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	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
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
Hot flush	699.95	18.97	294	11719	43875	50549236
Intercepted product preparation error	605.73	18.97	101	11912	290	50592821
Syringe issue	498.55	18.97	113	11900	2031	50591080
Pelvic pain	394.51	18.97	134	11879	11079	50582032
Ovarian hyperstimulation syndrome	334.84	18.97	89	11924	3155	50589956
Occupational exposure to product	334.04	18.97	79	11934	1721	50591390
Vaginal haemorrhage	267.70	18.97	126	11887	24425	50568686
Device leakage	257.79	18.97	83	11930	5795	50587316
Heavy menstrual bleeding	207.94	18.97	92	11921	15445	50577666
Injury associated with device	169.98	18.97	52	11961	3065	50590046
Off label use	166.51	18.97	354	11659	474072	50119039
Abscess sterile	165.86	18.97	25	11988	26	50593085
Hysterectomy	139.68	18.97	57	11956	7833	50585278
Injection site abscess	138.39	18.97	35	11978	1014	50592097
Mood swings	118.06	18.97	63	11950	15891	50577220
Intermenstrual bleeding	96.47	18.97	42	11971	6772	50586339
Uterine leiomyoma	87.46	18.97	41	11972	7850	50585261
Wrong technique in product usage process	83.13	18.97	83	11930	55427	50537684
Menstrual disorder	78.81	18.97	32	11981	4338	50588773
Oestradiol increased	76.82	18.97	14	11999	76	50593035
Injection site abscess sterile	76.03	18.97	11	12002	6	50593105
Ovarian cyst	75.66	18.97	45	11968	13951	50579160
Uterine haemorrhage	72.02	18.97	28	11985	3387	50589724
Haemorrhage	65.84	18.97	72	11941	53369	50539742
Epiphysiolysis	63.17	18.97	10	12003	18	50593093
Dysmenorrhoea	62.31	18.97	25	11988	3285	50589826
Injection site pain	59.93	18.97	100	11913	110924	50482187
Surgery	58.28	18.97	52	11961	30153	50562958
Depression	55.85	18.97	122	11891	165301	50427810
Night sweats	55.47	18.97	53	11960	33521	50559590
Amenorrhoea	53.08	18.97	30	11983	8454	50584657
Anger	52.46	18.97	33	11980	11300	50581811
Abdominal pain	52.06	18.97	148	11865	236080	50357031
Suicidal ideation	47.40	18.97	62	11951	55323	50537788
Migraine	46.33	18.97	72	11941	75208	50517903
Endometrial stromal sarcoma	44.08	18.97	7	12006	13	50593098
Vulvovaginal dryness	42.62	18.97	17	11996	2200	50590911
Product dispensing error	41.42	18.97	26	11987	8865	50584246
Fall	39.67	18.97	15	11998	334917	50258194
Focal nodular hyperplasia	39.01	18.97	11	12002	486	50592625
Blood luteinising hormone increased	37.90	18.97	8	12005	101	50593010
Adnexa uteri pain	37.00	18.97	10	12003	377	50592734
Endometriosis	35.60	18.97	18	11995	4057	50589054
Maternal exposure before pregnancy	35.57	18.97	20	11993	5577	50587534
Ovarian cyst ruptured	34.94	18.97	12	12001	1021	50592090
Joint swelling	34.45	18.97	8	12005	245278	50347833
Product leakage	33.85	18.97	10	12003	522	50592589
Blood follicle stimulating hormone abnormal	33.27	18.97	5	12008	5	50593106
Depressed mood	32.12	18.97	40	11973	33983	50559128
Aplastic anaemia	32.10	18.97	21	11992	7682	50585429
Rheumatoid arthritis	31.84	18.97	5	12008	202545	50390566
Pneumonia	31.76	18.97	26	11987	378375	50214736
Toxicity to various agents	31.75	18.97	6	12007	212493	50380618
Adnexal torsion	31.52	18.97	8	12005	235	50592876
Insomnia	30.47	18.97	101	11912	174764	50418347
Dyspareunia	29.44	18.97	13	12000	2166	50590945
Headache	28.82	18.97	212	11801	506323	50086788
Neoplasm progression	28.68	18.97	35	11978	29122	50563989
Menstruation irregular	28.66	18.97	18	11995	6144	50586967
Dental fistula	28.33	18.97	9	12004	600	50592511
Laparoscopy	28.12	18.97	5	12008	23	50593088
Breast enlargement	27.72	18.97	11	12002	1404	50591707
Prosopagnosia	26.73	18.97	5	12008	32	50593079
Vision blurred	26.48	18.97	58	11955	78589	50514522
Blood luteinising hormone decreased	26.47	18.97	5	12008	34	50593077
Adhesion	25.88	18.97	10	12003	1189	50591922
Myomectomy	25.72	18.97	4	12009	6	50593105
Uterine adhesions	25.23	18.97	5	12008	45	50593066
Genital haemorrhage	25.17	18.97	17	11996	6557	50586554
Metastases to liver	24.58	18.97	27	11986	20077	50573034
Calcium deficiency	24.41	18.97	9	12004	941	50592170
Breast cancer metastatic	24.38	18.97	20	11993	10344	50582767
Abdominal discomfort	23.31	18.97	13	12000	231628	50361483
Amnesia	22.67	18.97	38	11975	42222	50550889
Injection site mass	22.63	18.97	23	11990	15657	50577454
Idiopathic intracranial hypertension	22.36	18.97	11	12002	2338	50590773
Blood oestrogen increased	22.14	18.97	5	12008	88	50593023
Bone pain	22.12	18.97	40	11973	47189	50545922
