All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
histamine-H1 receptor antagonists, tricyclic compounds	1605	79794-75-5

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: loratadine claritin loracert loradex loratidine loratyne

A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness. Molecular weight: 382.89 Formula: C22H23ClN2O2 CLOGP: 5.05 LIPINSKI: 1 HAC: 4 HDO: 0 TPSA: 42.43 ALOGS: -4.46 ROTB: 2 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
S (Water solubility)	0.01 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	5 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.44 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	40 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPKAPK2,PDK1,PDK4,PRKDC	16
kinase-selectivity-class	ACVR2B,AXL,BRAF,GRK2,MAP2K6,MAPK12,STK33,TTK	8
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	0.438		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1		High	1
rat-kpuu-brain	Rat brain Kpuu	1.928	%	High	1

Approvals:

Date	Agency	Company	Orphan
April 12, 1993	FDA	BAYER HEALTHCARE LLC

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
Hand deformity	320.79	9.75	9	110839	296353	90221246
Glossodynia	320.68	9.75	18	110830	321761	90195838
Systemic lupus erythematosus	304.82	9.75	41	110807	361855	90155744
Contraindicated product administered	287.68	9.75	29	110819	320110	90197489
Wound	281.43	9.75	24	110824	302956	90214643
Pericarditis	279.10	9.75	12	110836	270139	90247460
Synovitis	273.81	9.75	39	110809	329713	90187886
Extra dose administered	269.45	9.75	157	110691	8961	90508638
Dermatitis atopic	226.84	9.75	205	110643	23267	90494332
Helicobacter infection	207.82	9.75	19	110829	226831	90290768
Folliculitis	204.85	9.75	11	110837	204342	90313257
Muscle injury	200.44	9.75	3	110845	176651	90340948
Drug intolerance	192.55	9.75	159	110689	447432	90070167
Treatment failure	186.95	9.75	69	110779	303859	90213740
Accidental exposure to product by child	176.21	9.75	65	110783	1268	90516331
Arthropathy	174.37	9.75	117	110731	366125	90151474
General physical health deterioration	173.75	9.75	110	110738	355005	90162594
Pneumonia aspiration	158.81	9.75	222	110626	40718	90476881
Joint swelling	150.16	9.75	240	110608	503060	90014539
Lower respiratory tract infection	142.59	9.75	64	110784	250595	90267004
Hepatic enzyme increased	142.08	9.75	139	110709	360597	90157002
Liver injury	141.89	9.75	20	110828	170547	90347052
Maternal exposure during pregnancy	141.51	9.75	139	110709	359924	90157675
Somnolence	141.43	9.75	568	110280	208516	90309083
Sleep disorder due to general medical condition, insomnia type	138.82	9.75	4	110844	128690	90388909
Impaired healing	136.05	9.75	58	110790	234141	90283458
Therapeutic product effect decreased	135.70	9.75	86	110762	277485	90240114
Cough	135.12	9.75	842	110006	368120	90149479
Human rhinovirus test positive	134.16	9.75	48	110800	855	90516744
Mobility decreased	127.71	9.75	74	110774	250660	90266939
Respiratory syncytial virus test positive	126.75	9.75	48	110800	1010	90516589
C-reactive protein abnormal	124.20	9.75	8	110840	127421	90390178
Failure of child resistant product closure	123.69	9.75	23	110825	9	90517590
Alopecia	120.41	9.75	267	110581	494804	90022795
Swelling	112.04	9.75	214	110634	418844	90098755
Anaphylactic reaction	104.22	9.75	288	110560	87236	90430363
Ill-defined disorder	100.82	9.75	50	110798	184841	90332758
Lip dry	99.40	9.75	6	110842	100949	90416650
Product dose omission issue	98.30	9.75	652	110196	291035	90226564
Off label use	95.51	9.75	876	109972	1101376	89416223
Urticaria	94.72	9.75	681	110167	312053	90205546
Gastrooesophageal reflux disease	93.99	9.75	428	110420	165909	90351690
Blister	93.87	9.75	104	110744	254894	90262705
Facet joint syndrome	93.49	9.75	7	110841	98382	90419217
Irritable bowel syndrome	91.19	9.75	72	110776	207376	90310223
Breast cancer stage III	89.72	9.75	3	110845	84444	90433155
Swelling face	89.35	9.75	260	110588	81092	90436507
Feeling abnormal	89.11	9.75	423	110425	166812	90350787
Chest discomfort	88.05	9.75	369	110479	137996	90379603
Drug ineffective	87.55	9.75	1182	109666	1383116	89134483
Viral test positive	87.38	9.75	32	110816	611	90516988
Type 2 diabetes mellitus	85.06	9.75	74	110774	203170	90314429
Pulmonary fibrosis	83.99	9.75	15	110833	107488	90410111
C-reactive protein increased	83.51	9.75	60	110788	181329	90336270
Lip swelling	81.31	9.75	159	110689	38451	90479148
Rheumatoid arthritis	80.57	9.75	205	110643	362409	90155190
Asthma	78.97	9.75	537	110311	241623	90275976
Wound infection	78.60	9.75	17	110831	106385	90411214
Fibromyalgia	78.26	9.75	82	110766	206187	90311412
Pruritus	77.76	9.75	1007	109841	540518	89977081
Angioedema	77.74	9.75	214	110634	64662	90452937
Psoriatic arthropathy	76.72	9.75	100	110748	228235	90289364
Musculoskeletal stiffness	75.27	9.75	156	110692	296376	90221223
Cholecystitis chronic	74.37	9.75	75	110773	9751	90507848
Impaired quality of life	73.15	9.75	114	110734	23030	90494569
Infusion related reaction	72.99	9.75	263	110585	416517	90101082
Pneumonia haemophilus	72.93	9.75	36	110812	1467	90516132
Joint range of motion decreased	71.97	9.75	38	110810	135605	90381994
Back pain	71.16	9.75	645	110203	316530	90201069
Dyspnoea	70.91	9.75	1489	109359	879466	89638133
Nasal congestion	70.87	9.75	244	110604	83170	90434429
Coma	70.24	9.75	222	110626	72410	90445189
Dizziness	70.15	9.75	1060	109788	588224	89929375
Palpitations	67.91	9.75	339	110509	136389	90381210
Tongue biting	66.40	9.75	38	110810	2095	90515504
Infective pulmonary exacerbation of cystic fibrosis	64.50	9.75	71	110777	10208	90507391
Stomatitis	64.37	9.75	151	110697	274547	90243052
Bronchitis	63.55	9.75	361	110487	152566	90365033
COVID-19	63.35	9.75	388	110460	168455	90349144
Seasonal allergy	62.83	9.75	106	110742	22877	90494722
Discomfort	62.54	9.75	153	110695	274182	90243417
Hypercholesterolaemia	61.81	9.75	23	110825	100869	90416730
Throat irritation	60.71	9.75	163	110685	48532	90469067
Anxiety	60.59	9.75	612	110236	309160	90208439
Drug abuse	59.13	9.75	14	110834	82333	90435266
Oropharyngeal pain	58.91	9.75	288	110560	114899	90402700
Intentional product use issue	58.56	9.75	110	110738	216782	90300817
Product use issue	58.52	9.75	207	110641	329712	90187887
Adjustment disorder with depressed mood	57.01	9.75	3	110845	56750	90460849
Prescribed overdose	56.94	9.75	24	110824	97601	90419998
Grip strength decreased	56.89	9.75	21	110827	92555	90425044
Blood cholesterol increased	56.59	9.75	105	110743	207907	90309692
Inflammation	56.18	9.75	82	110766	178510	90339089
Mouth haemorrhage	55.58	9.75	60	110788	8441	90509158
Gastrointestinal disorder	55.54	9.75	147	110701	256540	90261059
Emotional distress	55.39	9.75	132	110716	36530	90481069
Therapeutic product effect incomplete	55.34	9.75	95	110753	193801	90323798
Urinary tract infection	55.12	9.75	594	110254	305038	90212561
Vision blurred	53.73	9.75	272	110576	110021	90407578
Abdominal discomfort	52.96	9.75	354	110494	476974	90040625
Bursitis	52.61	9.75	50	110798	131604	90385995
Illness	52.43	9.75	219	110629	81750	90435849
Incorrect dose administered	52.16	9.75	213	110635	78717	90438882
Toxicity to various agents	52.12	9.75	179	110669	287667	90229932
Live birth	50.22	9.75	17	110831	79090	90438509
Peripheral venous disease	49.96	9.75	20	110828	83901	90433698
Gait inability	49.32	9.75	64	110784	146392	90371207
Headache	49.03	9.75	1391	109457	861355	89656244
Pharyngeal swelling	47.93	9.75	60	110788	9884	90507715
Prescribed underdose	47.84	9.75	16	110832	75003	90442596
Chronic spontaneous urticaria	47.67	9.75	29	110819	1791	90515808
Butterfly rash	47.66	9.75	31	110817	2154	90515445
Diarrhoea	47.37	9.75	1492	109356	937698	89579901
Upper respiratory tract infection	46.94	9.75	293	110555	128025	90389574
Nail disorder	46.66	9.75	8	110840	59059	90458540
Lung disorder	45.99	9.75	70	110778	149813	90367786
Mast cell activation syndrome	45.91	9.75	27	110821	1567	90516032
Infection	45.09	9.75	259	110589	361835	90155764
Dry skin	44.16	9.75	219	110629	87854	90429745
Temperature intolerance	43.35	9.75	63	110785	11967	90505632
Carbuncle	43.15	9.75	25	110823	1411	90516188
Head discomfort	42.89	9.75	74	110774	16259	90501340
Hip arthroplasty	42.45	9.75	20	110828	76188	90441411
Gallbladder disorder	42.24	9.75	82	110766	19721	90497878
Monoclonal immunoglobulin present	41.17	9.75	28	110820	2096	90515503
Lower limb fracture	40.60	9.75	27	110821	84986	90432613
Medication error	40.27	9.75	27	110821	84625	90432974
White blood cell count decreased	39.57	9.75	344	110504	166765	90350834
Onychomadesis	39.17	9.75	5	110843	45993	90471606
Throat tightness	39.10	9.75	101	110747	29383	90488216
Blepharospasm	38.69	9.75	10	110838	55435	90462164
Autoimmune disorder	38.54	9.75	23	110825	76721	90440878
Erythema	38.31	9.75	439	110409	228807	90288792
Eye swelling	38.29	9.75	100	110748	29286	90488313
Flushing	38.14	9.75	211	110637	88280	90429319
Eczema	37.60	9.75	146	110702	52724	90464875
Deep vein thrombosis	37.20	9.75	215	110633	91405	90426194
Nausea	36.59	9.75	1683	109165	1108633	89408966
Confusional state	36.31	9.75	300	110548	385905	90131694
Periorbital oedema	35.97	9.75	43	110805	6756	90510843
Delirium	35.76	9.75	45	110803	104314	90413285
Tinnitus	34.80	9.75	124	110724	42978	90474621
Bone pain	34.61	9.75	159	110689	61824	90455775
Post-traumatic stress disorder	34.20	9.75	42	110806	6786	90510813
