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

leuprorelin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
pituitary hormone-release stimulating peptides	1559	53714-56-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: leuprorelin leuprolide acetate eligard leupline leuprolide leuprorelin acetate leuprorelin mesilate	A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE. Molecular weight: 1209.42 Formula: C59H84N16O12 CLOGP: -3.18 LIPINSKI: 3 HAC: 28 HDO: 16 TPSA: 429.04 ALOGS: -4.55 ROTB: 32 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mcg	implant
1	mg	P
0.13	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	66.66 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.38 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.54 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.90 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
May 24, 2022	EMA	ACCORD HEALTHCARE S.L.U.
April 9, 1985	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intercepted product preparation error	965.68	17.58	162	13924	535	63474401
Syringe issue	753.61	17.58	165	13921	2704	63472232
Hot flush	753.19	17.58	317	13769	50842	63424094
Device leakage	504.07	17.58	143	13943	6953	63467983
Occupational exposure to product	401.31	17.58	93	13993	1985	63472951
Pelvic pain	382.55	17.58	135	13951	13384	63461552
Ovarian hyperstimulation syndrome	368.62	17.58	99	13987	3915	63471021
Off label use	309.47	17.58	541	13545	673921	62801015
Vaginal haemorrhage	283.62	17.58	133	13953	27354	63447582
Heavy menstrual bleeding	205.16	17.58	93	13993	17680	63457256
Abscess sterile	174.76	17.58	26	14060	26	63474910
Injection site abscess	170.96	17.58	42	14044	1156	63473780
Injury associated with device	169.29	17.58	53	14033	3613	63471323
Hysterectomy	143.16	17.58	60	14026	9439	63465497
Wrong technique in product usage process	130.18	17.58	109	13977	62231	63412705
Mood swings	116.85	17.58	64	14022	18184	63456752
Intermenstrual bleeding	109.26	17.58	47	14039	7879	63467057
Uterine leiomyoma	87.12	17.58	42	14044	9156	63465780
Oestradiol increased	83.23	17.58	15	14071	82	63474854
Menstrual disorder	78.17	17.58	33	14053	5280	63469656
Injection site pain	77.51	17.58	118	13968	129682	63345254
Injection site abscess sterile	76.77	17.58	11	14075	6	63474930
Uterine haemorrhage	76.24	17.58	30	14056	4011	63470925
Ovarian cyst	73.04	17.58	45	14041	15900	63459036
Epiphysiolysis	72.59	17.58	12	14074	35	63474901
Haemorrhage	72.28	17.58	78	14008	60944	63413992
Dysmenorrhoea	66.30	17.58	27	14059	3946	63470990
Surgery	55.47	17.58	53	14033	35859	63439077
Product physical consistency issue	53.74	17.58	15	14071	684	63474252
Depression	53.72	17.58	128	13958	196364	63278572
Amenorrhoea	53.25	17.58	31	14055	9883	63465053
Anger	51.64	17.58	33	14053	12423	63462513
Aplastic anaemia	51.60	17.58	30	14056	9539	63465397
Abdominal pain	49.29	17.58	160	13926	293296	63181640
Suicidal ideation	47.90	17.58	64	14022	62357	63412579
Focal nodular hyperplasia	47.34	17.58	13	14073	558	63474378
Night sweats	46.91	17.58	56	14030	48758	63426178
Fall	45.86	17.58	15	14071	392319	63082617
Joint swelling	45.04	17.58	9	14077	327657	63147279
Endometrial stromal sarcoma	43.57	17.58	7	14079	16	63474920
Infusion related reaction	42.87	17.58	3	14083	245518	63229418
Vulvovaginal dryness	42.61	17.58	18	14068	2883	63472053
Injection site mass	41.77	17.58	34	14052	18622	63456314
Pneumonia	40.17	17.58	26	14060	456741	63018195
Product dispensing error	39.52	17.58	26	14060	10279	63464657
Rheumatoid arthritis	39.30	17.58	5	14081	253814	63221122
Neoplasm progression	38.69	17.58	44	14042	36384	63438552
Blood luteinising hormone increased	38.44	17.58	8	14078	101	63474835
Endometriosis	37.79	17.58	20	14066	5300	63469636
Adnexa uteri pain	36.30	17.58	10	14076	434	63474502
Adnexal torsion	36.08	17.58	10	14076	444	63474492
Breast cancer metastatic	35.90	17.58	26	14060	11992	63462944
Migraine	35.73	17.58	74	14012	103272	63371664
Genital haemorrhage	34.36	17.58	21	14065	7311	63467625
Product leakage	34.04	17.58	11	14075	830	63474106
Ovarian cyst ruptured	33.98	17.58	12	14074	1187	63473749
Neuroendocrine breast tumour	33.74	17.58	6	14080	30	63474906
Maternal exposure before pregnancy	33.66	17.58	21	14065	7582	63467354
Blood follicle stimulating hormone abnormal	33.61	17.58	5	14081	5	63474931
Leiomyosarcoma recurrent	33.61	17.58	5	14081	5	63474931
Toxicity to various agents	33.53	17.58	7	14079	247243	63227693
Metastases to liver	32.97	17.58	33	14053	23606	63451330
Abdominal discomfort	32.95	17.58	15	14071	320870	63154066
Hepatic cytolysis	32.24	17.58	27	14059	15380	63459556
Headache	31.57	17.58	244	13842	632997	62841939
Depressed mood	30.50	17.58	41	14045	40150	63434786
Menstruation irregular	30.13	17.58	19	14067	6985	63467951
Contraindicated product administered	29.84	17.58	6	14080	217642	63257294
Dyspareunia	28.79	17.58	13	14073	2442	63472494
Malignant neoplasm progression	28.61	17.58	59	14027	82062	63392874
Dental fistula	28.49	17.58	9	14077	631	63474305
Injection site erythema	28.09	17.58	59	14027	83115	63391821
Breast enlargement	26.89	17.58	11	14075	1625	63473311
Blood luteinising hormone decreased	26.81	17.58	5	14081	34	63474902
Drug intolerance	26.52	17.58	18	14068	308643	63166293
Insomnia	26.39	17.58	106	13980	215146	63259790
Prosopagnosia	26.32	17.58	5	14081	38	63474898
Adhesion	26.09	17.58	10	14076	1246	63473690
Sinusitis	25.86	17.58	9	14077	226644	63248292
Uterine adhesions	25.47	17.58	5	14081	46	63474890
Injection site induration	25.39	17.58	19	14067	9207	63465729
Vision blurred	24.12	17.58	59	14027	91865	63383071
Idiopathic intracranial hypertension	23.64	17.58	12	14074	2919	63472017
Calcium deficiency	23.60	17.58	9	14077	1105	63473831
Wound	23.45	17.58	4	14082	163259	63311677
Infection	23.06	17.58	11	14075	229162	63245774
Myomectomy	22.84	17.58	4	14082	18	63474918
Arthropathy	22.53	17.58	12	14074	234780	63240156
Expired product administered	22.26	17.58	15	14071	6166	63468770
Nasopharyngitis	21.60	17.58	15	14071	254242	63220694
Blood oestrogen increased	21.55	17.58	5	14081	107	63474829
Oophorectomy	21.37	17.58	7	14079	551	63474385
