138391	328106	110122248
Muscle fatigue	21.72	10.23	26	138919	3981	110446373
Red blood cell sedimentation rate increased	21.51	10.23	41	138904	78261	110372093
Neutropenic sepsis	21.46	10.23	6	138939	30740	110419614
Walking aid user	21.45	10.23	3	138942	25072	110425282
Nasal ulcer	21.43	10.23	21	138924	2566	110447788
Immunodeficiency	21.41	10.23	11	138934	38827	110411527
Sleep apnoea syndrome	21.31	10.23	104	138841	40343	110410011
Sensorimotor disorder	21.29	10.23	15	138930	1157	110449197
Therapy cessation	21.29	10.23	112	138833	44745	110405609
Hepatic cytolysis	21.21	10.23	130	138815	54923	110395431
Bradycardia	21.14	10.23	293	138652	155224	110295130
Presyncope	21.14	10.23	119	138826	48768	110401586
Transient ischaemic attack	20.94	10.23	145	138800	63837	110386517
Respiratory disorder	20.84	10.23	36	138909	71346	110379008
Leukopenia	20.83	10.23	106	138839	148685	110301669
Eyelid disorder	20.82	10.23	20	138925	2385	110447969
Cholestatic liver injury	20.78	10.23	35	138910	7341	110443013
Musculoskeletal discomfort	20.76	10.23	71	138874	23467	110426887
Systemic infection	20.58	10.23	41	138904	9778	110440576
Status epilepticus	20.53	10.23	7	138938	31564	110418790
Tendon injury	20.51	10.23	20	138925	2429	110447925
Mucosal dryness	20.43	10.23	26	138919	4237	110446117
Neurotoxicity	20.39	10.23	14	138931	42193	110408161
Cardiac failure chronic	20.27	10.23	50	138895	13761	110436593
Cerebrovascular arteriovenous malformation	20.25	10.23	7	138938	109	110450245
Intervertebral disc degeneration	20.03	10.23	59	138886	18026	110432328
Copper metabolism disorder	19.96	10.23	4	138941	4	110450350
Chronic kidney disease	19.95	10.23	164	138781	76127	110374227
Gastric disorder	19.95	10.23	89	138856	33268	110417086
Osteoarthritis	19.82	10.23	141	138804	182482	110267872
Peripheral arterial occlusive disease	19.75	10.23	39	138906	9241	110441113
Hypoaesthesia	19.69	10.23	277	138668	313946	110136408
Vascular purpura	19.68	10.23	24	138921	3747	110446607
Mucosal inflammation	19.53	10.23	59	138886	96082	110354272
Dry mouth	19.52	10.23	159	138786	199789	110250565
Mean cell haemoglobin concentration abnormal	19.45	10.23	8	138937	205	110450149
Language disorder	19.34	10.23	24	138921	3814	110446540
Pancreatic neoplasm	19.32	10.23	17	138928	1812	110448542
Laryngitis	19.28	10.23	15	138930	42396	110407958
Cerebellar syndrome	19.23	10.23	31	138914	6271	110444083
Reaction to colouring	19.18	10.23	6	138939	67	110450287
Arterial stenosis	19.04	10.23	16	138929	1603	110448751
Diabetes mellitus inadequate control	18.99	10.23	81	138864	29694	110420660
Cardiac disorder	18.89	10.23	162	138783	76118	110374236
Paranasal sinus discomfort	18.86	10.23	31	138914	6374	110443980
Hypovolaemia	18.79	10.23	65	138880	21609	110428745
Feeling abnormal	18.65	10.23	325	138620	180386	110269968
Faeces pale	18.56	10.23	22	138923	3335	110447019
Miller Fisher syndrome	18.44	10.23	9	138936	348	110450006
Arrhythmia	18.43	10.23	150	138795	69425	110380929
Ligament rupture	18.39	10.23	24	138921	4011	110446343
Antinuclear antibody negative	18.36	10.23	7	138938	146	110450208
Anion gap abnormal	18.28	10.23	12	138933	824	110449530
Labelled drug-drug interaction medication error	18.14	10.23	79	138866	29223	110421131
Diabetic neuropathy	18.13	10.23	32	138913	6967	110443387
Ascites	18.11	10.23	58	138887	92750	110357604
Hepatic cirrhosis	18.06	10.23	36	138909	67590	110382764
Exercise tolerance decreased	18.04	10.23	44	138901	12023	110438331
