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

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

Stem definition	Drug id	CAS RN
estrogens	1057	50-28-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: estradiol 17Beta-Estradiol 17Beta-Oestradiol Beta-Estradiol estradiol hemihydrate	The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids. Molecular weight: 272.39 Formula: C18H24O2 CLOGP: 3.78 LIPINSKI: 0 HAC: 2 HDO: 2 TPSA: 40.46 ALOGS: -4.11 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	mg	N
2	mg	O
1	mg	P
0.30	mg	P
5	mg	R
50	mcg	TD
1	mg	TD
1.53	mg	TD
25	mcg	V
7.50	mcg	V

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.84 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	5 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.70 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 23, 1975	FDA	BRISTOL MYERS SQUIBB
Nov. 25, 2011	PMDA	Shiseido Company, Limited

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
Product adhesion issue	4001.61	9.76	1019	99585	3700	63384718
Hot flush	939.96	9.76	722	99882	50437	63337981
Application site rash	857.54	9.76	266	100338	2232	63386186
Application site erythema	560.34	9.76	230	100374	4605	63383813
Application site pruritus	494.19	9.76	199	100405	3785	63384633
Product quality issue	459.62	9.76	411	100193	35454	63352964
Application site irritation	404.07	9.76	138	100466	1612	63386806
Meningioma	403.73	9.76	171	100433	3714	63384704
Vulvovaginal discomfort	351.98	9.76	135	100469	2243	63386175
Pemphigus	244.49	9.76	11	100593	183715	63204703
Application site reaction	228.82	9.76	73	100531	677	63387741
Wrong technique in product usage process	225.75	9.76	376	100228	61964	63326454
Menopausal symptoms	209.09	9.76	94	100510	2367	63386051
Vulvovaginal pain	205.77	9.76	96	100508	2639	63385779
Schizoaffective disorder	201.81	9.76	103	100501	3459	63384959
Hand deformity	195.59	9.76	15	100589	159442	63228976
Vulvovaginal burning sensation	186.99	9.76	83	100521	2026	63386392
Glossodynia	184.16	9.76	31	100573	178845	63209573
Pneumonia viral	168.05	9.76	122	100482	7800	63380618
Death	160.74	9.76	215	100389	374166	63014252
Breast tenderness	159.99	9.76	77	100527	2273	63386145
Systemic lupus erythematosus	157.36	9.76	67	100537	208851	63179567
Vaginal haemorrhage	156.22	9.76	205	100399	27282	63361136
Vulvovaginal dryness	156.02	9.76	81	100523	2820	63385598
Application site pain	154.06	9.76	91	100513	4091	63384327
Product physical issue	149.30	9.76	95	100509	4885	63383533
Anti-cyclic citrullinated peptide antibody positive	148.13	9.76	9	100595	116203	63272215
Blood oestrogen decreased	146.80	9.76	41	100563	227	63388191
Application site vesicles	135.40	9.76	59	100545	1376	63387042
Toxicity to various agents	134.98	9.76	116	100488	247134	63141284
Wound	131.77	9.76	47	100557	163216	63225202
Soft tissue disorder	131.68	9.76	84	100520	4338	63384080
Maternal exposure during pregnancy	129.20	9.76	96	100508	219966	63168452
Product complaint	126.24	9.76	127	100477	12682	63375736
Pericarditis	124.44	9.76	28	100576	131551	63256867
Ovarian hyperstimulation syndrome	121.40	9.76	77	100527	3937	63384481
Arthropathy	120.02	9.76	117	100487	234675	63153743
Contraindicated product administered	116.50	9.76	104	100500	217544	63170874
Application site urticaria	116.08	9.76	34	100570	229	63388189
Feeling abnormal	115.75	9.76	504	100100	147888	63240530
Rheumatoid factor positive	112.40	9.76	5	100599	84401	63304017
Application site burn	111.57	9.76	44	100560	790	63387628
Vaginal discharge	111.07	9.76	102	100502	9096	63379322
Product substitution issue	109.57	9.76	131	100473	15865	63372553
Colitis microscopic	107.82	9.76	101	100503	9238	63379180
Migraine	107.26	9.76	384	100220	102962	63285456
Hormone level abnormal	104.71	9.76	59	100545	2424	63385994
Device adhesion issue	104.13	9.76	77	100527	5064	63383354
Duodenal ulcer perforation	99.43	9.76	11	100593	87198	63301220
Hysterectomy	95.11	9.76	95	100509	9404	63379014
Helicobacter infection	93.43	9.76	17	100587	92768	63295650
Exposure during pregnancy	91.07	9.76	68	100536	155479	63232939
Postmenopausal haemorrhage	90.60	9.76	51	100553	2091	63386327
Incorrect dose administered by product	88.15	9.76	26	100578	180	63388238
Infusion related reaction	86.26	9.76	161	100443	245360	63143058
Drug abuse	83.05	9.76	9	100595	72509	63315909
General physical health deterioration	81.96	9.76	120	100484	201282	63187136
Neutropenia	81.79	9.76	94	100510	174911	63213507
Salpingo-oophorectomy unilateral	79.16	9.76	35	100569	846	63387572
Completed suicide	78.64	9.76	69	100535	145604	63242814
Vaginal infection	78.63	9.76	77	100527	7441	63380977
Skin reaction	78.62	9.76	107	100497	14742	63373676
Febrile neutropenia	75.71	9.76	47	100557	118402	63270016
Device material issue	75.18	9.76	24	100580	223	63388195
Product dose omission issue	74.73	9.76	630	99974	233683	63154735
Acute kidney injury	72.73	9.76	197	100407	263218	63125200
Application site hypersensitivity	71.45	9.76	23	100581	220	63388198
Vaginal odour	71.03	9.76	28	100576	502	63387916
Sinusitis fungal	70.49	9.76	41	100563	1790	63386628
Treatment failure	70.35	9.76	130	100474	198913	63189505
Intermenstrual bleeding	69.82	9.76	74	100530	7852	63380566
Headache	69.82	9.76	1398	99206	631843	62756575
Glaucoma	69.69	9.76	115	100489	18790	63369628
No adverse event	68.35	9.76	181	100423	41224	63347194
Depression	66.76	9.76	536	100068	195956	63192462
Bronchitis	66.57	9.76	381	100223	124554	63263864
Fungal infection	65.82	9.76	166	100438	36708	63351710
Intentional overdose	65.78	9.76	18	100586	74134	63314284
Skin irritation	65.45	9.76	79	100525	9662	63378756
Sputum increased	64.15	9.76	43	100561	2416	63386002
Insomnia	64.04	9.76	570	100034	214682	63173736
Thrombocytopenia	63.52	9.76	88	100516	151069	63237349
Embolism venous	63.34	9.76	47	100557	3107	63385311
Vulvovaginal pruritus	62.17	9.76	47	100557	3196	63385222
Incorrect dose administered by device	62.03	9.76	53	100551	4295	63384123
Breast cancer	61.92	9.76	193	100411	48190	63340228
Blood oestrogen increased	60.74	9.76	17	100587	95	63388323
Liver function test abnormal	60.56	9.76	191	100413	47990	63340428
Diverticulitis	60.37	9.76	168	100436	39389	63349029
Pancytopenia	59.85	9.76	40	100564	96893	63291525
Herpes zoster	59.66	9.76	274	100330	82188	63306230
Cardiac arrest	58.75	9.76	37	100567	92508	63295910
Oestrogen receptor assay positive	58.11	9.76	24	100580	488	63387930
Hyperkalaemia	56.62	9.76	9	100595	54194	63334224
Application site scar	56.09	9.76	19	100585	216	63388202
Thyroid disorder	55.57	9.76	92	100512	15070	63373348
Folliculitis	55.42	9.76	21	100583	70296	63318122
Pyrexia	54.97	9.76	479	100125	469999	62918419
Incorrect dose administered	54.83	9.76	214	100390	59754	63328664
Drug level increased	54.53	9.76	115	100489	22621	63365797
Respiratory symptom	54.41	9.76	44	100560	3303	63385115
Sleep disorder due to general medical condition, insomnia type	53.80	9.76	9	100595	52208	63336210
Swelling	53.68	9.76	239	100365	275139	63113279
Vaginal erosion	53.65	9.76	12	100592	20	63388398
Product size issue	51.71	9.76	20	100584	340	63388078
Drug intolerance	50.93	9.76	284	100320	308377	63080041
Abdominal discomfort	50.40	9.76	300	100304	320585	63067833
Night sweats	50.28	9.76	181	100423	48633	63339785
Device use issue	50.16	9.76	38	100566	2592	63385826
Cardiac failure	49.59	9.76	41	100563	89101	63299317
Sepsis	48.95	9.76	106	100498	153017	63235401
Application site swelling	48.85	9.76	22	100582	556	63387862
Fibromyalgia	48.71	9.76	254	100350	80166	63308252
Hypotension	48.20	9.76	245	100359	272359	63116059
Liver injury	47.82	9.76	18	100586	60502	63327916
Progesterone receptor assay positive	47.68	9.76	19	100585	351	63388067
Application site discolouration	47.26	9.76	24	100580	797	63387621
Oral pain	46.73	9.76	124	100480	28270	63360148
Arthritis	46.54	9.76	329	100275	115592	63272826
Product packaging issue	46.42	9.76	27	100577	1179	63387239
Breast cancer in situ	45.78	9.76	29	100575	1479	63386939
Ophthalmic vein thrombosis	45.15	9.76	16	100588	210	63388208
Product odour abnormal	44.62	9.76	27	100577	1269	63387149
Hyperhidrosis	44.43	9.76	308	100296	107528	63280890
Application site dermatitis	44.24	9.76	15	100589	171	63388247
Fibrocystic breast disease	44.07	9.76	26	100578	1166	63387252
Sleep apnoea syndrome	43.73	9.76	123	100481	29010	63359408
Breast enlargement	43.62	9.76	29	100575	1607	63386811
Application site erosion	43.55	9.76	15	100589	180	63388238
Colitis ischaemic	43.38	9.76	68	100536	10640	63377778
Application site inflammation	43.35	9.76	18	100586	371	63388047
Therapeutic product effect decreased	43.07	9.76	159	100445	193028	63195390
Multiple organ dysfunction syndrome	43.00	9.76	18	100586	56734	63331684
Disease progression	42.62	9.76	81	100523	122677	63265741
Mucosal inflammation	42.36	9.76	11	100593	46917	63341501
Musculoskeletal stiffness	41.78	9.76	151	100453	184467	63203951
Muscle spasms	41.63	9.76	404	100200	155746	63232672
Mood swings	41.12	9.76	90	100514	18158	63370260