Confusional state	21.37	17.58	13	14073	236367	63238569
Mood altered	21.33	17.58	21	14065	14722	63460214
Laparoscopy	21.20	17.58	5	14081	115	63474821
Bone pain	21.11	17.58	41	14045	54600	63420336
Uterine pain	21.00	17.58	6	14080	298	63474638
Drug hypersensitivity	20.76	17.58	23	14063	310664	63164272
Hypotension	20.73	17.58	18	14068	272586	63202350
Pituitary apoplexy	20.69	17.58	5	14081	128	63474808
Product administration error	20.37	17.58	25	14061	22372	63452564
Metastases to bone	20.00	17.58	24	14062	20995	63453941
Completed suicide	19.99	17.58	4	14082	145669	63329267
Wrong product administered	19.99	17.58	14	14072	6127	63468809
Superior vena cava syndrome	19.83	17.58	7	14079	692	63474244
Blood follicle stimulating hormone increased	19.68	17.58	5	14081	158	63474778
Menopausal symptoms	19.63	17.58	10	14076	2451	63472485
Ovarian disorder	19.53	17.58	7	14079	723	63474213
Intercepted product administration error	19.52	17.58	6	14080	384	63474552
Urinary tract infection	19.50	17.58	18	14068	264666	63210270
Diarrhoea	18.99	17.58	88	13998	715278	62759658
Haematocolpos	18.90	17.58	4	14082	55	63474881
Libido decreased	18.85	17.58	10	14076	2662	63472274
Injection site discharge	18.30	17.58	7	14079	867	63474069
Blood oestrogen abnormal	18.08	17.58	3	14083	9	63474927
Placenta accreta	18.06	17.58	5	14081	221	63474715
Oestrogen receptor assay positive	17.92	17.58	6	14080	506	63474430
Abdominal pain lower	17.68	17.58	25	14061	25653	63449283
Device issue	17.65	17.58	24	14062	23757	63451179

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
Intercepted product preparation error	19156.83	13.92	3629	56648	449	34896205
Syringe issue	16475.73	13.92	3378	56899	2286	34894368
Device leakage	12708.38	13.92	2801	57476	3774	34892880
Wrong technique in product usage process	5891.54	13.92	2239	58038	33747	34862907
Prostatic specific antigen increased	2739.25	13.92	1008	59269	13672	34882982
Hot flush	2567.27	13.92	1017	59260	17049	34879605
Product physical consistency issue	2197.63	13.92	437	59840	177	34896477
Blood testosterone abnormal	989.87	13.92	213	60064	225	34896429
Death	928.92	13.92	2080	58197	395969	34500685
Intercepted medication error	822.52	13.92	188	60089	320	34896334
Blood testosterone increased	805.45	13.92	222	60055	1051	34895603
Prostate cancer metastatic	775.43	13.92	313	59964	5490	34891164
Intercepted product administration error	582.64	13.92	126	60151	139	34896515
Metastases to bone	575.79	13.92	319	59958	11651	34885003
Prostatic specific antigen abnormal	504.47	13.92	136	60141	582	34896072
Needle issue	497.39	13.92	233	60044	5932	34890722
Product leakage	374.37	13.92	102	60175	458	34896196
Osteonecrosis of jaw	338.40	13.92	266	60011	17623	34879031
Hormone-refractory prostate cancer	311.51	13.92	94	60183	646	34896008
Prostate cancer	305.44	13.92	359	59918	39290	34857364
Product administration error	304.77	13.92	241	60036	16103	34880551
Product preparation error	299.22	13.92	122	60155	2195	34894459
Terminal state	263.76	13.92	131	60146	3803	34892851
Injection site pain	253.21	13.92	324	59953	38681	34857973
Malignant neoplasm progression	245.20	13.92	497	59780	87549	34809105
Toxicity to various agents	224.40	13.92	38	60239	200324	34696330
Injection site mass	192.81	13.92	128	60149	6498	34890156
Prostate cancer recurrent	168.25	13.92	64	60213	949	34895705
Incorrect route of product administration	158.98	13.92	160	60117	14685	34881969
Marasmus	156.85	13.92	53	60224	545	34896109
Device connection issue	155.30	13.92	48	60229	361	34896293
Intercepted product storage error	149.76	13.92	41	60236	188	34896466
Fatigue	144.29	13.92	1111	59166	369542	34527112
Circumstance or information capable of leading to medication error	142.72	13.92	67	60210	1712	34894942
Injection site induration	131.39	13.92	74	60203	2786	34893868
Palliative care	125.05	13.92	47	60230	673	34895981
Completed suicide	120.58	13.92	14	60263	98154	34798500
Injection site haemorrhage	117.11	13.92	112	60165	9656	34886998
Metastases to lymph nodes	115.49	13.92	82	60195	4646	34892008
Acute kidney injury	112.35	13.92	223	60054	304765	34591889
Drug interaction	101.79	13.92	145	60132	225801	34670853
Pyrexia	101.26	13.92	270	60007	332743	34563911
Diarrhoea	97.37	13.92	346	59931	389566	34507088
Hypotension	92.35	13.92	150	60127	221499	34675155
Injection site granuloma	92.16	13.92	18	60259	5	34896649
Underdose	91.75	13.92	116	60161	13664	34882990
Injection site abscess	87.22	13.92	38	60239	811	34895843
Overdose	86.22	13.92	25	60252	91034	34805620
Cough	82.88	13.92	82	60195	150058	34746596
Hydronephrosis	81.77	13.92	95	60182	10251	34886403
Expired product administered	79.42	13.92	57	60220	3284	34893370
Bone pain	73.87	13.92	130	60147	20556	34876098
Drug hypersensitivity	72.84	13.92	24	60253	80505	34816149
Vomiting	72.72	13.92	204	60073	247417	34649237
Intentional dose omission	72.59	13.92	55	60222	3445	34893209
Product packaging quantity issue	71.49	13.92	34	60243	895	34895759
Neutropenia	71.13	13.92	100	60177	156678	34739976
Fall	70.27	13.92	593	59684	202292	34694362
Extra dose administered	70.19	13.92	57	60220	3952	34892702
Injection site necrosis	70.15	13.92	27	60250	414	34896240
Drug administered in wrong device	68.31	13.92	16	60261	32	34896622
Dyspnoea	67.58	13.92	378	59899	376404	34520250
Pelvic mass	66.47	13.92	22	60255	211	34896443
Victim of child abuse	65.50	13.92	32	60245	895	34895759
Injection site nodule	62.66	13.92	38	60239	1645	34895009
Cystitis radiation	59.47	13.92	17	60260	94	34896560
Metastases to lung	58.18	13.92	76	60201	9244	34887410
Product reconstitution quality issue	57.74	13.92	17	60260	106	34896548
Nausea	57.70	13.92	347	59930	339561	34557093
Blood creatinine increased	56.97	13.92	48	60229	94928	34801726
Injection site ulcer	56.26	13.92	20	60257	242	34896412
Rash	55.85	13.92	197	60080	222555	34674099
Condition aggravated	55.14	13.92	160	60117	192036	34704618
Gynaecomastia	54.43	13.92	77	60200	10103	34886551
Male sexual dysfunction	54.15	13.92	20	60257	272	34896382
Pneumonia	54.06	13.92	385	59892	362242	34534412
Foetal exposure during pregnancy	53.47	13.92	3	60274	38098	34858556