Somnolence	18.01	10.23	264	138681	297185	110153169
Lipase increased	17.96	10.23	58	138887	18614	110431740
Miosis	17.96	10.23	3	138942	21980	110428374
Multiple sclerosis relapse	17.94	10.23	22	138923	50218	110400136
Lipids abnormal	17.89	10.23	11	138934	674	110449680
Cutaneous lupus erythematosus	17.88	10.23	22	138923	3466	110446888
Exercise lack of	17.85	10.23	10	138935	515	110449839
Back injury	17.74	10.23	20	138925	47379	110402975
Aortic bruit	17.62	10.23	8	138937	262	110450092
Blood creatine phosphokinase abnormal	17.54	10.23	11	138934	698	110449656
Lactic acidosis	17.47	10.23	186	138759	92625	110357729
Cardiac valve disease	17.47	10.23	30	138915	6391	110443963
General physical condition	17.47	10.23	5	138940	40	110450314
Apolipoprotein B increased	17.45	10.23	4	138941	11	110450343
Hepatitis cholestatic	17.30	10.23	55	138890	17511	110432843
Urticaria	17.28	10.23	289	138656	318568	110131786
Amaurosis fugax	17.24	10.23	18	138927	2372	110447982
Biliary fibrosis	16.95	10.23	4	138941	13	110450341
Pancreatic carcinoma	16.93	10.23	49	138896	14823	110435531
Poisoning deliberate	16.84	10.23	6	138939	26325	110424029
Anembryonic gestation	16.78	10.23	9	138936	425	110449929
Lymphocyte count decreased	16.59	10.23	29	138916	57214	110393140
Cutaneous vasculitis	16.53	10.23	44	138901	12685	110437669
Drug tolerance decreased	16.42	10.23	7	138938	27533	110422821
Dystonia	16.30	10.23	6	138939	25799	110424555
Myoglobinuria	16.25	10.23	13	138932	1215	110449139
Eye irritation	16.20	10.23	84	138861	33368	110416986
Ventricular tachycardia	16.16	10.23	113	138832	49896	110400458
Aspergillus infection	16.11	10.23	6	138939	25610	110424744
Respiratory syncytial virus test positive	16.01	10.23	14	138931	1480	110448874
Delusion	15.92	10.23	5	138940	23750	110426604
Neoplasm progression	15.90	10.23	36	138909	64559	110385795
Helicobacter gastritis	15.90	10.23	18	138927	2598	110447756
Blood creatine phosphokinase	15.80	10.23	8	138937	335	110450019
Normal newborn	15.80	10.23	4	138941	21892	110428462
Bacteraemia	15.74	10.23	18	138927	42372	110407982
Gynaecomastia	15.71	10.23	36	138909	9454	110440900
Product substitution issue	15.70	10.23	64	138881	22997	110427357
White blood cell count decreased	15.53	10.23	199	138746	229191	110221163
Incorrect route of product administration	15.53	10.23	36	138909	64025	110386329
Type IIa hyperlipidaemia	15.39	10.23	9	138936	503	110449851
Microscopic polyangiitis	15.37	10.23	9	138936	504	110449850
Haemorrhagic transformation stroke	15.32	10.23	19	138926	3018	110447336
Gastrooesophageal reflux disease	15.24	10.23	314	138631	179662	110270692
Dermatitis atopic	15.16	10.23	68	138877	25473	110424881
Hepatic enzyme increased	15.14	10.23	298	138647	320594	110129760
International normalised ratio abnormal	15.11	10.23	28	138917	6329	110444025
Lichen planus	15.10	10.23	20	138925	3390	110446964
Vertebral foraminal stenosis	14.98	10.23	13	138932	1360	110448994
Haematotoxicity	14.93	10.23	4	138941	21078	110429276
Weight decreased	14.90	10.23	725	138220	467332	109983022
Coronary artery bypass	14.85	10.23	27	138918	6015	110444339
Therapeutic product effect incomplete	14.84	10.23	195	138750	223610	110226744
Loss of personal independence in daily activities	14.78	10.23	119	138826	149901	110300453
Genital pain	14.76	10.23	13	138932	1387	110448967
Diabetes mellitus	14.64	10.23	190	138755	99191	110351163