Product physical consistency issue	22.06	18.97	7	12006	465	50592646
Oophorectomy	21.99	18.97	7	12006	470	50592641
Wrong product administered	20.85	18.97	14	11999	5346	50587765
Diarrhoea	20.84	18.97	71	11942	588405	50004706
Expired product administered	20.80	18.97	14	11999	5368	50587743
Urinary tract infection	20.56	18.97	14	11999	224006	50369105
Hypotension	19.95	18.97	16	11997	235453	50357658
Blood follicle stimulating hormone increased	19.57	18.97	5	12008	151	50592960
Ovarian disorder	19.53	18.97	7	12006	675	50592436
Libido decreased	19.32	18.97	10	12003	2366	50590745
Completed suicide	19.11	18.97	4	12009	131885	50461226

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	11014.22	14.00	2055	44428	262	29527782
Syringe issue	10017.57	14.00	2056	44427	1722	29526322
Device leakage	6552.26	14.00	1497	44986	2998	29525046
Wrong technique in product usage process	3486.87	14.00	1440	45043	29988	29498056
Prostatic specific antigen increased	2143.09	14.00	788	45695	11776	29516268
Hot flush	2020.94	14.00	790	45693	14080	29513964
Product physical consistency issue	1395.35	14.00	274	46209	122	29527922
Intercepted medication error	842.64	14.00	186	46297	286	29527758
Prostate cancer metastatic	731.00	14.00	280	46203	4686	29523358
Death	719.55	14.00	1622	44861	340462	29187582
Blood testosterone increased	592.72	14.00	162	46321	826	29527218
Blood testosterone abnormal	557.20	14.00	123	46360	189	29527855
Needle issue	435.39	14.00	190	46293	4493	29523551
Intercepted product administration error	430.44	14.00	83	46400	26	29528018
Metastases to bone	424.57	14.00	237	46246	9661	29518383
Product leakage	412.16	14.00	102	46381	321	29527723
Prostate cancer	344.41	14.00	300	46183	25227	29502817
Osteonecrosis of jaw	338.29	14.00	248	46235	16262	29511782
Prostatic specific antigen abnormal	269.54	14.00	73	46410	357	29527687
Product preparation error	263.57	14.00	99	46384	1563	29526481
Malignant neoplasm progression	262.16	14.00	439	46044	73420	29454624
Hormone-refractory prostate cancer	259.41	14.00	77	46406	552	29527492
Product administration error	219.21	14.00	181	46302	14129	29513915
Injection site pain	197.26	14.00	249	46234	32197	29495847
Terminal state	195.78	14.00	100	46383	3394	29524650
Toxicity to various agents	179.57	14.00	29	46454	173632	29354412
Marasmus	158.96	14.00	50	46433	445	29527599
Prostate cancer recurrent	157.90	14.00	58	46425	857	29527187
Fatigue	154.76	14.00	936	45547	315885	29212159
Incorrect route of product administration	137.68	14.00	123	46360	10678	29517366
Injection site mass	132.60	14.00	91	46392	5364	29522680
Injection site induration	122.31	14.00	66	46417	2510	29525534
Intercepted product storage error	113.71	14.00	30	46453	130	29527914
Metastases to lymph nodes	97.61	14.00	67	46416	3950	29524094
Completed suicide	95.60	14.00	14	46469	90232	29437812
Circumstance or information capable of leading to medication error	89.41	14.00	45	46438	1479	29526565
Injection site granuloma	88.40	14.00	17	46466	5	29528039
Acute kidney injury	84.66	14.00	182	46301	265085	29262959
Hydronephrosis	83.79	14.00	85	46398	8645	29519399
Injection site abscess	83.34	14.00	34	46449	675	29527369
Underdose	79.99	14.00	96	46387	11773	29516271
Palliative care	78.67	14.00	29	46454	433	29527611
Injection site haemorrhage	73.91	14.00	78	46405	8308	29519736
Expired product administered	70.94	14.00	48	46435	2763	29525281
Pelvic mass	70.52	14.00	22	46461	190	29527854
Extra dose administered	69.33	14.00	49	46434	3028	29525016
Injection site necrosis	69.03	14.00	25	46458	354	29527690
Drug interaction	66.64	14.00	131	46352	197254	29330790
Overdose	65.27	14.00	22	46461	79797	29448247
Device connection issue	64.95	14.00	23	46460	304	29527740
Victim of child abuse	64.86	14.00	30	46453	815	29527229
Product reconstitution quality issue	62.61	14.00	17	46466	84	29527960
Bone pain	61.75	14.00	107	46376	18345	29509699
Hypotension	61.37	14.00	134	46349	194220	29333824
Pyrexia	60.59	14.00	240	46243	287382	29240662
Diarrhoea	60.19	14.00	294	46189	332404	29195640
Interstitial lung disease	59.68	14.00	213	46270	57505	29470539
Injection site ulcer	55.09	14.00	19	46464	231	29527813
Injection site nodule	54.43	14.00	32	46451	1438	29526606
Fall	53.82	14.00	468	46015	176710	29351334
Drug hypersensitivity	52.30	14.00	21	46462	68385	29459659
Cough	51.09	14.00	75	46408	126652	29401392
Neutropenia	49.25	14.00	82	46401	131629	29396415