Chills	34.06	9.75	277	110571	131704	90385895
Knee arthroplasty	33.92	9.75	31	110817	83151	90434448
Injection site pain	33.83	9.75	343	110505	173356	90344243
Post cholecystectomy syndrome	33.76	9.75	18	110830	863	90516736
Neuropathy peripheral	33.49	9.75	284	110564	136686	90380913
Rash macular	33.45	9.75	97	110751	30183	90487416
Cholelithiasis	33.35	9.75	140	110708	52366	90465233
Insomnia	33.28	9.75	583	110265	332891	90184708
Hypothalamo-pituitary disorder	32.90	9.75	25	110823	2227	90515372
Nervousness	32.83	9.75	104	110744	33952	90483647
Photosensitivity reaction	32.36	9.75	69	110779	17738	90499861
Overweight	32.17	9.75	38	110810	5896	90511703
Essential hypertension	31.88	9.75	39	110809	6276	90511323
Multiple allergies	31.43	9.75	62	110786	15084	90502515
Acute kidney injury	31.43	9.75	246	110602	320141	90197458
Tongue injury	31.07	9.75	15	110833	582	90517017
Fatigue	30.94	9.75	1715	109133	1152308	89365291
Hypersomnia	30.89	9.75	76	110772	21455	90496144
Swollen tongue	30.34	9.75	124	110724	45832	90471767
Oedema	30.19	9.75	134	110714	200161	90317438
Eye pruritus	30.17	9.75	91	110757	28936	90488663
Depression	30.15	9.75	526	110322	300075	90217524
Lupus-like syndrome	30.14	9.75	11	110837	48835	90468764
Night sweats	29.96	9.75	71	110777	128695	90388904
Joint dislocation	29.32	9.75	9	110839	44573	90473026
Muscle spasms	29.05	9.75	451	110397	251432	90266167
Pulmonary embolism	28.75	9.75	265	110583	130555	90387044
Tinea pedis	28.48	9.75	20	110828	1577	90516022
Myelosuppression	28.44	9.75	15	110833	53576	90464023
Syncope	28.29	9.75	267	110581	132396	90385203
Osteoarthritis	28.28	9.75	133	110715	195597	90322002
Therapy non-responder	27.53	9.75	81	110767	136623	90380976
Stress	27.39	9.75	182	110666	81213	90436386
Pathergy reaction	27.23	9.75	8	110840	73	90517526
Suicidal ideation	27.22	9.75	169	110679	73686	90443913
Dry eye	26.90	9.75	141	110707	57790	90459809
Red blood cell sedimentation rate increased	26.88	9.75	37	110811	82558	90435041
Exposure during pregnancy	26.80	9.75	176	110672	238234	90279365
Upper-airway cough syndrome	26.76	9.75	58	110790	15077	90502522
Liver disorder	26.55	9.75	69	110779	121200	90396399
Myalgia	26.02	9.75	328	110520	174797	90342802
Contusion	26.00	9.75	190	110658	251026	90266573
Product administration interrupted	25.76	9.75	51	110797	12441	90505158
Biliary dyskinesia	25.70	9.75	23	110825	2576	90515023
Cystoid macular oedema	25.70	9.75	21	110827	2079	90515520
Acquired haemophilia	25.38	9.75	16	110832	1053	90516546
Allergy test positive	25.21	9.75	14	110834	728	90516871
Adverse event	24.80	9.75	68	110780	117350	90400249
Vitamin D deficiency	24.17	9.75	61	110787	17495	90500104
Drug tolerance decreased	24.00	9.75	5	110843	32125	90485474
Ear discomfort	23.94	9.75	44	110804	10156	90507443
Vitamin B12 increased	23.91	9.75	19	110829	1807	90515792
Obesity	23.89	9.75	59	110789	105448	90412151
Hot flush	23.76	9.75	139	110709	59349	90458250
Sinus disorder	23.58	9.75	94	110754	34353	90483246
Constipation	23.41	9.75	477	110371	279918	90237681
Pre-existing condition improved	23.37	9.75	41	110807	9128	90508471
Urticaria pressure	23.17	9.75	7	110841	71	90517528
Hepatic cirrhosis	23.03	9.75	26	110822	63227	90454372
Heart rate increased	22.97	9.75	225	110623	112677	90404922
Musculoskeletal pain	22.65	9.75	120	110728	171131	90346468
Body height decreased	22.52	9.75	47	110801	11902	90505697
Granulocyte count increased	22.34	9.75	17	110831	1517	90516082
Stab wound	22.26	9.75	7	110841	82	90517517
Eye irritation	21.89	9.75	91	110757	33887	90483712
Crying	21.76	9.75	75	110773	25570	90492029
Expired product administered	21.74	9.75	34	110814	6888	90510711
Face oedema	21.38	9.75	70	110778	23248	90494351
Fibrosis	21.20	9.75	31	110817	5921	90511678
Skin exfoliation	21.15	9.75	149	110699	67764	90449835
Dysgeusia	21.11	9.75	123	110725	52437	90465162
Joint noise	20.98	9.75	29	110819	5261	90512338
Thermal burn	20.94	9.75	33	110815	6729	90510870
Surgery	20.67	9.75	109	110739	44778	90472821
Colitis ulcerative	20.63	9.75	26	110822	60240	90457359
Electric shock	20.61	9.75	17	110831	1705	90515894
Sinus headache	20.60	9.75	32	110816	6444	90511155
Thrombocytopenia	20.58	9.75	160	110688	208565	90309034
Blood immunoglobulin A increased	20.43	9.75	15	110833	1268	90516331
Infusion site erythema	20.41	9.75	49	110799	13621	90503978
Skin disorder	20.37	9.75	94	110754	36612	90480987
Malignant neoplasm progression	20.32	9.75	65	110783	106805	90410794
Exostosis	20.27	9.75	21	110827	53113	90464486
Oropharyngeal discomfort	20.25	9.75	35	110813	7700	90509899
Burning sensation	20.22	9.75	140	110708	63312	90454287
Status asthmaticus	20.21	9.75	13	110835	886	90516713
Gallbladder injury	20.19	9.75	15	110833	1291	90516308
Rash	20.07	9.75	1177	109671	794923	89722676
Cataract subcapsular	20.06	9.75	12	110836	719	90516880
Condition aggravated	20	9.75	565	110283	594980	89922619
Hepatitis	19.86	9.75	35	110813	70704	90446895
Rhabdomyolysis	19.85	9.75	20	110828	51236	90466363
Lupus hepatitis	19.78	9.75	5	110843	24	90517575
Pancytopenia	19.64	9.75	78	110770	120185	90397414
Red blood cell count decreased	19.62	9.75	110	110738	46241	90471358
Liver function test increased	19.57	9.75	47	110801	84808	90432791
Cystitis noninfective	19.56	9.75	15	110833	1354	90516245
Full blood count decreased	19.51	9.75	80	110768	29609	90487990
Emotional disorder	19.50	9.75	51	110797	14946	90502653
Lacrimation increased	19.46	9.75	75	110773	26987	90490612
Road traffic accident	19.41	9.75	67	110781	107559	90410040
Priapism	19.39	9.75	7	110841	128	90517471
Nasal disorder	19.39	9.75	22	110826	3270	90514329
Ligament sprain	19.35	9.75	50	110798	14549	90503050
Rash pruritic	19.32	9.75	169	110679	82045	90435554
Inappropriate schedule of product administration	19.04	9.75	273	110575	149660	90367939
Rhinorrhoea	18.95	9.75	178	110670	88138	90429461
Loss of personal independence in daily activities	18.77	9.75	94	110754	136011	90381588
Abnormal dreams	18.61	9.75	42	110806	11215	90506384
Inflammatory bowel disease	18.51	9.75	27	110821	5144	90512455
Chest pain	18.50	9.75	517	110331	319128	90198471
Neuralgia	18.47	9.75	82	110766	31418	90486181
Vitamin B12 deficiency	18.47	9.75	33	110815	7453	90510146
Injection site erythema	18.45	9.75	193	110655	98309	90419290
Anger	18.19	9.75	47	110801	13673	90503926
Glomerular filtration rate increased	17.98	9.75	17	110831	2043	90515556
Maternal exposure timing unspecified	17.86	9.75	3	110845	22480	90495119
Rhinitis allergic	17.80	9.75	53	110795	16732	90500867
Therapeutic response shortened	17.77	9.75	65	110783	22814	90494785
Onychomycosis	17.67	9.75	12	110836	37364	90480235
Scratch	17.66	9.75	38	110810	9828	90507771
Rheumatoid factor increased	17.51	9.75	18	110830	2393	90515206
Skin swelling	17.41	9.75	30	110818	6584	90511015
Sleep apnoea syndrome	17.39	9.75	81	110767	31666	90485933
Cytokine release syndrome	17.31	9.75	74	110774	27899	90489700
Skin oedema	17.28	9.75	13	110835	1141	90516458
Multiple organ dysfunction syndrome	17.27	9.75	36	110812	68300	90449299
Nephrolithiasis	17.27	9.75	111	110737	48974	90468625
Snoring	17.25	9.75	26	110822	5100	90512499
Frustration tolerance decreased	17.21	9.75	33	110815	7863	90509736
Migraine without aura	17.18	9.75	11	110837	744	90516855
Allergic cystitis	17.12	9.75	3	110845	0	90517599
Reflux gastritis	17.10	9.75	14	110834	1390	90516209
Limb injury	16.98	9.75	80	110768	31428	90486171
Drug resistance	16.94	9.75	8	110840	30441	90487158
Injury	16.88	9.75	157	110691	197192	90320407
Hyperlipidaemia	16.88	9.75	64	110784	22852	90494747
Flatulence	16.74	9.75	97	110751	41270	90476329
Anxiety disorder	16.62	9.75	25	110823	4897	90512702
Dactylitis	16.52	9.75	22	110826	3851	90513748
Infusion site swelling	16.42	9.75	41	110807	11679	90505920
Acute sinusitis	16.36	9.75	23	110825	4238	90513361
Epilepsy	16.34	9.75	49	110799	82157	90435442
Increased appetite	16.32	9.75	41	110807	11724	90505875
Abdominal distension	16.27	9.75	237	110611	130364	90387235
Multiple lentigines syndrome	16.24	9.75	7	110841	208	90517391
Cluster headache	15.91	9.75	11	110837	846	90516753
Injection site rash	15.78	9.75	65	110783	24108	90493491
Sciatica	15.77	9.75	67	110781	101315	90416284
Posterior reversible encephalopathy syndrome	15.64	9.75	4	110844	22335	90495264
Exposure via skin contact	15.58	9.75	38	110810	10667	90506932
Agranulocytosis	15.55	9.75	12	110836	34990	90482609
Hepatocellular injury	15.52	9.75	8	110840	28950	90488649
Dysphonia	15.52	9.75	131	110717	62953	90454646
Hepatotoxicity	15.46	9.75	20	110828	45822	90471777
Bed bug infestation	15.42	9.75	5	110843	65	90517534
Palmar erythema	15.22	9.75	15	110833	1896	90515703
Restless legs syndrome	15.12	9.75	61	110787	22409	90495190
Throat clearing	15.12	9.75	21	110827	3826	90513773
Blood potassium decreased	15.03	9.75	105	110743	47622	90469977
Hyperkalaemia	14.97	9.75	36	110812	64928	90452671
Depressed mood	14.95	9.75	109	110739	50113	90467486
Victim of chemical submission	14.94	9.75	10	110838	729	90516870
Hyperhidrosis	14.92	9.75	242	110606	136063	90381536
Foreign body in reproductive tract	14.89	9.75	12	110836	1165	90516434
Aspartate aminotransferase	14.87	9.75	10	110838	735	90516864
Mitochondrial myopathy	14.86	9.75	7	110841	257	90517342
Dyslipidaemia	14.85	9.75	36	110812	10071	90507528
Cerumen impaction	14.81	9.75	12	110836	1174	90516425
Somnambulism	14.79	9.75	27	110821	6201	90511398
Wrist deformity	14.76	9.75	19	110829	3219	90514380
Feeling hot	14.68	9.75	153	110695	77855	90439744
Coeliac disease	14.50	9.75	20	110828	44590	90473009
Chronic obstructive pulmonary disease	14.46	9.75	146	110702	73683	90443916
Sopor	14.46	9.75	6	110842	24638	90492961
Spinal disorder	14.46	9.75	39	110809	11640	90505959
Diabetic retinal oedema	14.44	9.75	8	110840	414	90517185
Bacterial test positive	14.42	9.75	25	110823	5514	90512085
Therapeutic response unexpected	14.41	9.75	59	110789	21821	90495778
Rhinovirus infection	14.34	9.75	26	110822	5937	90511662
Taste disorder	14.26	9.75	34	110814	61512	90456087
Skin discolouration	14.25	9.75	98	110750	44217	90473382
Plasma cell myeloma	14.16	9.75	92	110756	40736	90476863
Bone density decreased	14.09	9.75	50	110798	17295	90500304
Back injury	14.08	9.75	22	110826	46600	90470999
Diverticulitis	13.99	9.75	99	110749	45088	90472511
Oesophageal adenocarcinoma recurrent	13.97	9.75	4	110844	33	90517566
Cellulitis	13.96	9.75	172	110676	91165	90426434
Hepatic steatosis	13.90	9.75	85	110763	36860	90480739
Borderline personality disorder	13.85	9.75	11	110837	1045	90516554
Injection site urticaria	13.85	9.75	51	110797	17960	90499639
Multiple sclerosis	13.79	9.75	69	110779	27771	90489828
Bronchospasm	13.76	9.75	56	110792	20653	90496946
Blood glucose decreased	13.75	9.75	61	110787	23368	90494231
Arthropod bite	13.71	9.75	32	110816	8735	90508864
Spinal osteoarthritis	13.71	9.75	53	110795	19095	90498504
No adverse event	13.59	9.75	135	110713	67847	90449752
Walking aid user	13.58	9.75	14	110834	35492	90482107
Peripheral swelling	13.57	9.75	393	110455	412713	90104886
Tinea infection	13.56	9.75	12	110836	1324	90516275
Frequent bowel movements	13.56	9.75	31	110817	56904	90460695
Pulmonary thrombosis	13.48	9.75	34	110814	9748	90507851
Macular degeneration	13.40	9.75	16	110832	37954	90479645
Premature baby	13.33	9.75	7	110841	25070	90492529
Renal impairment	13.31	9.75	75	110773	105346	90412253
Drug-induced liver injury	13.25	9.75	61	110787	90257	90427342
Presbyoesophagus	13.24	9.75	3	110845	8	90517591
Normal newborn	13.21	9.75	6	110842	23356	90494243
Mitral valve prolapse	13.08	9.75	16	110832	2575	90515024
Coronary artery disease	13.06	9.75	78	110770	33545	90484054
Ulcer haemorrhage	13.06	9.75	8	110840	26313	90491286
Skin burning sensation	13.01	9.75	53	110795	19558	90498041
Vertebral lateral recess stenosis	12.95	9.75	7	110841	345	90517254
Autoimmune lung disease	12.91	9.75	5	110843	112	90517487
Renal cyst	12.90	9.75	40	110808	12910	90504689
Laryngeal oedema	12.89	9.75	27	110821	6854	90510745
Suicide attempt	12.85	9.75	145	110703	75254	90442345
Oropharyngeal swelling	12.80	9.75	10	110838	928	90516671
Nerve compression	12.80	9.75	35	110813	10531	90507068
Sleep disorder	12.77	9.75	168	110680	197862	90319737
Xanthogranuloma	12.74	9.75	3	110845	10	90517589
Pneumonia	12.73	9.75	925	109923	637134	89880465
Muscular weakness	12.73	9.75	177	110671	206489	90311110
Hypoaesthesia oral	12.69	9.75	45	110803	15555	90502044
Osteoarthropathy	12.66	9.75	7	110841	361	90517238
Cerebral disorder	12.66	9.75	24	110824	5670	90511929
Muscle strain	12.65	9.75	33	110815	9654	90507945
Nephropathy	12.62	9.75	32	110816	9203	90508396
Sensitive skin	12.61	9.75	18	110830	3363	90514236
Laryngitis	12.60	9.75	27	110821	50726	90466873
Tremor	12.58	9.75	260	110588	152913	90364686
Ventricular hypertrophy	12.57	9.75	18	110830	3373	90514226
Thrombosis	12.55	9.75	141	110707	73110	90444489
Injection site swelling	12.53	9.75	120	110728	59719	90457880
Torsade de pointes	12.53	9.75	44	110804	15138	90502461
Ligamentum flavum hypertrophy	12.50	9.75	7	110841	370	90517229
Initial insomnia	12.45	9.75	32	110816	9278	90508321
Acute hepatic failure	12.44	9.75	6	110842	22555	90495044
Lethargy	12.43	9.75	125	110723	63014	90454585
Balance disorder	12.42	9.75	177	110671	96903	90420696
Neurological examination abnormal	12.42	9.75	7	110841	375	90517224
Homicidal ideation	12.41	9.75	13	110835	1767	90515832
Influenza like illness	12.40	9.75	152	110696	80459	90437140
Biliary sepsis	12.36	9.75	10	110838	976	90516623
Neurological examination normal	12.27	9.75	4	110844	53	90517546
Septic shock	12.26	9.75	57	110791	84103	90433496
Autoimmune hepatitis	12.25	9.75	34	110814	10317	90507282
Cardiac failure congestive	12.25	9.75	179	110669	98515	90419084
Swelling of eyelid	12.14	9.75	23	110825	5431	90512168
Panic attack	12.12	9.75	64	110784	26301	90491298
Anhedonia	12.03	9.75	36	110812	11395	90506204
Influenza	11.97	9.75	238	110610	139026	90378573
Myxoedema coma	11.92	9.75	7	110841	405	90517194
Skeletal injury	11.87	9.75	11	110837	1288	90516311
Sinusitis	11.85	9.75	523	110325	342565	90175034
Aneurysm	11.75	9.75	18	110830	3582	90514017
Skin irritation	11.73	9.75	40	110808	13563	90504036
Middle insomnia	11.70	9.75	46	110802	16705	90500894
Blood pressure increased	11.69	9.75	320	110528	196897	90320702
Nightmare	11.59	9.75	55	110793	21670	90495929
Product availability issue	11.55	9.75	27	110821	7377	90510222
Sinus congestion	11.55	9.75	65	110783	27359	90490240
Mouth swelling	11.53	9.75	23	110825	5639	90511960
Burns first degree	11.45	9.75	3	110845	17	90517582
Pharyngeal oedema	11.44	9.75	40	110808	13731	90503868
Conjunctival pigmentation	11.41	9.75	4	110844	67	90517532
Streptococcal endocarditis	11.40	9.75	5	110843	155	90517444
Depressed level of consciousness	11.38	9.75	48	110800	72736	90444863
Hypothyroidism	11.35	9.75	107	110741	53020	90464579
Serotonin syndrome	11.32	9.75	18	110830	37869	90479730
Dry throat	11.32	9.75	28	110820	7932	90509667
Broad ligament tear	11.31	9.75	3	110845	18	90517581
Infusion site pain	11.29	9.75	51	110797	19687	90497912
Atopy	11.29	9.75	6	110842	286	90517313
Cholecystitis	11.26	9.75	46	110802	16994	90500605
Cardiac failure	11.23	9.75	83	110765	109413	90408186
Reversible cerebral vasoconstriction syndrome	11.22	9.75	19	110829	4111	90513488
Vaginitis gardnerella	11.19	9.75	4	110844	71	90517528
Red blood cell sedimentation rate abnormal	11.14	9.75	8	110840	24196	90493403
Mental status changes	11.10	9.75	93	110755	44586	90473013
Oropharyngeal spasm	11.10	9.75	6	110842	296	90517303
Dyspnoea exertional	10.99	9.75	136	110712	72152	90445447
Basophil count decreased	10.99	9.75	6	110842	302	90517297
Injection site scab	10.98	9.75	8	110840	668	90516931
Ear congestion	10.94	9.75	17	110831	3425	90514174
Hepatic cytolysis	10.94	9.75	13	110835	30903	90486696
Blood pressure orthostatic	10.89	9.75	4	110844	77	90517522
Toe operation	10.89	9.75	10	110838	1158	90516441
Polyneuropathy	10.89	9.75	5	110843	19336	90498263
Epistaxis	10.81	9.75	155	110693	84970	90432629
Panic disorder	10.77	9.75	16	110832	3099	90514500
Cytomegalovirus infection	10.74	9.75	10	110838	26592	90491007
Dysphagia	10.72	9.75	195	110653	112083	90405516
Blood pressure abnormal	10.67	9.75	50	110798	19595	90498004
Nasal discomfort	10.66	9.75	22	110826	5526	90512073
Purpura	10.66	9.75	41	110807	14737	90502862
Limb mass	10.62	9.75	17	110831	3511	90514088
Coronary ostial stenosis	10.61	9.75	4	110844	83	90517516
Cold-stimulus headache	10.61	9.75	4	110844	83	90517516
Psoriasis	10.60	9.75	246	110602	147508	90370091
Infusion site reaction	10.60	9.75	5	110843	19034	90498565
Nasal dryness	10.57	9.75	22	110826	5561	90512038
Fracture	10.55	9.75	7	110841	22069	90495530
Overdose	10.46	9.75	133	110715	157576	90360023
Creatinine renal clearance decreased	10.46	9.75	5	110843	18894	90498705
Drug interaction	10.38	9.75	258	110590	276195	90241404
Acne	10.36	9.75	65	110783	28442	90489157
Mood altered	10.34	9.75	45	110803	17099	90500500
Haemoptysis	10.31	9.75	73	110775	33247	90484352
Migraine with aura	10.31	9.75	16	110832	3220	90514379
Tympanic membrane disorder	10.29	9.75	5	110843	197	90517402
Glycosylated haemoglobin increased	10.28	9.75	42	110806	15520	90502079
Urticaria thermal	10.27	9.75	7	110841	526	90517073
Cholecystitis acute	10.26	9.75	30	110818	9374	90508225
Product container issue	10.26	9.75	13	110835	2168	90515431
Congenital torticollis	10.25	9.75	3	110845	27	90517572
Proctitis	10.18	9.75	3	110845	15256	90502343
Sedation complication	10.15	9.75	4	110844	16940	90500659
Skin necrosis	10.14	9.75	4	110844	16937	90500662
Pustular psoriasis	10.13	9.75	5	110843	18551	90499048
Platelet count decreased	10.12	9.75	229	110619	136740	90380859
Paraesthesia	10.10	9.75	388	110460	249938	90267661
Atrophic vulvovaginitis	10.09	9.75	12	110836	1875	90515724
Blood magnesium decreased	10.09	9.75	42	110806	15651	90501948
Paranasal sinus discomfort	10.08	9.75	23	110825	6187	90511412
Vertigo	10.04	9.75	130	110718	69681	90447918
Ear swelling	10.04	9.75	12	110836	1885	90515714
Dehydration	10.01	9.75	310	110538	194137	90323462
Patellofemoral pain syndrome	9.97	9.75	8	110840	772	90516827
Carbon monoxide poisoning	9.95	9.75	5	110843	212	90517387
Hyperuricaemia	9.94	9.75	24	110824	6695	90510904
Sinus pain	9.93	9.75	21	110827	5368	90512231
Skin discomfort	9.92	9.75	12	110836	1909	90515690
Monocyte count increased	9.91	9.75	29	110819	9068	90508531
Tendonitis	9.91	9.75	52	110796	21320	90496279
Skin fissures	9.90	9.75	51	110797	20758	90496841
Blood alkaline phosphatase increased	9.86	9.75	96	110752	47983	90469616
Immunisation reaction	9.79	9.75	8	110840	792	90516807
Cervical spinal stenosis	9.79	9.75	14	110834	2621	90514978
Dysuria	9.78	9.75	82	110766	39319	90478280
Oral pain	9.76	9.75	71	110777	32612	90484987

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
Accidental exposure to product by child	283.01	10.81	96	51327	1471	42568441
Extra dose administered	183.26	10.81	103	51320	5566	42564346
Urticaria	108.47	10.81	261	51162	73775	42496137
Dermatitis atopic	103.08	10.81	99	51324	12305	42557607
Pruritus	101.76	10.81	474	50949	188297	42381615
Rash	83.12	10.81	595	50828	276359	42293553
Drug abuse	79.56	10.81	15	51408	104756	42465156
Failure of child resistant product closure	78.59	10.81	16	51407	20	42569892
General physical health deterioration	77.52	10.81	43	51380	151203	42418709
Asthma	63.33	10.81	192	51231	62122	42507790
Off label use	58.90	10.81	491	50932	637844	41932068
Infective pulmonary exacerbation of cystic fibrosis	47.94	10.81	53	51370	7765	42562147
Acute kidney injury	47.59	10.81	255	51168	367082	42202830
Fatigue	47.54	10.81	763	50660	434878	42135034
Sinusitis	43.69	10.81	141	51282	47151	42522761
Cough	43.48	10.81	365	51058	177738	42392174
Drug ineffective	43.34	10.81	520	50903	629677	41940235
Toxicity to various agents	42.07	10.81	139	51284	228997	42340915
Drug interaction	38.16	10.81	179	51244	266820	42303092
Swelling face	32.91	10.81	90	51333	27464	42542448
Throat irritation	32.14	10.81	57	51366	12979	42556933
Dry skin	31.78	10.81	129	51294	48209	42521703
Eye pruritus	30.88	10.81	52	51371	11360	42558552
Completed suicide	30.62	10.81	43	51380	96422	42473490
Lacrimation increased	29.75	10.81	52	51371	11706	42558206
Sinus disorder	29.22	10.81	42	51381	8008	42561904
Drug resistance	27.99	10.81	4	51419	34244	42535668
Renal impairment	27.76	10.81	57	51366	110171	42459741
Rhinorrhoea	26.87	10.81	92	51331	31702	42538210
Illness	26.43	10.81	78	51345	24852	42545060
Chills	25.20	10.81	197	51226	93869	42476043
Dizziness	25.01	10.81	431	50992	248823	42321089
Myelosuppression	24.61	10.81	9	51414	40452	42529460
Pharyngeal dystonia	24.01	10.81	7	51416	63	42569849
Chronic spontaneous urticaria	23.81	10.81	10	51413	282	42569630
Muscle spasms	23.49	10.81	181	51242	85863	42484049
Expired product administered	23.44	10.81	27	51396	4136	42565776
Cardiogenic shock	23.31	10.81	7	51416	35633	42534279
Infusion related reaction	23.23	10.81	139	51284	60667	42509245
Nasal congestion	22.89	10.81	83	51340	29418	42540494
Sneezing	22.81	10.81	33	51390	6330	42563582
Laryngospasm	22.72	10.81	19	51404	1969	42567943
Agitation	22.67	10.81	144	51279	64170	42505742
Chest pain	21.44	10.81	260	51163	139270	42430642
Thrombocytopenia	21.42	10.81	138	51285	190141	42379771
Seasonal allergy	20.87	10.81	36	51387	8019	42561893
Ear infection	20.75	10.81	47	51376	12757	42557155
Gastrointestinal mucosal necrosis	20.37	10.81	8	51415	189	42569723
Injection site hypersensitivity	20.24	10.81	10	51413	414	42569498
Glossodynia	20.20	10.81	25	51398	4127	42565785
Product dose omission issue	20.09	10.81	279	51144	154086	42415826
Vasospasm	19.90	10.81	11	51412	575	42569337
Priapism	19.79	10.81	31	51392	6376	42563536
Visual evoked potentials abnormal	19.58	10.81	6	51417	65	42569847
Bronchitis	19.39	10.81	110	51313	47091	42522821
Multiple organ dysfunction syndrome	19.08	10.81	57	51366	96978	42472934
Insomnia	18.89	10.81	222	51201	118031	42451881
Conduction disorder	18.87	10.81	19	51404	2499	42567413
Treatment failure	18.81	10.81	29	51394	62595	42507317
Peripheral blood stem cell apheresis	18.50	10.81	7	51416	149	42569763
Pneumonia	18.29	10.81	651	50772	421498	42148414
Rhabdomyolysis	18.26	10.81	42	51381	77977	42491935
Erythema	18.16	10.81	206	51217	108587	42461325
Oropharyngeal pain	18.08	10.81	100	51323	42410	42527502
Lip swelling	17.76	10.81	57	51366	18996	42550916
PO2 increased	17.74	10.81	10	51413	543	42569369
C-reactive protein increased	17.63	10.81	31	51392	63529	42506383
Angioedema	17.46	10.81	99	51324	42378	42527534
Headache	17.29	10.81	394	51029	238975	42330937
CADASIL	17.27	10.81	6	51417	99	42569813
Intervertebral disc protrusion	17.24	10.81	40	51383	11032	42558880
Influenza	17.08	10.81	131	51292	62044	42507868
Ocular hyperaemia	16.97	10.81	50	51373	15913	42553999
Rhinitis allergic	16.90	10.81	22	51401	3820	42566092
Blood pH decreased	16.60	10.81	17	51406	2281	42567631
Interstitial lung disease	16.22	10.81	45	51378	78417	42491495
Anaphylactoid reaction	16.21	10.81	19	51404	2964	42566948
Drug intolerance	15.99	10.81	47	51376	80377	42489535
Vision blurred	15.80	10.81	115	51308	53584	42516328
Renal failure	15.78	10.81	105	51318	143621	42426291
Heart rate increased	15.64	10.81	114	51309	53141	42516771
Lactic acidosis	15.56	10.81	19	51404	45242	42524670
Altered state of consciousness	15.43	10.81	8	51415	29251	42540661
Oral pruritus	15.38	10.81	9	51414	525	42569387
Magnetic resonance imaging spinal abnormal	15.35	10.81	6	51417	140	42569772
Hyperkalaemia	15.29	10.81	48	51375	80410	42489502
Suicidal ideation	15.25	10.81	105	51318	48056	42521856
Therapy partial responder	14.90	10.81	3	51420	20018	42549894
Hypersensitivity	14.89	10.81	143	51280	72227	42497685
Upper respiratory tract infection	14.60	10.81	94	51329	42079	42527833
Saccadic eye movement	14.57	10.81	6	51417	161	42569751
Lymphopenia	14.53	10.81	4	51419	21559	42548353
Ascites	14.52	10.81	29	51394	56649	42513263
Rheumatoid arthritis	14.40	10.81	18	51405	42422	42527490
Tunnel vision	14.39	10.81	9	51414	592	42569320
Wheezing	14.26	10.81	114	51309	54667	42515245
Dyspnoea	14.18	10.81	661	50762	441960	42127952
Gastrooesophageal reflux disease	14.17	10.81	98	51325	44925	42524987
Anxiety	14.11	10.81	211	51212	118349	42451563
Metamorphopsia	14.02	10.81	9	51414	620	42569292
Ejaculation delayed	13.90	10.81	7	51416	302	42569610
Anaemia	13.65	10.81	247	51176	280031	42289881
Rash pruritic	13.60	10.81	78	51345	33525	42536387
Pancytopenia	13.44	10.81	85	51338	117658	42452254
Musculoskeletal discomfort	13.42	10.81	33	51390	9443	42560469
Intertrigo	13.36	10.81	8	51415	487	42569425
Muscle tightness	13.33	10.81	24	51399	5529	42564383
Leukopenia	13.23	10.81	46	51377	74700	42495212
Double stranded DNA antibody positive	13.21	10.81	6	51417	205	42569707
Dry eye	13.21	10.81	45	51378	15461	42554451
Blood bicarbonate decreased	13.21	10.81	17	51406	2918	42566994
Spinal osteoarthritis	13.11	10.81	31	51392	8655	42561257
Intercepted medication error	13.09	10.81	8	51415	505	42569407
Back pain	13.07	10.81	242	51181	141534	42428378
Spasmodic dysphonia	12.98	10.81	8	51415	513	42569399
Generalised anxiety disorder	12.96	10.81	10	51413	924	42568988
Cerebral microangiopathy	12.95	10.81	6	51417	215	42569697
Haematopoietic stem cell mobilisation	12.86	10.81	7	51416	355	42569557
Cytomegalovirus infection	12.85	10.81	12	51411	32294	42537618
Skin exfoliation	12.81	10.81	90	51333	41463	42528449
Central nervous system inflammation	12.75	10.81	6	51417	223	42569689
Nasopharyngitis	12.66	10.81	156	51267	83840	42486072
Sleep disorder due to a general medical condition	12.61	10.81	48	51375	17405	42552507
Papule	12.50	10.81	24	51399	5802	42564110
Electrocardiogram QRS complex shortened	12.50	10.81	6	51417	233	42569679
Sensory level abnormal	12.46	10.81	4	51419	51	42569861
Therapeutic response unexpected	12.43	10.81	36	51387	11345	42558567
Allergic eosinophilia	12.19	10.81	4	51419	55	42569857
Depression	12.03	10.81	195	51228	111168	42458744
Tendinous contracture	11.97	10.81	5	51418	139	42569773
Impaired quality of life	11.95	10.81	41	51382	14136	42555776
Upper-airway cough syndrome	11.95	10.81	20	51403	4346	42565566
Myalgia	11.82	10.81	172	51251	95908	42474004
Thought blocking	11.71	10.81	5	51418	147	42569765
Pneumocystis jirovecii pneumonia	11.71	10.81	8	51415	25173	42544739
Tachycardia induced cardiomyopathy	11.65	10.81	5	51418	149	42569763
Dermatitis contact	11.50	10.81	20	51403	4483	42565429
Malignant neoplasm progression	11.49	10.81	80	51343	108320	42461592
Foetal exposure during pregnancy	11.45	10.81	25	51398	47286	42522626
Testicular cyst	11.41	10.81	4	51419	68	42569844
Drug level increased	11.31	10.81	9	51414	26191	42543721
Mucosal inflammation	11.22	10.81	27	51396	49347	42520565
Product quality issue	11.18	10.81	47	51376	17835	42552077
Victim of chemical submission	11.17	10.81	5	51418	165	42569747
Intentional self-injury	11.14	10.81	42	51381	15160	42554752
Feeling abnormal	11.13	10.81	131	51292	69655	42500257
Acute respiratory distress syndrome	11.04	10.81	12	51411	30096	42539816
Crying	10.96	10.81	24	51399	6370	42563542
Keratoacanthoma	10.91	10.81	9	51414	915	42568997

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
Extra dose administered	480.15	9.92	250	129630	11909	110447510
Accidental exposure to product by child	451.67	9.92	162	129718	3036	110456383
Dermatitis atopic	226.84	9.92	209	129671	25332	110434087
Hand deformity	217.70	9.92	9	129871	218497	110240922
General physical health deterioration	203.26	9.92	124	129756	425171	110034248
Failure of child resistant product closure	200.86	9.92	39	129841	32	110459387
Synovitis	194.67	9.92	42	129838	274050	110185369
Systemic lupus erythematosus	186.80	9.92	36	129844	254302	110205117
Urticaria	185.50	9.92	804	129076	318053	110141366
Pericarditis	183.93	9.92	21	129859	219093	110240326
Contraindicated product administered	182.63	9.92	35	129845	248232	110211187
Helicobacter infection	167.21	9.92	12	129868	181865	110277554
Glossodynia	166.07	9.92	30	129850	221974	110237445
Drug intolerance	157.68	9.92	147	129733	406365	110053054
Wound	156.46	9.92	41	129839	234396	110225023
Pruritus	153.02	9.92	1187	128693	580373	109879046
Muscle injury	150.44	9.92	3	129877	140804	110318615
Off label use	143.98	9.92	1103	128777	1499082	108960337
Treatment failure	143.69	9.92	73	129807	277161	110182258
Folliculitis	138.38	9.92	17	129863	167636	110291783
Drug abuse	128.38	9.92	26	129854	177385	110282034
Human rhinovirus test positive	127.61	9.92	50	129830	1207	110458212
C-reactive protein abnormal	123.84	9.92	7	129873	129688	110329731
Respiratory syncytial virus test positive	122.61	9.92	51	129829	1443	110457976
Cough	116.22	9.92	933	128947	460708	109998711
Drug ineffective	115.79	9.92	1186	128694	1519354	108940065
Infective pulmonary exacerbation of cystic fibrosis	106.88	9.92	108	129772	14663	110444756
Therapeutic product effect decreased	106.21	9.92	79	129801	244237	110215182
Swelling face	104.85	9.92	291	129589	92030	110367389
Lip swelling	103.25	9.92	201	129679	50466	110408953
Sleep disorder due to general medical condition, insomnia type	103.07	9.92	5	129875	105638	110353781
Joint swelling	102.75	9.92	230	129650	442615	110016804
Somnolence	95.93	9.92	638	129242	296811	110162608
Impaired healing	92.98	9.92	58	129822	196659	110262760
Mobility decreased	89.49	9.92	88	129792	237334	110222085
C-reactive protein increased	89.00	9.92	75	129805	217844	110241575
Asthma	88.16	9.92	549	129331	249742	110209677
Arthropathy	86.65	9.92	127	129753	287395	110172024
Anaphylactic reaction	86.34	9.92	313	129567	113987	110345432
Throat irritation	84.13	9.92	191	129689	53361	110406058
Lower respiratory tract infection	83.93	9.92	97	129783	243009	110216410
Product dose omission issue	83.44	9.92	655	129225	321127	110138292
Viral test positive	82.41	9.92	33	129847	845	110458574
Facet joint syndrome	81.93	9.92	9	129871	96819	110362600
Maternal exposure during pregnancy	81.38	9.92	108	129772	254775	110204644
Gastrooesophageal reflux disease	80.62	9.92	421	129459	179555	110279864
Liver injury	78.81	9.92	39	129841	150374	110309045
Nasal congestion	76.67	9.92	272	129608	98010	110361409
Lip dry	75.96	9.92	13	129867	100070	110359349
Angioedema	75.47	9.92	271	129609	98229	110361190
Toxicity to various agents	75.07	9.92	300	129580	480255	109979164
Dizziness	74.45	9.92	1192	128688	697001	109762418
Acute kidney injury	73.12	9.92	442	129438	634988	109824431
Dyspnoea	72.81	9.92	1756	128124	1105116	109354303
Hepatic enzyme increased	70.90	9.92	171	129709	320721	110138698
Chronic spontaneous urticaria	70.26	9.92	38	129842	1955	110457464
Irritable bowel syndrome	70.19	9.92	54	129826	164161	110295258
Pulmonary fibrosis	69.68	9.92	17	129863	102025	110357394
Intentional product use issue	68.52	9.92	116	129764	247790	110211629
Fibromyalgia	68.34	9.92	60	129820	170849	110288570
Rheumatoid arthritis	68.32	9.92	157	129723	299456	110159963
Pneumonia aspiration	66.99	9.92	229	129651	81004	110378415
Ill-defined disorder	66.51	9.92	52	129828	156801	110302618
Rash	66.12	9.92	1341	128539	819623	109639796
Chest discomfort	66.06	9.92	389	129491	173459	110285960
Fatigue	65.21	9.92	1878	128002	1214080	109245339
Oropharyngeal pain	65.16	9.92	323	129557	134953	110324466
Back pain	65.02	9.92	694	129186	370302	110089117
Upper respiratory tract infection	64.27	9.92	315	129565	131013	110328406
Psoriatic arthropathy	64.21	9.92	82	129798	196679	110262740
Wound infection	62.21	9.92	18	129862	96447	110362972
Feeling abnormal	61.50	9.92	393	129487	180318	110279101
Vision blurred	61.39	9.92	307	129573	128715	110330704
Dry skin	61.37	9.92	270	129610	107383	110352036
Cholecystitis chronic	60.72	9.92	65	129815	9435	110449984
Illness	59.51	9.92	222	129658	81949	110377470
Bronchitis	59.42	9.92	351	129529	156681	110302738
Pneumonia haemophilus	59.36	9.92	38	129842	2677	110456742
Tongue biting	59.02	9.92	39	129841	2900	110456519
Emotional distress	58.65	9.92	149	129731	44698	110414721
Impaired quality of life	58.64	9.92	117	129763	29900	110429519
Chills	54.45	9.92	397	129483	190183	110269236
Headache	54.37	9.92	1388	128492	880989	109578430
Myelosuppression	53.26	9.92	22	129858	94318	110365101
Therapeutic product effect incomplete	52.04	9.92	116	129764	223689	110235730
Lung disorder	51.84	9.92	82	129798	179965	110279454
Palpitations	51.57	9.92	342	129538	158870	110300549
Urinary tract infection	50.18	9.92	595	129285	325687	110133732
Peripheral venous disease	50.17	9.92	18	129862	84099	110375320
Butterfly rash	49.52	9.92	31	129849	2100	110457319
COVID-19	48.94	9.92	471	129409	244589	110214830
Alopecia	48.31	9.92	242	129638	364511	110094908
Swelling	48.17	9.92	230	129650	350811	110108608
Nail disorder	47.49	9.92	6	129874	57929	110401490
Mouth haemorrhage	46.92	9.92	68	129812	13420	110445999
Erythema	46.82	9.92	536	129344	290911	110168508
Incorrect dose administered	46.08	9.92	242	129638	103399	110356020
Chest pain	45.98	9.92	658	129222	375717	110083702
Gastrointestinal disorder	45.85	9.92	139	129741	241813	110217606
Blister	45.73	9.92	127	129753	227249	110232170
Eye pruritus	45.07	9.92	111	129769	32664	110426755
Musculoskeletal stiffness	44.08	9.92	174	129706	279648	110179771
Joint range of motion decreased	43.80	9.92	47	129833	121785	110337634
Carbuncle	43.60	9.92	25	129855	1442	110457977
Inflammation	43.43	9.92	102	129778	193136	110266283
Expired product administered	43.05	9.92	51	129829	8269	110451150
Drug interaction	42.95	9.92	378	129502	499805	109959614
Type 2 diabetes mellitus	42.74	9.92	90	129790	177142	110282277
Bursitis	42.53	9.92	54	129826	129864	110329555
Lacrimation increased	41.69	9.92	104	129776	30846	110428573
Grip strength decreased	41.67	9.92	21	129859	80153	110379266
Live birth	41.21	9.92	15	129865	69469	110389950
Pharyngeal swelling	40.90	9.92	60	129820	11972	110447447
Adjustment disorder with depressed mood	40.02	9.92	3	129877	43880	110415539
Seasonal allergy	39.88	9.92	78	129802	19644	110439775
Renal impairment	39.59	9.92	103	129777	188342	110271077
Rhabdomyolysis	39.46	9.92	50	129830	120351	110339068
Eye swelling	39.33	9.92	106	129774	32942	110426477
Drug resistance	39.26	9.92	9	129871	56365	110403054
Onychomadesis	39.26	9.92	4	129876	45659	110413760
Gait inability	38.42	9.92	63	129817	136313	110323106
Thrombocytopenia	38.34	9.92	246	129634	348639	110110780
Anxiety	38.13	9.92	593	129287	344485	110114934
Hypercholesterolaemia	37.39	9.92	31	129849	90806	110368613
Skin exfoliation	36.48	9.92	201	129679	87450	110371969
Syncope	35.49	9.92	379	129501	202157	110257262
Monoclonal immunoglobulin present	35.46	9.92	27	129853	2513	110456906
Head discomfort	34.67	9.92	72	129808	18928	110440491
Throat tightness	34.55	9.92	102	129778	33387	110426032
Lower limb fracture	34.52	9.92	23	129857	75325	110384094
Obesity	34.19	9.92	50	129830	113301	110346118
Gallbladder disorder	34.14	9.92	76	129804	20953	110438466
Myalgia	33.93	9.92	405	129475	221976	110237443
Flushing	33.92	9.92	225	129655	104511	110354908
Insomnia	33.71	9.92	603	129277	359987	110099432
X-ray abnormal	33.66	9.92	3	129877	38114	110421305
Dry eye	33.37	9.92	142	129738	55651	110403768
Swollen tongue	33.34	9.92	150	129730	60212	110399207
Pancytopenia	33.22	9.92	130	129750	209483	110249936
Bone pain	33.13	9.92	158	129722	64975	110394444
Temperature intolerance	32.99	9.92	59	129821	13891	110445528
Liver disorder	32.83	9.92	74	129806	142169	110317250
Rash macular	32.71	9.92	110	129770	38576	110420843
Stomatitis	32.60	9.92	185	129695	270057	110189362
Hepatic cytolysis	32.46	9.92	12	129868	55041	110404378
Overweight	32.42	9.92	39	129841	6425	110452994
Eczema	32.27	9.92	169	129711	72124	110387295
Therapy non-responder	32.27	9.92	87	129793	157220	110302199
Blepharospasm	32.26	9.92	12	129868	54839	110404580
Post cholecystectomy syndrome	32.16	9.92	17	129863	835	110458584
Priapism	32.11	9.92	37	129843	5824	110453595
Multiple organ dysfunction syndrome	31.80	9.92	83	129797	151627	110307792
Autoimmune disorder	31.35	9.92	19	129861	65464	110393955
Tongue injury	30.84	9.92	15	129865	617	110458802
Hypothalamo-pituitary disorder	30.68	9.92	26	129854	2820	110456599
Burning sensation	30.34	9.92	161	129719	69051	110390368
Blood cholesterol increased	29.67	9.92	114	129766	184671	110274748
Deep vein thrombosis	29.47	9.92	272	129608	139615	110319804
Heart rate increased	28.47	9.92	276	129604	143558	110315861
Prescribed underdose	28.40	9.92	21	129859	65153	110394266
Night sweats	28.32	9.92	73	129807	133910	110325509
Crying	28.31	9.92	80	129800	25548	110433871
Delirium	28.20	9.92	74	129806	134951	110324468
Muscle spasms	27.72	9.92	470	129410	277687	110181732
Photosensitivity reaction	27.42	9.92	79	129801	25510	110433909
Hyperkalaemia	27.18	9.92	76	129804	135720	110323699
Sopor	27.18	9.92	5	129875	36541	110422878
Rhinorrhoea	27.12	9.92	210	129670	102456	110356963
Nervousness	27.04	9.92	100	129780	36751	110422668
Hip arthroplasty	27.00	9.92	16	129864	55797	110403622
Medication error	26.68	9.92	52	129828	105314	110354105
Status asthmaticus	26.66	9.92	16	129864	1005	110458414
Nausea	26.23	9.92	1734	128146	1233956	109225463
Victim of chemical submission	26.18	9.92	15	129865	864	110458555
Rash pruritic	26.13	9.92	201	129679	97868	110361551
Infection	25.92	9.92	286	129594	361914	110097505
Pneumonia	25.90	9.92	1268	128612	875446	109583973
Cardiogenic shock	25.60	9.92	18	129862	57320	110402099
Face oedema	25.55	9.92	92	129788	33377	110426042
Hepatic cirrhosis	25.54	9.92	25	129855	67601	110391818
Colitis ulcerative	25.48	9.92	32	129848	77331	110382088
Injection site pain	25.39	9.92	320	129560	177602	110281817
Coma	25.24	9.92	230	129650	117639	110341780
Cytomegalovirus infection	24.43	9.92	17	129863	54427	110404992
Upper-airway cough syndrome	24.28	9.92	56	129824	15801	110443618
Red blood cell sedimentation rate increased	24.14	9.92	34	129846	78268	110381151
Body height decreased	24.12	9.92	44	129836	10519	110448900
Post-traumatic stress disorder	24.04	9.92	34	129846	6562	110452857
Tinnitus	23.97	9.92	137	129743	60403	110399016
Thrombotic microangiopathy	23.93	9.92	3	129877	29146	110430273
Lupus-like syndrome	23.87	9.92	9	129871	40783	110418636
Hepatocellular injury	23.82	9.92	15	129865	50627	110408792
Exposure during pregnancy	23.35	9.92	109	129771	167315	110292104
Urticaria pressure	23.27	9.92	7	129873	73	110459346
Malignant neoplasm progression	22.99	9.92	116	129764	174451	110284968
Allergy test positive	22.90	9.92	14	129866	909	110458510
Rhinitis allergic	22.87	9.92	59	129821	17863	110441556
Skin swelling	22.84	9.92	37	129843	8043	110451376
Periorbital oedema	22.70	9.92	42	129838	10150	110449269
Lactic acidosis	22.48	9.92	47	129833	92764	110366655
Prescribed overdose	22.37	9.92	43	129837	87538	110371881
Essential hypertension	22.27	9.92	36	129844	7811	110451608
White blood cell count decreased	22.27	9.92	386	129494	229004	110230415
Hypersomnia	22.16	9.92	78	129802	27983	110431436
Condition aggravated	22.05	9.92	676	129204	734160	109725259
Injection site rash	21.98	9.92	69	129811	23350	110436069
Skin disorder	21.75	9.92	104	129776	42809	110416610
Cholelithiasis	21.60	9.92	138	129742	63284	110396135
Product use issue	21.55	9.92	248	129632	311447	110147972
Ocular hyperaemia	21.23	9.92	97	129783	39189	110420230
Gallbladder injury	20.93	9.92	15	129865	1273	110458146
Cellulitis	20.77	9.92	233	129647	125783	110333636
Confusional state	20.64	9.92	407	129473	468273	109991146
Vitamin B12 increased	20.58	9.92	18	129862	2037	110457382
Interstitial lung disease	20.46	9.92	89	129791	139245	110320174
Limb injury	20.39	9.92	93	129787	37543	110421876
Discomfort	20.33	9.92	158	129722	214549	110244870
Fibrosis	20.26	9.92	34	129846	7608	110451811
Full blood count decreased	20.21	9.92	83	129797	32016	110427403
Sinus disorder	20.12	9.92	84	129796	32644	110426775
Frequent bowel movements	20.08	9.92	33	129847	71357	110388062
Laryngospasm	19.96	9.92	26	129854	4642	110454777
Biliary dyskinesia	19.93	9.92	19	129861	2402	110457017
Joint noise	19.47	9.92	27	129853	5116	110454303
Diarrhoea	19.20	9.92	1570	128310	1137935	109321484
Gastrointestinal mucosal necrosis	19.11	9.92	8	129872	230	110459189
Loss of personal independence in daily activities	19.01	9.92	101	129779	149919	110309500
Sinus headache	18.96	9.92	29	129851	6003	110453416
Therapy partial responder	18.82	9.92	10	129870	37051	110422368
Drug level increased	18.77	9.92	17	129863	47702	110411717
Ear discomfort	18.65	9.92	41	129839	11208	110448211
Mast cell activation syndrome	18.65	9.92	15	129865	1513	110457906
Spinal disorder	18.60	9.92	42	129838	11686	110447733
Peripheral blood stem cell apheresis	18.56	9.92	7	129873	152	110459267
Multiple lentigines syndrome	18.55	9.92	8	129872	248	110459171
Product administration interrupted	18.54	9.92	41	129839	11251	110448168
Spinal osteoarthritis	18.51	9.92	59	129821	20124	110439295
Suicidal ideation	18.46	9.92	180	129700	93757	110365662
Influenza	18.42	9.92	290	129590	168811	110290608
Emotional disorder	18.40	9.92	51	129829	16109	110443310
Eye irritation	18.37	9.92	83	129797	33369	110426050
Electric shock	18.29	9.92	16	129864	1812	110457607
Adverse event	18.20	9.92	66	129814	108743	110350676
Feeling hot	18.11	9.92	175	129705	90931	110368488
Sinusitis	17.97	9.92	466	129414	296222	110163197
Hot flush	17.96	9.92	136	129744	65900	110393519
Agranulocytosis	17.89	9.92	28	129852	61732	110397687
Dactylitis	17.64	9.92	23	129857	4110	110455309
Cystoid macular oedema	17.62	9.92	19	129861	2781	110456638
Rheumatoid factor increased	17.55	9.92	18	129862	2487	110456932
Acute respiratory distress syndrome	17.52	9.92	22	129858	53176	110406243
Infusion site swelling	17.52	9.92	37	129843	9840	110449579
Rhinovirus infection	17.36	9.92	41	129839	11748	110447671
Onychomycosis	17.33	9.92	12	129868	38519	110420900
Leukopenia	17.32	9.92	103	129777	148688	110310731
Lethargy	17.27	9.92	177	129703	93399	110366020
Allergic cystitis	17.24	9.92	3	129877	0	110459419
Blood pressure systolic abnormal	17.24	9.92	4	129876	24846	110434573
Breast pain	17.21	9.92	37	129843	9963	110449456
Tinea pedis	17.20	9.92	19	129861	2856	110456563
Hepatotoxicity	17.20	9.92	30	129850	63370	110396049
Granulocyte count increased	17.17	9.92	16	129864	1967	110457452
Neuropathy peripheral	17.16	9.92	301	129579	178976	110280443
Cystitis noninfective	17.11	9.92	15	129865	1703	110457716
Product label confusion	17.08	9.92	3	129877	22674	110436745
Infusion related reaction	17.08	9.92	330	129550	380832	110078587
Transplant rejection	16.95	9.92	4	129876	24563	110434856
Anxiety disorder	16.94	9.92	25	129855	5015	110454404
Arthropod bite	16.89	9.92	36	129844	9635	110449784
Skin discolouration	16.87	9.92	107	129773	48939	110410480
Acquired haemophilia	16.81	9.92	18	129862	2613	110456806
Abdominal discomfort	16.74	9.92	344	129536	393514	110065905
Cataract subcapsular	16.72	9.92	13	129867	1248	110458171
Eye pain	16.44	9.92	108	129772	49991	110409428
Musculoskeletal pain	16.27	9.92	137	129743	182886	110276533
Blood immunoglobulin A increased	16.24	9.92	14	129866	1554	110457865
Surgery	16.07	9.92	93	129787	41190	110418229
Posterior reversible encephalopathy syndrome	15.97	9.92	10	129870	33851	110425568
Pneumocystis jirovecii pneumonia	15.90	9.92	16	129864	42719	110416700
Altered state of consciousness	15.87	9.92	27	129853	57599	110401820
Depression	15.75	9.92	486	129394	316849	110142570
Polyneuropathy	15.73	9.92	9	129871	32003	110427416
Dry throat	15.69	9.92	34	129846	9204	110450215
Cerebral haemorrhage	15.65	9.92	33	129847	64935	110394484
Carotid artery disease	15.62	9.92	16	129864	2207	110457212
Wrist deformity	15.60	9.92	19	129861	3170	110456249
Non-cardiac chest pain	15.60	9.92	36	129844	10162	110449257
Cardiac failure	15.55	9.92	143	129737	187483	110271936
Glomerular filtration rate increased	15.52	9.92	15	129865	1930	110457489
Hyperlipidaemia	15.45	9.92	83	129797	35765	110423654
Inappropriate schedule of product administration	15.44	9.92	330	129550	203307	110256112
Thermal burn	15.44	9.92	31	129849	7957	110451462
Haematotoxicity	15.43	9.92	3	129877	21079	110438340
Coronary artery disease	15.40	9.92	140	129740	71550	110387869
Status epilepticus	15.34	9.92	9	129871	31562	110427857
Haemophagocytic lymphohistiocytosis	15.33	9.92	9	129871	31550	110427869
Therapeutic response unexpected	15.29	9.92	62	129818	23781	110435638
Bed bug infestation	15.22	9.92	5	129875	71	110459348
Osteoarthritis	15.21	9.92	139	129741	182484	110276935
Pathergy reaction	15.15	9.92	5	129875	72	110459347
Serotonin syndrome	15.14	9.92	29	129851	59124	110400295
Coeliac disease	15.14	9.92	17	129863	43170	110416249
Bone marrow failure	15.13	9.92	28	129852	57820	110401599
Laryngeal pain	15.07	9.92	26	129854	5949	110453470
Anaphylactoid reaction	15.04	9.92	28	129852	6798	110452621
Overdose	15.02	9.92	189	129691	233605	110225814
Oral pruritus	14.99	9.92	19	129861	3301	110456118
Circulatory collapse	14.99	9.92	17	129863	42976	110416443
Sinus operation	14.93	9.92	18	129862	2973	110456446
Conduction disorder	14.92	9.92	21	129859	4034	110455385
Dermatitis contact	14.87	9.92	43	129837	13910	110445509
Hepatic failure	14.87	9.92	37	129843	68702	110390717
Tinea infection	14.84	9.92	13	129867	1475	110457944
Knee arthroplasty	14.81	9.92	34	129846	64914	110394505
Neuroleptic malignant syndrome	14.80	9.92	11	129869	34048	110425371
Depressed mood	14.76	9.92	122	129758	60687	110398732
Injection site erythema	14.56	9.92	172	129708	94004	110365415
Oedema	14.53	9.92	167	129713	209809	110249610
Flatulence	14.52	9.92	108	129772	52041	110407378
Middle insomnia	14.51	9.92	55	129825	20447	110438972
Exposure via skin contact	14.48	9.92	41	129839	13106	110446313
Rotator cuff syndrome	14.42	9.92	48	129832	16746	110442673
Septic shock	14.41	9.92	117	129763	157411	110302008
Ventricular hypertrophy	14.41	9.92	28	129852	7017	110452402
Diabetic retinal oedema	14.37	9.92	8	129872	436	110458983
Bacterial test positive	14.29	9.92	30	129850	7947	110451472
Normal newborn	14.27	9.92	4	129876	21892	110437527
Stab wound	14.06	9.92	7	129873	303	110459116
Migraine without aura	14.06	9.92	9	129871	634	110458785
Vasospasm	14.05	9.92	13	129867	1583	110457836
Burns first degree	14.03	9.92	4	129876	34	110459385
Cytokine release syndrome	13.95	9.92	135	129745	70171	110389248
Increased appetite	13.94	9.92	44	129836	14933	110444486
Bone density decreased	13.91	9.92	46	129834	15996	110443423
Inflammatory bowel disease	13.89	9.92	28	129852	7206	110452213
Ligament sprain	13.86	9.92	46	129834	16022	110443397
Dermatitis	13.77	9.92	67	129813	27770	110431649
Transient ischaemic attack	13.77	9.92	125	129755	63857	110395562
Epilepsy	13.53	9.92	66	129814	100143	110359276
Bezoar	13.47	9.92	20	129860	4034	110455385
Product dose omission in error	13.41	9.92	59	129821	23453	110435966
Red blood cell sedimentation rate abnormal	13.38	9.92	6	129874	24503	110434916
Musculoskeletal discomfort	13.38	9.92	59	129821	23479	110435940
Neurological examination normal	13.36	9.92	4	129876	41	110459378
Skin oedema	13.35	9.92	14	129866	1985	110457434
Heart rate decreased	13.31	9.92	51	129829	82705	110376714
Wrong technique in product usage process	13.27	9.92	159	129721	87189	110372230
Back injury	13.25	9.92	22	129858	47377	110412042
Vertebral lateral recess stenosis	13.22	9.92	7	129873	345	110459074
Palmar erythema	13.22	9.92	15	129865	2323	110457096
Pharyngeal dystonia	13.11	9.92	4	129876	44	110459375
Swelling of eyelid	13.07	9.92	26	129854	6627	110452792
Urticaria thermal	13.04	9.92	8	129872	523	110458896
Oesophageal adenocarcinoma recurrent	13.02	9.92	4	129876	45	110459374
Psoriasis	13.02	9.92	234	129646	139759	110319660
Shock haemorrhagic	12.91	9.92	8	129872	27239	110432180
Infusion site erythema	12.89	9.92	37	129843	11922	110447497
Aspartate aminotransferase	12.87	9.92	10	129870	959	110458460
Foreign body in reproductive tract	12.83	9.92	10	129870	964	110458455
Parkinsonism	12.81	9.92	5	129875	22182	110437237
Ligamentum flavum hypertrophy	12.80	9.92	7	129873	368	110459051
Red blood cell count decreased	12.79	9.92	126	129754	65797	110393622
Accident at home	12.78	9.92	6	129874	228	110459191
Patellofemoral pain syndrome	12.74	9.92	8	129872	545	110458874
Osteoarthropathy	12.73	9.92	7	129873	372	110459047
Injection site discolouration	12.70	9.92	31	129849	9072	110450347
Gastritis	12.64	9.92	107	129773	53592	110405827
Influenza like illness	12.60	9.92	159	129721	88253	110371166
Infusion site pain	12.56	9.92	47	129833	17372	110442047
Blood alkaline phosphatase increased	12.54	9.92	133	129747	70802	110388617
Vitamin D deficiency	12.50	9.92	49	129831	18503	110440916
Cystic fibrosis	12.48	9.92	21	129859	4710	110454709
Mood altered	12.47	9.92	54	129826	21321	110438098
Meniscus injury	12.46	9.92	28	129852	7765	110451654
Throat clearing	12.46	9.92	20	129860	4313	110455106
Frustration tolerance decreased	12.46	9.92	30	129850	8701	110450718
Therapeutic response shortened	12.41	9.92	68	129812	29515	110429904
Pharyngeal oedema	12.41	9.92	45	129835	16383	110443036
PO2 increased	12.39	9.92	12	129868	1547	110457872
Multiple allergies	12.32	9.92	37	129843	12226	110447193
Acute sinusitis	12.27	9.92	22	129858	5189	110454230
Sedation complication	12.27	9.92	4	129876	19851	110439568
Dysgeusia	12.27	9.92	131	129749	69854	110389565
Product availability issue	12.23	9.92	28	129852	7862	110451557
Complication of device insertion	12.22	9.92	30	129850	8808	110450611
Skin fissures	12.20	9.92	59	129821	24399	110435020
Exposure to toxic agent	12.17	9.92	38	129842	12820	110446599
Skin necrosis	12.17	9.92	5	129875	21507	110437912
Epistaxis	12.15	9.92	218	129662	130154	110329265
Liver function test increased	12.14	9.92	58	129822	88490	110370929
Sinus congestion	12.11	9.92	69	129811	30390	110429029
Taste disorder	12.07	9.92	38	129842	65349	110394070
Injection site urticaria	12.04	9.92	46	129834	17169	110442250
Nasal discomfort	11.96	9.92	24	129856	6157	110453262
Osteonecrosis of jaw	11.89	9.92	24	129856	47993	110411426
Haemodynamic instability	11.88	9.92	6	129874	22882	110436537
Haematopoietic stem cell mobilisation	11.86	9.92	7	129873	426	110458993
Lymphopenia	11.84	9.92	18	129862	40152	110419267
Sciatica	11.82	9.92	62	129818	92337	110367082
Diverticulitis	11.74	9.92	105	129775	53417	110406002
Skin irritation	11.74	9.92	44	129836	16275	110443144
Borderline personality disorder	11.66	9.92	10	129870	1102	110458317
Pain in extremity	11.64	9.92	691	129189	486427	109972992
Injection site scab	11.60	9.92	8	129872	638	110458781
Rash erythematous	11.59	9.92	147	129733	81685	110377734
Obsessive-compulsive disorder	11.56	9.92	26	129854	7215	110452204
Papule	11.56	9.92	32	129848	10101	110449318
Ear pruritus	11.52	9.92	26	129854	7234	110452185
Vaginitis gardnerella	11.51	9.92	4	129876	68	110459351
Skin warm	11.51	9.92	30	129850	9140	110450279
Pneumonitis	11.49	9.92	139	129741	76392	110383027
No adverse event	11.48	9.92	135	129745	73704	110385715
Neurotoxicity	11.42	9.92	20	129860	42187	110417232
Multiple sclerosis	11.41	9.92	60	129820	25638	110433781
Joint dislocation	11.41	9.92	14	129866	34176	110425243
Panic disorder	11.39	9.92	17	129863	3444	110455975
Mitral valve prolapse	11.36	9.92	14	129866	2364	110457055
Eye discharge	11.36	9.92	29	129851	8725	110450694
Cerebrovascular accident	11.34	9.92	286	129594	180998	110278421
Allergic eosinophilia	11.30	9.92	4	129876	72	110459347
Mouth swelling	11.29	9.92	26	129854	7328	110452091
Oedema mouth	11.21	9.92	16	129864	3114	110456305
Oropharyngeal discomfort	11.18	9.92	32	129848	10295	110449124
Intervertebral disc protrusion	11.18	9.92	63	129817	27635	110431784
Incorrect dosage administered	11.15	9.92	18	129862	3900	110455519
Skin burning sensation	11.14	9.92	53	129827	21772	110437647
PCO2 decreased	11.09	9.92	16	129864	3145	110456274
Bronchial hyperreactivity	11.09	9.92	17	129863	3527	110455892
Chronic obstructive pulmonary disease	11.06	9.92	185	129695	108973	110350446
Initial insomnia	11.06	9.92	32	129848	10357	110449062
Skin discomfort	11.03	9.92	13	129867	2097	110457322
Limb mass	10.98	9.92	18	129862	3951	110455468
Conjunctival pigmentation	10.96	9.92	4	129876	79	110459340
Reflux gastritis	10.94	9.92	11	129869	1485	110457934
Schizophrenia	10.92	9.92	6	129874	21820	110437599
Ear swelling	10.90	9.92	13	129867	2123	110457296
White blood cells urine positive	10.90	9.92	26	129854	7498	110451921
Acute myocardial infarction	10.82	9.92	148	129732	83629	110375790
Pulmonary embolism	10.78	9.92	329	129551	214145	110245274
Gluten sensitivity	10.77	9.92	7	129873	506	110458913
Aneurysm	10.76	9.92	19	129861	4427	110454992
Skin plaque	10.73	9.92	36	129844	12609	110446810
Biliary sepsis	10.72	9.92	12	129868	1831	110457588
Dysphagia	10.72	9.92	246	129634	153354	110306065
Autoimmune hepatitis	10.72	9.92	40	129840	14764	110444655
Head deformity	10.68	9.92	4	129876	85	110459334
Renal cyst	10.67	9.92	46	129834	18126	110441293
Uterine cyst	10.59	9.92	6	129874	338	110459081
Muscular weakness	10.56	9.92	217	129663	248251	110211168
Exostosis	10.53	9.92	24	129856	45932	110413487
Sneezing	10.53	9.92	69	129811	31915	110427504
Cervical spinal stenosis	10.48	9.92	15	129865	2927	110456492
Snoring	10.43	9.92	24	129856	6760	110452659
Bronchospasm	10.42	9.92	66	129814	30173	110429246
Sinus pain	10.40	9.92	22	129858	5857	110453562
Toe operation	10.39	9.92	9	129871	1005	110458414
Allergy to animal	10.34	9.92	12	129868	1904	110457515
Neurological examination abnormal	10.31	9.92	8	129872	766	110458653
Tuberculosis	10.27	9.92	4	129876	17770	110441649
Somnambulism	10.23	9.92	23	129857	6382	110453037
Cholestasis	10.22	9.92	40	129840	64478	110394941
Agitation	10.17	9.92	188	129692	112863	110346556
Irritability	10.08	9.92	93	129787	47716	110411703
Chromaturia	10.07	9.92	64	129816	29296	110430123
Drug ineffective for unapproved indication	10.05	9.92	75	129805	102763	110356656
Melaena	10.04	9.92	44	129836	68713	110390706
Intervertebral disc degeneration	10.03	9.92	45	129835	18040	110441379
Haematochezia	10.03	9.92	87	129793	115437	110343982
Hiatus hernia	9.98	9.92	61	129819	27545	110431874

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R06AX13	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Other antihistamines for systemic use
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:35480	analgesic
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35705	immunosuppressive agent
CHEBI has role	CHEBI:35842	antirheumatic drug
CHEBI has role	CHEBI:37955	H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role	CHEBI:48873	cholinergic antagonist
CHEBI has role	CHEBI:50177	dermatologic drug
CHEBI has role	CHEBI:50857	anti-allergic agent
CHEBI has role	CHEBI:65023	anti-asthmatic agent
CHEBI has role	CHEBI:176497	geroprotector
MeSH PA	D000982	Antipruritics
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D006633	Histamine Antagonists
MeSH PA	D006634	Histamine H1 Antagonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018926	Anti-Allergic Agents
MeSH PA	D039563	Histamine H1 Antagonists, Non-Sedating

Related Drugs by ATC class:

R06AX Other antihistamines for systemic use 26 drugs

acrivastineantazolineastemizoleazatadineazelastinebamipinebilastinecyproheptadinedeptropinedesloratadineebastineepinastine show all 26 →

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

Disease	Relation	SNOMED_ID	DOID
Vasomotor rhinitis	indication	8229003	DOID:4730
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Sneezing	indication	76067001
Common cold	indication	82272006	DOID:10459
Chronic idiopathic urticaria	indication	302162004
Seasonal allergic rhinitis	indication	367498001
Allergic conjunctivitis	indication	473460002	DOID:11204
Bone pain after neupogen	off-label use	12584003
Urticaria	off-label use	126485001
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Coronary arteriosclerosis	contraindication	53741008	DOID:3393
Hepatic failure	contraindication	59927004
Diabetes mellitus	contraindication	73211009	DOID:9351
Kidney disease	contraindication	90708001	DOID:557
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Benign prostatic hyperplasia	contraindication	266569009
Retention of urine	contraindication	267064002
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Hypertensive urgency	contraindication	443482000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.43	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST	Ki	6.97		WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Ki	4.94		WOMBAT-PK
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	6.81		DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN		EC50	5.52		CHEMBL
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	7.80		DRUG MATRIX
Potassium channel subfamily K member 9	Ion channel	Q9NPC2	KCNK9_HUMAN		IC50	4.20		CHEMBL
Bile acid receptor	Nuclear hormone receptor	Q96RI1	NR1H4_HUMAN		IC50	5.51		CHEMBL
Sodium-dependent neutral amino acid transporter B(0)AT2	Transporter	Q9H2J7	S6A15_HUMAN		IC50	5.40		CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	6.77		WOMBAT-PK
Transient receptor potential cation channel subfamily V member 2	Ion channel	Q9Y5S1	TRPV2_HUMAN	BLOCKER	IC50	5.52		IUPHAR
Histamine H1 receptor	GPCR		HRH1_CAVPO		Kd	7.14		CHEMBL
Histamine H1 receptor	GPCR		HRH1_RAT		Ki	6.46		CHEMBL

External reference:

ID	Source
4020716	VUID
N0000148306	NUI
D00364	KEGG_DRUG
4020716	VANDF
C0065180	UMLSCUI
CHEBI:6538	CHEBI
CHEMBL998	ChEMBL_ID
DB00455	DRUGBANK_ID
D017336	MESH_DESCRIPTOR_UI
3957	PUBCHEM_CID
7216	IUPHAR_LIGAND_ID
5864	INN_ID
7AJO3BO7QN	UNII
203576	RXNORM
191	MMSL
45829	MMSL
4994	MMSL
d03050	MMSL
003909	NDDF
015760	NDDF
108652002	SNOMEDCT_US
386884002	SNOMEDCT_US
7AJO3BO7QN	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
allergy relief	HUMAN OTC DRUG LABEL	1	0067-6066	TABLET	10 mg	ORAL	NDA	15 sections
allergy relief	HUMAN OTC DRUG LABEL	1	0067-6122	TABLET	10 mg	ORAL	NDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-0612	TABLET	10 mg	ORAL	ANDA	15 sections
Good Sense childrens allergy relief	HUMAN OTC DRUG LABEL	1	0113-0671	SOLUTION	5 mg	ORAL	ANDA	14 sections
good sense childrens allergy relief	HUMAN OTC DRUG LABEL	1	0113-1019	TABLET, CHEWABLE	5 mg	ORAL	ANDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-1191	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	ANDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-1612	TABLET	10 mg	ORAL	ANDA	15 sections
good sense childrens allergy relief	HUMAN OTC DRUG LABEL	1	0113-1719	SOLUTION	5 mg	ORAL	ANDA	14 sections
Allergy and Congestion Relief	HUMAN OTC DRUG LABEL	2	0113-2007	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	14 sections
perrigo allergy d	HUMAN OTC DRUG LABEL	2	0113-7777	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	15 sections
allergy d	HUMAN OTC DRUG LABEL	2	0113-9004	TABLET, EXTENDED RELEASE	10 mg	ORAL	ANDA	15 sections
good sense allergy relief	HUMAN OTC DRUG LABEL	1	0113-9755	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	ANDA	15 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0522	TABLET	10 mg	ORAL	ANDA	15 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0527	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	ANDA	15 sections
Loratadine and Pseudoephedrine	HUMAN OTC DRUG LABEL	2	0363-0725	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	16 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0752	TABLET, CHEWABLE	5 mg	ORAL	ANDA	16 sections
Wal-itin	HUMAN OTC DRUG LABEL	1	0363-0754	TABLET, CHEWABLE	5 mg	ORAL	ANDA	16 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0771	SOLUTION	5 mg	ORAL	ANDA	16 sections
Loratadine	HUMAN OTC DRUG LABEL	1	0363-0771	SOLUTION	5 mg	ORAL	ANDA	16 sections
Indoor Outdoor Allergy Relief	HUMAN OTC DRUG LABEL	1	0363-0858	TABLET	10 mg	ORAL	ANDA	14 sections
allergy relief	HUMAN OTC DRUG LABEL	1	0363-1612	TABLET	10 mg	ORAL	ANDA	15 sections
WAL-ITIN	HUMAN OTC DRUG LABEL	1	0363-1686	CAPSULE, LIQUID FILLED	10 mg	ORAL	ANDA	16 sections
Allergy Relief D	HUMAN OTC DRUG LABEL	2	0363-2010	TABLET, EXTENDED RELEASE	10 mg	ORAL	ANDA	15 sections
Wal-itin Allergy Relief	HUMAN OTC DRUG LABEL	1	0363-2085	SOLUTION	5 mg	ORAL	ANDA	15 sections
Childrens Wal-itin	HUMAN OTC DRUG LABEL	1	0363-2092	SOLUTION	5 mg	ORAL	ANDA	16 sections
Childrens Walitin	HUMAN OTC DRUG LABEL	1	0363-2108	SOLUTION	5 mg	ORAL	ANDA	16 sections
Childrens Loratadine Sugar Free	HUMAN OTC DRUG LABEL	1	0363-2131	SOLUTION	5 mg	ORAL	ANDA	16 sections
CHILDRENS LORATADINE ODT	Human OTC Drug Label	1	0363-4020	TABLET, ORALLY DISINTEGRATING	10 mg	ORAL	ANDA	15 sections
allergy relief d 12	HUMAN OTC DRUG LABEL	2	0363-7023	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	15 sections
Wal-itin	HUMAN OTC DRUG LABEL	1	0363-9150	TABLET	10 mg	ORAL	ANDA	14 sections