Therapy partial responder	14.58	10.23	15	138930	37046	110413308
Spontaneous haematoma	14.56	10.23	15	138930	1946	110448408
Injection site reaction	14.52	10.23	60	138885	89010	110361344
Urogenital haemorrhage	14.48	10.23	11	138934	953	110449401
Graft versus host disease	14.44	10.23	3	138942	18803	110431551
Cerebral infarction	14.40	10.23	113	138832	51725	110398629
Chronic spontaneous urticaria	14.36	10.23	15	138930	1978	110448376
Gastric ulcer haemorrhage	14.24	10.23	36	138909	10058	110440296
Anxiety	14.21	10.23	549	138396	344529	110105825
Small fibre neuropathy	14.09	10.23	11	138934	992	110449362
Injection site extravasation	14.07	10.23	36	138909	10133	110440221
Palmar erythema	14.06	10.23	16	138929	2322	110448032
Pallor	14.02	10.23	120	138825	56347	110394007
Overdose	13.97	10.23	208	138737	233586	110216768
Duplicate therapy error	13.95	10.23	8	138937	431	110449923
Cytomegalovirus infection reactivation	13.92	10.23	3	138942	18330	110432024
Erythromelalgia	13.88	10.23	8	138937	435	110449919
Gout	13.87	10.23	86	138859	36480	110413874
Tumour lysis syndrome	13.86	10.23	11	138934	30790	110419564
Renal pain	13.84	10.23	35	138910	9782	110440572
Blood uric acid abnormal	13.83	10.23	8	138937	438	110449916
FEV1/FVC ratio decreased	13.78	10.23	7	138938	295	110450059
Hypoparathyroidism	13.77	10.23	13	138932	1517	110448837
Frequent bowel movements	13.66	10.23	45	138900	71345	110379009
Pemphigoid	13.66	10.23	55	138890	19652	110430702
Renovascular hypertension	13.64	10.23	5	138940	93	110450261
Blood cholesterol abnormal	13.64	10.23	20	138925	3726	110446628
Hip fracture	13.54	10.23	83	138862	35068	110415286
Serum ferritin abnormal	13.46	10.23	8	138937	461	110449893
Device difficult to use	13.45	10.23	53	138892	18752	110431602
Gastrointestinal haemorrhage	13.44	10.23	287	138658	165231	110285123
Nasal cyst	13.37	10.23	4	138941	38	110450316
Hypotony of eye	13.36	10.23	8	138937	467	110449887
Tuberculosis	13.31	10.23	3	138942	17771	110432583
Haemoglobin increased	13.30	10.23	33	138912	9114	110441240
Metastases to central nervous system	13.29	10.23	6	138939	22811	110427543
Acquired epidermolysis bullosa	13.26	10.23	5	138940	101	110450253
Oral herpes	13.15	10.23	84	138861	35996	110414358
Lower gastrointestinal haemorrhage	13.14	10.23	52	138893	18434	110431920
Blood creatine phosphokinase MM increased	13.09	10.23	4	138941	41	110450313
Dyspnoea at rest	13.09	10.23	31	138914	8315	110442039
Photopsia	13.09	10.23	26	138919	6188	110444166
Maternal exposure timing unspecified	13.08	10.23	5	138940	21008	110429346
Gait inability	13.05	10.23	109	138836	136267	110314087
Thrombocytopenia	13.04	10.23	336	138609	348549	110101805
Generalised tonic-clonic seizure	13.04	10.23	31	138914	54649	110395705
Posterior reversible encephalopathy syndrome	12.99	10.23	14	138931	33847	110416507
Urinary tract disorder	12.97	10.23	25	138920	5819	110444535
Aortic stenosis	12.96	10.23	41	138904	13018	110437336
Aortic valve calcification	12.95	10.23	10	138935	888	110449466
Vision blurred	12.94	10.23	231	138714	128791	110321563
Nephrogenic systemic fibrosis	12.85	10.23	24	138921	5459	110444895
Coronary artery thrombosis	12.81	10.23	18	138927	3226	110447128
Vertebral lateral recess stenosis	12.78	10.23	7	138938	345	110450009
Intentional self-injury	12.73	10.23	17	138928	37412	110412942
Colitis ulcerative	12.68	10.23	52	138893	77311	110373043
Accidental overdose	12.67	10.23	29	138916	51805	110398549
