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)	250 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 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	757.83	17.04	127	13132	384	56278424
Hot flush	712.45	17.04	302	12957	46424	56232384
Syringe issue	635.28	17.04	141	13118	2315	56276493
Endometriosis	588.23	17.04	150	13109	4552	56274256
Occupational exposure to product	413.83	17.04	96	13163	1934	56276874
Pelvic pain	391.90	17.04	135	13124	11732	56267076
Device leakage	368.59	17.04	111	13148	6264	56272544
Ovarian hyperstimulation syndrome	338.74	17.04	92	13167	3572	56275236
Vaginal haemorrhage	272.39	17.04	129	13130	25544	56253264
Off label use	213.10	17.04	428	12831	555752	55723056
Heavy menstrual bleeding	204.87	17.04	92	13167	16117	56262691
Uterine leiomyoma	182.26	17.04	70	13189	8272	56270536
Abscess sterile	173.21	17.04	26	13233	26	56278782
Injury associated with device	166.93	17.04	52	13207	3281	56275527
Injection site abscess	157.36	17.04	39	13220	1047	56277761
Hysterectomy	142.14	17.04	59	13200	8532	56270276
Mood swings	118.42	17.04	64	13195	16683	56262125
Wrong technique in product usage process	108.79	17.04	98	13161	58070	56220738
Intermenstrual bleeding	102.06	17.04	44	13215	6983	56271825
Oestradiol increased	82.81	17.04	15	13244	79	56278729
Menstrual disorder	76.96	17.04	32	13227	4643	56274165
Injection site abscess sterile	76.11	17.04	11	13248	6	56278802
Ovarian cyst	76.04	17.04	46	13213	14820	56263988
Dysmenorrhoea	71.67	17.04	28	13231	3458	56275350
Uterine haemorrhage	71.25	17.04	28	13231	3512	56275296
Rheumatoid arthritis	70.93	17.04	5	13254	382599	55896209
Epiphysiolysis	68.49	17.04	11	13248	23	56278785
Haemorrhage	66.52	17.04	74	13185	56323	56222485
Injection site pain	65.87	17.04	107	13152	117011	56161797
Surgery	57.30	17.04	53	13206	32433	56246375
Depression	52.76	17.04	125	13134	179992	56098816
Anger	51.80	17.04	33	13226	11639	56267169
Amenorrhoea	51.69	17.04	30	13229	8956	56269852
Night sweats	50.18	17.04	55	13204	41158	56237650
Abdominal pain	49.08	17.04	153	13106	258652	56020156
Endometrial stromal sarcoma	48.00	17.04	8	13251	23	56278785
Breast cancer metastatic	47.86	17.04	35	13224	15434	56263374
Focal nodular hyperplasia	47.75	17.04	13	13246	508	56278300
Suicidal ideation	47.27	17.04	63	13196	57679	56221129
Vulvovaginal dryness	44.41	17.04	18	13241	2447	56276361
Fall	43.51	17.04	15	13244	357495	55921313
Joint swelling	41.16	17.04	9	13250	289791	55989017
Product dispensing error	40.63	17.04	26	13233	9238	56269570
Migraine	40.46	17.04	73	13186	86724	56192084
Aplastic anaemia	39.01	17.04	25	13234	8903	56269905
Blood luteinising hormone increased	37.96	17.04	8	13251	101	56278707
Infusion related reaction	37.90	17.04	3	13256	208928	56069880
Adnexa uteri pain	36.85	17.04	10	13249	386	56278422
Hepatic cytolysis	36.77	17.04	26	13233	10880	56267928
Pneumonia	36.14	17.04	26	13233	407072	55871736
Ovarian cyst ruptured	34.89	17.04	12	13247	1033	56277775
Injection site mass	34.76	17.04	30	13229	16763	56262045
Neoplasm progression	34.32	17.04	40	13219	31976	56246832
Neuroendocrine breast tumour	33.38	17.04	6	13253	30	56278778
Blood follicle stimulating hormone abnormal	33.31	17.04	5	13254	5	56278803
Adnexal torsion	32.45	17.04	9	13250	377	56278431
Maternal exposure before pregnancy	32.05	17.04	20	13239	6803	56272005
Metastases to liver	31.98	17.04	32	13227	21554	56257254
Toxicity to various agents	31.82	17.04	7	13252	224557	56054251
Headache	31.46	17.04	232	13027	558812	55719996
Product leakage	31.26	17.04	10	13249	687	56278121
Menstruation irregular	30.68	17.04	19	13240	6377	56272431
Depressed mood	30.25	17.04	40	13219	36319	56242489
Insomnia	29.70	17.04	106	13153	191754	56087054
Dyspareunia	29.08	17.04	13	13246	2247	56276561
Product physical consistency issue	28.94	17.04	9	13250	564	56278244
Abdominal discomfort	28.34	17.04	15	13244	277259	56001549
Dental fistula	28.24	17.04	9	13250	611	56278197
Breast enlargement	27.46	17.04	11	13248	1450	56277358
Precocious puberty	27.30	17.04	7	13252	216	56278592
Leiomyosarcoma recurrent	26.64	17.04	4	13255	4	56278804
Blood luteinising hormone decreased	26.51	17.04	5	13254	34	56278774
Prosopagnosia	26.38	17.04	5	13254	35	56278773
Adhesion	25.83	17.04	10	13249	1205	56277603
Uterine adhesions	25.27	17.04	5	13254	45	56278763
Vision blurred	24.71	17.04	58	13201	82885	56195923
Drug intolerance	24.69	17.04	16	13243	264802	56014006
Genital haemorrhage	24.63	17.04	17	13242	6845	56271963
Calcium deficiency	23.88	17.04	9	13250	1008	56277800
Injection site induration	23.33	17.04	18	13241	8597	56270211
Myomectomy	22.98	17.04	4	13255	16	56278792
Sinusitis	22.80	17.04	9	13250	197572	56081236
Wound	22.56	17.04	3	13256	138801	56140007
Laparoscopy	22.45	17.04	5	13254	83	56278725
Hypotension	22.19	17.04	16	13243	250492	56028316
Blood oestrogen increased	22.18	17.04	5	13254	88	56278720
Bone pain	21.85	17.04	41	13218	50144	56228664
Injection site erythema	21.82	17.04	53	13206	77395	56201413
Urinary tract infection	21.78	17.04	15	13244	240498	56038310