Diastolic dysfunction	41.08	9.76	51	100553	6420	63381998
Cardio-respiratory arrest	40.85	9.76	22	100582	59937	63328481
Bladder prolapse	40.79	9.76	31	100573	2125	63386293
Disease recurrence	40.77	9.76	117	100487	27913	63360505
Malignant neoplasm progression	40.67	9.76	42	100562	82079	63306339
Alopecia	40.10	9.76	342	100262	337194	63051224
Platelet count decreased	39.98	9.76	77	100527	116045	63272373
Product shape issue	39.85	9.76	12	100592	90	63388328
Butterfly rash	39.19	9.76	28	100576	1745	63386673
Vulvovaginal mycotic infection	38.80	9.76	46	100558	5520	63382898
Nasal polyps	37.38	9.76	47	100557	5992	63382426
Therapeutic response unexpected	37.25	9.76	88	100516	18671	63369747
Breast pain	37.22	9.76	57	100547	8741	63379677
Discomfort	36.49	9.76	139	100465	167235	63221183
Diverticulum	36.45	9.76	67	100537	11924	63376494
Lower respiratory tract infection	36.43	9.76	99	100505	132208	63256210
Muscle injury	36.41	9.76	30	100574	65315	63323103
Oestradiol increased	36.13	9.76	11	100593	86	63388332
Wrong technique in device usage process	36.05	9.76	36	100568	3562	63384856
Product packaging quantity issue	36.02	9.76	24	100580	1335	63387083
Joint swelling	35.86	9.76	339	100265	327327	63061091
Influenza like illness	35.71	9.76	204	100400	66620	63321798
Respiratory failure	35.54	9.76	67	100537	101791	63286627
Dyspareunia	35.18	9.76	30	100574	2425	63385993
Type 2 diabetes mellitus	34.75	9.76	30	100574	63838	63324580
Dermatitis contact	34.08	9.76	62	100542	10946	63377472
Placenta accreta	34.05	9.76	13	100591	213	63388205
Endometrial cancer	33.67	9.76	33	100571	3192	63385226
Application site dryness	33.62	9.76	12	100592	161	63388257
Eczema	33.48	9.76	120	100484	32171	63356247
Osteopenia	33.16	9.76	87	100517	19698	63368720
Abdominal distension	33.12	9.76	243	100361	86372	63302046
Septic shock	33.08	9.76	34	100570	66595	63321823
Vision blurred	32.96	9.76	254	100350	91670	63296748
Lactic acidosis	32.65	9.76	10	100594	38277	63350141
Oestradiol decreased	32.54	9.76	8	100596	24	63388394
Overdose	32.52	9.76	85	100519	114993	63273425
Vulvovaginal injury	32.34	9.76	16	100588	502	63387916
Anxiety	32.29	9.76	504	100100	217037	63171381
Hepatic enzyme increased	31.81	9.76	189	100415	202139	63186279
Tricuspid valve incompetence	31.69	9.76	71	100533	14550	63373868
Application site exfoliation	31.28	9.76	15	100589	439	63387979
Hepatic function abnormal	31.14	9.76	10	100594	37132	63351286
Mobility decreased	30.91	9.76	94	100510	121065	63267353
Tinnitus	30.84	9.76	125	100479	35503	63352915
Palpitations	30.65	9.76	293	100311	112477	63275941
Hypoglycaemia	30.56	9.76	30	100574	60035	63328383
Irritability	30.52	9.76	115	100489	31579	63356839
Confusional state	30.11	9.76	235	100369	236145	63152273
Spinal operation	30.06	9.76	50	100554	8221	63380197
Rectal prolapse	29.99	9.76	25	100579	1958	63386460
Decreased appetite	29.96	9.76	254	100350	250798	63137620
Endometrial stromal sarcoma	29.84	9.76	7	100597	16	63388402
Stomatitis	29.73	9.76	116	100488	138609	63249809
Lung disorder	29.54	9.76	33	100571	62228	63326190
Surgery	29.51	9.76	124	100480	35788	63352630
Endometrial hyperplasia	29.44	9.76	18	100586	862	63387556
Female genital tract fistula	29.24	9.76	47	100557	7512	63380906
Renal failure	28.80	9.76	93	100511	117559	63270859
Endometrial cancer stage I	28.57	9.76	12	100592	255	63388163
Coma	28.52	9.76	36	100568	64328	63324090
Delirium	28.41	9.76	23	100581	50518	63337900
Cholestasis	28.35	9.76	6	100598	29428	63358990
Renal impairment	27.53	9.76	62	100542	88293	63300125
White blood cell count decreased	27.51	9.76	120	100484	138984	63249434
Pseudoprecocious puberty	27.25	9.76	5	100599	0	63388418
Application site ulcer	27.08	9.76	9	100595	96	63388322
Nipple pain	26.92	9.76	12	100592	296	63388122
Skin burning sensation	26.67	9.76	61	100543	12673	63375745
Stress	26.58	9.76	190	100414	66977	63321441
Therapy non-responder	26.41	9.76	50	100554	75851	63312567
Blood creatinine increased	26.28	9.76	63	100541	87781	63300637
Bone marrow failure	26.18	9.76	7	100597	29283	63359135
Application site discharge	26.02	9.76	10	100594	167	63388251
Emphysema	25.85	9.76	55	100549	10883	63377535
Gastrooesophageal reflux disease	25.74	9.76	248	100356	95391	63293027
Spinal stenosis	25.39	9.76	66	100538	14859	63373559
Periodontal disease	25.39	9.76	21	100583	1627	63386791
Poor quality product administered	25.24	9.76	28	100576	3128	63385290
Pre-existing condition improved	24.98	9.76	46	100558	8198	63380220
Red blood cell sedimentation rate increased	24.74	9.76	20	100584	43962	63344456
Crying	24.41	9.76	87	100517	23256	63365162
Blood cholesterol increased	24.41	9.76	242	100362	93790	63294628
Photosensitivity reaction	24.19	9.76	65	100539	14929	63373489
Hypothalamo-pituitary disorder	24.17	9.76	15	100589	738	63387680
Therapeutic product effect increased	24.16	9.76	18	100586	1197	63387221
Vulvovaginal erythema	24.10	9.76	11	100593	287	63388131
Condition aggravated	24.03	9.76	471	100133	401746	62986672
Application site discomfort	23.98	9.76	12	100592	386	63388032
Bradycardia	23.96	9.76	50	100554	73177	63315241
Haemoglobin decreased	23.88	9.76	134	100470	145351	63243067
Carpal tunnel syndrome	23.87	9.76	80	100524	20737	63367681
Feeling hot	23.87	9.76	149	100455	50205	63338213
Incorrect product administration duration	23.84	9.76	55	100549	11491	63376927
Insulin-like growth factor increased	23.81	9.76	16	100588	903	63387515
Loss of personal independence in daily activities	23.74	9.76	77	100527	97213	63291205
Gastrointestinal haemorrhage	23.67	9.76	59	100545	81117	63307301
Libido decreased	23.63	9.76	25	100579	2647	63385771
Bone density abnormal	23.55	9.76	28	100576	3370	63385048
Endometrial hypertrophy	23.45	9.76	11	100593	306	63388112
Meniscus injury	23.22	9.76	41	100563	7073	63381345
Live birth	23.15	9.76	6	100598	25624	63362794
Suicide attempt	23.12	9.76	38	100566	60880	63327538
Hyponatraemia	23.06	9.76	95	100509	111805	63276613
Vulvovaginal swelling	22.98	9.76	13	100591	538	63387880
Hypoxia	22.97	9.76	37	100567	59755	63328663
Vomiting	22.85	9.76	694	99910	558923	62829495
Psoriasis	22.67	9.76	224	100380	86733	63301685
Pneumonia	22.65	9.76	551	100053	456216	62932202
Uterine leiomyoma	22.61	9.76	47	100557	9151	63379267
Breast mass	22.50	9.76	43	100561	7879	63380539
Sinus rhythm	22.41	9.76	15	100589	841	63387577
Memory impairment	22.26	9.76	258	100346	104000	63284418
Cystocele	22.22	9.76	17	100587	1177	63387241
Sinusitis	22.09	9.76	492	100112	226161	63162257
Pleural effusion	21.90	9.76	75	100529	93135	63295283
Uterine polyp	21.44	9.76	21	100583	2029	63386389
Ventricular dyskinesia	21.36	9.76	8	100596	124	63388294
Breast discomfort	21.29	9.76	12	100592	493	63387925
Metabolic acidosis	21.26	9.76	24	100580	45045	63343373
Neoplasm progression	21.20	9.76	16	100588	36412	63352006
Breast calcifications	21.20	9.76	17	100587	1261	63387157
Impaired healing	21.17	9.76	87	100517	102455	63285963
Chronic sinusitis	21.04	9.76	56	100548	12787	63375631
Hypokalaemia	20.85	9.76	89	100515	103715	63284703
Altered state of consciousness	20.79	9.76	7	100597	25223	63363195
Stress urinary incontinence	20.77	9.76	22	100582	2333	63386085
Drug ineffective	20.74	9.76	1922	98682	1042843	62345575
Gastrointestinal disorder	20.40	9.76	123	100481	131116	63257302
Atrophic vulvovaginitis	20.17	9.76	19	100585	1749	63386669
Histamine intolerance	20.16	9.76	6	100598	43	63388375
Pulmonary fibrosis	20.12	9.76	20	100584	39789	63348629
Oral herpes	19.86	9.76	88	100516	25986	63362432
Vessel puncture site bruise	19.81	9.76	11	100593	439	63387979
Hiatus hernia	19.68	9.76	77	100527	21517	63366901
Interstitial lung disease	19.65	9.76	43	100561	61865	63326553
Device expulsion	19.49	9.76	16	100588	34906	63353512
Intervertebral disc degeneration	19.43	9.76	62	100542	15670	63372748
Burning sensation	19.31	9.76	150	100454	54257	63334161
Product availability issue	19.29	9.76	28	100576	4093	63384325
Muscle fatigue	19.23	9.76	22	100582	2542	63385876
Breast cancer female	19.14	9.76	56	100548	13503	63374915
Dermal absorption impaired	19.06	9.76	6	100598	53	63388365
Expulsion of medication	19.04	9.76	5	100599	21	63388397
Lymphogranuloma venereum	19.03	9.76	4	100600	4	63388414
Corticosteroid binding globulin increased	19.03	9.76	4	100600	4	63388414
Vaginal disorder	19.01	9.76	13	100591	755	63387663
Hypomagnesaemia	18.92	9.76	11	100593	28726	63359692
Retinal vein occlusion	18.86	9.76	20	100584	2123	63386295
Application site infection	18.77	9.76	6	100598	56	63388362
Withdrawal bleed	18.49	9.76	6	100598	59	63388359
Intestinal polyp	18.49	9.76	17	100587	1518	63386900
Thyroxine decreased	18.44	9.76	12	100592	641	63387777
Product colour issue	18.38	9.76	12	100592	645	63387773
Paraesthesia	18.33	9.76	350	100254	156616	63231802
Anaemia	18.31	9.76	341	100263	293089	63095329
Vitamin D decreased	18.16	9.76	46	100558	10196	63378222
Intentional self-injury	18.13	9.76	9	100595	25678	63362740
Neutrophil count decreased	18.05	9.76	39	100565	56367	63332051
Palmar-plantar erythrodysaesthesia syndrome	17.92	9.76	7	100597	23008	63365410