Liver disorder	12.59	10.23	116	138829	142127	110308227
Product administration error	12.56	10.23	85	138860	37132	110413222
Hyperparathyroidism secondary	12.56	10.23	18	138927	3286	110447068
Suspected suicide attempt	12.56	10.23	7	138938	357	110449997
Aldolase increased	12.46	10.23	6	138939	225	110450129
Cognitive disorder	12.44	10.23	62	138883	87449	110362905
Liver function test increased	12.44	10.23	63	138882	88485	110361869
Pulmonary embolism	12.41	10.23	192	138753	214282	110236072
Agitation	12.40	10.23	87	138858	112964	110337390
Pneumonia	12.40	10.23	941	138004	875773	109574581
Mitral valve incompetence	12.40	10.23	78	138867	33251	110417103
Ligamentum flavum hypertrophy	12.36	10.23	7	138938	368	110449986
Paresis	12.36	10.23	22	138923	4822	110445532
Cardiac aneurysm	12.33	10.23	13	138932	1732	110448622
Transferrin decreased	12.31	10.23	8	138937	540	110449814
BRASH syndrome	12.31	10.23	19	138926	3704	110446650
Osteoarthropathy	12.29	10.23	7	138938	372	110449982
Blood loss anaemia	12.25	10.23	50	138895	17975	110432379
Hypoglycaemic seizure	12.25	10.23	10	138935	962	110449392
Product confusion	12.25	10.23	6	138939	234	110450120
Urinary occult blood	12.23	10.23	4	138941	52	110450302
Lip swelling	12.23	10.23	107	138838	50560	110399794
Drug dependence	12.21	10.23	28	138917	49992	110400362
Product prescribing error	12.18	10.23	108	138837	51223	110399131
Haemophagocytic lymphohistiocytosis	12.16	10.23	13	138932	31546	110418808
Duodenitis	12.15	10.23	32	138913	9164	110441190
Hypogammaglobulinaemia	12.13	10.23	5	138940	20071	110430283
Orthostatic hypotension	12.11	10.23	132	138813	66117	110384237
Cytopenia	12.06	10.23	12	138933	30104	110420250
Ear pain	12.05	10.23	31	138914	53195	110397159
Palatal swelling	11.99	10.23	6	138939	245	110450109
Bronchiectasis	11.99	10.23	17	138928	36476	110413878
Dyskinesia oesophageal	11.96	10.23	4	138941	56	110450298
Vertigo	11.94	10.23	164	138781	86706	110363648
Biopsy kidney	11.92	10.23	6	138939	248	110450106
Muscle strength abnormal	11.86	10.23	7	138938	398	110449956
Swollen tongue	11.85	10.23	122	138823	60240	110390114
Coma	11.84	10.23	93	138852	117776	110332578
Myasthenia gravis	11.83	10.23	56	138889	21455	110428899
Small intestinal haemorrhage	11.82	10.23	21	138924	4597	110445757
Loss of libido	11.81	10.23	17	138928	3116	110447238
Ventricular extrasystoles	11.77	10.23	58	138887	22583	110427771
Tubulointerstitial nephritis	11.76	10.23	112	138833	54172	110396182
Gastritis	11.74	10.23	111	138834	53588	110396766
Left ventricular hypertrophy	11.73	10.23	40	138905	13204	110437150
Mouth ulceration	11.71	10.23	27	138918	48111	110402243
Lichenoid keratosis	11.66	10.23	25	138920	6277	110444077
Melanaemia	11.65	10.23	4	138941	61	110450293
Lipoma excision	11.65	10.23	5	138940	143	110450211
Gastrointestinal pain	11.55	10.23	37	138908	11823	110438531
Hyperchylomicronaemia	11.53	10.23	4	138941	63	110450291
Breath sounds abnormal	11.53	10.23	9	138936	25395	110424959
Serotonin syndrome	11.52	10.23	37	138908	59116	110391238
Cytomegalovirus viraemia	11.44	10.23	4	138941	17760	110432594
Biliary obstruction	11.40	10.23	23	138922	5535	110444819
Acute on chronic liver failure	11.38	10.23	7	138938	429	110449925
Self esteem decreased	11.36	10.23	10	138935	1067	110449287
Allergy to animal	11.33	10.23	13	138932	1903	110448451
Sleep disorder due to a general medical condition	11.30	10.23	31	138914	52081	110398273