Infection	21.70	17.04	10	13249	200196	56078612
Idiopathic intracranial hypertension	21.57	17.04	11	13248	2543	56276265
Oophorectomy	21.38	17.04	7	13252	518	56278290
Nasopharyngitis	21.07	17.04	13	13246	220946	56057862
Intercepted product administration error	20.67	17.04	5	13254	121	56278687
Expired product administered	20.39	17.04	14	13245	5588	56273220
Amnesia	20.36	17.04	38	13221	46284	56232524
Wrong product administered	20.23	17.04	14	13245	5658	56273150
Drug hypersensitivity	20.23	17.04	21	13238	275184	56003624
Confusional state	20.19	17.04	12	13247	208143	56070665
Blood follicle stimulating hormone increased	19.54	17.04	5	13254	153	56278655
Ovarian disorder	19.48	17.04	7	13252	686	56278122
Autoimmune dermatitis	19.41	17.04	4	13255	45	56278763
Completed suicide	19.29	17.04	4	13255	133829	56144979
Libido decreased	19.27	17.04	10	13249	2398	56276410
Product administration error	18.93	17.04	24	13235	20905	56257903
Arthropathy	18.79	17.04	12	13247	200263	56078545
Haematocolpos	18.66	17.04	4	13255	55	56278753
Mood altered	18.33	17.04	19	13240	13336	56265472
Malignant neoplasm progression	18.26	17.04	48	13211	73539	56205269
Diarrhoea	18.23	17.04	83	13176	638424	55640384
Oestrogen receptor assay positive	18.02	17.04	6	13253	468	56278340
Inner ear disorder	17.98	17.04	6	13253	471	56278337
Blood oestrogen abnormal	17.91	17.04	3	13256	9	56278799
Placenta accreta	17.90	17.04	5	13254	215	56278593
Abdominal distension	17.62	17.04	49	13210	77577	56201231
Pelvic venous thrombosis	17.57	17.04	8	13251	1443	56277365
Uterine pain	17.33	17.04	5	13254	242	56278566
Blood oestrogen decreased	17.29	17.04	5	13254	244	56278564
Menopausal symptoms	17.27	17.04	9	13250	2176	56276632
Ovarian adhesion	17.24	17.04	3	13256	12	56278796
Device issue	17.22	17.04	23	13236	21083	56257725
Metastases to bone	17.06	17.04	22	13237	19486	56259322

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	15063.90	14.24	2838	50476	326	31643704
Syringe issue	13638.51	14.24	2802	50512	2054	31641976
Device leakage	9684.30	14.24	2156	51158	3257	31640773
Wrong technique in product usage process	4867.46	14.24	1896	51418	31447	31612583
Prostatic specific antigen increased	2365.62	14.24	880	52434	12658	31631372
Hot flush	2282.33	14.24	900	52414	15296	31628734
Product physical consistency issue	1761.04	14.24	349	52965	145	31643885
Prostate cancer	1360.06	14.24	824	52490	36777	31607253
Prostate cancer metastatic	884.40	14.24	345	52969	5659	31638371
Intercepted medication error	832.82	14.24	188	53126	305	31643725
Death	797.26	14.24	1817	51497	358752	31285278
Blood testosterone abnormal	739.62	14.24	161	53153	197	31643833
Blood testosterone increased	672.28	14.24	184	53130	870	31643160
Intercepted product administration error	522.59	14.24	104	53210	46	31643984
Needle issue	476.51	14.24	214	53100	5059	31638971
Metastases to bone	446.89	14.24	259	53055	10589	31633441
Product leakage	396.57	14.24	102	53212	359	31643671
Prostatic specific antigen abnormal	390.39	14.24	102	53212	388	31643642
Osteonecrosis of jaw	335.48	14.24	257	53057	16814	31627216
Hormone-refractory prostate cancer	289.23	14.24	108	53206	1559	31642471
Product preparation error	282.88	14.24	109	53205	1723	31642307
Product administration error	259.65	14.24	211	53103	15036	31628994
Malignant neoplasm progression	235.21	14.24	452	52862	78546	31565484
Injection site pain	232.62	14.24	289	53025	34345	31609685
Terminal state	220.99	14.24	113	53201	3585	31640445
Toxicity to various agents	206.37	14.24	30	53284	181457	31462573
Injection site mass	167.66	14.24	111	53203	5753	31638277
Marasmus	161.13	14.24	52	53262	470	31643560
Prostate cancer recurrent	158.93	14.24	60	53254	894	31643136
Fatigue	151.09	14.24	1021	52293	334185	31309845
Incorrect route of product administration	148.92	14.24	137	53177	11536	31632494
Intercepted product storage error	135.13	14.24	37	53277	175	31643855
Circumstance or information capable of leading to medication error	125.78	14.24	59	53255	1544	31642486
Injection site induration	119.15	14.24	67	53247	2580	31641450
Completed suicide	106.54	14.24	14	53300	91500	31552530
Acute kidney injury	104.44	14.24	195	53119	279519	31364511
Injection site haemorrhage	97.61	14.24	97	53217	8988	31635042
Metastases to lymph nodes	96.63	14.24	70	53244	4198	31639832
Palliative care	93.10	14.24	34	53280	459	31643571
Injection site granuloma	92.61	14.24	18	53296	5	31644025
Drug interaction	86.34	14.24	136	53178	208407	31435623
Underdose	84.24	14.24	105	53209	12502	31631528
Diarrhoea	83.87	14.24	308	53006	352101	31291929
Pyrexia	81.51	14.24	252	53062	303588	31340442
Hydronephrosis	79.23	14.24	88	53226	9273	31634757
Injection site abscess	79.01	14.24	34	53280	722	31643308
Hypotension	76.84	14.24	142	53172	204476	31439554
Overdose	74.04	14.24	25	53289	84639	31559391
Bulbospinal muscular atrophy congenital	72.61	14.24	15	53299	11	31644019
Extra dose administered	70.75	14.24	53	53261	3347	31640683
Injection site necrosis	70.47	14.24	26	53288	362	31643668