Urinary tract toxicity	48.17	14.00	10	46473	9	29528035
Cystitis radiation	47.92	14.00	13	46470	64	29527980
Metastasis	45.58	14.00	40	46443	3389	29524655
Injection site erythema	45.49	14.00	80	46403	13876	29514168
Colon cancer stage III	45.18	14.00	14	46469	118	29527926
Product preparation issue	43.77	14.00	16	46467	233	29527811
Blood urea abnormal	43.48	14.00	22	46461	731	29527313
Reproductive toxicity	42.89	14.00	9	46474	9	29528035
Intercepted product prescribing error	42.88	14.00	13	46470	101	29527943
Radiation proctitis	42.54	14.00	12	46471	70	29527974
Back pain	42.03	14.00	290	46193	101994	29426050
Foetal exposure during pregnancy	41.63	14.00	3	46480	33864	29494180
Drug administered in wrong device	41.01	14.00	10	46473	29	29528015
Blood creatinine increased	40.92	14.00	44	46439	85058	29442986
Product colour issue	40.83	14.00	17	46466	356	29527688
Occupational exposure to product	40.31	14.00	16	46467	295	29527749
Stress urinary incontinence	40.07	14.00	12	46471	89	29527955
Metastases to lung	39.54	14.00	55	46428	7800	29520244
Suicide attempt	39.26	14.00	4	46479	34106	29493938
Vomiting	39.18	14.00	186	46297	212074	29315970
Bone lesion	38.90	14.00	33	46450	2671	29525373
Drug abuse	38.75	14.00	41	46442	79842	29448202
Metastatic salivary gland cancer	38.20	14.00	7	46476	0	29528044
White blood cell count decreased	38.01	14.00	45	46438	83317	29444727
Pneumonia	37.81	14.00	322	46161	319850	29208194
Intentional dose omission	37.75	14.00	29	46454	2037	29526007
Injection site swelling	37.41	14.00	59	46424	9358	29518686
Agitation	37.22	14.00	17	46466	51287	29476757
Blood electrolytes abnormal	37.14	14.00	21	46462	876	29527168
Injection site inflammation	36.62	14.00	19	46464	666	29527378
Infection	36.55	14.00	40	46443	76711	29451333
Dyspnoea	36.21	14.00	334	46149	326398	29201646
Angioedema	36.07	14.00	4	46479	31911	29496133
Malignant transformation	35.82	14.00	20	46463	814	29527230
Seizure	35.70	14.00	57	46426	93066	29434978
Prostatic specific antigen decreased	35.47	14.00	11	46472	93	29527951
Cardiac arrest	35.12	14.00	50	46433	85541	29442503
Febrile neutropenia	34.86	14.00	78	46405	112162	29415882
Metastases to spine	34.30	14.00	28	46455	2148	29525896
Psoriasis	34.10	14.00	5	46478	32222	29495822
Condition aggravated	34.03	14.00	117	46366	146178	29381866
Abscess sterile	33.67	14.00	8	46475	20	29528024
Haematuria	33.58	14.00	148	46335	43991	29484053
Rash	33.47	14.00	169	46314	189650	29338394
Gynaecomastia	33.36	14.00	52	46431	8165	29519879
Renal impairment	32.89	14.00	48	46435	81285	29446759
Pituitary haemorrhage	32.56	14.00	12	46471	179	29527865
Asthma	32.03	14.00	7	46476	33842	29494202
Coma	32.01	14.00	11	46472	39439	29488605
Asthenia	31.97	14.00	495	45988	214755	29313289
International normalised ratio increased	31.72	14.00	15	46468	44357	29483687
Product dosage form issue	31.45	14.00	8	46475	29	29528015
Metabolic acidosis	31.44	14.00	10	46473	37652	29490392
Bone cancer metastatic	31.30	14.00	11	46472	142	29527902
Somnolence	31.08	14.00	63	46420	93892	29434152
Incorrect dose administered	30.94	14.00	118	46365	32866	29495178
Sepsis	30.61	14.00	118	46365	142564	29385480
Product prescribing error	30.51	14.00	79	46404	17897	29510147
Epidural lipomatosis	30.40	14.00	17	46466	694	29527350
Hip fracture	30.20	14.00	57	46426	10435	29517609
Intercepted product selection error	29.90	14.00	7	46476	16	29528028
Fracture	29.89	14.00	42	46441	6011	29522033
Infusion related reaction	29.63	14.00	16	46467	43870	29484174
Pancreatitis	29.10	14.00	9	46474	34505	29493539
Tachycardia	29.01	14.00	43	46440	72367	29455677
Abdominal pain	29.00	14.00	112	46371	135245	29392799
Cancer pain	28.47	14.00	26	46457	2321	29525723
Urinary retention	28.20	14.00	112	46371	31786	29496258
Foreign body reaction	28.17	14.00	8	46475	48	29527996
Off label use	28.13	14.00	320	46163	300480	29227564
Rheumatoid arthritis	27.81	14.00	8	46475	32144	29495900
Gastrointestinal haemorrhage	27.45	14.00	52	46431	79481	29448563
Injection site abscess sterile	27.29	14.00	5	46478	0	29528044
Septic shock	27.22	14.00	35	46448	62525	29465519
Sinusitis	27.15	14.00	10	46473	34340	29493704
Product quality issue	27.13	14.00	70	46413	15825	29512219
Femur fracture	26.67	14.00	43	46440	6948	29521096
Urticaria	26.56	14.00	28	46455	54632	29473412
Metastases to soft tissue	26.48	14.00	11	46472	229	29527815
Male sexual dysfunction	26.39	14.00	11	46472	231	29527813
Disease progression	26.17	14.00	219	46264	81697	29446347
Urinary tract obstruction	26.13	14.00	29	46454	3268	29524776
Loss of libido	25.09	14.00	24	46459	2272	29525772
Macroenzyme creatine kinase	24.97	14.00	6	46477	16	29528028
Product storage error	24.96	14.00	40	46443	6430	29521614
Renal failure	24.84	14.00	99	46384	118500	29409544
Nocturia	24.78	14.00	46	46437	8316	29519728
Hypersensitivity	24.71	14.00	28	46455	52875	29475169
C-reactive protein increased	24.66	14.00	20	46463	44243	29483801
Induration	24.62	14.00	16	46467	860	29527184
Blood creatine phosphokinase increased	24.40	14.00	17	46466	40627	29487417
Bradycardia	24.37	14.00	41	46442	65588	29462456
Dementia	23.79	14.00	55	46428	11603	29516441
Radical prostatectomy	23.72	14.00	7	46476	49	29527995
Mucosal inflammation	23.65	14.00	10	46473	31585	29496459
Nausea	23.53	14.00	317	46166	288938	29239106
Anti-androgen withdrawal syndrome	23.35	14.00	5	46478	6	29528038
Radiotherapy	22.50	14.00	11	46472	339	29527705
Breast tenderness	22.35	14.00	14	46469	706	29527338
Haemoptysis	22.34	14.00	10	46473	30540	29497504
Bone cancer	22.17	14.00	17	46466	1191	29526853
Platelet count decreased	22.15	14.00	87	46396	104585	29423459
Chest pain	21.88	14.00	96	46387	111877	29416167
Inappropriate schedule of product administration	21.86	14.00	132	46351	44340	29483704
Neuroendocrine carcinoma of prostate	21.83	14.00	4	46479	0	29528044
Rib fracture	21.69	14.00	56	46427	12662	29515382
Respiratory arrest	21.31	14.00	7	46476	25826	29502218
Product dispensing error	21.31	14.00	34	46449	5446	29522598
Spinal compression fracture	21.25	14.00	36	46447	6058	29521986
Pruritus	21.16	14.00	103	46380	116746	29411298
Bone density decreased	21.14	14.00	19	46464	1661	29526383
Pancytopenia	21.06	14.00	64	46419	83104	29444940
Bladder neck obstruction	21.02	14.00	8	46475	131	29527913
Injection site reaction	20.90	14.00	51	46432	11137	29516907
Chest discomfort	20.76	14.00	25	46458	45958	29482086
Product administered at inappropriate site	20.76	14.00	19	46464	1701	29526343
Oxygen saturation decreased	20.75	14.00	24	46459	44913	29483131
Drug reaction with eosinophilia and systemic symptoms	20.73	14.00	9	46474	27983	29500061
Pollakiuria	20.61	14.00	66	46417	16850	29511194
Tremor	20.53	14.00	54	46429	73484	29454560
Lower respiratory tract infection	20.47	14.00	8	46475	26494	29501550
Cardiogenic shock	20.25	14.00	3	46480	19187	29508857
Product size issue	20.06	14.00	12	46471	557	29527487
Juvenile idiopathic arthritis	20.02	14.00	17	46466	1377	29526667
Metastases to liver	20.01	14.00	52	46431	11804	29516240
Blood pressure increased	20.00	14.00	55	46428	73748	29454296
Respiratory distress	19.85	14.00	13	46470	32093	29495951
White blood cell count increased	19.63	14.00	18	46465	37498	29490546
Thrombocytopenia	19.46	14.00	128	46355	134695	29393349
Traumatic fracture	19.11	14.00	9	46474	255	29527789
Liver function test abnormal	18.86	14.00	11	46472	28907	29499137
Injection site discomfort	18.79	14.00	16	46467	1301	29526743
Aggression	18.65	14.00	17	46466	35524	29492520
Injection site extravasation	18.60	14.00	21	46462	2412	29525632
Meningioma	18.55	14.00	16	46467	1324	29526720
Testicular atrophy	18.47	14.00	11	46472	506	29527538
Eye haematoma	18.45	14.00	6	46477	60	29527984
Intercepted product dispensing error	18.45	14.00	6	46477	60	29527984
Neutrophil count decreased	18.31	14.00	25	46458	43542	29484502
Leukopenia	18.26	14.00	37	46446	55166	29472878
Hyperkalaemia	17.97	14.00	44	46439	61348	29466696
Hepatic enzyme increased	17.94	14.00	16	46467	33783	29494261
Osteoporosis	17.94	14.00	47	46436	10722	29517322
Metastases to breast	17.79	14.00	4	46479	7	29528037
Respiratory failure	17.36	14.00	86	46397	97045	29430999
Nasopharyngitis	17.28	14.00	43	46440	59622	29468422
Transitional cell carcinoma	17.05	14.00	18	46465	1917	29526127
Product availability issue	16.94	14.00	14	46469	1093	29526951
Dysuria	16.87	14.00	75	46408	22365	29505679
Urethral intrinsic sphincter deficiency	16.56	14.00	4	46479	11	29528033
Bone marrow tumour cell infiltration	16.56	14.00	4	46479	11	29528033
Hospice care	16.44	14.00	29	46454	5039	29523005
Anaplastic meningioma	16.37	14.00	3	46480	0	29528044
Blood testosterone normal	16.37	14.00	3	46480	0	29528044
Metastases to penis	16.37	14.00	3	46480	0	29528044
Coagulopathy	16.35	14.00	4	46479	17903	29510141
Hypoglycaemia	16.33	14.00	32	46451	48314	29479730
Hypoxia	16.32	14.00	31	46452	47348	29480696
Metastases to spinal cord	16.30	14.00	4	46479	12	29528032
Pancreatitis acute	16.30	14.00	9	46474	24376	29503668
Intentional product use issue	16.28	14.00	26	46457	42472	29485572
Headache	16.26	14.00	185	46298	173822	29354222
Eye colour change	16.23	14.00	8	46475	251	29527793
Vipoma	16.06	14.00	4	46479	13	29528031
Pelvic pain	15.98	14.00	18	46465	2061	29525983
Injection site discharge	15.95	14.00	6	46477	95	29527949
Product physical issue	15.92	14.00	18	46465	2070	29525974
Plasma cell myeloma	15.89	14.00	21	46462	37094	29490950
Diabetes mellitus	15.78	14.00	112	46371	39719	29488325
Mental status changes	15.75	14.00	19	46464	34908	29493136
Bronchitis	15.65	14.00	21	46462	36847	29491197
Premature baby	15.50	14.00	4	46479	17276	29510768
Culture positive	15.33	14.00	11	46472	696	29527348
Muscular weakness	15.31	14.00	157	46326	61895	29466149
Breast cancer male	15.20	14.00	8	46475	289	29527755
Urinary tract infection	15.07	14.00	177	46306	72177	29455867
Eosinophilia	15.07	14.00	8	46475	22153	29505891
Injection site infection	15.06	14.00	12	46471	889	29527155
Encephalopathy	14.96	14.00	16	46467	31027	29497017
Respiratory depression	14.90	14.00	51	46432	13472	29514572
Abnormal behaviour	14.79	14.00	9	46474	23118	29504926
Blood testosterone decreased	14.75	14.00	24	46459	3906	29524138
Lymphocyte count decreased	14.58	14.00	6	46477	19265	29508779
Euthanasia	14.53	14.00	4	46479	21	29528023
Anxiety	14.45	14.00	77	46406	85288	29442756
Product solubility abnormal	14.44	14.00	9	46474	450	29527594
Cardiac ventricular scarring	14.30	14.00	3	46480	3	29528041
Extradural neoplasm	14.30	14.00	3	46480	3	29528041
Multiple organ dysfunction syndrome	14.30	14.00	51	46432	63065	29464979
Neovascular age-related macular degeneration	14.27	14.00	6	46477	129	29527915
Hypervolaemia	14.04	14.00	5	46478	17540	29510504
Wheezing	14.04	14.00	19	46464	33221	29494823
Lymphadenopathy	14.04	14.00	77	46406	24972	29503072
Metastases to bone marrow	14.03	14.00	9	46474	473	29527571

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	8488.81	12.55	1409	41708	499	64455116
Syringe issue	7456.08	12.55	1426	41691	2860	64452755
Device leakage	4551.66	12.55	1064	42053	7202	64448413
Wrong technique in product usage process	2093.20	12.55	969	42148	64005	64391610
Prostatic specific antigen increased	2081.30	12.55	577	42540	8183	64447432
Hot flush	1337.77	12.55	641	42476	45594	64410021
Product physical consistency issue	995.14	12.55	188	42929	334	64455281
Intercepted medication error	659.56	12.55	142	42975	613	64455002
Blood testosterone increased	436.03	12.55	102	43015	684	64454931
Prostate cancer metastatic	435.03	12.55	138	42979	3166	64452449
Death	421.86	12.55	967	42150	481738	63973877
Blood testosterone abnormal	404.31	12.55	74	43043	99	64455516
Prostate cancer	356.76	12.55	200	42917	19595	64436020
Intercepted product administration error	338.57	12.55	64	43053	114	64455501
Metastases to bone	313.69	12.55	186	42931	20249	64435366
Needle issue	293.51	12.55	137	42980	9135	64446480
Osteonecrosis of jaw	293.06	12.55	230	42887	39595	64416020
Product leakage	265.21	12.55	66	43051	592	64455023
Malignant neoplasm progression	240.59	12.55	335	42782	112536	64343079
Prostate cancer recurrent	194.90	12.55	53	43064	692	64454923
Prostatic specific antigen abnormal	190.39	12.55	41	43076	177	64455438
Hormone-refractory prostate cancer	189.19	12.55	45	43072	327	64455288
Pelvic pain	171.84	12.55	101	43016	10809	64444806
Toxicity to various agents	152.89	12.55	29	43088	363484	64092131
Injection site abscess	142.03	12.55	48	43069	1350	64454265
Ovarian hyperstimulation syndrome	135.36	12.55	56	43061	2789	64452826
Occupational exposure to product	116.38	12.55	34	43083	584	64455031
Abscess sterile	112.50	12.55	22	43095	51	64455564
Product preparation error	110.93	12.55	54	43063	3951	64451664
Injection site pain	109.82	12.55	235	42882	111173	64344442
Product administration error	99.48	12.55	107	43010	27536	64428079
Completed suicide	98.42	12.55	16	43101	224398	64231217
Vaginal haemorrhage	97.61	12.55	90	43027	19254	64436361
Hydronephrosis	94.09	12.55	77	43040	14048	64441567
Victim of child abuse	88.85	12.55	30	43087	841	64454774
Intercepted product storage error	86.84	12.55	21	43096	165	64455450
Injection site granuloma	85.33	12.55	17	43100	45	64455570
Drug hypersensitivity	79.14	12.55	30	43087	237785	64217830
Fatigue	77.70	12.55	802	42315	747928	63707687
Injection site mass	76.94	12.55	75	43042	17195	64438420
Rheumatoid arthritis	75.98	12.55	10	43107	164284	64291331
Marasmus	69.67	12.55	25	43092	843	64454772
Incorrect route of product administration	66.53	12.55	80	43037	23218	64432397
Injection site abscess sterile	64.64	12.55	11	43106	6	64455609
Injection site induration	64.39	12.55	51	43066	8881	64446734
Interstitial lung disease	62.90	12.55	175	42942	97557	64358058
Terminal state	61.84	12.55	38	43079	4406	64451209
Heavy menstrual bleeding	60.56	12.55	56	43061	12021	64443594
Pelvic mass	60.39	12.55	24	43093	1076	64454539
Infusion related reaction	59.47	12.55	18	43099	164449	64291166
Sinusitis	56.45	12.55	14	43103	145914	64309701
Joint swelling	55.49	12.55	38	43079	215344	64240271
Haematuria	55.49	12.55	124	42993	60347	64395268
Hysterectomy	54.74	12.55	37	43080	5048	64450567
Extra dose administered	54.01	12.55	41	43076	6709	64448906
Cystitis radiation	52.91	12.55	13	43104	110	64455505
Cough	52.87	12.55	75	43042	302073	64153542
Metastases to lymph nodes	52.83	12.55	45	43072	8672	64446943
Product reconstitution quality issue	52.33	12.55	14	43103	171	64455444
Overdose	51.63	12.55	21	43096	159545	64296070
Underdose	51.00	12.55	74	43043	25755	64429860
Oestradiol increased	50.59	12.55	12	43105	86	64455529
Nasopharyngitis	49.97	12.55	35	43082	196038	64259577
Blood urea abnormal	48.24	12.55	21	43096	1187	64454428
Injection site haemorrhage	47.12	12.55	69	43048	24209	64431406
Malignant transformation	46.10	12.55	20	43097	1121	64454494
Infection	45.80	12.55	34	43083	184846	64270769
Mood swings	45.07	12.55	57	43060	17411	64438204
Circumstance or information capable of leading to medication error	45.05	12.55	28	43089	3312	64452303
Metastatic salivary gland cancer	44.18	12.55	7	43110	0	64455615
Lower respiratory tract infection	43.16	12.55	6	43111	94608	64361007
Male sexual dysfunction	43.03	12.55	12	43105	173	64455442
Metastases to lung	42.91	12.55	52	43065	15212	64440403
Pituitary haemorrhage	41.43	12.55	13	43104	287	64455328
Radiation proctitis	40.98	12.55	10	43107	82	64455533
Epidural lipomatosis	40.83	12.55	17	43100	860	64454755
Metastases to liver	40.74	12.55	64	43053	23877	64431738
Product prescribing error	40.14	12.55	79	43038	35190	64420425
Epiphysiolysis	40.05	12.55	10	43107	91	64455524
Diarrhoea	39.61	12.55	302	42815	722402	63733213
Urinary retention	38.70	12.55	95	43022	49106	64406509
Expired product administered	38.54	12.55	32	43085	5955	64449660
Gynaecomastia	38.40	12.55	32	43085	5984	64449631
Urinary tract obstruction	38.01	12.55	27	43090	3990	64451625
Disease progression	37.79	12.55	191	42926	141489	64314126
Swelling	37.74	12.55	31	43086	160187	64295428
Bone pain	37.57	12.55	92	43025	47480	64408135
Blood electrolytes abnormal	37.52	12.55	20	43097	1771	64453844
Hypersensitivity	37.16	12.55	46	43071	196406	64259209
Blood luteinising hormone increased	37.06	12.55	11	43106	200	64455415
Blood testosterone decreased	36.99	12.55	21	43096	2104	64453511
Condition aggravated	36.65	12.55	127	42990	372299	64083316
Drug intolerance	36.64	12.55	43	43074	187949	64267666
Rash	36.53	12.55	170	42947	458379	63997236
Drug administered in wrong device	36.52	12.55	8	43109	38	64455577
Product dosage form issue	36.35	12.55	8	43109	39	64455576
Bone lesion	36.32	12.55	29	43088	5108	64450507
Hypotension	36.10	12.55	132	42985	380842	64074773
Hepatic enzyme increased	36.10	12.55	21	43096	129922	64325693
Arthropathy	35.87	12.55	18	43099	120949	64334666
Metastasis	35.75	12.55	30	43087	5665	64449950
Maternal exposure during pregnancy	35.55	12.55	10	43107	95874	64359741
Intercepted product selection error	35.44	12.55	6	43111	3	64455612
Back pain	35.40	12.55	287	42830	249884	64205731
Coma	34.67	12.55	8	43109	87607	64368008
Device connection issue	34.19	12.55	15	43102	864	64454751
Injury associated with device	33.71	12.55	22	43095	2831	64452784
Injection site nodule	33.58	12.55	23	43094	3207	64452408
Uterine leiomyoma	33.12	12.55	28	43089	5341	64450274
Product quality issue	33.01	12.55	66	43051	29733	64425882
Menstrual disorder	32.73	12.55	23	43094	3342	64452273
Wound	32.29	12.55	6	43111	76471	64379144
Somnolence	32.28	12.55	54	43063	203591	64252024
Endometrial stromal sarcoma	31.63	12.55	6	43111	11	64455604
Asthenia	31.11	12.55	429	42688	427615	64028000
Metastases to spine	31.09	12.55	23	43094	3620	64451995
Pericarditis	30.91	12.55	3	43114	62513	64393102
Intentional dose omission	29.88	12.55	27	43090	5625	64449990
Loss of libido	29.54	12.55	19	43098	2385	64453230
Drug interaction	28.95	12.55	134	42983	361949	64093666
Systemic lupus erythematosus	28.95	12.55	8	43109	77604	64378011
Asthma	28.48	12.55	14	43103	95211	64360404
Prostatic specific antigen decreased	28.30	12.55	7	43110	61	64455554
Bronchitis	28.23	12.55	19	43098	108724	64346891
Intermenstrual bleeding	28.12	12.55	25	43092	5100	64450515
Diabetes mellitus	28.06	12.55	103	43014	66371	64389244
Injection site ulcer	27.96	12.55	12	43105	655	64454960
Erectile dysfunction	27.62	12.55	38	43079	12589	64443026
Anti-androgen withdrawal syndrome	27.62	12.55	5	43112	6	64455609
Therapeutic product effect decreased	27.55	12.55	22	43095	115329	64340286
Dyspnoea	27.52	12.55	328	42789	718346	63737269
Night sweats	26.67	12.55	68	43049	35978	64419637
Intercepted product prescribing error	26.63	12.55	9	43108	253	64455362
Dysmenorrhoea	26.48	12.55	18	43099	2479	64453136
Psoriasis	25.63	12.55	8	43109	71695	64383920
Meningioma	25.51	12.55	21	43096	3861	64451754
Bladder neck obstruction	25.35	12.55	7	43110	97	64455518
Product colour issue	25.26	12.55	11	43106	622	64454993
Neuroendocrine carcinoma of prostate	25.25	12.55	4	43113	0	64455615
Adnexa uteri pain	25.04	12.55	9	43108	305	64455310
Focal nodular hyperplasia	24.87	12.55	11	43106	646	64454969
Macroenzyme creatine kinase	24.64	12.55	5	43112	15	64455600
Palliative care	24.41	12.55	11	43106	675	64454940
Foreign body reaction	24.31	12.55	7	43110	114	64455501
Dental fistula	24.21	12.55	10	43107	496	64455119
Vomiting	24.06	12.55	244	42873	550873	63904742
Acute kidney injury	23.94	12.55	189	42928	449051	64006564
Dysuria	23.84	12.55	72	43045	41985	64413630
Metabolic acidosis	23.49	12.55	9	43108	70949	64384666
Intercepted product dispensing error	23.35	12.55	7	43110	132	64455483
International normalised ratio increased	23.14	12.55	12	43105	79155	64376460
Metastases to soft tissue	23.09	12.55	9	43108	383	64455232
Intentional product use issue	23.01	12.55	18	43099	95346	64360269
Tachycardia	22.48	12.55	41	43076	149538	64306077
Abdominal discomfort	22.38	12.55	56	43061	182266	64273349
Cancer pain	21.85	12.55	20	43097	4237	64451378
Lipid metabolism disorder	21.77	12.55	8	43109	289	64455326
Prosopagnosia	21.71	12.55	5	43112	31	64455584
Laparoscopy	21.58	12.55	4	43113	6	64455609
Respiratory depression	21.41	12.55	48	43069	23395	64432220
Adnexal torsion	21.02	12.55	7	43110	188	64455427
Transitional cell carcinoma	21.01	12.55	15	43102	2234	64453381
Pollakiuria	20.80	12.55	57	43060	31473	64424142
Nocturia	20.61	12.55	31	43086	11134	64444481
Pyrexia	20.57	12.55	257	42860	558387	63897228
Product preparation issue	20.51	12.55	10	43107	734	64454881
Oxygen saturation decreased	20.35	12.55	25	43092	107151	64348464
Urine flow decreased	20.30	12.55	11	43106	1006	64454609
Angioedema	20.20	12.55	8	43109	61813	64393802
Injection site necrosis	20.16	12.55	12	43105	1313	64454302
Metastases to spinal cord	20.07	12.55	5	43112	45	64455570
Product dispensing error	20.02	12.55	31	43086	11419	64444196
Breast enlargement	20.02	12.55	12	43105	1330	64454285
Incorrect dose administered	19.91	12.55	87	43030	60678	64394937
Eye haematoma	19.87	12.55	6	43111	116	64455499
Hospice care	19.86	12.55	25	43092	7600	64448015
Ovarian cyst	19.50	12.55	30	43087	10988	64444627
Juvenile idiopathic arthritis	19.47	12.55	18	43099	3861	64451754
Prostatic mass	19.47	12.55	4	43113	13	64455602
Vipoma	19.47	12.55	4	43113	13	64455602
Radical prostatectomy	19.47	12.55	4	43113	13	64455602
Lymphadenopathy	19.42	12.55	72	43045	46614	64409001
Product size issue	19.31	12.55	9	43108	597	64455018
Uterine haemorrhage	19.18	12.55	15	43102	2564	64453051
Urethral intrinsic sphincter deficiency	19.02	12.55	4	43113	15	64455600
Pancreatitis	19.01	12.55	8	43109	59599	64396016
Anaplastic meningioma	18.93	12.55	3	43114	0	64455615
Blood testosterone normal	18.93	12.55	3	43114	0	64455615
Rib fracture	18.46	12.55	46	43071	23992	64431623
Loss of personal independence in daily activities	18.35	12.55	13	43104	72441	64383174
Pruritus	18.25	12.55	128	42989	312272	64143343
Injection site inflammation	18.25	12.55	16	43101	3205	64452410
Blood pressure fluctuation	18.16	12.55	6	43111	51865	64403750
Vulvovaginal dryness	18.03	12.55	12	43105	1596	64454019
Drug dependence	17.92	12.55	56	43061	33256	64422359
Spinal compression fracture	17.91	12.55	34	43083	14741	64440874