Peripheral artery occlusion	11.30	10.23	16	138929	2889	110447465
Joint space narrowing	11.28	10.23	9	138936	838	110449516
Memory impairment	11.16	10.23	177	138768	196767	110253587
Genital ulceration	11.01	10.23	13	138932	1962	110448392
Respiratory arrest	10.98	10.23	37	138908	58262	110392092
Tricuspid valve incompetence	10.91	10.23	59	138886	23814	110426540
Oesophageal irritation	10.89	10.23	6	138939	299	110450055
Staphylococcal infection	10.86	10.23	48	138897	69896	110380458
Peyronie's disease	10.83	10.23	3	138942	21	110450333
Abdominal pain lower	10.76	10.23	82	138863	37201	110413153
Cystitis noninfective	10.75	10.23	12	138933	1706	110448648
Bronchopulmonary aspergillosis	10.74	10.23	13	138932	29850	110420504
Adverse drug reaction	10.73	10.23	83	138862	105476	110344878
Macular degeneration	10.71	10.23	7	138938	21652	110428702
Bronchomalacia	10.69	10.23	6	138939	310	110450044
Restless legs syndrome	10.68	10.23	60	138885	24566	110425788
Drug-induced liver injury	10.67	10.23	211	138734	119856	110330498
Cardiac failure	10.65	10.23	310	138635	187316	110263038
Productive cough	10.65	10.23	92	138853	114213	110336141
Osteoporosis	10.61	10.23	65	138880	87087	110363267
Proctitis	10.59	10.23	4	138941	16923	110433431
Clostridium difficile infection	10.58	10.23	32	138913	52097	110398257
Dysuria	10.55	10.23	119	138826	60112	110390242
Food allergy	10.49	10.23	6	138939	19942	110430412
Acute myeloid leukaemia	10.42	10.23	20	138925	38090	110412264
Subdural haematoma	10.42	10.23	80	138865	36374	110413980
Diplopia	10.39	10.23	89	138856	41805	110408549
Arcus lipoides	10.37	10.23	3	138942	25	110450329
Nasal neoplasm	10.33	10.23	5	138940	190	110450164
Hypercapnic coma	10.32	10.23	7	138938	508	110449846
Ketoacidosis	10.31	10.23	32	138913	10055	110440299
Quadriparesis	10.28	10.23	20	138925	4687	110445667
Erythema	10.28	10.23	283	138662	291164	110159190
Ear haemorrhage	10.28	10.23	14	138931	2437	110447917
Urticaria pigmentosa	10.27	10.23	3	138942	26	110450328

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C10AX09	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Other lipid modifying agents
ATC	C10BA02	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA05	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA06	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA10	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA11	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA12	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA13	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
ATC	C10BA15	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents
FDA PE	N0000008553	Decreased Cholesterol Absorption
MeSH PA	D000924	Anticholesteremic Agents
MeSH PA	D000960	Hypolipidemic Agents
MeSH PA	D000963	Antimetabolites
MeSH PA	D057847	Lipid Regulating Agents
FDA EPC	N0000175911	Dietary Cholesterol Absorption Inhibitor
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:35679	antilipemic drug
CHEBI has role	CHEBI:35821	anticholesteremic drug

Related Drugs by ATC class:

C10AX Other lipid modifying agents 15 drugs

alipogene tiparvovec alirocumab bempedoic acid dextrothyroxine evinacumab evolocumab inclisiran lerodalcibep-liga lomitapide meglutol mipomersen policosanol show all 15 →

C10BA Combinations of various lipid modifying agents 9 drugs

atorvastatin bempedoic acid fenofibrate lovastatin nicotinic acid pitavastatin pravastatin rosuvastatin simvastatin