Injection site inflammation	17.83	9.76	26	100578	3817	63384601
Ill-defined disorder	17.74	9.76	68	100536	81687	63306731
Product taste abnormal	17.68	9.76	19	100585	2048	63386370
Right ventricular failure	17.62	9.76	3	100601	17185	63371233
Breast hyperplasia	17.61	9.76	9	100595	303	63388115
International normalised ratio increased	17.58	9.76	29	100575	46396	63342022
Periorbital oedema	17.58	9.76	32	100572	5652	63382766
Prescribed overdose	17.44	9.76	17	100587	34136	63354282
Low density lipoprotein increased	17.44	9.76	34	100570	6323	63382095
Thermal burn	17.40	9.76	33	100571	6013	63382405
Rectocele	17.36	9.76	14	100590	1047	63387371
Product prescribing error	17.29	9.76	85	100519	26204	63362214
Respiratory distress	17.22	9.76	17	100587	33934	63354484
Atypical haemolytic uraemic syndrome	17.16	9.76	12	100592	723	63387695
Osteoporosis	17.09	9.76	152	100452	57186	63331232
Pregnancy	16.96	9.76	20	100584	36816	63351602
Shock	16.89	9.76	8	100596	23455	63364963
Emotional disorder	16.77	9.76	53	100551	13326	63375092
Head discomfort	16.68	9.76	53	100551	13362	63375056
Craniopharyngioma	16.57	9.76	7	100597	151	63388267
Pituitary tumour	16.56	9.76	13	100591	935	63387483
Prosopagnosia	16.55	9.76	5	100599	38	63388380
Endometriosis	16.51	9.76	30	100574	5290	63383128
Poor quality sleep	16.51	9.76	69	100535	19866	63368552
Creatinine renal clearance decreased	16.38	9.76	3	100601	16305	63372113
Abnormal dreams	16.37	9.76	45	100559	10471	63377947
Bacterial vulvovaginitis	16.30	9.76	12	100592	784	63387634
Drug resistance	16.24	9.76	8	100596	22925	63365493
Breast disorder	16.15	9.76	20	100584	2510	63385908
Hip arthroplasty	16.04	9.76	32	100572	47614	63340804
Ovarian atrophy	16.02	9.76	6	100598	93	63388325
Pelvic infection	16.01	9.76	9	100595	368	63388050
COVID-19	15.99	9.76	260	100344	112843	63275575
Spinal osteoarthritis	15.81	9.76	59	100545	16127	63372291
Acute respiratory distress syndrome	15.50	9.76	9	100595	23525	63364893
Uterine haemorrhage	15.46	9.76	25	100579	4016	63384402
Dyspnoea	15.46	9.76	874	99730	660439	62727979
Soft tissue swelling	15.42	9.76	14	100590	1230	63387188
Infusion site erythema	15.32	9.76	47	100557	11632	63376786
Pericardial effusion	15.30	9.76	15	100589	30043	63358375
Blood pressure increased	15.22	9.76	350	100254	161712	63226706
Myalgia	15.20	9.76	321	100283	146208	63242210
Back pain	15.19	9.76	536	100068	263609	63124809
Inflammation	15.05	9.76	73	100531	82200	63306218
Blood pressure systolic abnormal	14.96	9.76	51	100553	13335	63375083
Aptyalism	14.95	9.76	10	100594	560	63387858
Drug reaction with eosinophilia and systemic symptoms	14.91	9.76	19	100585	33817	63354601
Umbilical hernia	14.88	9.76	21	100583	2993	63385425
Transfusion	14.86	9.76	3	100601	15214	63373204
Periodontitis	14.83	9.76	22	100582	3281	63385137
Mediastinal effusion	14.75	9.76	5	100599	57	63388361
Urinary incontinence	14.72	9.76	94	100510	31920	63356498
Device colour issue	14.66	9.76	4	100600	20	63388398
Expired product administered	14.51	9.76	31	100573	6150	63382268
Melaena	14.51	9.76	16	100588	30349	63358069
Product outer packaging issue	14.50	9.76	4	100600	21	63388397
Myelosuppression	14.33	9.76	10	100594	23693	63364725
Tachycardia	14.32	9.76	119	100485	118037	63270381
Product design issue	14.27	9.76	3	100601	3	63388415
Vaginal prolapse	14.21	9.76	9	100595	459	63387959
Cold urticaria	14.18	9.76	6	100598	130	63388288
Tenderness	14.14	9.76	72	100532	22506	63365912
Poikiloderma	14.08	9.76	7	100597	222	63388196
Foetal exposure during pregnancy	14.03	9.76	18	100586	31944	63356474
Irritable bowel syndrome	14.01	9.76	75	100529	82337	63306081
Injection site pain	14.00	9.76	286	100318	129514	63258904
Inappropriate schedule of product administration	13.96	9.76	237	100367	103728	63284690
Thyrotoxic periodic paralysis	13.91	9.76	4	100600	25	63388393
Amnesia	13.91	9.76	142	100462	55443	63332975
Retinal vein thrombosis	13.83	9.76	9	100595	481	63387937
Trans-sexualism	13.81	9.76	3	100601	4	63388414
Mood altered	13.78	9.76	53	100551	14690	63373728
Application site pustules	13.78	9.76	4	100600	26	63388392
Poor venous access	13.70	9.76	53	100551	14732	63373686
Budd-Chiari syndrome	13.69	9.76	5	100599	72	63388346
Intentional product use issue	13.67	9.76	133	100471	127759	63260659
Vulvovaginal inflammation	13.57	9.76	11	100593	828	63387590
Scar	13.26	9.76	50	100554	13732	63374686
Neck pain	13.25	9.76	168	100436	69150	63319268
Hepatic cytolysis	13.18	9.76	4	100600	15403	63373015
Oestrogen deficiency	13.10	9.76	6	100598	158	63388260
Weight increased	13.02	9.76	521	100083	260271	63128147
Medication error	13.02	9.76	41	100563	52243	63336175
Obesity	13.01	9.76	17	100587	29935	63358483
Device physical property issue	13.00	9.76	16	100588	1996	63386422
Lip swelling	12.94	9.76	89	100515	30974	63357444
Post procedural cellulitis	12.93	9.76	5	100599	85	63388333
Vertebrobasilar insufficiency	12.86	9.76	6	100598	165	63388253
Cor pulmonale acute	12.83	9.76	8	100596	397	63388021
Electrolyte imbalance	12.77	9.76	8	100596	20068	63368350
Pituitary tumour recurrent	12.77	9.76	5	100599	88	63388330
Chest discomfort	12.76	9.76	245	100359	109724	63278694
Product administered at inappropriate site	12.76	9.76	20	100584	3129	63385289
Application site nodule	12.75	9.76	3	100601	7	63388411
Respiratory arrest	12.73	9.76	20	100584	32625	63355793
Endometrial disorder	12.62	9.76	10	100594	729	63387689
Breast cyst	12.61	9.76	15	100589	1806	63386612
Pain	12.57	9.76	1007	99597	739621	62648797
Infusion site swelling	12.52	9.76	39	100565	9731	63378687
Limb injury	12.46	9.76	76	100528	25401	63363017
Heliotrope rash	12.35	9.76	6	100598	181	63388237
Premature delivery	12.34	9.76	18	100586	30263	63358155
Neck injury	12.33	9.76	16	100588	2105	63386313
Sedation	12.28	9.76	27	100577	38782	63349636
Pulmonary embolism	12.22	9.76	256	100348	116428	63271990
Blood oestrogen abnormal	12.20	9.76	3	100601	9	63388409
Application site laceration	12.20	9.76	3	100601	9	63388409
Breast swelling	12.16	9.76	13	100591	1393	63387025
Adnexa uteri pain	12.15	9.76	8	100596	436	63387982
Muscle tightness	12.14	9.76	44	100560	11856	63376562
Blood pressure abnormal	12.11	9.76	52	100552	15146	63373272
Application site scab	12.08	9.76	6	100598	190	63388228
Liver disorder	12.07	9.76	44	100560	53643	63334775
Product use complaint	11.86	9.76	17	100587	2457	63385961
Hypogonadism	11.83	9.76	5	100599	108	63388310
Product storage error	11.79	9.76	51	100553	14905	63373513
Tandem gait test abnormal	11.77	9.76	4	100600	46	63388372
Limb discomfort	11.71	9.76	84	100520	29632	63358786
Gingival recession	11.70	9.76	13	100591	1454	63386964
External ear disorder	11.69	9.76	4	100600	47	63388371
Intercepted product prescribing error	11.69	9.76	6	100598	204	63388214
Eye irritation	11.68	9.76	67	100537	21904	63366514
Candida infection	11.68	9.76	81	100523	28270	63360148
XIth nerve injury	11.61	9.76	4	100600	48	63388370
Disseminated intravascular coagulation	11.57	9.76	8	100596	19043	63369375
Exposure keratitis	11.54	9.76	4	100600	49	63388369
Eosinophilic pleural effusion	11.54	9.76	4	100600	49	63388369
Tracheal pain	11.47	9.76	4	100600	50	63388368
Ultrasound liver abnormal	11.47	9.76	4	100600	50	63388368
Rotator cuff syndrome	11.39	9.76	47	100557	13455	63374963
Pelvic pain	11.35	9.76	47	100557	13472	63374946
Parotid gland enlargement	11.31	9.76	10	100594	848	63387570
Encephalopathy	11.31	9.76	28	100576	38592	63349826
Uterine disorder	11.31	9.76	19	100585	3150	63385268
Suspected product quality issue	11.30	9.76	6	100598	219	63388199
Product dispensing error	11.29	9.76	39	100565	10266	63378152
Agranulocytosis	11.19	9.76	14	100590	25120	63363298
Pain in extremity	11.18	9.76	637	99967	330849	63057569
Blood testosterone decreased	11.12	9.76	4	100600	55	63388363
Dry eye	11.11	9.76	106	100498	40655	63347763
Acne	11.08	9.76	69	100535	23224	63365194
Alanine aminotransferase abnormal	11.05	9.76	23	100581	4481	63383937
Musculoskeletal discomfort	11.04	9.76	57	100547	17910	63370508
Hyperglycaemia	11.02	9.76	32	100572	41835	63346583
Low turnover osteopathy	11.02	9.76	22	100582	4163	63384255
Respiratory depression	10.99	9.76	47	100557	13668	63374750
Meningioma surgery	10.99	9.76	4	100600	57	63388361
Procedural pain	10.97	9.76	65	100539	21504	63366914
Product physical consistency issue	10.96	9.76	9	100595	690	63387728
Pneumonia aspiration	10.95	9.76	24	100580	34516	63353902
Full blood count abnormal	10.94	9.76	21	100583	31696	63356722
Xanthoma	10.93	9.76	4	100600	58	63388360
Posterior reversible encephalopathy syndrome	10.91	9.76	7	100597	17338	63371080
Frontotemporal dementia	10.89	9.76	7	100597	366	63388052
Tachypnoea	10.86	9.76	7	100597	17295	63371123
Muscle atrophy	10.85	9.76	30	100574	7003	63381415
Carpal tunnel decompression	10.83	9.76	10	100594	898	63387520
Application site haemorrhage	10.81	9.76	11	100593	1113	63387305
Transferrin decreased	10.79	9.76	6	100598	240	63388178
Adenomyosis	10.77	9.76	8	100596	530	63387888
Breast disorder female	10.76	9.76	5	100599	136	63388282
Neck surgery	10.76	9.76	14	100590	1846	63386572
Orthostatic hypotension	10.76	9.76	26	100578	36134	63352284
Product prescribing issue	10.74	9.76	17	100587	2682	63385736
Cystitis interstitial	10.73	9.76	13	100591	1595	63386823
Acute hepatic failure	10.73	9.76	8	100596	18319	63370099
Gingival ulceration	10.62	9.76	10	100594	920	63387498
Hyperlipidaemia	10.61	9.76	60	100544	19511	63368907
Impatience	10.59	9.76	7	100597	384	63388034
Product residue present	10.57	9.76	21	100583	3958	63384460
Atrial fibrillation	10.57	9.76	126	100478	116510	63271908
Hepatic rupture	10.57	9.76	4	100600	64	63388354
Hypervolaemia	10.52	9.76	18	100586	28395	63360023
Neurotoxicity	10.50	9.76	7	100597	16983	63371435
Productive cough	10.48	9.76	58	100546	63150	63325268
Spinal disorder	10.43	9.76	37	100567	9865	63378553
Essential hypertension	10.42	9.76	24	100580	5009	63383409
Stress fracture	10.40	9.76	32	100572	7931	63380487
Blister	10.37	9.76	144	100460	129670	63258748
Accidental overdose	10.36	9.76	13	100591	23296	63365122
Eye haematoma	10.34	9.76	4	100600	68	63388350
Leukopenia	10.30	9.76	176	100428	77114	63311304
Lip injury	10.30	9.76	10	100594	956	63387462
Mammogram abnormal	10.30	9.76	9	100595	752	63387666
Blood corticotrophin increased	10.24	9.76	4	100600	70	63388348
Menopause	10.16	9.76	17	100587	2808	63385610
Upper gastrointestinal haemorrhage	10.08	9.76	9	100595	18843	63369575
Body height decreased	10.06	9.76	37	100567	10041	63378377
Hyperthyroidism	10.05	9.76	48	100556	14625	63373793
Iron deficiency anaemia	10.04	9.76	60	100544	19909	63368509
Peliosis hepatis	10.03	9.76	4	100600	74	63388344
Withdrawal syndrome	10.00	9.76	60	100544	19937	63368481
Spider naevus	9.96	9.76	5	100599	162	63388256
Seasonal allergy	9.93	9.76	62	100542	20888	63367530
Increased tendency to bruise	9.92	9.76	38	100566	10514	63377904
Benign breast neoplasm	9.91	9.76	11	100593	1229	63387189
Vaginal ulceration	9.90	9.76	7	100597	429	63387989
Tongue erythema	9.87	9.76	7	100597	431	63387987
Facial asymmetry	9.86	9.76	9	100595	796	63387622
Toothache	9.85	9.76	58	100546	19141	63369277
Repetitive strain injury	9.85	9.76	5	100599	166	63388252
Fall	9.79	9.76	515	100089	391819	62996599

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
Meningioma	140.91	40.55	26	1020	1410	34954475
Off label use	68.06	40.55	72	974	419452	34536433
Invasive ductal breast carcinoma	60.24	40.55	8	1038	45	34955840
Keratoconus	53.25	40.55	8	1038	119	34955766
Foetal exposure during pregnancy	50.52	40.55	24	1022	38077	34917808
Product use issue	49.68	40.55	28	1018	63188	34892697
Gynaecomastia	47.80	40.55	16	1030	10164	34945721
Prolactin-producing pituitary tumour	45.61	40.55	6	1040	31	34955854
Hyperprolactinaemia	43.54	40.55	10	1036	1586	34954299
Oestradiol increased	42.04	40.55	6	1040	61	34955824
Premature baby	40.92	40.55	17	1029	19616	34936269

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
Product adhesion issue	1415.18	10.57	357	73872	2347	79667812
Meningioma	532.33	10.57	186	74043	4112	79666047
Application site rash	415.77	10.57	130	74099	2002	79668157
Hot flush	359.93	10.57	342	73887	54535	79615624
Vulvovaginal discomfort	264.46	10.57	89	74140	1749	79668410
Application site pruritus	257.75	10.57	106	74123	3704	79666455
Application site erythema	240.34	10.57	110	74119	5000	79665159
Product quality issue	208.29	10.57	204	74025	33736	79636423
Death	175.04	10.57	162	74067	566352	79103807
Application site irritation	172.81	10.57	64	74165	1680	79668479
Vulvovaginal pain	161.39	10.57	65	74164	2150	79668009
Ovarian hyperstimulation syndrome	158.97	10.57	74	74155	3497	79666662
Vaginal haemorrhage	141.12	10.57	135	74094	21682	79648477
Toxicity to various agents	135.54	10.57	116	74113	421424	79248735
Acute kidney injury	132.31	10.57	174	74055	519230	79150929
Menopausal symptoms	130.70	10.57	54	74175	1909	79668250
Pneumonia viral	121.35	10.57	86	74143	9072	79661087
Vulvovaginal burning sensation	116.26	10.57	47	74182	1570	79668589
Hysterectomy	112.24	10.57	71	74158	6201	79663958
Colitis microscopic	111.07	10.57	87	74142	10681	79659478
Migraine	110.91	10.57	249	73980	87244	79582915
Headache	109.30	10.57	1006	73223	652766	79017393
Vulvovaginal dryness	104.98	10.57	48	74181	2176	79667983
Febrile neutropenia	101.41	10.57	44	74185	230955	79439204
Application site reaction	97.69	10.57	34	74195	742	79669417
Drug abuse	97.38	10.57	17	74212	162674	79507485
Neutropenia	95.08	10.57	77	74152	287633	79382526
Breast tenderness	94.80	10.57	45	74184	2223	79667936
Vaginal discharge	94.10	10.57	68	74161	7395	79662764
Soft tissue disorder	92.36	10.57	51	74178	3464	79666695
Salpingo-oophorectomy unilateral	91.52	10.57	33	74196	801	79669358
Bronchitis	90.91	10.57	298	73931	130346	79539813
Product physical issue	89.27	10.57	53	74176	4132	79666027
Blood oestrogen decreased	88.46	10.57	22	74207	135	79670024
Product complaint	87.08	10.57	83	74146	13266	79656893
Thrombocytopenia	82.75	10.57	75	74154	265184	79404975
Fibromyalgia	78.07	10.57	180	74049	64160	79605999
Glaucoma	77.77	10.57	94	74135	19667	79650492
Application site vesicles	77.28	10.57	34	74195	1406	79668753
Device adhesion issue	76.97	10.57	59	74170	7016	79663143
Sinusitis fungal	75.18	10.57	39	74190	2335	79667824
Postmenopausal haemorrhage	74.84	10.57	34	74195	1518	79668641
Feeling abnormal	73.97	10.57	319	73910	158880	79511279
Product substitution issue	72.71	10.57	92	74137	20164	79649995
Skin reaction	72.52	10.57	82	74147	15986	79654173
Diverticulitis	72.47	10.57	143	74086	45793	79624366
Oestrogen receptor assay positive	72.28	10.57	22	74207	308	79669851
Cardiac arrest	72.06	10.57	35	74194	172061	79498098
Application site pain	70.93	10.57	48	74181	4699	79665460
Wrong technique in product usage process	69.94	10.57	188	74041	73687	79596472
Breast cancer	69.55	10.57	118	74111	33663	79636496
Hyperkalaemia	68.35	10.57	12	74217	114386	79555773
Application site burn	68.35	10.57	27	74202	848	79669311
Sepsis	67.71	10.57	91	74138	269337	79400822
Pancytopenia	67.46	10.57	35	74194	165710	79504449
Application site urticaria	65.03	10.57	19	74210	229	79669930
Depression	63.79	10.57	382	73847	216408	79453751
Multiple organ dysfunction syndrome	62.95	10.57	17	74212	120229	79549930
Cardiac failure	62.57	10.57	33	74196	154809	79515350
Hypotension	62.43	10.57	206	74023	440111	79230048
Device use issue	61.33	10.57	36	74193	2748	79667411
Sinusitis	61.08	10.57	350	73879	195151	79475008
Progesterone receptor assay positive	60.65	10.57	18	74211	230	79669929
Vulvovaginal pruritus	60.52	10.57	35	74194	2598	79667561
Device material issue	60.51	10.57	18	74211	232	79669927
Thyroid disorder	60.41	10.57	70	74159	14009	79656150
Vaginal infection	59.55	10.57	47	74182	5833	79664326
Breast cancer in situ	59.54	10.57	25	74204	921	79669238
Embolism venous	58.93	10.57	41	74188	4198	79665961
Pemphigus	58.29	10.57	11	74218	99571	79570588
Completed suicide	57.79	10.57	87	74142	245680	79424479
Butterfly rash	56.99	10.57	29	74200	1667	79668492
General physical health deterioration	56.81	10.57	106	74123	275132	79395027
Respiratory symptom	56.66	10.57	42	74187	4749	79665410
Fungal infection	56.48	10.57	122	74107	41626	79628533
Pyrexia	56.00	10.57	386	73843	678323	78991836
Sputum increased	55.81	10.57	41	74188	4572	79665587
Hand deformity	55.72	10.57	14	74215	103905	79566254
Oestradiol increased	55.34	10.57	14	74215	93	79670066
Bladder prolapse	55.30	10.57	27	74202	1420	79668739
Platelet count decreased	54.98	10.57	60	74169	194604	79475555
Incorrect dose administered by product	53.94	10.57	16	74213	204	79669955
Ophthalmic vein thrombosis	52.57	10.57	16	74213	224	79669935
Anti-cyclic citrullinated peptide antibody positive	49.06	10.57	9	74220	83134	79587025
Blood cholesterol increased	48.69	10.57	180	74049	83540	79586619
Cardio-respiratory arrest	48.66	10.57	20	74209	108490	79561669
Incorrect dose administered by device	48.64	10.57	39	74190	4950	79665209
Vaginal odour	47.33	10.57	17	74212	408	79669751
Osteopenia	47.22	10.57	71	74158	18293	79651866
Hormone level abnormal	47.05	10.57	27	74202	1975	79668184
Intentional overdose	46.76	10.57	20	74209	105940	79564219
Malignant neoplasm progression	46.65	10.57	35	74194	135955	79534204
Female genital tract fistula	46.47	10.57	41	74188	5934	79664225
Product dose omission issue	45.83	10.57	390	73839	247147	79423012
Respiratory failure	45.53	10.57	61	74168	180850	79489309
Hypoglycaemia	45.11	10.57	19	74210	101575	79568584
Septic shock	44.23	10.57	30	74199	122771	79547388
Pericarditis	43.93	10.57	21	74208	104215	79565944
Prolactin-producing pituitary tumour	43.66	10.57	12	74217	114	79670045
Colitis ischaemic	43.27	10.57	62	74167	15297	79654862
Fibrocystic breast disease	43.15	10.57	18	74211	652	79669507
Renal impairment	43.06	10.57	50	74179	157733	79512426
Nasal polyps	43.01	10.57	43	74186	7284	79662875
Mucosal inflammation	42.87	10.57	9	74220	75571	79594588
Renal failure	41.80	10.57	77	74152	200891	79469268
Muscle spasms	41.63	10.57	292	73937	174438	79495721
Placenta accreta	41.58	10.57	13	74216	200	79669959
Herpes zoster	41.28	10.57	184	74045	92899	79577260
Vulvovaginal mycotic infection	40.96	10.57	34	74195	4532	79665627
Diverticulum	40.32	10.57	59	74170	14837	79655322
Insomnia	40.10	10.57	376	73853	244794	79425365
Overdose	39.73	10.57	69	74160	184137	79486022
Wound	39.72	10.57	30	74199	116149	79554010
Disease recurrence	39.49	10.57	110	74119	43999	79626160
Bradycardia	39.14	10.57	41	74188	135516	79534643
Hepatic function abnormal	38.90	10.57	10	74219	73097	79597062
Rheumatoid factor positive	38.67	10.57	5	74224	59834	79610325
Breast cancer female	37.92	10.57	50	74179	11411	79658748
Eczema	37.74	10.57	103	74126	40715	79629444
Vulvovaginal injury	37.68	10.57	13	74216	276	79669883
Oral pain	37.51	10.57	88	74141	31710	79638449
Gastrooesophageal reflux disease	37.50	10.57	194	74035	104052	79566107
Influenza like illness	37.45	10.57	149	74080	71558	79598601
Arthritis	37.39	10.57	208	74021	114672	79555487
Rectal prolapse	37.34	10.57	24	74205	2154	79668005
Carpal tunnel syndrome	37.30	10.57	66	74163	19462	79650697
Osteoporosis	37.22	10.57	123	74106	53989	79616170
Anaemia	37.17	10.57	252	73977	444763	79225396
Gastrointestinal haemorrhage	36.97	10.57	50	74179	147669	79522490
Arthralgia	36.73	10.57	741	73488	571062	79099097
Lactic acidosis	36.72	10.57	10	74219	70349	79599810
Delirium	35.73	10.57	17	74212	84610	79585549
Vaginal erosion	35.66	10.57	7	74222	10	79670149
Disease progression	35.43	10.57	74	74155	184288	79485871
Liver function test abnormal	35.31	10.57	136	74093	64339	79605820
Blood creatinine increased	34.43	10.57	57	74172	155000	79515159
Bone density abnormal	34.35	10.57	26	74203	3034	79667125
Keratoconus	34.34	10.57	10	74219	119	79670040
Drug interaction	34.22	10.57	236	73993	414947	79255212
Application site scar	34.22	10.57	11	74218	186	79669973
Product odour abnormal	33.94	10.57	19	74210	1325	79668834
Glossodynia	33.67	10.57	28	74201	103309	79566850
Uterine polyp	33.63	10.57	20	74209	1564	79668595
Hypoxia	33.60	10.57	28	74201	103215	79566944
Breast enlargement	33.57	10.57	20	74209	1569	79668590
Pseudoprecocious puberty	33.45	10.57	6	74223	3	79670156
Decreased appetite	33.22	10.57	185	74044	342233	79327926
Blood oestrogen increased	33.08	10.57	9	74220	82	79670077
Pneumonia	33.06	10.57	425	73804	659821	79010338
Pain in extremity	32.94	10.57	499	73730	364039	79306120
Spinal stenosis	32.29	10.57	55	74174	15736	79654423
Cholestasis	32.16	10.57	5	74224	52104	79618055
Vulvovaginal erythema	31.78	10.57	11	74218	236	79669923
Product shape issue	31.77	10.57	8	74221	52	79670107
Spinal operation	31.71	10.57	38	74191	7879	79662280
Duodenal ulcer perforation	31.69	10.57	11	74218	66200	79603959
Vision blurred	31.36	10.57	187	74042	105711	79564448
Oral herpes	31.32	10.57	75	74154	27379	79642780
Palpitations	30.98	10.57	213	74016	126397	79543762
Endometrial cancer	30.87	10.57	21	74208	2073	79668086
Tricuspid valve incompetence	30.64	10.57	61	74168	19651	79650508
Memory impairment	30.38	10.57	193	74036	111541	79558618
Injection site pain	30.34	10.57	216	74013	129622	79540537
Endometrial cancer stage I	30.07	10.57	10	74219	189	79669970
Intermenstrual bleeding	29.97	10.57	32	74197	5852	79664307
Breast mass	29.68	10.57	34	74195	6720	79663439
Coma	29.55	10.57	30	74199	100619	79569540
Diastolic dysfunction	29.52	10.57	43	74186	10768	79659391
Helicobacter infection	29.43	10.57	14	74215	69690	79600469
Systemic lupus erythematosus	29.32	10.57	42	74187	121107	79549052
Interstitial lung disease	29.32	10.57	37	74192	112563	79557596
Bone marrow failure	29.16	10.57	6	74223	51101	79619058
Sleep apnoea syndrome	28.83	10.57	87	74142	36391	79633768
Chronic sinusitis	28.81	10.57	47	74182	12979	79657180
Endometrial stromal sarcoma	28.67	10.57	6	74223	14	79670145
Metabolic acidosis	28.61	10.57	21	74208	82508	79587651
Paraesthesia	28.60	10.57	270	73959	176053	79494106
Periodontal disease	28.16	10.57	19	74210	1851	79668308
Back pain	28.09	10.57	418	73811	303762	79366397
Feeling hot	27.94	10.57	120	74109	59614	79610545
Product size issue	27.85	10.57	14	74215	784	79669375
Endometrial hyperplasia	27.75	10.57	13	74216	623	79669536
Endometrial hypertrophy	26.83	10.57	9	74220	175	79669984
Neutrophil count decreased	26.47	10.57	29	74200	93930	79576229
Injection site inflammation	26.46	10.57	25	74204	3951	79666208
Head discomfort	26.40	10.57	48	74181	14454	79655705
Anxiety	26.36	10.57	350	73879	248162	79421997
Tinnitus	26.34	10.57	96	74133	44237	79625922
Burning sensation	26.06	10.57	116	74113	58516	79611643
Weight increased	25.93	10.57	382	73847	277004	79393155
Hiatus hernia	25.86	10.57	63	74166	23249	79646910
Stress	25.80	10.57	144	74085	79468	79590691
Porphyria non-acute	25.73	10.57	13	74216	736	79669423
Vitamin D decreased	25.57	10.57	38	74191	9687	79660472
Therapeutic response unexpected	25.51	10.57	57	74172	19889	79650270
White blood cell count decreased	25.33	10.57	90	74139	188198	79481961
Altered state of consciousness	25.31	10.57	5	74224	43817	79626342
Confusional state	25.09	10.57	183	74046	317814	79352345
Arthropathy	24.95	10.57	83	74146	177028	79493131
Meniscus injury	24.70	10.57	31	74198	6737	79663422
Dermatitis contact	24.66	10.57	40	74189	10993	79659166
Pneumonia aspiration	24.59	10.57	16	74213	66951	79603208
Melaena	24.55	10.57	13	74216	60877	79609282
Photosensitivity reaction	24.41	10.57	58	74171	21069	79649090
Haemoglobin decreased	24.35	10.57	115	74114	222004	79448155
Breast pain	24.22	10.57	34	74195	8231	79661928
Respiratory distress	24.20	10.57	12	74217	58327	79611832
Histamine intolerance	24.10	10.57	6	74223	37	79670122
International normalised ratio increased	24.03	10.57	26	74203	84695	79585464
Vessel puncture site bruise	24.01	10.57	11	74218	501	79669658
Psoriasis	23.89	10.57	154	74075	89433	79580726
Prosopagnosia	23.83	10.57	6	74223	39	79670120
Vaginal disorder	23.43	10.57	11	74218	530	79669629
Osteoarthritis	23.23	10.57	150	74079	87159	79583000
Shock	23.08	10.57	6	74223	43542	79626617
Dyspareunia	22.94	10.57	17	74212	1921	79668238
Blood pressure systolic abnormal	22.87	10.57	50	74179	17197	79652962
Uterine haemorrhage	22.74	10.57	20	74209	2883	79667276
Uterine leiomyoma	22.70	10.57	29	74200	6414	79663745
Hypothalamo-pituitary disorder	22.58	10.57	14	74215	1180	79668979
Lung disorder	22.54	10.57	25	74204	80532	79589627
Application site dermatitis	22.51	10.57	8	74221	186	79669973
Emphysema	22.46	10.57	48	74181	16252	79653907
Intervertebral disc degeneration	22.35	10.57	47	74182	15738	79654421
Product packaging issue	22.17	10.57	14	74215	1219	79668940
Hyponatraemia	21.98	10.57	88	74141	177760	79492399
Pleural effusion	21.91	10.57	66	74163	145196	79524963
Application site hypersensitivity	21.60	10.57	9	74220	325	79669834
Invasive ductal breast carcinoma	21.52	10.57	27	74202	5865	79664294
Application site ulcer	21.47	10.57	7	74222	124	79670035
Stress urinary incontinence	21.42	10.57	16	74213	1830	79668329
Muscle tightness	21.33	10.57	41	74188	12873	79657286
Crying	21.15	10.57	58	74171	22985	79647174
Corticosteroid binding globulin increased	21.15	10.57	4	74225	4	79670155
Thyroxine decreased	21.12	10.57	12	74217	861	79669298
Limb discomfort	21.11	10.57	73	74156	32777	79637382
Procedural pain	21.09	10.57	58	74171	23026	79647133
Nausea	21.00	10.57	1090	73139	956106	78714053
Prostate cancer	20.97	10.57	3	74226	33265	79636894
Periorbital oedema	20.91	10.57	32	74197	8370	79661789
Respiratory arrest	20.79	10.57	14	74215	57536	79612623
Hyperglycaemia	20.61	10.57	21	74208	70314	79599845
Dehydration	20.46	10.57	141	74088	248046	79422113
Therapy non-responder	20.42	10.57	34	74195	92271	79577888
Body height decreased	20.41	10.57	32	74197	8548	79661611
Oestradiol decreased	20.26	10.57	4	74225	6	79670153
Mood swings	20.24	10.57	52	74177	19828	79650331
Skin irritation	20.20	10.57	37	74192	11203	79658956
Poor venous access	20.08	10.57	49	74180	18100	79652059
Tachypnoea	19.96	10.57	3	74226	32060	79638099
Acute respiratory distress syndrome	19.95	10.57	8	74221	44059	79626100
Lymphogranuloma venereum	19.88	10.57	4	74225	7	79670152
Pituitary tumour	19.81	10.57	13	74216	1209	79668950
Vulvovaginal swelling	19.72	10.57	9	74220	406	79669753
Poor quality sleep	19.69	10.57	56	74173	22666	79647493
Cystocele	19.68	10.57	11	74218	765	79669394
Intestinal polyp	19.57	10.57	16	74213	2088	79668071
Application site erosion	19.49	10.57	8	74221	278	79669881
Night sweats	19.46	10.57	98	74131	51997	79618162
Atrophic vulvovaginitis	19.44	10.57	13	74216	1248	79668911
Ovarian atrophy	19.39	10.57	6	74223	89	79670070
Rhabdomyolysis	19.30	10.57	42	74187	103089	79567070
Insulin-like growth factor increased	18.94	10.57	15	74214	1871	79668288
Thermal burn	18.86	10.57	28	74201	7132	79663027
Encephalopathy	18.77	10.57	21	74208	67376	79602783
Retinal vein occlusion	18.58	10.57	19	74210	3304	79666855
Application site inflammation	18.58	10.57	9	74220	465	79669694
Atrial fibrillation	18.58	10.57	108	74121	197778	79472381
Drug resistance	18.57	10.57	8	74221	42205	79627954
Product taste abnormal	18.50	10.57	16	74213	2255	79667904
Incorrect product administration duration	18.44	10.57	37	74192	11985	79658174
Infusion related reaction	18.39	10.57	132	74097	230105	79440054
Breast calcifications	18.37	10.57	11	74218	871	79669288
Ovarian failure	18.29	10.57	10	74219	666	79669493
Fatigue	18.26	10.57	1048	73181	928679	78741480
Skin burning sensation	18.19	10.57	39	74190	13233	79656926
Sleep disorder due to general medical condition, insomnia type	18.00	10.57	9	74220	43547	79626612
Drug reaction with eosinophilia and systemic symptoms	17.91	10.57	20	74209	64224	79605935
Gender dysphoria	17.87	10.57	5	74224	51	79670108
Expulsion of medication	17.78	10.57	5	74224	52	79670107
Electrocardiogram QT prolonged	17.59	10.57	36	74193	90350	79579809
Hyperhidrosis	17.59	10.57	217	74012	151275	79518884
Low density lipoprotein increased	17.59	10.57	30	74199	8592	79661567
Hypomagnesaemia	17.51	10.57	11	74218	46900	79623259
Soft tissue swelling	17.39	10.57	13	74216	1488	79668671
Tenderness	17.39	10.57	55	74174	23587	79646572
Neck pain	17.34	10.57	125	74104	75292	79594867
Subdural haematoma	17.31	10.57	4	74225	31430	79638729
Wrong technique in device usage process	17.23	10.57	20	74209	4008	79666151
Application site dryness	17.23	10.57	7	74222	237	79669922
Pelvic infection	17.22	10.57	8	74221	376	79669783
Mediastinal effusion	17.21	10.57	5	74224	59	79670100
Endometriosis	17.03	10.57	19	74210	3649	79666510
Spinal osteoarthritis	16.95	10.57	44	74185	16883	79653276
Dermal absorption impaired	16.94	10.57	4	74225	19	79670140
Uterine disorder	16.88	10.57	15	74214	2192	79667967
Atypical haemolytic uraemic syndrome	16.78	10.57	11	74218	1021	79669138
Transposition of the great vessels	16.77	10.57	5	74224	65	79670094
Ventricular dyskinesia	16.76	10.57	8	74221	400	79669759
Exposure during pregnancy	16.69	10.57	44	74185	101088	79569071
Stress fracture	16.58	10.57	25	74204	6455	79663704
Haematuria	16.52	10.57	24	74205	68812	79601347
Breast discomfort	16.47	10.57	8	74221	416	79669743
Upper gastrointestinal haemorrhage	16.44	10.57	9	74220	41371	79628788
Urinary tract infection	16.34	10.57	352	73877	274160	79395999
Rectocele	16.23	10.57	9	74220	616	79669543
Meningioma benign	16.04	10.57	7	74222	284	79669875
Muscle fatigue	15.95	10.57	18	74211	3501	79666658
Hepatic cytolysis	15.88	10.57	3	74226	27148	79643011
Oestrone increased	15.86	10.57	3	74226	3	79670156
Pruritus	15.82	10.57	480	73749	394168	79275991
Folliculitis	15.70	10.57	17	74212	55363	79614796
Iron deficiency anaemia	15.59	10.57	56	74173	25616	79644543
Cytokine release syndrome	15.55	10.57	7	74222	35991	79634168
Disseminated intravascular coagulation	15.44	10.57	7	74222	35835	79634324
Poor quality product administered	15.43	10.57	18	74211	3627	79666532
Trans-sexualism	15.40	10.57	3	74226	4	79670155
Injection site bruising	15.22	10.57	77	74152	40925	79629234
Swelling face	15.22	10.57	116	74113	71096	79599063
Exposure via skin contact	15.21	10.57	7	74222	322	79669837
Neck surgery	15.19	10.57	13	74216	1806	79668353
Toothache	15.19	10.57	47	74182	19923	79650236
Palmar-plantar erythrodysaesthesia syndrome	15.02	10.57	6	74223	33128	79637031
Heliotrope rash	14.97	10.57	6	74223	196	79669963
Dizziness	14.84	10.57	615	73614	525826	79144333
Tooth fracture	14.80	10.57	33	74196	11497	79658662
Application site exfoliation	14.70	10.57	8	74221	528	79669631
Breast cyst	14.59	10.57	11	74218	1276	79668883
Vulvovaginal inflammation	14.56	10.57	8	74221	538	79669621
Poor quality device used	14.51	10.57	14	74215	2271	79667888
Neoplasm progression	14.50	10.57	16	74213	51666	79618493
Pericardial effusion	14.48	10.57	13	74216	46224	79623935
Hormone receptor positive breast cancer	14.48	10.57	7	74222	360	79669799
Full blood count abnormal	14.42	10.57	10	74219	40464	79629695
Hypokalaemia	14.39	10.57	77	74152	143963	79526196
Blood pressure diastolic decreased	14.36	10.57	61	74168	30155	79640004
Limb injury	14.33	10.57	60	74169	29468	79640691
Illness	14.32	10.57	83	74146	46428	79623731
Liver injury	14.32	10.57	19	74210	56595	79613564
Myelosuppression	14.29	10.57	10	74219	40286	79629873
Cardiogenic shock	14.09	10.57	11	74218	41903	79628256
Paranasal sinus inflammation	14.09	10.57	6	74223	229	79669930
Myalgia	14.08	10.57	247	73982	185394	79484765
Pain in jaw	13.98	10.57	82	74147	46069	79624090
Pulmonary embolism	13.97	10.57	231	73998	171423	79498736
Haemoptysis	13.96	10.57	19	74210	55980	79614179
Visual impairment	13.91	10.57	139	74090	91992	79578167
Cystitis interstitial	13.89	10.57	11	74218	1372	79668787
Poikiloderma	13.86	10.57	7	74222	396	79669763
Pneumonitis	13.85	10.57	22	74207	60838	79609321
Bacterial vulvovaginitis	13.79	10.57	8	74221	597	79669562
Abdominal distension	13.72	10.57	171	74058	119479	79550680
Breast disorder	13.69	10.57	13	74216	2068	79668091
Frontotemporal dementia	13.67	10.57	8	74221	607	79669552
Tachycardia	13.67	10.57	103	74126	177665	79492494
Candida infection	13.65	10.57	71	74158	38143	79632016
Maternal exposure during pregnancy	13.64	10.57	73	74156	136465	79533694
Type 2 diabetes mellitus	13.62	10.57	20	74209	57102	79613057
Benign breast neoplasm	13.56	10.57	9	74220	853	79669306
Application site discolouration	13.54	10.57	9	74220	855	79669304
COVID-19	13.50	10.57	214	74015	157460	79512699
Jaundice	13.40	10.57	18	74211	53331	79616828
Electrolyte imbalance	13.35	10.57	6	74223	30875	79639284
Tumour lysis syndrome	13.27	10.57	3	74226	23936	79646223
Vaginal ulceration	13.10	10.57	6	74223	273	79669886
Orthostatic hypotension	13.07	10.57	20	74209	56144	79614015
Neurotoxicity	13.02	10.57	7	74222	32511	79637648
Nipple pain	12.97	10.57	9	74220	917	79669242
Intentional self-injury	12.95	10.57	7	74222	32412	79637747
Right ventricular failure	12.92	10.57	3	74226	23494	79646665
Breast hyperplasia	12.90	10.57	5	74224	149	79670010
Retinal vein thrombosis	12.87	10.57	8	74221	677	79669482
Libido decreased	12.87	10.57	20	74209	5301	79664858
Vertigo	12.84	10.57	109	74120	68973	79601186
Repetitive strain injury	12.81	10.57	5	74224	152	79670007
Spider naevus	12.78	10.57	5	74224	153	79670006
Spinal disorder	12.76	10.57	29	74200	10231	79659928
Cor pulmonale acute	12.76	10.57	8	74221	688	79669471
Gastroenteritis	12.65	10.57	64	74165	34018	79636141
Urinary incontinence	12.60	10.57	73	74156	40836	79629323
Agranulocytosis	12.57	10.57	14	74215	45016	79625143
Vertebrobasilar insufficiency	12.48	10.57	6	74223	305	79669854
Testicular cancer metastatic	12.48	10.57	4	74225	67	79670092
Intercepted product prescribing error	12.46	10.57	6	74223	306	79669853
Hypocalcaemia	12.38	10.57	17	74212	49907	79620252
Inflammatory myofibroblastic tumour	12.34	10.57	5	74224	168	79669991
Post procedural cellulitis	12.32	10.57	4	74225	70	79670089
Pre-existing condition improved	12.21	10.57	20	74209	5543	79664616
Application site swelling	12.18	10.57	8	74221	745	79669414
Testicular mass	12.16	10.57	4	74225	73	79670086
Pulmonary congestion	12.14	10.57	5	74224	27095	79643064
Dry eye	12.09	10.57	67	74162	36864	79633295
Obesity	12.09	10.57	9	74220	35116	79635043
Precocious puberty	12.05	10.57	6	74223	329	79669830
Emotional disorder	12.02	10.57	35	74194	14352	79655807
Growth accelerated	11.98	10.57	3	74226	19	79670140
Unresponsive to stimuli	11.92	10.57	21	74208	55767	79614392
Hyperprolactinaemia	11.91	10.57	18	74211	4658	79665501
Atypical femur fracture	11.85	10.57	19	74210	5170	79664989
Withdrawal syndrome	11.83	10.57	53	74176	26801	79643358
Pituitary tumour recurrent	11.81	10.57	5	74224	188	79669971
Irritability	11.76	10.57	72	74157	41072	79629087
Intraductal proliferative breast lesion	11.73	10.57	13	74216	2478	79667681
Chest discomfort	11.68	10.57	187	74042	137857	79532302
Breast injury	11.68	10.57	4	74225	83	79670076
Eyelid pain	11.68	10.57	6	74223	352	79669807
Blood bilirubin increased	11.56	10.57	28	74201	66204	79603955
Eye swelling	11.49	10.57	52	74177	26416	79643743
Deep vein thrombosis	11.47	10.57	167	74062	120752	79549407
Myelodysplastic syndrome	11.45	10.57	7	74222	30294	79639865
External ear disorder	11.42	10.57	4	74225	89	79670070
Diabetic ketoacidosis	11.42	10.57	9	74220	34113	79636046
Feeling cold	11.41	10.57	55	74174	28674	79641485
Uterine haematoma	11.37	10.57	3	74226	24	79670135
Product administration interrupted	11.37	10.57	16	74213	3883	79666276
Injection site erythema	11.33	10.57	117	74112	78080	79592079
Pulmonary oedema	11.32	10.57	43	74186	88211	79581948
Increased tendency to bruise	11.31	10.57	28	74201	10436	79659723
Blood pressure increased	11.31	10.57	267	73962	211093	79459066
Rash maculo-papular	11.20	10.57	22	74207	56056	79614103
Cerebral haemorrhage	11.20	10.57	23	74206	57650	79612509
Lip injury	11.19	10.57	9	74220	1147	79669012
Cardiac failure congestive	11.19	10.57	82	74147	142320	79527839
Transferrin decreased	11.18	10.57	6	74223	385	79669774
Product outer packaging issue	11.16	10.57	3	74226	26	79670133
Surgery	11.10	10.57	60	74169	32706	79637453
Uterine cervix stenosis	11.07	10.57	5	74224	220	79669939
Iron binding capacity total decreased	11.07	10.57	6	74223	393	79669766
Deep dissecting haematoma	11.06	10.57	3	74226	27	79670132
Product colour issue	11.05	10.57	8	74221	872	79669287
Acute myocardial infarction	10.91	10.57	36	74193	77000	79593159
Budd-Chiari syndrome	10.91	10.57	4	74225	102	79670057
Migraine with aura	10.86	10.57	13	74216	2692	79667467
Incorrect dose administered	10.80	10.57	114	74115	76516	79593643
Hospitalisation	10.79	10.57	48	74181	94188	79575971
Hepatic rupture	10.76	10.57	4	74225	106	79670053
Gait disturbance	10.76	10.57	261	73968	207245	79462914
Oropharyngeal pain	10.75	10.57	152	74077	109201	79560958
Spondylolisthesis	10.73	10.57	14	74215	3161	79666998
Multiple use of single-use product	10.70	10.57	8	74221	916	79669243
Sedation	10.68	10.57	20	74209	51875	79618284

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G03AA14	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations
ATC	G03AA17	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations
ATC	G03AB08	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations
ATC	G03CA03	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ESTROGENS Natural and semisynthetic estrogens, plain
ATC	G03CA53	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ESTROGENS Natural and semisynthetic estrogens, plain
ATC	H01CC53	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones
ATC	H01CC54	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones
FDA CS	M0447348	Estradiol Congeners
FDA MoA	N0000000100	Estrogen Receptor Agonists
MeSH PA	D004967	Estrogens
MeSH PA	D006728	Hormones
FDA EPC	N0000175825	Estrogen
CHEBI has role	CHEBI:50114	estrogens
CHEBI has role	CHEBI:62872	quinoline oxidase inhibitors
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:83056	Daphnia magna metabolites
CHEBI has role	CHEBI:176497	geroprotectors

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

Disease	Relation	SNOMED_ID	DOID
Premenstrual dysphoric disorder	indication	596004
Contraception	indication	13197004
Female hypogonadism syndrome	indication	16041008
Atrophic vaginitis	indication	52441000
Urethral atrophy	indication	52620003
Primary ovarian failure	indication	65846009
Acne vulgaris	indication	88616000
Postmenopausal osteoporosis	indication	102447009
Ovarian deficiency symptoms	indication	111550004
Vasomotor symptoms associated with menopausal disorder	indication	123756000
Menopausal flushing	indication	198436008
Atrophic vulva	indication	248861000	DOID:14275
Hormone replacement cycle in embryo transfer	indication	266717002
Controlled ovarian stimulation	indication	732970000
Advanced Prostatic Carcinoma	indication
Metastatic Prostate Carcinoma	indication
Metastatic Breast Carcinoma	indication
Amenorrhea	off-label use	14302001	DOID:13938
Polycystic ovaries	off-label use	69878008
Dysmenorrhea	off-label use	266599000
Postcoital contraception	off-label use	268463003
Abnormal uterine bleeding unrelated to menstrual cycle	off-label use	312984006
Menorrhagia	off-label use	386692008
Pre-Menopausal Osteoporosis	off-label use
Heart valve disorder	contraindication	368009	DOID:4079
Hyperlipoproteinemia	contraindication	3744001	DOID:1168
Gynecomastia	contraindication	4754008	DOID:12698
Hypocalcemia	contraindication	5291005
Alcoholism	contraindication	7200002
Weight gain finding	contraindication	8943002
Hypercholesterolemia	contraindication	13644009
Hyperkalemia	contraindication	14140009
Jaundice	contraindication	18165001
Toxic shock syndrome	contraindication	18504008	DOID:14115
Myocardial infarction	contraindication	22298006	DOID:5844
Fibroadenosis of breast	contraindication	23260002	DOID:10352
Diplopia	contraindication	24982008
Retinal hemorrhage	contraindication	28998008
Depressive disorder	contraindication	35489007
Chloasma	contraindication	36209000
Migraine	contraindication	37796009	DOID:6364
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Hypothyroidism	contraindication	40930008	DOID:1459
Body fluid retention	contraindication	43498006
Thrombosis of retinal vein	contraindication	46085004
Humoral hypercalcemia of malignancy	contraindication	47709007
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Dementia	contraindication	52448006
Hepatic porphyria	contraindication	55056006	DOID:3133
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Hyperlipidemia	contraindication	55822004	DOID:1168
Heart disease	contraindication	56265001	DOID:114
Anorexia nervosa	contraindication	56882008	DOID:8689
Benign mammary dysplasia	contraindication	57993004
Acute nephropathy	contraindication	58574008
Obstructive hyperbilirubinemia	contraindication	59848001
Hepatic failure	contraindication	59927004
Cerebrovascular disease	contraindication	62914000	DOID:6713
Thrombophlebitis	contraindication	64156001	DOID:3875
Osteoporosis	contraindication	64859006	DOID:11476
Intermenstrual bleeding - irregular	contraindication	64996003
Hypercalcemia	contraindication	66931009	DOID:12678
Diabetes mellitus	contraindication	73211009	DOID:9351
Sleep apnea	contraindication	73430006	DOID:0050847
Hyperglycemia	contraindication	80394007	DOID:4195
Heart failure	contraindication	84114007	DOID:6000
Epilepsy	contraindication	84757009	DOID:1826
Breast lump	contraindication	89164003
Kidney disease	contraindication	90708001	DOID:557
Malignant neoplasm of liver	contraindication	93870000	DOID:3571
Uterine fibroids	contraindication	95315005	DOID:13223
Neoplasm of prostate	contraindication	126906006	DOID:10283
Neoplasm of female genital organ	contraindication	126907002	DOID:120
Deep venous thrombosis	contraindication	128053003
Seizure disorder	contraindication	128613002
Endometriosis	contraindication	129103003
Bed-ridden	contraindication	160685001
Liver function tests abnormal	contraindication	166603001
Mammography abnormal	contraindication	168750009
Angina pectoris	contraindication	194828000
Asthma	contraindication	195967001	DOID:2841
Cerebrovascular accident	contraindication	230690007
Pulmonary thromboembolism	contraindication	233935004
Thrombophilia	contraindication	234467004	DOID:2452
Disease of liver	contraindication	235856003	DOID:409
Cholestasis of pregnancy	contraindication	235888006
Metabolic syndrome X	contraindication	237602007	DOID:14221
Endometrial carcinoma	contraindication	254878006	DOID:2871
Benign prostatic hyperplasia	contraindication	266569009
Edema	contraindication	267038008
Chorea	contraindication	271700006
Pregnancy, function	contraindication	289908002
Hypertriglyceridemia	contraindication	302870006
Osteopenia	contraindication	312894000
Functional visual loss	contraindication	313165001
Non-Q wave myocardial infarction	contraindication	314207007
Malignant tumor of cervix	contraindication	363354003	DOID:4362
Malignant tumor of ovary	contraindication	363443007	DOID:2394
Thromboembolic disorder	contraindication	371039008
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Cardiovascular event risk	contraindication	395112001
Breastfeeding (mother)	contraindication	413712001
Chronic lung disease	contraindication	413839001
Disorder of coronary artery	contraindication	414024009
Obesity	contraindication	414916001	DOID:9970
Estrogen receptor positive tumor	contraindication	416053008
Porphyria	contraindication	418470004
Resistance to activated protein C due to Factor V Leiden	contraindication	421527008
Optic disc edema	contraindication	423341008	DOID:146
Family history of malignant neoplasm of breast	contraindication	429740004
Hypertensive urgency	contraindication	443482000
Carcinoma of female breast	contraindication	447782002
Smokes tobacco daily	contraindication	449868002
Nonspecific Abnormal Papanicolaou Smear of Cervix	contraindication
Diabetes with Vascular Disease Complication	contraindication
Major Surgery with Prolonged Post-Operative Immobilization	contraindication
Worsening Headache Disorder	contraindication
Acute Thromboembolic Stroke	contraindication
Benign Hepatic Cell Adenoma	contraindication
Breast Carcinoma in Males	contraindication

🐶 Veterinary Drug Use

Species	Use	Relation
Cattle	To increase rate of weight gain	Indication
Cattle	To improve feed efficiency	Indication
Cattle	Synchronization of estrus/ovulation	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Compudose 200, Encore (Compudose 400 )	Elanco US Inc.	2
Component E-H with Tylan	Elanco US Inc.	3
Revalor-G, Revalor-IS, Revalor-S	Intervet Inc.	2
Revalor-200, Revalor-H, Revalor-IH	Intervet Inc.	2
Revalor-XH, Revalor-XS	Intervet Inc.	2
Revalor-XR	Intervet Inc.	2
Component TE-G, Component TE-G with Tylan, Component TE-ID with Tylan, Component TE-IS, Component TE-IS with Tylan, Component TE-S, Component TE-S with Tylan	Elanco US Inc.	3
Component TE-200 with Tylan, Component TE-H with Tylan, Component TE-IH with Tylan	Elanco US Inc.	3
Synovex T120, Synovex T40, Synovex T80	Zoetis Inc.	2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.13	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	9346822	Feb. 17, 2024	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
0.025MG/24HR	MINIVELLE	NOVEN	N203752	Sept. 23, 2014	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.0375MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.05MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.075MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.1MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE	N213388	May 29, 2020	RX	CAPSULE	ORAL	11459305	Nov. 7, 2028	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11351182	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11351182	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11497709	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11497709	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11351182	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11351182	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11497709	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11497709	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	10206932	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	10675288	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	11033626	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	8846648	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	8846649	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	8933059	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	9114145	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	9114146	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Dec. 28, 2021	DISCN	CAPSULE	ORAL	9301920	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10206932	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10675288	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10806740	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	11033626	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	11103513	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	8846648	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	8846649	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9006222	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9114145	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9114146	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	MAYNE PHARMA	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9301920	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11266661	Feb. 2, 2034	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11266661	Feb. 2, 2034	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11266661	Feb. 2, 2034	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	MAYNE PHARMA	N208564	May 29, 2018	RX	INSERT	VAGINAL	11266661	Feb. 2, 2034	TREATMENT OF DYSPAREUNIA
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE	N213388	May 29, 2020	RX	CAPSULE	ORAL	10881659	March 14, 2034	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE	N213388	May 29, 2020	RX	CAPSULE	ORAL	11045470	March 14, 2034	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	11033551	Sept. 29, 2037	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE	N213388	May 29, 2020	RX	CAPSULE	ORAL	11690845	Aug. 27, 2040	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) USING 300 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.1%	ESTRADIOL	CHEMO RESEARCH SL	A211783	Aug. 10, 2022	RX	GEL	TRANSDERMAL	April 8, 2023	COMPETITIVE GENERIC THERAPY
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE	N213388	May 29, 2020	RX	CAPSULE	ORAL	May 29, 2023	NEW PRODUCT
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE	N213388	May 29, 2020	RX	CAPSULE	ORAL	July 23, 2023	NEW CHEMICAL ENTITY
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	May 26, 2024	NEW PRODUCT
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	Aug. 5, 2025	FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	Dec. 18, 2025	NEW CHEMICAL ENTITY
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	Jan. 27, 2026	INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Estrogen receptor	Nuclear hormone receptor	P03372	ESR1_HUMAN	AGONIST	EC50	10.30		WOMBAT-PK	CHEMBL
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN		IC50	6.54		WOMBAT-PK
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		Ki	4.73		DRUG MATRIX
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	4.93		DRUG MATRIX
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		IC50	7.72		CHEMBL
Calcium-activated potassium channel subunit alpha-1	Ion channel	Q12791	KCMA1_HUMAN	ACTIVATOR	EC50	5.60		IUPHAR
Estrogen receptor beta	Nuclear hormone receptor	Q92731	ESR2_HUMAN		EC50	9.70		WOMBAT-PK
G-protein coupled estrogen receptor 1	GPCR	Q99527	GPER1_HUMAN		EC50	9.52		WOMBAT-PK
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	5		CHEMBL
Steryl-sulfatase	Enzyme	P08842	STS_HUMAN		IC50	4.08		CHEMBL
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	8.83		CHEMBL
Steroid hormone receptor ERR1	Nuclear hormone receptor	P11474	ERR1_HUMAN		IC50	8.44		CHEMBL
Steroid hormone receptor ERR2	Nuclear hormone receptor	O95718	ERR2_HUMAN		IC50	8.49		CHEMBL
Cytochrome P450 1B1	Enzyme	Q16678	CP1B1_HUMAN		Ki	5.72		CHEMBL
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	5.24		DRUG MATRIX
Alpha-synuclein	Transporter	P37840	SYUA_HUMAN		IC50	4.22		CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		IC50	6.39		CHEMBL
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	4.95		DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	5.37		DRUG MATRIX
Estrogen receptor	Transcription factor		ESR1_RAT		IC50	8.72		CHEMBL
Estrogen receptor beta	Transcription factor		ESR2_RAT		IC50	8.77		CHEMBL
Estrogen receptor beta	Transcription factor		ESR2_MOUSE		IC50	8.64		CHEMBL
Estrogen receptor	Transcription factor		ESR1_MOUSE		IC50	8.66		CHEMBL
Estrogen receptor	Transcription factor		ESR1_RAT ESR2_RAT		IC50	9.45		CHEMBL

External reference:

ID	Source
4021205	VUID
N0000148651	NUI
D00105	KEGG_DRUG
35380-71-3	SECONDARY_CAS_RN
4017609	VANDF
4021205	VANDF
C0014912	UMLSCUI
CHEBI:16469	CHEBI
EST	PDB_CHEM_ID
CHEMBL135	ChEMBL_ID
DB00783	DRUGBANK_ID
D004958	MESH_DESCRIPTOR_UI
5757	PUBCHEM_CID
406	INN_ID
4TI98Z838E	UNII
236859	RXNORM
160774	MMSL
18201	MMSL
36188	MMSL
4684	MMSL
6157	MMSL
73244	MMSL
8602	MMSL
d00537	MMSL
001265	NDDF
007018	NDDF
116070003	SNOMEDCT_US
126172005	SNOMEDCT_US
12839006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Estring	HUMAN PRESCRIPTION DRUG LABEL	1	0013-1042	SYSTEM	2 mg	VAGINAL	NDA	27 sections
Estring	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2150	RING	2 mg	VAGINAL	NDA	27 sections
Estring	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2150	RING	2 mg	VAGINAL	NDA	27 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5885	PATCH	0.03 mg	TRANSDERMAL	NDA	35 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5886	PATCH	0.05 mg	TRANSDERMAL	NDA	35 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5887	PATCH	0.08 mg	TRANSDERMAL	NDA	35 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5888	PATCH	0.10 mg	TRANSDERMAL	NDA	35 sections
ELESTRIN	HUMAN PRESCRIPTION DRUG LABEL	1	0037-4801	GEL, METERED	0.52 mg	TOPICAL	NDA	33 sections
ELESTRIN	HUMAN PRESCRIPTION DRUG LABEL	1	0037-4801	GEL, METERED	0.52 mg	TOPICAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0343	PATCH, EXTENDED RELEASE	0.04 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0343	PATCH, EXTENDED RELEASE	0.04 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0344	PATCH, EXTENDED RELEASE	0.05 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0344	PATCH, EXTENDED RELEASE	0.05 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0345	PATCH, EXTENDED RELEASE	0.08 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0345	PATCH, EXTENDED RELEASE	0.08 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0346	PATCH, EXTENDED RELEASE	0.10 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0346	PATCH, EXTENDED RELEASE	0.10 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0365	PATCH, EXTENDED RELEASE	0.03 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0365	PATCH, EXTENDED RELEASE	0.03 mg	TRANSDERMAL	NDA	33 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3223	INSERT	10 ug	VAGINAL	ANDA	29 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3223	INSERT	10 ug	VAGINAL	ANDA	29 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3541	CREAM	0.10 mg	VAGINAL	ANDA	25 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3541	CREAM	0.10 mg	VAGINAL	ANDA	25 sections
Mimvey	HUMAN PRESCRIPTION DRUG LABEL	2	0093-5455	TABLET, FILM COATED	1 mg	ORAL	ANDA	30 sections
Estradiol Vaginal	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1518	CREAM	0.10 mg	VAGINAL	ANDA	23 sections
Vagifem	HUMAN PRESCRIPTION DRUG LABEL	1	0169-5176	INSERT	10 ug	VAGINAL	NDA	31 sections
Vagifem	HUMAN PRESCRIPTION DRUG LABEL	1	0169-5176	INSERT	10 ug	VAGINAL	NDA	31 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3349	PATCH	0.03 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3350	PATCH	0.05 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3351	PATCH	0.08 mg	TRANSDERMAL	ANDA	30 sections