Nausea	17.61	12.55	396	42721	785404	63670211
Neuroendocrine carcinoma	17.48	12.55	8	43109	509	64455106
Bone cancer metastatic	17.38	12.55	6	43111	180	64455435
Testicular atrophy	17.18	12.55	7	43110	335	64455280
Respiratory arrest	17.08	12.55	7	43110	52978	64402637
Acute coronary syndrome	17.04	12.55	39	43078	19271	64436344
Lactic acidosis	16.94	12.55	10	43107	61400	64394215
Renal impairment	16.93	12.55	41	43076	134976	64320639
Cardiac ventricular scarring	16.86	12.55	3	43114	3	64455612
Drug abuse	16.76	12.55	40	43077	132334	64323281
Pulmonary embolism	16.58	12.55	160	42957	146196	64309419
Stomatitis	16.50	12.55	30	43087	109575	64346040
Child abuse	16.40	12.55	6	43111	214	64455401
Blood follicle stimulating hormone abnormal	16.39	12.55	3	43114	4	64455611
Suicide attempt	16.39	12.55	14	43103	70993	64384622
Breast cancer male	16.37	12.55	6	43111	215	64455400
Tremor	16.33	12.55	48	43069	148182	64307433
Hypervolaemia	16.17	12.55	3	43114	38282	64417333
Drug reaction with eosinophilia and systemic symptoms	16.17	12.55	8	43109	54209	64401406
Neovascular age-related macular degeneration	15.79	12.55	6	43111	238	64455377
Stress urinary incontinence	15.72	12.55	11	43106	1587	64454028
Oophorectomy	15.65	12.55	6	43111	244	64455371
Myomectomy	15.64	12.55	3	43114	6	64455609
Bone marrow tumour cell infiltration	15.59	12.55	4	43113	41	64455574
Product storage error	15.35	12.55	30	43087	13288	64442327
Inappropriate schedule of product administration	15.33	12.55	110	43007	92176	64363439
Induration	15.32	12.55	11	43106	1653	64453962
Pathological fracture	15.22	12.55	24	43093	8981	64446634
Urethral stenosis	15.19	12.55	9	43108	977	64454638
Hypoglycaemia	15.02	12.55	23	43094	89869	64365746
Gastrointestinal disorder	14.94	12.55	23	43094	89686	64365929
Haematocolpos	14.94	12.55	4	43113	49	64455566
Blood creatinine increased	14.93	12.55	44	43073	135738	64319877
Pneumonia	14.89	12.55	274	42843	559302	63896313
Radiation injury	14.82	12.55	8	43109	726	64454889
Calcium deficiency	14.78	12.55	8	43109	730	64454885
Bradycardia	14.74	12.55	36	43081	118183	64337432
Liver function test abnormal	14.60	12.55	11	43106	59390	64396225
Euthanasia	14.58	12.55	4	43113	54	64455561
Culture positive	14.57	12.55	9	43108	1053	64454562
Agitation	14.39	12.55	23	43094	88344	64367271
Polyneuropathy in malignant disease	14.33	12.55	5	43112	155	64455460
Injection site infection	14.20	12.55	11	43106	1854	64453761
Injection site swelling	14.15	12.55	60	43057	41293	64414322
Therapeutic product effect incomplete	14.13	12.55	30	43087	103452	64352163
Inner ear disorder	14.13	12.55	7	43110	532	64455083
Traumatic fracture	14.07	12.55	8	43109	804	64454811
Inguinal hernia	14.06	12.55	18	43099	5563	64450052
Prostatic obstruction	14.01	12.55	4	43113	63	64455552
Chest discomfort	13.98	12.55	36	43081	116070	64339545
Ill-defined disorder	13.91	12.55	6	43111	44046	64411569
Pituitary apoplexy	13.84	12.55	5	43112	172	64455443
Blood pressure increased	13.68	12.55	64	43053	172488	64283127
Oropharyngeal pain	13.67	12.55	24	43093	88843	64366772
Ovarian cyst ruptured	13.63	12.55	8	43109	853	64454762
Cardiac arrest	13.52	12.55	55	43062	154009	64301606
Psoriatic arthropathy	13.50	12.55	6	43111	43275	64412340
Placenta accreta	13.47	12.55	5	43112	186	64455429
Bone density decreased	13.45	12.55	24	43093	9928	64445687
Maternal exposure before pregnancy	13.44	12.55	14	43103	3469	64452146
Exposed bone in jaw	13.43	12.55	14	43103	3473	64452142
Extradural neoplasm	13.41	12.55	3	43114	16	64455599
Hysteroscopy	13.41	12.55	3	43114	16	64455599
Eye colour change	13.29	12.55	6	43111	370	64455245
Breast tenderness	13.29	12.55	11	43106	2038	64453577
Metastases to pleura	13.14	12.55	9	43108	1255	64454360
Tongue discomfort	13.06	12.55	11	43106	2088	64453527
Injection site discomfort	12.83	12.55	15	43102	4226	64451389
Cardiogenic shock	12.75	12.55	3	43114	32424	64423191
Arthritis	12.56	12.55	23	43094	83791	64371824

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 (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Endometriosis	indication	129103003
Precocious puberty	indication	400179000
Advanced Prostatic Carcinoma	indication
Anemia due to Bleeding Uterine Leiomyoma	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
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
37JNS02E7V	UNII
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
5025	INN_ID

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