Off label use	53.46	13.92	465	59812	419059	34477595
Intercepted product prescribing error	53.01	13.92	16	60261	110	34896544
Radiation proctitis	52.64	13.92	16	60261	113	34896541
Drug abuse	52.51	13.92	56	60221	99040	34797614
Metastasis	52.50	13.92	49	60228	4095	34892559
Abdominal pain	52.38	13.92	129	60148	163489	34733165
Somnolence	52.26	13.92	69	60208	111047	34785607
Suicide attempt	52.18	13.92	4	60273	39112	34857542
Interstitial lung disease	52.15	13.92	237	60040	65045	34831609
Epidural lipomatosis	50.40	13.92	28	60249	1026	34895628
Nocturia	49.89	13.92	74	60203	10136	34886518
White blood cell count decreased	48.31	13.92	56	60221	95389	34801265
Urinary tract toxicity	47.24	13.92	10	60267	9	34896645
Agitation	47.04	13.92	20	60257	57379	34839275
Psoriasis	46.48	13.92	6	60271	38806	34857848
Infection	46.38	13.92	53	60224	90862	34805792
Intercepted product dispensing error	46.08	13.92	13	60264	68	34896586
Cardiac arrest	45.94	13.92	59	60218	96100	34800554
Occupational exposure to product	45.88	13.92	19	60258	356	34896298
Asthma	45.68	13.92	9	60268	42647	34854007
Sepsis	45.36	13.92	142	60135	166419	34730235
Incorrect dose administered	45.03	13.92	163	60114	40352	34856302
Tachycardia	44.80	13.92	48	60229	84724	34811930
Febrile neutropenia	44.49	13.92	107	60170	136742	34759912
Infusion related reaction	44.27	13.92	18	60259	53039	34843615
Pollakiuria	44.25	13.92	102	60175	19572	34877082
Angioedema	44.23	13.92	6	60271	37368	34859286
Intercepted product selection error	44.12	13.92	10	60267	16	34896638
Bone lesion	43.37	13.92	38	60239	2925	34893729
Blood urea abnormal	42.89	13.92	23	60254	785	34895869
Reproductive toxicity	42.06	13.92	9	60268	9	34896645
Pruritus	41.57	13.92	117	60160	141864	34754790
Product colour issue	41.31	13.92	20	60257	548	34896106
Renal impairment	41.14	13.92	62	60215	94451	34802203
Rheumatoid arthritis	41.09	13.92	8	60269	38230	34858424
Platelet count decreased	41.00	13.92	91	60186	119626	34777028
Coma	40.62	13.92	14	60263	45664	34850990
Cancer pain	40.58	13.92	35	60242	2637	34894017
Asthenia	40.43	13.92	620	59657	244631	34652023
Seizure	39.91	13.92	75	60202	104782	34791872
Sinusitis	39.85	13.92	11	60266	41391	34855263
Metabolic acidosis	39.51	13.92	13	60264	43667	34852987
Injection site erythema	38.63	13.92	85	60192	15814	34880840
Stress urinary incontinence	38.62	13.92	12	60265	92	34896562
Product storage error	38.44	13.92	58	60219	8064	34888590
Colon cancer stage III	38.27	13.92	14	60263	185	34896469
Pancreatitis	38.06	13.92	10	60267	38881	34857773
Metastatic salivary gland cancer	37.55	13.92	7	60270	0	34896654
Product preparation issue	37.45	13.92	17	60260	401	34896253
Prostatic specific antigen decreased	37.28	13.92	13	60264	148	34896506
Renal failure	37.18	13.92	109	60168	130448	34766206
C-reactive protein increased	36.74	13.92	24	60253	54074	34842580
International normalised ratio increased	36.43	13.92	18	60259	47309	34849345
Mucosal inflammation	35.81	13.92	11	60266	38611	34858043
Haematuria	35.76	13.92	176	60101	49890	34846764
Juvenile idiopathic arthritis	35.40	13.92	28	60249	1869	34894785
Hip fracture	35.12	13.92	69	60208	11856	34884798
Gastrointestinal haemorrhage	34.80	13.92	62	60215	88415	34808239
Urticaria	34.45	13.92	34	60243	62343	34834311
Septic shock	34.38	13.92	44	60233	71790	34824864
Blood electrolytes abnormal	33.85	13.92	21	60256	947	34895707
Malignant transformation	33.72	13.92	20	60257	831	34895823
Lipid metabolism disorder	33.56	13.92	15	60262	341	34896313
Thrombocytopenia	33.49	13.92	147	60130	156100	34740554
Bone cancer	33.49	13.92	25	60252	1531	34895123
Abscess sterile	32.93	13.92	8	60269	20	34896634
Tremor	32.37	13.92	58	60219	82529	34814125
Injection site inflammation	32.32	13.92	20	60257	898	34895756
Anti-androgen withdrawal syndrome	32.23	13.92	7	60270	8	34896646
Diabetes mellitus	32.22	13.92	163	60114	46710	34849944
Injection site abscess sterile	32.19	13.92	6	60271	0	34896654
Cardiogenic shock	32.15	13.92	4	60273	26614	34870040
Chest discomfort	32.15	13.92	28	60249	54502	34842152
Injection site swelling	31.91	13.92	65	60212	11462	34885192
Chest pain	31.79	13.92	112	60165	126650	34770004
Foreign body reaction	31.75	13.92	9	60268	48	34896606
Metastases to spine	31.67	13.92	30	60247	2554	34894100
Radical prostatectomy	31.60	13.92	9	60268	49	34896605
Bradycardia	31.36	13.92	51	60226	75367	34821287
Spinal compression fracture	31.13	13.92	49	60228	7067	34889587
Back pain	31.11	13.92	334	59943	121455	34775199
Pituitary haemorrhage	30.94	13.92	12	60265	188	34896466
Hypersensitivity	30.66	13.92	36	60241	60999	34835655
Blood creatine phosphokinase increased	30.32	13.92	20	60257	44837	34851817
Blood pressure increased	30.13	13.92	67	60210	88035	34808619
Product dosage form issue	30.10	13.92	8	60269	32	34896622
BRCA1 gene mutation	29.90	13.92	8	60269	33	34896621
Hyperkalaemia	29.72	13.92	46	60231	69343	34827311
Pancytopenia	29.65	13.92	76	60201	95081	34801573
Product prescribing error	29.62	13.92	97	60180	22830	34873824
Urinary retention	29.15	13.92	132	60145	36156	34860498
Dysuria	29.12	13.92	108	60169	27044	34869610
Haemoptysis	29.00	13.92	12	60265	34994	34861660
Oxygen saturation decreased	27.84	13.92	31	60246	53787	34842867
Agranulocytosis	27.77	13.92	4	60273	23817	34872837
Hypoglycaemia	27.69	13.92	32	60245	54608	34842046
Drug level increased	27.49	13.92	3	60274	22093	34874561
Headache	27.42	13.92	218	60059	200417	34696237
Multiple organ dysfunction syndrome	27.20	13.92	57	60220	76509	34820145
Respiratory failure	27.16	13.92	96	60181	108476	34788178
Nasopharyngitis	26.65	13.92	50	60227	69918	34826736
Pituitary apoplexy	26.63	13.92	8	60269	54	34896600
Bone cancer metastatic	26.57	13.92	11	60266	206	34896448
Femur fracture	26.38	13.92	49	60228	8075	34888579
Induration	26.36	13.92	18	60259	957	34895697
Dementia	26.33	13.92	67	60210	13681	34882973
Injection site discomfort	26.32	13.92	22	60255	1588	34895066
Anxiety	26.17	13.92	86	60191	99342	34797312
Neutrophil count decreased	25.82	13.92	30	60247	51074	34845580
Fracture	25.69	13.92	44	60233	6805	34889849
Leukopenia	25.67	13.92	43	60234	62813	34833841
Hepatic enzyme increased	25.65	13.92	18	60259	39062	34857592
Injection site infection	25.53	13.92	18	60259	1008	34895646
Liver function test abnormal	25.18	13.92	11	60266	31063	34865591
Child abuse	25.06	13.92	13	60264	414	34896240
Urinary tract obstruction	24.93	13.92	31	60246	3589	34893065
Second primary malignancy	24.90	13.92	47	60230	7839	34888815
BRCA2 gene mutation	24.59	13.92	7	60270	38	34896616
Metastases to liver	24.54	13.92	65	60212	13598	34883056
Product dispensing error	24.45	13.92	41	60236	6233	34890421
Macroenzyme creatine kinase	24.42	13.92	6	60271	16	34896638
White blood cell count increased	24.41	13.92	21	60256	41130	34855524
Toxic epidermal necrolysis	24.40	13.92	4	60273	21642	34875012
Respiratory distress	23.97	13.92	16	60261	35649	34861005
Testicular atrophy	23.68	13.92	14	60263	578	34896076
Eosinophilia	23.37	13.92	8	60269	26214	34870440
Wrong device used	23.20	13.92	6	60271	21	34896633
Bladder neck obstruction	23.15	13.92	9	60268	142	34896512
Mental status changes	23.12	13.92	19	60258	38064	34858590
Aggression	22.97	13.92	20	60257	38944	34857710
Bone density decreased	22.89	13.92	22	60255	1907	34894747
Product quality issue	22.85	13.92	73	60204	16962	34879692
Ascites	22.83	13.92	28	60249	46543	34850111
Breast tenderness	22.68	13.92	15	60262	756	34895898
Product use in unapproved indication	22.54	13.92	115	60162	117384	34779270
Erythema	22.54	13.92	78	60199	88702	34807952
Abdominal pain upper	22.34	13.92	57	60220	71433	34825221
Neuroendocrine carcinoma	22.23	13.92	12	60265	415	34896239
Polyneuropathy in malignant disease	22.07	13.92	10	60267	235	34896419
Metastases to soft tissue	22.00	13.92	12	60265	424	34896230
Plasma cell myeloma	21.98	13.92	24	60253	42013	34854641
Radiotherapy	21.94	13.92	12	60265	426	34896228
Haematochezia	21.75	13.92	29	60248	46505	34850149
Pelvic pain	21.68	13.92	24	60253	2456	34894198
Product temperature excursion issue	21.54	13.92	7	60270	63	34896591
Lower respiratory tract infection	21.53	13.92	14	60263	31623	34865031
Metastases to penis	21.46	13.92	4	60273	0	34896654
Administration site induration	21.46	13.92	4	60273	0	34896654
Inappropriate schedule of product administration	21.43	13.92	182	60095	62114	34834540
Premature baby	21.32	13.92	4	60273	19629	34877025
Hypoxia	21.31	13.92	39	60238	55056	34841598
Pancreatitis acute	21.21	13.92	11	60266	28130	34868524
Product physical issue	21.20	13.92	24	60253	2517	34894137
Loss of libido	21.12	13.92	24	60253	2528	34894126
Bronchitis	20.81	13.92	25	60252	41938	34854716
Urogenital haemorrhage	20.73	13.92	14	60263	731	34895923
Lactic acidosis	20.31	13.92	18	60259	34754	34861900
Ankle fracture	20.30	13.92	30	60247	4095	34892559
Wheezing	20.18	13.92	25	60252	41377	34855277
Joint swelling	20.10	13.92	46	60231	59844	34836810
Small cell carcinoma	19.98	13.92	8	60269	137	34896517
Stress	19.88	13.92	14	60263	30333	34866321
Encephalopathy	19.78	13.92	19	60258	35300	34861354
Therapy non-responder	19.75	13.92	23	60254	39123	34857531
Coagulopathy	19.53	13.92	5	60272	19784	34876870
Injection site discharge	19.50	13.92	9	60268	221	34896433
Respiratory depression	19.45	13.92	67	60210	16178	34880476
Ectopic ACTH syndrome	19.45	13.92	5	60272	17	34896637
Drug reaction with eosinophilia and systemic symptoms	19.39	13.92	17	60260	32995	34863659
Drug-induced liver injury	19.29	13.92	13	60264	28819	34867835
Psychotic disorder	19.27	13.92	9	60268	24443	34872211
Neurotoxicity	18.86	13.92	4	60273	18006	34878648
Skin exfoliation	18.85	13.92	12	60265	27420	34869234
Oropharyngeal pain	18.84	13.92	20	60257	35465	34861189
Transitional cell carcinoma	18.82	13.92	21	60256	2168	34894486
Mobility decreased	18.79	13.92	102	60175	30026	34866628
Muscle atrophy	18.45	13.92	40	60237	7364	34889290
Disease progression	18.43	13.92	275	60002	107802	34788852
Injection site extravasation	18.38	13.92	24	60253	2918	34893736
Lymphocyte count decreased	18.34	13.92	8	60269	22614	34874040
Respiratory arrest	18.29	13.92	13	60264	28030	34868624
Meningioma	18.23	13.92	17	60260	1419	34895235
Staphylococcal infection	17.92	13.92	18	60259	32742	34863912
Rib fracture	17.78	13.92	60	60217	14340	34882314
Osteoporosis	17.64	13.92	55	60222	12613	34884041
Pathological fracture	17.52	13.92	29	60248	4362	34892292
Eye haematoma	17.48	13.92	6	60271	65	34896589
Metastases to breast	17.42	13.92	4	60273	7	34896647
Product administered by wrong person	17.42	13.92	4	60273	7	34896647
Shock	17.42	13.92	10	60267	24169	34872485
Anaphylactic reaction	17.38	13.92	18	60259	32283	34864371
Cardio-respiratory arrest	17.32	13.92	44	60233	55229	34841425
Radiation injury	17.32	13.92	11	60266	517	34896137
Productive cough	17.23	13.92	24	60253	37789	34858865
Muscular weakness	16.81	13.92	196	60081	72701	34823953
Haemorrhage	16.80	13.92	40	60237	51330	34845324
Blood bilirubin increased	16.77	13.92	25	60252	38271	34858383
Colitis ulcerative	16.64	13.92	4	60273	16516	34880138
Erectile dysfunction	16.52	13.92	75	60202	20562	34876092
Lymphopenia	16.36	13.92	4	60273	16331	34880323
Blood testosterone decreased	16.35	13.92	28	60249	4329	34892325
Traumatic fracture	16.32	13.92	9	60268	325	34896329
Labelled drug-drug interaction medication error	16.31	13.92	3	60274	14936	34881718
Product size issue	16.26	13.92	12	60265	722	34895932
Urethral intrinsic sphincter deficiency	16.19	13.92	4	60273	11	34896643
Tubulointerstitial nephritis	16.17	13.92	8	60269	21016	34875638
Blood testosterone normal	16.09	13.92	3	60274	0	34896654
Anaplastic meningioma	16.09	13.92	3	60274	0	34896654
Metastases to spinal cord	15.93	13.92	4	60273	12	34896642
Neuroendocrine carcinoma of prostate	15.93	13.92	4	60273	12	34896642
Therapeutic product effect decreased	15.88	13.92	22	60255	34721	34861933
Injection site reaction	15.82	13.92	54	60223	12979	34883675
Fungal infection	15.77	13.92	4	60273	15931	34880723
Abnormal behaviour	15.73	13.92	12	60265	24957	34871697
Vipoma	15.69	13.92	4	60273	13	34896641
Stomatitis	15.64	13.92	31	60246	42483	34854171
Pulmonary oedema	15.55	13.92	37	60240	47492	34849162
Diabetic ketoacidosis	15.23	13.92	6	60271	18026	34878628