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hypercholesterolemia	indication	13644009
Hyperlipidemia	indication	55822004	DOID:1168
Familial hypercholesterolemia - homozygous	indication	238078005
Familial hypercholesterolemia - heterozygous	indication	238079002
Sitosterolemia	indication	238104009	DOID:0090019
Mixed hyperlipidemia	indication	267434003
Alopecia areata	off-label use	68225006	DOID:986
Alcoholism	contraindication	7200002
Acute nephropathy	contraindication	58574008
Disorder of muscle	contraindication	129565002	DOID:423
Liver function tests abnormal	contraindication	166603001
Acute pancreatitis	contraindication	197456007	DOID:2913
Hemorrhagic cerebral infarction	contraindication	230706003
Disease of liver	contraindication	235856003	DOID:409
Rhabdomyolysis	contraindication	240131006
Pregnancy, function	contraindication	289908002
Surgical procedure	contraindication	387713003
Breastfeeding (mother)	contraindication	413712001
SLCO1B1 Gene Variant for OATP1B1 Transporter Affecting Hepatic Clearance	contraindication
Myopathy related to SLCO1B1 Gene Variant	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.48	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	ZETIA	ORGANON	N021445	Oct. 25, 2002	RX	TABLET	ORAL	7612058	Oct. 30, 2025	REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
10MG	ZETIA	ORGANON	N021445	Oct. 25, 2002	RX	TABLET	ORAL	7612058	Oct. 30, 2025	TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A STATIN OR WITH FENOFIBRATE
10MG;EQ 10MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 10MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	10376470	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE	ROSZET	ALTHERA PHARMS	N213072	March 23, 2021	DISCN	TABLET	ORAL	9763885	May 1, 2033	TREATMENT OF HYPERLIPIDEMIA
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	10912751	March 14, 2036	A METHOD OF LOWERING LDL-C OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA USING A FIXED-DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	10912751	March 14, 2036	A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	11744816	March 14, 2036	A METHOD OF LOWERING LDL-C OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA USING 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	11744816	March 14, 2036	A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	11926584	June 19, 2040	A METHOD OF LOWERING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) IN A HUMAN PATIENT IN NEED THEREOF COMPRISING ADMINISTRATION OF BEMPEDOIC ACID ALONE OR IN COMBINATION WITH OTHER LIPID LOWERING THERAPIES
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	12404227	June 19, 2040	A METHOD OF TREATING PRIMARY HYPERLIPIDEMIA USING BEMPEDOIC ACID

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	March 22, 2027	EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET, ALONE OR IN COMBINATION WITH OTHER LDL-C LOWERING THERAPIES, TO REDUCE LDL-C IN ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)
180MG;10MG	NEXLIZET	ESPERION THERAPS INC	N211617	Feb. 26, 2020	RX	TABLET	ORAL	March 22, 2027	TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND CORONARY REVASCULARIZATION IN ADULTS WHO ARE UNABLE TO TAKE RECOMMENDED STATIN THERAPY (INCLUDING THOSE NOT TAKING A STATIN) WITH ESTABLISHED CARDIOVASCULAR DISEASE (CVD), OR AT HIGH RISK FOR A CVD EVENT BUT WITHOUT ESTABLISHED CVD