Device connection issue	69.59	14.24	25	53289	321	31643709
Expired product administered	68.83	14.24	50	53264	3011	31641019
Pelvic mass	68.55	14.24	22	53292	195	31643835
Victim of child abuse	66.76	14.24	32	53282	880	31643150
Cough	65.72	14.24	78	53236	134736	31509294
Drug hypersensitivity	62.50	14.24	22	53292	72577	31571453
Injection site nodule	61.91	14.24	36	53278	1478	31642552
Bone pain	61.51	14.24	114	53200	19237	31624793
Neutropenia	61.45	14.24	88	53226	140276	31503754
Occupational exposure to product	60.83	14.24	23	53291	344	31643686
Product reconstitution quality issue	60.04	14.24	17	53297	93	31643937
Fall	57.89	14.24	521	52793	185568	31458462
Psoriasis	57.20	14.24	6	53308	46713	31597317
Injection site ulcer	57.05	14.24	20	53294	238	31643792
Vomiting	54.96	14.24	193	53121	223780	31420250
Intentional dose omission	54.60	14.24	42	53272	2760	31641270
Drug administered in wrong device	54.56	14.24	13	53301	30	31644000
Rheumatoid arthritis	54.00	14.24	8	53306	47801	31596229
Intercepted product prescribing error	53.91	14.24	16	53298	106	31643924
Foetal exposure during pregnancy	53.42	14.24	4	53310	40872	31603158
Cystitis radiation	52.83	14.24	15	53299	83	31643947
Interstitial lung disease	52.07	14.24	223	53091	61180	31582850
Blood creatinine increased	52.02	14.24	44	53270	89034	31554996
Pneumonia	49.88	14.24	345	52969	334967	31309063
Dyspnoea	49.83	14.24	356	52958	343123	31300907
Asthma	48.43	14.24	7	53307	42604	31601426
Suicide attempt	47.68	14.24	4	53310	37244	31606786
Urinary tract toxicity	47.49	14.24	10	53304	9	31644021
Drug abuse	46.92	14.24	47	53267	87711	31556319
Product colour issue	46.46	14.24	20	53294	425	31643605
Infection	45.99	14.24	42	53272	81889	31562141
Radiation proctitis	45.19	14.24	13	53301	76	31643954
Metastasis	45.17	14.24	42	53272	3582	31640448
Blood urea abnormal	44.41	14.24	23	53291	749	31643281
Intercepted product selection error	44.37	14.24	10	53304	16	31644014
White blood cell count decreased	44.26	14.24	49	53265	87349	31556681
Gynaecomastia	44.04	14.24	65	53249	9089	31634941
Metastases to lung	43.72	14.24	62	53252	8360	31635670
Rash	43.36	14.24	183	53131	201303	31442727
Off label use	43.34	14.24	375	52939	346899	31297131
Injection site erythema	43.23	14.24	83	53231	14379	31629651
Condition aggravated	43.15	14.24	137	53177	163872	31480158
Metastatic salivary gland cancer	43.12	14.24	8	53306	0	31644030
Cardiac arrest	42.87	14.24	52	53262	89010	31555020
Agitation	42.37	14.24	19	53295	54150	31589880
Reproductive toxicity	42.28	14.24	9	53305	9	31644021
Product preparation issue	42.13	14.24	17	53297	305	31643725
Renal impairment	42.01	14.24	50	53264	86299	31557731
Angioedema	41.98	14.24	4	53310	33614	31610416
Abdominal pain	41.94	14.24	117	53197	145835	31498195
Febrile neutropenia	41.84	14.24	89	53225	121760	31522270
Seizure	41.26	14.24	65	53249	99703	31544327
Plasma cell myeloma	40.93	14.24	22	53292	56509	31587521
Somnolence	39.99	14.24	66	53248	99379	31544651
Bone lesion	39.84	14.24	35	53279	2772	31641258
Nocturia	39.37	14.24	62	53252	9173	31634857
Nausea	39.08	14.24	331	52983	307616	31336414
Stress urinary incontinence	38.80	14.24	12	53302	93	31643937
Male sexual dysfunction	38.30	14.24	15	53299	248	31643782
Colon cancer stage III	38.00	14.24	14	53300	194	31643836
Sepsis	37.83	14.24	130	53184	151799	31492231
Cancer pain	36.79	14.24	32	53282	2501	31641529
Tachycardia	36.14	14.24	45	53269	76162	31567868
Prostatic specific antigen decreased	36.10	14.24	12	53302	120	31643910
Incorrect dose administered	36.00	14.24	137	53177	35615	31608415
Infusion related reaction	35.83	14.24	18	53296	48037	31595993
Metabolic acidosis	35.79	14.24	11	53303	39566	31604464
Blood electrolytes abnormal	35.45	14.24	21	53293	893	31643137
Injection site swelling	35.33	14.24	62	53252	10025	31634005
Back pain	35.31	14.24	309	53005	109104	31534926
International normalised ratio increased	35.15	14.24	16	53298	45207	31598823
Injection site inflammation	34.77	14.24	19	53295	691	31643339
Coma	34.50	14.24	13	53301	41137	31602893
Malignant transformation	34.49	14.24	20	53294	817	31643213
Pancreatitis	34.09	14.24	9	53305	35762	31608268
C-reactive protein increased	33.69	14.24	20	53294	48630	31595400
Sinusitis	33.55	14.24	10	53304	36686	31607344
Abscess sterile	33.13	14.24	8	53306	20	31644010
Epidural lipomatosis	33.01	14.24	19	53295	765	31643265
Platelet count decreased	32.85	14.24	87	53227	110348	31533682
Urticaria	32.85	14.24	29	53285	57488	31586542
Renal failure	32.43	14.24	103	53211	123227	31520803
Anti-androgen withdrawal syndrome	32.41	14.24	7	53307	8	31644022
Injection site abscess sterile	32.34	14.24	6	53308	0	31644030
Gastrointestinal haemorrhage	32.06	14.24	56	53258	82493	31561537
Pituitary haemorrhage	31.77	14.24	12	53302	179	31643851
Hip fracture	31.55	14.24	62	53252	10924	31633106
Metastases to spine	31.51	14.24	28	53286	2252	31641778
Septic shock	31.44	14.24	39	53275	66119	31577911
Product prescribing error	31.28	14.24	88	53226	19554	31624476
Product dosage form issue	30.91	14.24	8	53306	29	31644001
Asthenia	30.48	14.24	539	52775	224216	31419814
Mucosal inflammation	30.37	14.24	10	53304	34417	31609613
Pruritus	29.87	14.24	109	53205	125058	31518972
Product storage error	29.52	14.24	47	53267	7019	31637011
Blood creatine phosphokinase increased	29.42	14.24	17	53297	41957	31602073
Pollakiuria	29.29	14.24	81	53233	17821	31626209
Bone cancer	29.19	14.24	22	53292	1402	31642628
Haematuria	28.91	14.24	154	53160	46160	31597870
Thrombocytopenia	28.64	14.24	133	53181	142614	31501416
Metastases to soft tissue	28.50	14.24	12	53302	241	31643789
Bone cancer metastatic	28.25	14.24	11	53303	179	31643851
Dementia	27.65	14.24	63	53251	12297	31631733
Foreign body reaction	27.63	14.24	8	53306	48	31643982
Urinary retention	27.43	14.24	121	53193	33604	31610426
Haemoptysis	27.27	14.24	10	53304	32179	31611851
Cardiogenic shock	27.11	14.24	3	53311	22405	31621625
Product packaging quantity issue	27.10	14.24	17	53297	802	31643228
Bradycardia	26.95	14.24	47	53267	69280	31574750
Blood pressure increased	26.62	14.24	59	53255	79574	31564456
Pancytopenia	26.56	14.24	68	53246	87248	31556782
Fracture	26.55	14.24	42	53272	6238	31637792
Chest pain	26.51	14.24	104	53210	116853	31527177
Product quality issue	26.46	14.24	73	53241	16038	31627992
Hypersensitivity	26.33	14.24	33	53281	55710	31588320
Tremor	26.06	14.24	56	53258	76364	31567666
Drug reaction with eosinophilia and systemic symptoms	25.99	14.24	9	53305	30009	31614021
Chest discomfort	25.73	14.24	27	53287	49342	31594688
Intercepted product dispensing error	25.65	14.24	8	53306	64	31643966
Oxygen saturation decreased	25.45	14.24	27	53287	49088	31594942
Induration	25.36	14.24	17	53297	899	31643131
Urinary tract obstruction	24.95	14.24	30	53284	3441	31640589
Injection site discomfort	24.93	14.24	20	53294	1397	31642633
Product dispensing error	24.79	14.24	39	53275	5765	31638265
Femur fracture	24.71	14.24	45	53269	7488	31636542
Hyperkalaemia	24.67	14.24	44	53270	64307	31579723
Intentional product use issue	24.60	14.24	28	53286	49319	31594711
Macroenzyme creatine kinase	24.57	14.24	6	53308	16	31644014
Respiratory distress	24.37	14.24	13	53301	33540	31610490
White blood cell count increased	24.34	14.24	18	53296	38982	31605048
Spinal compression fracture	24.03	14.24	41	53273	6481	31637549
Child abuse	23.98	14.24	12	53302	363	31643667
Respiratory failure	23.77	14.24	89	53225	101360	31542670
Drug level increased	23.68	14.24	3	53311	20183	31623847
Bladder neck obstruction	23.60	14.24	9	53305	138	31643892
Leukopenia	23.58	14.24	38	53276	57790	31586240
Nasopharyngitis	23.57	14.24	44	53270	63201	31580829
Neutrophil count decreased	23.48	14.24	26	53288	46368	31597662
Radical prostatectomy	23.25	14.24	7	53307	49	31643981
Agranulocytosis	22.99	14.24	4	53310	21243	31622787
Loss of libido	22.87	14.24	24	53290	2371	31641659
Inappropriate schedule of product administration	22.77	14.24	155	53159	50668	31593362
Respiratory arrest	22.51	14.24	8	53306	26249	31617781
Testicular atrophy	22.42	14.24	13	53301	531	31643499
Liver function test abnormal	22.31	14.24	11	53303	29681	31614349
Product physical issue	22.25	14.24	23	53291	2232	31641798
Hypoglycaemia	22.20	14.24	32	53282	50914	31593116
Hepatic enzyme increased	21.86	14.24	17	53297	35891	31608139
Multiple organ dysfunction syndrome	21.61	14.24	52	53262	68151	31575879
Antiandrogen therapy	21.56	14.24	4	53310	0	31644030
Breast tenderness	21.36	14.24	14	53300	713	31643317
Anxiety	21.23	14.24	80	53234	90953	31553077
Disease progression	21.15	14.24	239	53075	90225	31553805
Aggression	21.05	14.24	19	53295	37272	31606758
Headache	20.78	14.24	203	53111	183449	31460581
Lower respiratory tract infection	20.42	14.24	11	53303	28226	31615804
Injection site infection	20.18	14.24	15	53299	936	31643094
Pancreatitis acute	19.98	14.24	9	53305	25591	31618439
Radiotherapy	19.96	14.24	11	53303	407	31643623
Rib fracture	19.60	14.24	58	53256	13258	31630772
Juvenile idiopathic arthritis	19.54	14.24	19	53295	1714	31642316
Bone density decreased	19.52	14.24	19	53295	1716	31642314
Mental status changes	19.51	14.24	19	53295	35949	31608081
Meningioma	19.42	14.24	17	53297	1340	31642690
Colitis ulcerative	18.96	14.24	4	53310	18525	31625505
Coagulopathy	18.94	14.24	4	53310	18511	31625519
Dysuria	18.88	14.24	86	53228	24208	31619822
Injection site discharge	18.87	14.24	7	53307	99	31643931
Product size issue	18.54	14.24	12	53302	598	31643432
Eosinophilia	18.42	14.24	8	53306	23245	31620785
Product administered at inappropriate site	18.41	14.24	19	53295	1841	31642189
Premature baby	18.28	14.24	4	53310	18062	31625968
Lymphocyte count decreased	18.20	14.24	6	53308	20643	31623387
Bronchitis	18.20	14.24	23	53291	38694	31605336
Neuroendocrine carcinoma of prostate	17.90	14.24	4	53310	6	31644024
Hypoxia	17.88	14.24	36	53278	50277	31593753
Eye haematoma	17.88	14.24	6	53308	62	31643968
Abdominal pain upper	17.84	14.24	52	53262	63950	31580080
Encephalopathy	17.79	14.24	17	53297	32457	31611573
Blood pressure fluctuation	17.73	14.24	8	53306	22728	31621302
Small cell carcinoma	17.54	14.24	7	53307	122	31643908
Metastases to breast	17.52	14.24	4	53310	7	31644023
Blood glucose increased	17.49	14.24	49	53265	61034	31582996
Injection site reaction	17.39	14.24	51	53263	11600	31632430
Metastases to liver	17.38	14.24	54	53260	12673	31631357
Haematochezia	17.06	14.24	26	53288	40438	31603592
Therapy non-responder	17.05	14.24	19	53295	33792	31610238
Transitional cell carcinoma	16.81	14.24	19	53295	2040	31641990
Lipid metabolism disorder	16.78	14.24	9	53305	315	31643715
Product use in unapproved indication	16.73	14.24	98	53216	99073	31544957
Muscular weakness	16.71	14.24	176	53138	65272	31578758
Traumatic fracture	16.68	14.24	9	53305	319	31643711
Ascites	16.67	14.24	27	53287	40986	31603044
Respiratory depression	16.62	14.24	58	53256	14452	31629578
Pituitary apoplexy	16.37	14.24	5	53309	37	31643993
Diabetes mellitus	16.30	14.24	125	53189	42431	31601599
Urethral intrinsic sphincter deficiency	16.29	14.24	4	53310	11	31644019
Injection site extravasation	16.26	14.24	21	53293	2589	31641441
Product availability issue	16.25	14.24	16	53298	1465	31642565
Anaplastic meningioma	16.17	14.24	3	53311	0	31644030
Blood testosterone normal	16.17	14.24	3	53311	0	31644030
Prostatic specific antigen	16.17	14.24	3	53311	0	31644030
Metastases to penis	16.17	14.24	3	53311	0	31644030
Shock	16.11	14.24	9	53305	22636	31621394
Pelvic pain	16.06	14.24	19	53295	2142	31641888
Erythema	16.06	14.24	75	53239	80330	31563700
Lactic acidosis	16.05	14.24	18	53296	31919	31612111
Metastases to spinal cord	16.03	14.24	4	53310	12	31644018
Stomatitis	16.00	14.24	26	53288	39412	31604618
Haemorrhage	15.87	14.24	35	53279	47299	31596731
Urine flow decreased	15.83	14.24	14	53300	1119	31642911
Ectopic ACTH syndrome	15.79	14.24	4	53310	13	31644017
Vipoma	15.79	14.24	4	53310	13	31644017
Psychotic disorder	15.66	14.24	9	53305	22284	31621746
Neurotoxicity	15.62	14.24	4	53310	16222	31627808
Anaphylactic reaction	15.58	14.24	16	53298	29537	31614493
Therapeutic response decreased	15.57	14.24	13	53301	26496	31617534
Eye colour change	15.46	14.24	8	53306	260	31643770
Heart rate decreased	15.25	14.24	15	53299	28251	31615779
Skin exfoliation	14.92	14.24	11	53303	23863	31620167
Hypervolaemia	14.91	14.24	6	53308	18245	31625785
Erectile dysfunction	14.88	14.24	68	53246	19167	31624863
Second primary malignancy	14.81	14.24	35	53279	6997	31637033
Diabetic ketoacidosis	14.75	14.24	5	53309	16900	31627130
Blood testosterone decreased	14.62	14.24	26	53288	4247	31639783
Staphylococcal infection	14.60	14.24	18	53296	30614	31613416
Wrong device used	14.59	14.24	4	53310	19	31644011
Bone marrow tumour cell infiltration	14.59	14.24	4	53310	19	31644011
Product use issue	14.48	14.24	48	53266	56711	31587319
Joint swelling	14.47	14.24	44	53270	53387	31590643
Enzyme induction	14.46	14.24	5	53309	57	31643973
Culture positive	14.42	14.24	11	53303	714	31643316
Tumour lysis syndrome	14.41	14.24	4	53310	15381	31628649
Urethral obstruction	14.38	14.24	5	53309	58	31643972
Wheezing	14.34	14.24	24	53290	35962	31608068
Pleural effusion	14.31	14.24	71	53243	74849	31569181

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	12103.15	13.03	2008	46867	634	70878935
Syringe issue	10652.02	13.03	2001	46874	3327	70876242
Device leakage	7119.40	13.03	1574	47301	7734	70871835
Wrong technique in product usage process	3174.07	13.03	1331	47544	67367	70812202
Prostatic specific antigen increased	2296.60	13.03	638	48237	8828	70870741
Hot flush	1495.21	13.03	714	48161	48870	70830699
Product physical consistency issue	1317.71	13.03	250	48625	439	70879130
Prostate cancer	1170.87	13.03	523	48352	30640	70848929
Intercepted medication error	639.52	13.03	143	48732	734	70878835
Prostate cancer metastatic	576.69	13.03	180	48695	3789	70875780
Blood testosterone abnormal	561.58	13.03	101	48774	107	70879462
Blood testosterone increased	519.99	13.03	120	48755	726	70878843
Death	441.33	13.03	1037	47838	509024	70370545
Intercepted product administration error	394.68	13.03	76	48799	150	70879419
Metastases to bone	323.19	13.03	198	48677	22178	70857391
Prostatic specific antigen abnormal	305.37	13.03	63	48812	202	70879367
Needle issue	303.67	13.03	149	48726	10766	70868803
Osteonecrosis of jaw	300.03	13.03	239	48636	40763	70838806
Endometriosis	256.27	13.03	93	48782	3143	70876426
Product leakage	251.99	13.03	66	48809	715	70878854
Malignant neoplasm progression	234.58	13.03	350	48525	121389	70758180
Hormone-refractory prostate cancer	221.96	13.03	63	48812	941	70878628
Prostate cancer recurrent	195.57	13.03	54	48821	725	70878844
Pelvic pain	168.70	13.03	103	48772	11457	70868112
Toxicity to various agents	166.58	13.03	31	48844	382141	70497428
Rheumatoid arthritis	161.44	13.03	10	48865	291795	70587774
Injection site abscess	154.68	13.03	52	48823	1394	70878175
Occupational exposure to product	142.97	13.03	42	48833	713	70878856
Injection site pain	137.54	13.03	271	48604	117348	70762221
Ovarian hyperstimulation syndrome	133.19	13.03	58	48817	3182	70876387
Product preparation error	129.83	13.03	63	48812	4439	70875130
Product administration error	124.22	13.03	126	48749	29397	70850172
Abscess sterile	117.62	13.03	23	48852	51	70879518
Intercepted product storage error	106.00	13.03	26	48849	211	70879358
Completed suicide	104.23	13.03	16	48859	227119	70652450
Injection site mass	101.34	13.03	91	48784	18252	70861317
Victim of child abuse	93.53	13.03	32	48843	906	70878663
Vaginal haemorrhage	93.26	13.03	91	48784	20261	70859308
Hydronephrosis	92.98	13.03	80	48795	15162	70864407
Drug hypersensitivity	91.94	13.03	33	48842	262426	70617143
Injection site granuloma	90.54	13.03	18	48857	45	70879524
Infusion related reaction	77.90	13.03	20	48855	197514	70682055
Bulbospinal muscular atrophy congenital	77.75	13.03	14	48861	15	70879554
Incorrect route of product administration	76.73	13.03	93	48782	26399	70853170
Joint swelling	74.29	13.03	41	48834	253170	70626399
Sinusitis	73.02	13.03	14	48861	169181	70710388
Injection site haemorrhage	72.94	13.03	89	48786	25438	70854131
Injection site induration	70.36	13.03	55	48820	9113	70870456
Fatigue	69.45	13.03	869	48006	823450	70056119
Marasmus	67.30	13.03	25	48850	903	70878666
Cough	66.21	13.03	76	48799	325301	70554268
Terminal state	64.18	13.03	40	48835	4612	70874957
Nasopharyngitis	63.70	13.03	37	48838	222169	70657400
Circumstance or information capable of leading to medication error	62.89	13.03	36	48839	3554	70876015
Injection site abscess sterile	62.52	13.03	11	48864	9	70879560
Cystitis radiation	61.45	13.03	15	48860	119	70879450
Extra dose administered	60.98	13.03	46	48829	7231	70872338
Infection	60.56	13.03	35	48840	210750	70668819
Male sexual dysfunction	59.74	13.03	16	48859	190	70879379
Gynaecomastia	59.11	13.03	44	48831	6779	70872790
Uterine leiomyoma	59.06	13.03	41	48834	5666	70873903
Pelvic mass	58.94	13.03	24	48851	1112	70878457
Interstitial lung disease	58.69	13.03	182	48693	104503	70775066
Heavy menstrual bleeding	56.85	13.03	56	48819	12609	70866960
Overdose	55.04	13.03	24	48851	169721	70709848
Hysterectomy	55.01	13.03	39	48836	5573	70873996
Haematuria	54.21	13.03	129	48746	63444	70816125
Lower respiratory tract infection	53.37	13.03	7	48868	111906	70767663
Diarrhoea	52.97	13.03	320	48555	783021	70096548
Drug administered in wrong device	52.46	13.03	11	48864	39	70879530
Underdose	51.59	13.03	81	48794	29302	70850267
Metastases to lymph nodes	51.36	13.03	46	48829	9192	70870377
Product reconstitution quality issue	51.26	13.03	14	48861	180	70879389
Drug intolerance	51.21	13.03	48	48827	225639	70653930
Arthropathy	50.61	13.03	20	48855	150037	70729532
Metastatic salivary gland cancer	50.25	13.03	8	48867	0	70879569
Oestradiol increased	49.87	13.03	12	48863	89	70879480
Blood urea abnormal	49.77	13.03	22	48853	1251	70878318
Hepatic enzyme increased	49.64	13.03	23	48852	156967	70722602
Maternal exposure during pregnancy	48.80	13.03	10	48865	115335	70764234
Hypersensitivity	48.57	13.03	52	48823	229760	70649809
Mood swings	47.83	13.03	61	48814	18225	70861344
Rash	47.55	13.03	186	48689	510376	70369193
Wound	47.50	13.03	6	48869	98726	70780843
Condition aggravated	46.37	13.03	146	48729	427489	70452080
Epidural lipomatosis	45.52	13.03	19	48856	938	70878631
Malignant transformation	44.98	13.03	20	48855	1153	70878416
Metastases to liver	44.96	13.03	71	48804	25807	70853762
Systemic lupus erythematosus	44.88	13.03	8	48867	101894	70777675
Metastases to lung	44.72	13.03	56	48819	16428	70863141
Radiation proctitis	44.55	13.03	11	48864	92	70879477
Asthma	44.33	13.03	14	48861	120779	70758790
Epiphysiolysis	44.13	13.03	11	48864	96	70879473
Swelling	44.07	13.03	39	48836	188500	70691069
Hypotension	43.18	13.03	139	48736	404242	70475327
Product prescribing error	42.19	13.03	87	48788	38865	70840704
Therapeutic product effect decreased	42.14	13.03	23	48852	142995	70736574
Disease progression	41.88	13.03	216	48659	156456	70723113
Intentional dose omission	41.46	13.03	36	48839	6905	70872664
Pericarditis	41.11	13.03	5	48870	84700	70794869
Pituitary haemorrhage	40.83	13.03	13	48862	292	70879277
Bone pain	39.99	13.03	100	48775	50722	70828847
Expired product administered	39.80	13.03	34	48841	6379	70873190
Device connection issue	39.71	13.03	17	48858	894	70878675
Intercepted product selection error	39.64	13.03	7	48868	6	70879563
Injection site nodule	39.13	13.03	26	48849	3344	70876225
Anti-androgen withdrawal syndrome	38.64	13.03	7	48868	8	70879561
Bone lesion	38.30	13.03	31	48844	5399	70874170
Urinary tract obstruction	37.88	13.03	28	48847	4269	70875300
Urinary retention	37.87	13.03	100	48775	52420	70827149
Blood testosterone decreased	37.35	13.03	22	48853	2291	70877278
Somnolence	37.05	13.03	57	48818	215549	70664020
Psoriasis	36.85	13.03	11	48864	98422	70781147
Blood luteinising hormone increased	36.74	13.03	11	48864	200	70879369
Blood electrolytes abnormal	36.71	13.03	20	48855	1794	70877775
Dyspnoea	36.59	13.03	347	48528	769713	70109856
Product dosage form issue	36.11	13.03	8	48867	39	70879530
Drug interaction	36.09	13.03	138	48737	381303	70498266
Intentional product use issue	35.86	13.03	19	48856	120123	70759446
Nocturia	35.59	13.03	43	48832	12161	70867408
Metastasis	35.09	13.03	31	48844	6083	70873486
Endometrial stromal sarcoma	35.07	13.03	7	48868	18	70879551
Coma	34.87	13.03	10	48865	91834	70787735
Child abuse	34.38	13.03	12	48863	361	70879208
Injection site ulcer	34.01	13.03	14	48861	667	70878902
Product quality issue	33.97	13.03	69	48806	30492	70849077
Abdominal discomfort	33.86	13.03	60	48815	214598	70664971
Product colour issue	32.98	13.03	14	48861	721	70878848
Vomiting	32.71	13.03	257	48618	592854	70286715
Diabetes mellitus	32.34	13.03	116	48759	71708	70807861
Prostatic specific antigen decreased	32.28	13.03	8	48867	68	70879501
Dysmenorrhoea	32.19	13.03	21	48854	2619	70876950
Injury associated with device	32.02	13.03	22	48853	2990	70876579
Bronchitis	31.53	13.03	21	48854	117222	70762347
Intermenstrual bleeding	30.89	13.03	27	48848	5223	70874346
Menstrual disorder	30.79	13.03	23	48852	3563	70876006
Focal nodular hyperplasia	30.51	13.03	13	48862	676	70878893
Erectile dysfunction	30.47	13.03	42	48833	13520	70866049
Metastases to spine	29.45	13.03	23	48852	3806	70875763
Bladder neck obstruction	29.42	13.03	8	48867	101	70879468
Asthenia	29.23	13.03	460	48415	457206	70422363
Lipid metabolism disorder	28.61	13.03	10	48865	302	70879267
Loss of libido	28.36	13.03	19	48856	2478	70877091
Pyrexia	28.15	13.03	275	48600	606677	70272892
Back pain	28.08	13.03	298	48577	270854	70608715
Intercepted product dispensing error	27.22	13.03	8	48867	136	70879433
Neuroendocrine breast tumour	26.96	13.03	6	48869	30	70879539
Dysuria	26.94	13.03	81	48794	45713	70833856
Nausea	26.73	13.03	420	48455	851668	70027901
Psoriatic arthropathy	26.61	13.03	6	48869	64765	70814804
Meningioma	26.37	13.03	22	48853	3996	70875573
Respiratory depression	26.35	13.03	55	48820	24776	70854793
Incorrect dose administered	26.09	13.03	103	48772	66616	70812953
Pruritus	26.05	13.03	136	48739	345424	70534145
Palliative care	26.05	13.03	12	48863	752	70878817
Acute kidney injury	25.98	13.03	206	48669	474418	70405151
Intercepted product prescribing error	25.50	13.03	9	48866	280	70879289
Pollakiuria	25.44	13.03	65	48810	33396	70846173
Tachycardia	25.28	13.03	44	48831	158502	70721067
Neuroendocrine carcinoma of prostate	25.12	13.03	4	48871	0	70879569
Pituitary apoplexy	25.07	13.03	8	48867	181	70879388
Stomatitis	25.05	13.03	31	48844	128480	70751089
Metabolic acidosis	24.91	13.03	10	48865	74336	70805233
Cancer pain	24.61	13.03	23	48852	4851	70874718
Adnexa uteri pain	24.60	13.03	9	48866	311	70879258
Macroenzyme creatine kinase	24.48	13.03	5	48870	15	70879554
Angioedema	23.94	13.03	8	48867	66602	70812967
International normalised ratio increased	23.75	13.03	13	48862	80713	70798856
Dental fistula	23.70	13.03	10	48865	507	70879062
Foreign body reaction	23.04	13.03	7	48868	134	70879435
Oxygen saturation decreased	22.78	13.03	28	48847	116401	70763168
Metastases to soft tissue	22.54	13.03	9	48866	396	70879173
Leiomyosarcoma recurrent	22.35	13.03	4	48871	4	70879565
Product dispensing error	22.33	13.03	34	48841	11974	70867595
Injection site necrosis	22.14	13.03	13	48862	1346	70878223
Transitional cell carcinoma	22.11	13.03	16	48859	2361	70877208
Discomfort	22.09	13.03	24	48851	105412	70774157
Gastrointestinal disorder	22.09	13.03	24	48851	105403	70774166
Loss of personal independence in daily activities	21.78	13.03	16	48859	84894	70794675
Pancreatitis	21.71	13.03	8	48867	62660	70816909
Suicide attempt	21.70	13.03	14	48861	79496	70800073
Blood pressure fluctuation	21.36	13.03	7	48868	59005	70820564
Prosopagnosia	21.16	13.03	5	48870	34	70879535
Adnexal torsion	21	13.03	8	48867	310	70879259
Blister	20.93	13.03	23	48852	100503	70779066
Night sweats	20.91	13.03	72	48803	43612	70835957
Therapeutic product effect incomplete	20.29	13.03	32	48843	119850	70759719
Renal impairment	20.28	13.03	43	48832	143894	70735675
Injection site infection	20.07	13.03	14	48861	1950	70877619
Testicular atrophy	20.04	13.03	8	48867	352	70879217
Metastases to spinal cord	19.92	13.03	5	48870	45	70879524
Urine flow decreased	19.62	13.03	11	48864	1043	70878526
Spinal compression fracture	19.57	13.03	37	48838	15516	70864053
Eye haematoma	19.45	13.03	6	48869	121	70879448
Radical prostatectomy	19.35	13.03	4	48871	13	70879556
Prostatic mass	19.35	13.03	4	48871	13	70879556
Breast enlargement	19.34	13.03	12	48863	1372	70878197
Drug dependence	19.18	13.03	63	48812	37258	70842311
Tremor	19.12	13.03	50	48825	155574	70723995
Drug reaction with eosinophilia and systemic symptoms	19.12	13.03	8	48867	58005	70821564
Drug abuse	19.11	13.03	46	48829	147210	70732359
Blood creatinine increased	19.09	13.03	44	48831	142957	70736612
Pneumonia	18.94	13.03	293	48582	595939	70283630
Ill-defined disorder	18.94	13.03	7	48868	54734	70824835
Libido decreased	18.90	13.03	20	48855	4896	70874673
Urethral intrinsic sphincter deficiency	18.90	13.03	4	48871	15	70879554
Anaplastic meningioma	18.84	13.03	3	48872	0	70879569
Blood testosterone normal	18.84	13.03	3	48872	0	70879569
Product packaging quantity issue	18.80	13.03	11	48864	1131	70878438
Vulvovaginal dryness	18.75	13.03	13	48862	1793	70877776
Vipoma	18.70	13.03	4	48871	16	70879553
Lactic acidosis	18.37	13.03	11	48864	65013	70814556
Uterine haemorrhage	18.25	13.03	15	48860	2669	70876900
Prostatic obstruction	18.18	13.03	5	48870	66	70879503
Hypoglycaemia	18.14	13.03	23	48852	94341	70785228
Product size issue	18.04	13.03	9	48866	673	70878896
Therapy non-responder	17.85	13.03	16	48859	76899	70802670
Hospice care	17.82	13.03	25	48850	8180	70871389
Musculoskeletal stiffness	17.75	13.03	48	48827	147712	70731857
Product preparation issue	17.63	13.03	10	48865	970	70878599
Product storage error	17.57	13.03	34	48841	14507	70865062
Pulmonary embolism	17.40	13.03	174	48701	155693	70723876
Ovarian cyst	17.35	13.03	30	48845	11742	70867827
Precocious puberty	17.34	13.03	7	48868	317	70879252
Rib fracture	16.99	13.03	47	48828	25309	70854260
Oropharyngeal pain	16.98	13.03	25	48850	96285	70783284
Injection site inflammation	16.93	13.03	16	48859	3422	70876147
Respiratory arrest	16.89	13.03	8	48867	53925	70825644
Laparoscopy	16.83	13.03	4	48871	28	70879541
Chest discomfort	16.82	13.03	38	48837	124343	70755226
Irritable bowel syndrome	16.77	13.03	7	48868	50843	70828726
Cardiac ventricular scarring	16.77	13.03	3	48872	3	70879566
Arthritis	16.72	13.03	26	48849	97954	70781615
Urticaria	16.70	13.03	57	48818	162992	70716577
Blood pressure increased	16.66	13.03	70	48805	188447	70691122
Inappropriate schedule of product administration	16.64	13.03	129	48746	107426	70772143
Induration	16.62	13.03	12	48863	1764	70877805
Lymphadenopathy	16.47	13.03	72	48803	48719	70830850
Abdominal pain upper	16.43	13.03	73	48802	193529	70686040
Bone cancer metastatic	16.41	13.03	6	48869	207	70879362
Liver function test abnormal	16.37	13.03	11	48864	61135	70818434
Blood follicle stimulating hormone abnormal	16.30	13.03	3	48872	4	70879565
Injection site discomfort	16.21	13.03	18	48857	4651	70874918
Juvenile idiopathic arthritis	16.21	13.03	20	48855	5780	70873789
Prostate cancer stage IV	16.21	13.03	13	48862	2235	70877334
Agranulocytosis	16.02	13.03	4	48871	40294	70839275
Neuroendocrine carcinoma	16.02	13.03	8	48867	600	70878969
Product physical issue	15.89	13.03	16	48859	3698	70875871
Use of accessory respiratory muscles	15.74	13.03	7	48868	404	70879165
Agitation	15.73	13.03	25	48850	93350	70786219
Hypervolaemia	15.68	13.03	4	48871	39702	70839867
Cardiogenic shock	15.66	13.03	3	48872	36304	70843265
Cardiac arrest	15.62	13.03	57	48818	159777	70719792
Septic shock	15.42	13.03	34	48841	112224	70767345
Acute coronary syndrome	15.26	13.03	39	48836	20040	70859529
Stress urinary incontinence	14.93	13.03	11	48864	1669	70877900
Pathological fracture	14.89	13.03	25	48850	9558	70870011
Haematocolpos	14.82	13.03	4	48871	49	70879520
Bone marrow tumour cell infiltration	14.82	13.03	4	48871	49	70879520
Erythema	14.76	13.03	79	48796	199484	70680085
Oophorectomy	14.75	13.03	6	48869	277	70879292
Urethral stenosis	14.60	13.03	9	48866	1018	70878551
Inguinal hernia	14.50	13.03	19	48856	5826	70873743
Respiratory distress	14.41	13.03	10	48865	54640	70824929
Oncologic complication	14.34	13.03	6	48869	298	70879271
Blood cholesterol increased	14.33	13.03	14	48861	64590	70814979
Exposure during pregnancy	14.29	13.03	24	48851	87693	70791876
Autoimmune dermatitis	14.27	13.03	4	48871	57	70879512
Polyneuropathy in malignant disease	14.18	13.03	5	48870	155	70879414
Calcium deficiency	14.18	13.03	8	48867	768	70878801
Culture positive	14.10	13.03	9	48866	1081	70878488
Radiation injury	14.05	13.03	8	48867	782	70878787
Breast cancer male	14.04	13.03	6	48869	314	70879255
Myomectomy	14.02	13.03	3	48872	12	70879557
Alopecia	13.90	13.03	80	48795	198410	70681159
Hip fracture	13.89	13.03	47	48828	28216	70851353
Bone cancer	13.89	13.03	11	48864	1857	70877712
Inner ear disorder	13.78	13.03	7	48868	544	70879025
Drug withdrawal syndrome	13.50	13.03	3	48872	32712	70846857
Clavicle fracture	13.47	13.03	15	48860	3889	70875680
Carcinoid tumour	13.37	13.03	7	48868	579	70878990
Wheezing	13.37	13.03	28	48847	94142	70785427
Hysteroscopy	13.32	13.03	3	48872	16	70879553
Extradural neoplasm	13.32	13.03	3	48872	16	70879553
Injection site swelling	13.30	13.03	62	48813	43095	70836474
Ovarian cyst ruptured	13.30	13.03	8	48867	866	70878703
Traumatic fracture	13.26	13.03	8	48867	870	70878699
Bradycardia	13.15	13.03	43	48832	124572	70754997
Neovascular age-related macular degeneration	13.07	13.03	6	48869	373	70879196

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 THERAP	N021379	July 24, 2002	RX	POWDER	SUBCUTANEOUS	8470359	Oct. 15, 2023	METHOD OF TREATING CANCER
30MG	ELIGARD KIT	TOLMAR THERAP	N021488	Feb. 13, 2003	RX	POWDER	SUBCUTANEOUS	8470359	Oct. 15, 2023	METHOD OF TREATING CANCER
45MG	ELIGARD KIT	TOLMAR THERAP	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/VIAL	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)

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