Hyperglycaemia	15.21	13.92	28	60249	39452	34857202
Product administered at inappropriate site	15.16	13.92	19	60258	2217	34894437
Neuropathy peripheral	15.12	13.92	83	60194	83180	34813474
Depressed level of consciousness	15.12	13.92	32	60245	42809	34853845
Therapeutic response decreased	15.03	13.92	17	60260	29296	34867358
Hydroureter	15.02	13.92	9	60268	381	34896273
Allodynia	14.94	13.92	12	60265	819	34895835
Eye colour change	14.86	13.92	8	60269	275	34896379
Candida infection	14.79	13.92	6	60271	17709	34878945
Brain oedema	14.62	13.92	3	60274	13818	34882836
Full blood count abnormal	14.52	13.92	7	60270	18661	34877993
Acute respiratory distress syndrome	14.51	13.92	14	60263	25955	34870699
Bone marrow tumour cell infiltration	14.50	13.92	4	60273	19	34896635
Humerus fracture	14.50	13.92	20	60257	2563	34894091
Cellulitis	14.48	13.92	45	60232	52906	34843748
Hypervolaemia	14.42	13.92	8	60269	19701	34876953
Urine flow decreased	14.41	13.92	14	60263	1230	34895424
Product availability issue	14.36	13.92	17	60260	1870	34894784
Enzyme induction	14.33	13.92	5	60272	57	34896597
Body temperature increased	14.31	13.92	6	60271	17362	34879292
Deep vein thrombosis	14.19	13.92	61	60216	65187	34831467
Pericardial effusion	14.13	13.92	13	60264	24649	34872005
Urethral stenosis	14.08	13.92	12	60265	890	34895764
Cardiac ventricular scarring	14.02	13.92	3	60274	3	34896651
Follicular cystitis	14.02	13.92	3	60274	3	34896651
Extradural neoplasm	14.02	13.92	3	60274	3	34896651
Myoclonus	14.00	13.92	4	60273	14721	34881933
Neutrophil count increased	14.00	13.92	6	60271	17140	34879514
Metastases to bladder	13.95	13.92	5	60272	62	34896592
Blood pressure decreased	13.93	13.92	44	60233	51471	34845183

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
Intercepted product preparation error	16225.99	13.03	2694	52482	866	79688346
Syringe issue	13403.57	13.03	2494	52682	3804	79685408
Device leakage	9993.47	13.03	2138	53038	8718	79680494
Wrong technique in product usage process	4038.61	13.03	1616	53560	72259	79616953
Prostatic specific antigen increased	2743.48	13.03	749	54427	9637	79679575
Product physical consistency issue	1733.52	13.03	329	54847	576	79688636
Hot flush	1724.50	13.03	814	54362	54063	79635149
Blood testosterone abnormal	672.87	13.03	121	55055	127	79689085
Intercepted medication error	630.71	13.03	143	55033	786	79688426
Blood testosterone increased	623.60	13.03	145	55031	907	79688305
Death	506.99	13.03	1170	54006	565344	79123868
Prostate cancer metastatic	475.68	13.03	156	55020	3851	79685361
Intercepted product administration error	446.10	13.03	94	55082	342	79688870
Metastases to bone	414.13	13.03	240	54936	24187	79665025
Prostatic specific antigen abnormal	401.33	13.03	87	55089	374	79688838
Prostate cancer	372.17	13.03	251	54925	33017	79656195
Needle issue	326.35	13.03	166	55010	12902	79676310
Osteonecrosis of jaw	309.05	13.03	249	54927	42977	79646235
Malignant neoplasm progression	270.92	13.03	398	54778	135592	79553620
Product leakage	237.55	13.03	66	55110	904	79688308
Hormone-refractory prostate cancer	228.71	13.03	55	55121	405	79688807
Prostate cancer recurrent	211.12	13.03	58	55118	760	79688452
Toxicity to various agents	176.81	13.03	38	55138	421502	79267710
Product administration error	171.53	13.03	156	55020	31690	79657522
Injection site abscess	171.34	13.03	58	55118	1582	79687630
Injection site pain	166.73	13.03	312	54864	129526	79559686
Pelvic pain	166.66	13.03	108	55068	13273	79675939
Ovarian hyperstimulation syndrome	150.05	13.03	65	55111	3506	79685706
Product preparation error	142.91	13.03	73	55103	5720	79683492
Injection site mass	120.86	13.03	105	55071	20079	79669133
Occupational exposure to product	119.60	13.03	36	55140	664	79688548
Abscess sterile	117.53	13.03	23	55153	51	79689161
Completed suicide	116.45	13.03	16	55160	245751	79443461
Intercepted product storage error	113.20	13.03	28	55148	235	79688977
Rheumatoid arthritis	107.72	13.03	10	55166	208460	79480752
Drug hypersensitivity	106.41	13.03	37	55139	298879	79390333
Infusion related reaction	97.98	13.03	20	55156	230217	79458995
Device connection issue	97.56	13.03	34	55142	1014	79688198
Hydronephrosis	96.92	13.03	87	55089	17367	79671845
Vaginal haemorrhage	93.07	13.03	94	55082	21723	79667489
Victim of child abuse	92.90	13.03	32	55144	921	79688291
Injection site haemorrhage	90.60	13.03	104	55072	27766	79661446
Joint swelling	89.38	13.03	44	55132	288602	79400610
Injection site granuloma	88.57	13.03	18	55158	52	79689160
Terminal state	88.07	13.03	50	55126	4839	79684373
Sinusitis	87.41	13.03	15	55161	195486	79493726
Incorrect route of product administration	87.08	13.03	114	55062	34815	79654397
Injection site induration	84.13	13.03	63	55113	9756	79679456
Cough	81.70	13.03	80	55096	366709	79322503
Circumstance or information capable of leading to medication error	78.27	13.03	43	55133	3905	79685307
Male sexual dysfunction	76.41	13.03	20	55156	215	79688997
Gynaecomastia	74.23	13.03	53	55123	7628	79681584
Nasopharyngitis	72.31	13.03	43	55133	253838	79435374
Product packaging quantity issue	71.59	13.03	29	55147	1320	79687892
Epidural lipomatosis	70.72	13.03	28	55148	1200	79688012
Marasmus	68.29	13.03	26	55150	1002	79688210
Haematuria	67.52	13.03	148	55028	68688	79620524
Drug intolerance	66.81	13.03	51	55125	264068	79425144
Interstitial lung disease	65.66	13.03	199	54977	112401	79576811
Infection	64.63	13.03	44	55132	241668	79447544
Arthropathy	64.60	13.03	21	55155	177090	79512122
Overdose	63.48	13.03	24	55152	184182	79505030
Hepatic enzyme increased	62.58	13.03	24	55152	182586	79506626
Injection site abscess sterile	62.48	13.03	11	55165	9	79689203
Maternal exposure during pregnancy	62.08	13.03	10	55166	136528	79552684
Metastases to lymph nodes	62.07	13.03	54	55122	10343	79678869
Rash	61.82	13.03	200	54976	578158	79111054
Diarrhoea	61.47	13.03	358	54818	880131	78809081
Fatigue	61.40	13.03	942	54234	928785	78760427
Drug administered in wrong device	61.12	13.03	13	55163	50	79689162
Cystitis radiation	60.23	13.03	16	55160	183	79689029
Lower respiratory tract infection	59.80	13.03	9	55167	129211	79560001
Hypersensitivity	59.76	13.03	56	55120	262183	79427029
Extra dose administered	59.09	13.03	48	55128	8367	79680845
Pelvic mass	57.21	13.03	24	55152	1195	79688017
Intentional dose omission	57.13	13.03	48	55128	8769	79680443
Systemic lupus erythematosus	57.08	13.03	8	55168	121141	79568071
Pemphigus	56.54	13.03	3	55173	99579	79589633
Wound	56.35	13.03	7	55169	116172	79573040
Diabetes mellitus	55.89	13.03	149	55027	78241	79610971
Radiation proctitis	54.86	13.03	14	55162	135	79689077
Condition aggravated	54.43	13.03	172	55004	500952	79188260
Therapeutic product effect decreased	53.76	13.03	23	55153	163840	79525372
Underdose	53.30	13.03	88	55088	33063	79656149
Hysterectomy	53.19	13.03	40	55136	6232	79682980
Metastases to liver	52.18	13.03	80	55096	28234	79660978
Heavy menstrual bleeding	51.93	13.03	56	55120	13955	79675257
Hypotension	50.76	13.03	147	55029	440170	79249042
Product reconstitution quality issue	50.17	13.03	14	55162	195	79689017
Dyspnoea	49.88	13.03	368	54808	856657	78832555
Metastases to lung	49.54	13.03	62	55114	18101	79671111
Bone pain	49.26	13.03	115	55061	55627	79633585
Oestradiol increased	49.13	13.03	12	55164	95	79689117
Pericarditis	48.83	13.03	7	55169	104229	79584983
Blood urea abnormal	48.80	13.03	22	55154	1305	79687907
Swelling	48.52	13.03	47	55129	216664	79472548
Abdominal discomfort	47.80	13.03	62	55114	250665	79438547
Epiphysiolysis	47.57	13.03	12	55164	110	79689102
Asthma	47.55	13.03	17	55159	135078	79554134
Lipid metabolism disorder	47.18	13.03	15	55161	334	79688878
Expired product administered	46.96	13.03	39	55137	7012	79682200
Metastasis	45.71	13.03	38	55138	6842	79682370
Somnolence	45.65	13.03	59	55117	238922	79450290
Vomiting	45.17	13.03	273	54903	665555	79023657
Nocturia	44.37	13.03	51	55125	13630	79675582
Malignant transformation	44.18	13.03	20	55156	1198	79688014
Metastatic salivary gland cancer	43.94	13.03	7	55169	0	79689212
Mood swings	43.63	13.03	61	55115	19819	79669393
Product prescribing error	43.54	13.03	96	55080	44717	79644495
Drug interaction	43.32	13.03	145	55031	415038	79274174
Disease progression	43.25	13.03	246	54930	184116	79505096
Nausea	42.40	13.03	441	54735	956755	78732457
Bone lesion	42.06	13.03	34	55142	5885	79683327
Pituitary apoplexy	40.95	13.03	12	55164	201	79689011
Urinary retention	40.73	13.03	108	55068	56522	79632690
Pituitary haemorrhage	40.53	13.03	13	55163	298	79688914
Coma	40.27	13.03	10	55166	100639	79588573
Incorrect dose administered	39.67	13.03	130	55046	76500	79612712
Intercepted product dispensing error	39.63	13.03	11	55165	150	79689062
Blood testosterone decreased	39.32	13.03	23	55153	2354	79686858
Pyrexia	38.68	13.03	293	54883	678416	79010796
Injection site nodule	38.65	13.03	27	55149	3753	79685459
Intercepted product selection error	38.61	13.03	7	55169	8	79689204
Anti-androgen withdrawal syndrome	38.61	13.03	7	55169	8	79689204
Dysuria	37.49	13.03	98	55078	50853	79638359
Pollakiuria	37.46	13.03	81	55095	37236	79651976
Juvenile idiopathic arthritis	37.37	13.03	29	55147	4734	79684478
Urinary tract obstruction	37.36	13.03	29	55147	4736	79684476
Asthenia	37.35	13.03	528	54648	511161	79178051
Prostatic specific antigen decreased	37.10	13.03	9	55167	69	79689143
Blood luteinising hormone increased	36.69	13.03	11	55165	200	79689012
Injection site ulcer	36.59	13.03	15	55161	704	79688508
Child abuse	36.43	13.03	13	55163	416	79688796
Pruritus	36.43	13.03	145	55031	394503	79294709
Bronchitis	35.96	13.03	23	55153	130621	79558591
Blood electrolytes abnormal	35.43	13.03	20	55156	1914	79687298
Product dosage form issue	35.43	13.03	8	55168	43	79689169
Erectile dysfunction	35.21	13.03	47	55129	14617	79674595
Psoriatic arthropathy	34.81	13.03	6	55170	77993	79611219
Product colour issue	33.67	13.03	15	55161	865	79688347
Respiratory depression	32.47	13.03	64	55112	27566	79661646
Palliative care	32.20	13.03	15	55161	960	79688252
Product quality issue	32.17	13.03	72	55104	33868	79655344
Intermenstrual bleeding	32.01	13.03	29	55147	5855	79683357
Injury associated with device	31.16	13.03	23	55153	3483	79685729
Metastases to spine	31.07	13.03	25	55151	4299	79684913
Endometrial stromal sarcoma	30.45	13.03	6	55170	14	79689198
Loss of personal independence in daily activities	29.71	13.03	17	55159	102563	79586649
Discomfort	29.57	13.03	26	55150	125591	79563621
Focal nodular hyperplasia	29.53	13.03	13	55163	729	79688483
Bladder neck obstruction	29.39	13.03	8	55168	101	79689111
Polyneuropathy in malignant disease	29.36	13.03	10	55166	278	79688934
Urogenital haemorrhage	29.11	13.03	14	55162	963	79688249
Tachycardia	28.95	13.03	49	55127	177719	79511493
Cancer pain	28.83	13.03	26	55150	5219	79683993
Psoriasis	28.70	13.03	13	55163	89574	79599638
Neuroendocrine carcinoma	28.63	13.03	12	55164	596	79688616
Stomatitis	28.25	13.03	36	55140	146721	79542491
Menstrual disorder	28.14	13.03	23	55153	4044	79685168
Metabolic acidosis	28.01	13.03	11	55165	82518	79606694
Uterine leiomyoma	27.91	13.03	28	55148	6415	79682797
Injection site infection	27.90	13.03	18	55158	2194	79687018
Blister	27.80	13.03	25	55151	119451	79569761
Drug dependence	27.55	13.03	76	55100	40693	79648519
Spinal compression fracture	27.23	13.03	45	55131	16913	79672299
Loss of libido	27.04	13.03	19	55157	2666	79686546
Meningioma	27.03	13.03	23	55153	4275	79684937
Neuroendocrine breast tumour	26.93	13.03	6	55170	30	79689182
Gastrointestinal disorder	26.76	13.03	27	55149	122178	79567034
Leiomyosarcoma recurrent	26.61	13.03	5	55171	8	79689204
Foreign body reaction	26.02	13.03	8	55168	159	79689053
Intentional product use issue	25.63	13.03	41	55135	152071	79537141
Transitional cell carcinoma	25.63	13.03	18	55158	2523	79686689
Radical prostatectomy	24.99	13.03	5	55171	13	79689199
Dysmenorrhoea	24.90	13.03	19	55157	3026	79686186
Intercepted product prescribing error	24.79	13.03	9	55167	303	79688909
Wrong device used	24.74	13.03	6	55170	46	79689166
Acute kidney injury	24.70	13.03	235	54941	519169	79170043
Macroenzyme creatine kinase	24.46	13.03	5	55171	15	79689197
Angioedema	24.41	13.03	11	55165	76024	79613188
Second primary malignancy	24.29	13.03	39	55137	14311	79674901
Therapeutic product effect incomplete	24.04	13.03	38	55138	141607	79547605
Adnexa uteri pain	23.78	13.03	9	55167	341	79688871
Product administered by wrong person	23.77	13.03	5	55171	18	79689194
Ill-defined disorder	23.67	13.03	8	55168	65867	79623345
Injection site necrosis	23.66	13.03	14	55162	1464	79687748
Suicide attempt	23.65	13.03	14	55162	82918	79606294
Abdominal pain upper	23.42	13.03	78	55098	223741	79465471
Dental fistula	23.39	13.03	10	55166	522	79688690
Irritable bowel syndrome	23.36	13.03	7	55169	62234	79626978
Testicular atrophy	23.27	13.03	9	55167	362	79688850
Tremor	23.25	13.03	52	55124	170031	79519181
Adnexal torsion	22.99	13.03	9	55167	374	79688838
Musculoskeletal stiffness	22.72	13.03	55	55121	174953	79514259
Blood cholesterol increased	22.68	13.03	15	55161	83705	79605507
Arthritis	22.30	13.03	28	55148	114852	79574360
Back pain	22.19	13.03	314	54862	303866	79385346
Alopecia	21.96	13.03	84	55092	231271	79457941
Radiation injury	21.89	13.03	11	55165	832	79688380
Pancreatitis	21.89	13.03	10	55166	68565	79620647
International normalised ratio increased	21.86	13.03	16	55160	84705	79604507
Hypoglycaemia	21.62	13.03	23	55153	101571	79587641
Oxygen saturation decreased	21.54	13.03	35	55141	129012	79560200
Lactic acidosis	21.33	13.03	11	55165	70348	79618864
Pneumonia	21.33	13.03	325	54851	659921	79029291
Lymphadenopathy	21.27	13.03	83	55093	53164	79636048
Administration site induration	21.27	13.03	5	55171	33	79689179
Libido decreased	21.01	13.03	22	55154	5299	79683913
Toxic epidermal necrolysis	20.86	13.03	3	55173	44578	79644634
Oropharyngeal pain	20.86	13.03	27	55149	109326	79579886
Product storage error	20.80	13.03	39	55137	16187	79673025
Erythema	20.60	13.03	82	55094	223208	79466004
Injection site inflammation	20.47	13.03	19	55157	3957	79685255
Prosopagnosia	20.43	13.03	5	55171	40	79689172
Treatment failure	20.28	13.03	56	55120	170430	79518782
Wheezing	20.08	13.03	31	55145	116633	79572579
Blood creatinine increased	19.92	13.03	49	55127	155008	79534204
Chest discomfort	19.87	13.03	41	55135	138003	79551209
Neuroendocrine carcinoma of prostate	19.83	13.03	4	55172	11	79689201
Pathological fracture	19.73	13.03	30	55146	10507	79678705
Product dispensing error	19.71	13.03	34	55142	13229	79675983
Metastases to spinal cord	19.34	13.03	5	55171	51	79689161
Vipoma	19.33	13.03	4	55172	13	79689199
Injection site discharge	19.24	13.03	10	55166	812	79688400
Uterine haemorrhage	19.21	13.03	16	55160	2887	79686325
Prostatic mass	19.10	13.03	4	55172	14	79689198
Urticaria	19.06	13.03	65	55111	185136	79504076
Metastases to soft tissue	18.98	13.03	9	55167	600	79688612
Agranulocytosis	18.95	13.03	4	55172	45026	79644186
Urine flow decreased	18.95	13.03	11	55165	1110	79688102
Urethral intrinsic sphincter deficiency	18.89	13.03	4	55172	15	79689197
Anaplastic meningioma	18.83	13.03	3	55173	0	79689212
Metastases to penis	18.83	13.03	3	55173	0	79689212
Blood testosterone normal	18.83	13.03	3	55173	0	79689212
Blood pressure increased	18.63	13.03	79	55097	211281	79477931
Exposure during pregnancy	18.25	13.03	26	55150	101106	79588106
Liver function test abnormal	18.22	13.03	11	55165	64464	79624748
Drug abuse	18.21	13.03	55	55121	162636	79526576
Prostatic obstruction	18.16	13.03	5	55171	66	79689146
Hydroureter	18.12	13.03	9	55167	664	79688548
Septic shock	18.07	13.03	36	55140	122765	79566447
Injection site discomfort	18.02	13.03	20	55156	5146	79684066
Knee arthroplasty	17.88	13.03	4	55172	43244	79645968
Breast enlargement	17.78	13.03	12	55164	1577	79687635
Eye haematoma	17.78	13.03	6	55170	162	79689050
Agitation	17.64	13.03	26	55150	99689	79589523
Allodynia	17.39	13.03	12	55164	1636	79687576
Renal impairment	17.19	13.03	54	55122	157729	79531483
Embolic stroke	17.15	13.03	24	55152	7802	79681410
Cardiogenic shock	17.08	13.03	4	55172	41910	79647302
Use of accessory respiratory muscles	17.07	13.03	8	55168	519	79688693
Night sweats	16.75	13.03	76	55100	52019	79637193
Follicular cystitis	16.75	13.03	3	55173	3	79689209
Cardiac ventricular scarring	16.75	13.03	3	55173	3	79689209
Prescribed overdose	16.71	13.03	3	55173	37880	79651332
Product size issue	16.67	13.03	9	55167	789	79688423
Urethral stenosis	16.47	13.03	10	55166	1096	79688116
Blood follicle stimulating hormone abnormal	16.29	13.03	3	55173	4	79689208
Vulvovaginal dryness	16.28	13.03	13	55163	2211	79687001
Cardiac arrest	16.00	13.03	63	55113	172033	79517179
Product physical issue	15.99	13.03	17	55159	4168	79685044
Rib fracture	15.91	13.03	49	55127	27898	79661314
Inguinal hernia	15.89	13.03	21	55155	6467	79682745
Ovarian cyst	15.70	13.03	30	55146	12625	79676587
Blood pressure fluctuation	15.68	13.03	14	55162	67131	79622081
Hypervolaemia	15.66	13.03	5	55171	42685	79646527
Blood pressure systolic increased	15.60	13.03	14	55162	66972	79622240
Induration	15.56	13.03	12	55164	1940	79687272
Cytokine release syndrome	15.56	13.03	3	55173	35995	79653217
Hydrocalyx	15.54	13.03	3	55173	6	79689206
Fibromyalgia	15.52	13.03	13	55163	64327	79624885
Eosinophilia	15.46	13.03	6	55170	45339	79643873
Therapy non-responder	15.43	13.03	25	55151	92280	79596932
Bone cancer metastatic	15.41	13.03	6	55170	246	79688966
Impaired healing	15.36	13.03	23	55153	87632	79601580
Bone cancer	15.24	13.03	12	55164	2000	79687212
Bradycardia	15.04	13.03	46	55130	135511	79553701
Injury	14.92	13.03	19	55157	77477	79611735
Acute coronary syndrome	14.88	13.03	40	55136	21093	79668119
Hip fracture	14.86	13.03	51	55125	30710	79658502
Stress	14.83	13.03	20	55156	79592	79609620
Haematocolpos	14.81	13.03	4	55172	49	79689163
Drug withdrawal syndrome	14.79	13.03	3	55173	34715	79654497
Hyponatraemia	14.75	13.03	68	55108	177780	79511432
Fall	14.59	13.03	441	54735	487188	79202024
Inappropriate schedule of product administration	14.59	13.03	149	55027	133479	79555733
Bone marrow tumour cell infiltration	14.59	13.03	4	55172	52	79689160
Eye pain	14.52	13.03	4	55172	37574	79651638
Oophorectomy	14.41	13.03	6	55170	293	79688919
Product preparation issue	14.25	13.03	10	55166	1400	79687812
Transient acantholytic dermatosis	14.10	13.03	5	55171	157	79689055
Retroperitoneal lymphadenopathy	13.99	13.03	9	55167	1091	79688121
Stress urinary incontinence	13.96	13.03	11	55165	1835	79687377
Drug level increased	13.93	13.03	5	55171	39646	79649566
Joint range of motion decreased	13.92	13.03	3	55173	33279	79655933
Injection site swelling	13.86	13.03	67	55109	47065	79642147
Culture positive	13.80	13.03	9	55167	1117	79688095
Breast cancer male	13.79	13.03	6	55170	327	79688885
Carcinoid tumour	13.68	13.03	7	55169	550	79688662
Oncologic complication	13.65	13.03	6	55170	335	79688877
Pneumonia aspiration	13.54	13.03	86	55090	66881	79622331
Bursitis	13.51	13.03	4	55172	35840	79653372
Contusion	13.49	13.03	55	55121	148721	79540491
Hospice care	13.46	13.03	25	55151	10299	79678913
Uterine pain	13.40	13.03	5	55171	182	79689030
Extradural neoplasm	13.30	13.03	3	55173	16	79689196
Myomectomy	13.30	13.03	3	55173	16	79689196
Rhinorrhoea	13.29	13.03	20	55156	76054	79613158
Pulmonary embolism	13.23	13.03	179	54997	171475	79517737
Laparoscopy	13.18	13.03	4	55172	76	79689136
Paraneoplastic dermatomyositis	13.18	13.03	4	55172	76	79689136
Product use issue	13.15	13.03	88	55088	209734	79479478
Calcium deficiency	13.06	13.03	8	55168	891	79688321
Medication error	13.04	13.03	17	55159	68625	79620587

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L02AE02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONES AND RELATED AGENTS Gonadotropin releasing hormone analogues
ATC	L02AE51	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONES AND RELATED AGENTS Gonadotropin releasing hormone analogues
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:50751	anti-estrogenic drug
CHEBI has role	CHEBI:63533	gonadotropin releasing hormone agonists
FDA MoA	N0000175654	Gonadotropin Releasing Hormone Receptor Agonists
FDA EPC	N0000175655	Gonadotropin Releasing Hormone Receptor Agonist
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D018931	Antineoplastic Agents, Hormonal
MeSH PA	D005300	Fertility Agents, Female
MeSH PA	D012102	Reproductive Control Agents

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

Disease	Relation	SNOMED_ID	DOID
Endometriosis	indication	129103003
Precocious puberty	indication	400179000
Anemia due to Bleeding Uterine Leiomyoma	indication
Advanced Prostatic Carcinoma	indication
Malignant tumor of ovary	off-label use	363443007	DOID:2394
Urinary tract obstruction	contraindication	7163005	DOID:5200
Hypercholesterolemia	contraindication	13644009
Myocardial infarction	contraindication	22298006	DOID:5844
Hypertensive disorder	contraindication	38341003	DOID:10763
Diabetes mellitus	contraindication	73211009	DOID:9351
Hyperglycemia	contraindication	80394007	DOID:4195
Cerebrovascular accident	contraindication	230690007
Orchiectomy	contraindication	236334001
Pregnancy, function	contraindication	289908002
Osteopenia	contraindication	312894000
Cardiovascular event risk	contraindication	395112001
Breastfeeding (mother)	contraindication	413712001
Obesity	contraindication	414916001	DOID:9970
Smokes tobacco daily	contraindication	449868002
Vertebral Metastases	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	9.65	acidic
pKa2	11.9	acidic
pKa3	12.73	acidic
pKa4	13.09	acidic
pKa5	13.39	acidic
pKa6	13.69	acidic
pKa7	10.75	Basic
pKa8	6.69	Basic

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
22.5MG	ELIGARD KIT	TOLMAR	N021379	July 24, 2002	RX	POWDER	SUBCUTANEOUS	8470359	Oct. 15, 2023	METHOD OF TREATING CANCER
30MG	ELIGARD KIT	TOLMAR	N021488	Feb. 13, 2003	RX	POWDER	SUBCUTANEOUS	8470359	Oct. 15, 2023	METHOD OF TREATING CANCER
45MG	ELIGARD KIT	TOLMAR	N021731	Dec. 14, 2004	RX	POWDER	SUBCUTANEOUS	8470359	Oct. 15, 2023	METHOD OF TREATING CANCER
45MG	FENSOLVI KIT	TOLMAR	N213150	May 1, 2020	RX	POWDER	SUBCUTANEOUS	8470359	Oct. 15, 2023	METHOD OF TREATING PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY
45MG	LUPRON DEPOT-PED KIT	ABBVIE ENDOCRINE INC	N020263	April 14, 2023	RX	POWDER	INTRAMUSCULAR	9617303	March 22, 2028	TREATMENT OF PEDIATRIC PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY
45MG	LUPRON DEPOT	ABBVIE ENDOCRINE INC	N020517	June 17, 2011	RX	INJECTABLE	INJECTION	8921326	Feb. 5, 2031	PALLIATIVE TREATMENT OF PROSTATE CANCER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
45MG	FENSOLVI KIT	TOLMAR	N213150	May 1, 2020	RX	POWDER	SUBCUTANEOUS	May 1, 2023	TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY (CPP)
45MG	LUPRON DEPOT-PED KIT	ABBVIE ENDOCRINE INC	N020263	April 14, 2023	RX	POWDER	INTRAMUSCULAR	April 14, 2026	NEW STRENGTH

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Gonadotropin-releasing hormone receptor	GPCR	P30968	GNRHR_HUMAN	AGONIST	IC50	9.52		WOMBAT-PK	CHEMBL
Gonadotropin-releasing hormone receptor	GPCR		GNRHR_RAT		IC50	9.30		CHEMBL

External reference:

ID	Source
4019800	VUID
N0000147889	NUI
D00989	KEGG_DRUG
74381-53-6	SECONDARY_CAS_RN
4018977	VANDF
4019800	VANDF
C0085272	UMLSCUI
CHEBI:6427	CHEBI
CHEMBL1201199	ChEMBL_ID
CHEMBL1200775	ChEMBL_ID
DB00007	DRUGBANK_ID
C493311	MESH_SUPPLEMENTAL_RECORD_UI
1175	IUPHAR_LIGAND_ID
657181	PUBCHEM_CID
203217	RXNORM
11929	MMSL
43716	MMSL
4966	MMSL
8763	MMSL
d01353	MMSL
002675	NDDF
004751	NDDF
008314	NDDF
008315	NDDF
350364005	SNOMEDCT_US
397198002	SNOMEDCT_US
70562007	SNOMEDCT_US
D016729	MESH_DESCRIPTOR_UI
CHEMBL4802223	ChEMBL_ID
5025	INN_ID
37JNS02E7V	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Leuprolide Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0185-7400	INJECTION, SOLUTION	1 mg	SUBCUTANEOUS	ANDA	25 sections
Fensolvi	HUMAN PRESCRIPTION DRUG LABEL	1	62935-163	INJECTION, SUSPENSION, EXTENDED RELEASE	45 mg	SUBCUTANEOUS	NDA	25 sections
Eligard	HUMAN PRESCRIPTION DRUG LABEL	1	62935-227	INJECTION, SUSPENSION, EXTENDED RELEASE	22.50 mg	SUBCUTANEOUS	NDA	26 sections
Eligard	HUMAN PRESCRIPTION DRUG LABEL	1	62935-306	INJECTION, SUSPENSION, EXTENDED RELEASE	30 mg	SUBCUTANEOUS	NDA	26 sections
Eligard	HUMAN PRESCRIPTION DRUG LABEL	1	62935-461	INJECTION, SUSPENSION, EXTENDED RELEASE	45 mg	SUBCUTANEOUS	NDA	26 sections
Eligard	HUMAN PRESCRIPTION DRUG LABEL	1	62935-756	INJECTION, SUSPENSION, EXTENDED RELEASE	7.50 mg	SUBCUTANEOUS	NDA	26 sections