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Niemann-Pick C1-like protein 1	Membrane other	Q9UHC9	NPCL1_HUMAN	ANTAGONIST	Kd	6.66	IUPHAR	CHEMBL
Sodium/bile acid cotransporter	Transporter	Q14973	NTCP_HUMAN		Ki	4.60	CHEMBL
Niemann-Pick C1-like protein 1	Membrane other		NPCL1_RAT		Ki	6.70	CHEMBL

External reference:

ID	Source
4021366	VUID
N0000148785	NUI
D01966	KEGG_DRUG
4021366	VANDF
C1142985	UMLSCUI
CHEBI:49040	CHEBI
CHEMBL1138	ChEMBL_ID
D000069438	MESH_DESCRIPTOR_UI
DB00973	DRUGBANK_ID
150311	PUBCHEM_CID
6816	IUPHAR_LIGAND_ID
8010	INN_ID
EOR26LQQ24	UNII
341248	RXNORM
17026	MMSL
229065	MMSL
45364	MMSL
d04824	MMSL
009817	NDDF
408041006	SNOMEDCT_US
409149001	SNOMEDCT_US
H56	PDB_CHEM_ID
EOR26LQQ24	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3713	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5690	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7103	TABLET	10 mg	ORAL	ANDA	25 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	10135-787	TABLET	10 mg	ORAL	ANDA	23 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	10135-787	TABLET	10 mg	ORAL	ANDA	23 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-778	TABLET	10 mg	ORAL	ANDA	26 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-779	TABLET	10 mg	ORAL	ANDA	26 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-780	TABLET	10 mg	ORAL	ANDA	26 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	16714-781	TABLET	10 mg	ORAL	ANDA	26 sections
Ezetimibe	Human Prescription Drug Label	1	16714-813	TABLET	10 mg	ORAL	ANDA	27 sections
EZETIMIBE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-433	TABLET	10 mg	ORAL	ANDA	29 sections
EZETIMIBE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-433	TABLET	10 mg	ORAL	ANDA	29 sections
VYTORIN	HUMAN PRESCRIPTION DRUG LABEL	2	21695-325	TABLET	10 mg	ORAL	NDA	28 sections
VYTORIN	HUMAN PRESCRIPTION DRUG LABEL	2	21695-339	TABLET	10 mg	ORAL	NDA	28 sections
Zetia	HUMAN PRESCRIPTION DRUG LABEL	1	21695-778	TABLET	10 mg	ORAL	NDA	29 sections
VYTORIN	HUMAN PRESCRIPTION DRUG LABEL	2	21695-827	TABLET	10 mg	ORAL	NDA	28 sections
EZETIMIBE	HUMAN PRESCRIPTION DRUG LABEL	1	31722-628	TABLET	10 mg	ORAL	ANDA	25 sections
Ezetimibe	Human Prescription Drug Label	1	33342-373	TABLET	10 mg	ORAL	ANDA	26 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-742	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-743	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-744	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	43598-745	TABLET	10 mg	ORAL	ANDA	28 sections
Ezetimibe	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3087	TABLET	10 mg	ORAL	ANDA	26 sections
Ezetimibe	Human Prescription Drug Label	1	50090-3422	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	Human Prescription Drug Label	1	50090-3657	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe and Simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	50090-3984	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe and Simvastatin	Human Prescription Drug Label	2	50090-4772	TABLET	10 mg	ORAL	ANDA	26 sections
Ezetimibe	Human Prescription Drug Label	1	50090-6630	TABLET	10 mg	ORAL	ANDA	27 sections
Ezetimibe	Human Prescription Drug Label	1	50090-6631	TABLET	10 mg	ORAL	ANDA	27 sections
ezetimibe and simvastatin	HUMAN PRESCRIPTION DRUG LABEL	2	50090-7047	TABLET	10 mg	ORAL	ANDA	28 sections

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ezetimibe 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: