botulinum toxin type A Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5368	None

Description:

Molecule	Description
Synonyms: botulinum toxin type A nuceiva	Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings, thereby leading to denervation of the muscle and a flaccid paralysis. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

botulinum toxin type A
nuceiva

Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings, thereby leading to denervation of the muscle and a flaccid paralysis.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Sept. 27, 2019	EMA	Evolus Pharma 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
Drug ineffective	21988.15	21.85	12633	53538	665205	45954686
Product preparation error	7240.22	21.85	1565	64606	2474	46617417
Therapeutic response decreased	6827.23	21.85	2485	63686	40660	46579231
Off label use	5554.12	21.85	4426	61745	375415	46244476
Eyelid ptosis	4954.92	21.85	1247	64924	4941	46614950
Wrong technique in product usage process	3865.24	21.85	1767	64404	52655	46567236
Multiple use of single-use product	2399.89	21.85	460	65711	191	46619700
Injection site pain	2271.47	21.85	1573	64598	105579	46514312
Facial paresis	1361.14	21.85	391	65780	2777	46617114
Brow ptosis	953.83	21.85	182	65989	69	46619822
Poor quality product administered	817.55	21.85	261	65910	2748	46617143
Injection site swelling	667.09	21.85	511	65660	39816	46580075
Dysphagia	662.38	21.85	674	65497	76638	46543253
Drug ineffective for unapproved indication	639.29	21.85	356	65815	16057	46603834
Product storage error	595.18	21.85	304	65867	11488	46608403
Swelling face	577.78	21.85	528	65643	52531	46567360
Eye swelling	569.77	21.85	355	65816	19748	46600143
Product preparation issue	553.39	21.85	126	66045	281	46619610
Muscular weakness	551.90	21.85	665	65506	91179	46528712
Eyelid oedema	468.18	21.85	248	65923	10109	46609782
Botulism	401.81	21.85	82	66089	77	46619814
Vision blurred	365.32	21.85	505	65666	79203	46540688
Diarrhoea	332.99	21.85	191	65980	559411	46060480
Migraine	321.34	21.85	444	65727	69582	46550309
Skin wrinkling	308.05	21.85	93	66078	799	46619092
Facial asymmetry	304.32	21.85	86	66085	570	46619321
Anaemia	297.51	21.85	16	66155	255763	46364128
Facial paralysis	296.88	21.85	202	65969	13048	46606843
Neck pain	289.46	21.85	374	65797	54932	46564959
Diplopia	282.03	21.85	228	65943	19177	46600714
Acute kidney injury	276.65	21.85	14	66157	235841	46384050
Neuromuscular toxicity	271.24	21.85	59	66112	96	46619795
Headache	252.20	21.85	1337	64834	477015	46142876
Rheumatoid arthritis	245.79	21.85	27	66144	240188	46379703
Pneumonia	241.73	21.85	116	66055	376204	46243687
Influenza like illness	238.88	21.85	348	65823	57222	46562669
Skin tightness	227.77	21.85	111	66060	3782	46616109
Toxicity to various agents	213.59	21.85	25	66146	211741	46408150
Arthralgia	204.38	21.85	133	66038	364470	46255421
Injection site rash	195.00	21.85	169	66002	15644	46604247
Hypotension	193.68	21.85	46	66125	232543	46387348
Drug interaction	192.81	21.85	29	66142	203065	46416826
Facial pain	187.03	21.85	123	66048	7502	46612389
Product administered at inappropriate site	182.97	21.85	82	66089	2301	46617590
Eyelid sensory disorder	182.16	21.85	35	66136	15	46619876
Completed suicide	179.89	21.85	6	66165	145914	46473977
Neutropenia	176.14	21.85	6	66165	143198	46476693
Fall	173.80	21.85	128	66043	328969	46290922
Death	168.96	21.85	137	66034	335411	46284480
Thrombocytopenia	164.37	21.85	3	66168	126578	46493313
Inappropriate schedule of product administration	162.26	21.85	313	65858	64700	46555191
Lagophthalmos	161.30	21.85	44	66127	251	46619640
Sepsis	150.53	21.85	11	66160	136003	46483888
Abdominal pain	145.78	21.85	72	66099	229959	46389932
Drug hypersensitivity	141.88	21.85	85	66086	243740	46376151
Incorrect dose administered	134.69	21.85	236	65935	45314	46574577
Vomiting	130.53	21.85	280	65891	452514	46167377
Periorbital swelling	130.35	21.85	54	66117	1244	46618647
Joint swelling	130.22	21.85	37	66134	166036	46453855
Oedema peripheral	130.10	21.85	33	66138	159673	46460218
Renal failure	126.22	21.85	9	66162	113585	46506306
Therapeutic response shortened	125.40	21.85	83	66088	5116	46614775
Injection site mass	124.64	21.85	129	66042	14911	46604980
Injection site erythema	122.49	21.85	303	65868	74124	46545767
Incorrect route of product administration	122.44	21.85	133	66038	16250	46603641
Haemoglobin decreased	120.96	21.85	19	66152	128930	46490961
Hypoaesthesia	120.88	21.85	407	65764	118462	46501429
Hyponatraemia	118.72	21.85	6	66165	101326	46518565
Head discomfort	116.38	21.85	105	66066	10246	46609645
General physical health deterioration	111.01	21.85	16	66155	115753	46504138
Infusion related reaction	109.67	21.85	9	66162	101199	46518692
Maternal exposure during pregnancy	108.72	21.85	10	66161	102539	46517352
Muscle twitching	107.71	21.85	118	66053	14554	46605337
Hypertension	106.60	21.85	74	66097	196282	46423609
Platelet count decreased	105.39	21.85	10	66161	100014	46519877
Cough	104.94	21.85	103	66068	230146	46389745
Drug intolerance	104.28	21.85	39	66132	147010	46472881
Periorbital oedema	101.59	21.85	72	66099	4963	46614928
Hypokalaemia	100.66	21.85	6	66165	88018	46531873
Asthenopia	100.06	21.85	51	66120	1915	46617976
Dry eye	100.06	21.85	165	66006	30157	46589734
Contraindicated product administered	99.51	21.85	3	66168	79944	46539947
Overdose	98.25	21.85	343	65828	101636	46518255
Condition aggravated	98.07	21.85	122	66049	244930	46374961
Disease progression	96.52	21.85	9	66162	91291	46528600
Gastrointestinal haemorrhage	95.96	21.85	3	66168	77370	46542521
Peripheral swelling	94.86	21.85	53	66118	158018	46461873
Pleural effusion	93.82	21.85	6	66165	82946	46536945
Pyrexia	93.60	21.85	224	65947	348578	46271313
Dehydration	93.59	21.85	55	66116	159485	46460406
Atrial fibrillation	93.30	21.85	17	66154	103573	46516318
Infection	92.12	21.85	37	66134	133555	46486336
Cardiac failure congestive	91.98	21.85	11	66160	91739	46528152
Renal impairment	91.81	21.85	3	66168	74369	46545522
Blepharospasm	90.32	21.85	50	66121	2224	46617667
Hepatic enzyme increased	89.36	21.85	7	66164	81780	46538111
Abdominal discomfort	88.83	21.85	52	66119	151113	46468778
Swelling of eyelid	88.31	21.85	40	66131	1151	46618740
Eye pain	88.13	21.85	149	66022	27791	46592100
Blood creatinine increased	87.99	21.85	5	66166	76398	46543493
Dysphonia	87.42	21.85	178	65993	38236	46581655
Lacrimation increased	87.20	21.85	110	66061	15751	46604140
Myocardial infarction	85.72	21.85	17	66154	97511	46522380
Pulmonary embolism	85.43	21.85	24	66147	108561	46511330
Product quality issue	84.48	21.85	168	66003	35480	46584411
White blood cell count decreased	84.32	21.85	27	66144	112204	46507687
Pain in extremity	83.84	21.85	149	66022	258531	46361360
Cardiac arrest	83.23	21.85	14	66157	90385	46529506
Muscle tightness	82.90	21.85	87	66084	10218	46609673
Aspartate aminotransferase increased	82.55	21.85	8	66163	78692	46541199
Nausea	81.61	21.85	606	65565	686848	45933043
Cardiac failure	81.60	21.85	9	66162	79939	46539952
Hypoaesthesia oral	81.14	21.85	87	66084	10472	46609419
Alanine aminotransferase increased	80.77	21.85	14	66157	88437	46531454
Decreased appetite	80.17	21.85	94	66077	193742	46426149
Weight increased	79.11	21.85	70	66101	164403	46455488
Product dose omission issue	78.35	21.85	74	66097	168446	46451445
Injection site bruising	77.41	21.85	162	66009	35474	46584417
Injection site urticaria	77.20	21.85	90	66081	11877	46608014
Nasopharyngitis	77.17	21.85	63	66108	153935	46465956
Bronchitis	76.99	21.85	27	66144	105952	46513939
Confusional state	75.76	21.85	69	66102	159823	46460068
Injection site paraesthesia	73.63	21.85	27	66144	443	46619448
Drug abuse	73.48	21.85	4	66167	63404	46556487
Psoriasis	72.75	21.85	12	66159	78592	46541299
Intentional overdose	72.54	21.85	5	66166	64939	46554952
Deep vein thrombosis	72.02	21.85	13	66158	79760	46540131
Arthropathy	71.89	21.85	16	66155	84684	46535207
Treatment failure	70.62	21.85	22	66149	93065	46526826
Systemic lupus erythematosus	70.04	21.85	6	66165	65174	46554717
Back pain	68.91	21.85	120	66051	209919	46409972
Facial spasm	68.36	21.85	28	66143	626	46619265
Injection site nodule	67.54	21.85	48	66123	3323	46616568
Arthritis	66.85	21.85	14	66157	77302	46542589
Urinary tract infection	66.81	21.85	132	66039	220134	46399757
Neuropathy peripheral	66.28	21.85	23	66148	90870	46529021
Product distribution issue	63.13	21.85	22	66149	309	46619582
Burning sensation	62.93	21.85	171	66000	44240	46575651
Leukopenia	61.99	21.85	11	66160	68332	46551559
Bradycardia	61.62	21.85	10	66161	66288	46553603
Coma	61.01	21.85	6	66165	58343	46561548
Respiratory failure	61.00	21.85	29	66142	94787	46525104
Hypoxia	60.92	21.85	3	66168	51835	46568056
Septic shock	60.41	21.85	6	66165	57887	46562004
Electrocardiogram QT prolonged	60.22	21.85	3	66168	51322	46568569
Speech disorder	59.19	21.85	147	66024	36020	46583871
Blood glucose increased	58.36	21.85	15	66156	71998	46547893
Thrombosis	58.01	21.85	6	66165	56063	46563828
Fatigue	57.99	21.85	568	65603	608129	46011762
Suicide attempt	56.66	21.85	6	66165	55030	46564861
Hypoglycaemia	55.76	21.85	6	66165	54343	46565548
Intentional product misuse	55.68	21.85	170	66001	46958	46572933
Lid sulcus deepened	54.83	21.85	13	66158	37	46619854
International normalised ratio increased	54.19	21.85	3	66168	46880	46573011
Pulmonary oedema	54.10	21.85	5	66166	51100	46568791
Stomatitis	53.88	21.85	15	66156	68282	46551609
Liver function test abnormal	53.65	21.85	3	66168	46484	46573407
Ocular discomfort	53.51	21.85	40	66131	2995	46616896
Mastication disorder	53.41	21.85	34	66137	1960	46617931
Chronic obstructive pulmonary disease	52.88	21.85	9	66162	57624	46562267
Injection site oedema	52.75	21.85	24	66147	698	46619193
Exposure during pregnancy	52.07	21.85	46	66125	108166	46511725
Paralysis	51.98	21.85	63	66108	8658	46611233
Cardio-respiratory arrest	51.42	21.85	11	66160	59858	46560033
Abnormal sensation in eye	50.31	21.85	31	66140	1687	46618204
Central nervous system function test abnormal	50.04	21.85	9	66162	0	46619891
Photophobia	49.13	21.85	80	66091	14464	46605427
Pain	48.79	21.85	437	65734	476511	46143380
Injection site discomfort	48.05	21.85	40	66131	3502	46616389
C-reactive protein increased	47.87	21.85	12	66159	58578	46561313
Eyelid pain	47.70	21.85	17	66154	256	46619635
Product reconstitution quality issue	47.68	21.85	12	66159	47	46619844
Constipation	47.22	21.85	111	66060	173986	46445905
Throat tightness	45.01	21.85	94	66077	20545	46599346
Somnolence	44.72	21.85	97	66074	156424	46463467
Manufacturing product shipping issue	44.51	21.85	12	66159	65	46619826
Neutrophil count decreased	44.02	21.85	5	66166	43421	46576470
Eye discharge	43.98	21.85	44	66127	4884	46615007
Mucosal inflammation	43.52	21.85	3	66168	38973	46580918
Extraocular muscle paresis	43.44	21.85	14	66157	152	46619739
Chronic kidney disease	43.26	21.85	4	66167	40867	46579024
Oxygen saturation decreased	43.20	21.85	22	66149	69142	46550749
Erythema of eyelid	43.17	21.85	29	66142	1832	46618059
Osteoporosis	42.91	21.85	4	66167	40604	46579287
Injection site haemorrhage	42.49	21.85	92	66079	20617	46599274
Therapeutic product effect decreased	42.48	21.85	230	65941	82371	46537520
Strabismus	42.18	21.85	28	66143	1734	46618157
Abdominal distension	41.98	21.85	26	66145	73325	46546566
Paraesthesia	41.55	21.85	297	65874	117140	46502751
Diabetes mellitus	41.39	21.85	10	66161	50055	46569836
Eye pruritus	40.94	21.85	66	66105	11832	46608059
Fluid retention	40.66	21.85	11	66160	51035	46568856
Agitation	40.43	21.85	14	66157	55401	46564490
Tension headache	40.06	21.85	32	66139	2642	46617249
Osteoarthritis	39.84	21.85	19	66152	62006	46557885
Weight decreased	39.66	21.85	159	66012	210690	46409201
Injection site hypoaesthesia	39.51	21.85	16	66155	347	46619544
Madarosis	39.45	21.85	27	66144	1759	46618132
Depression	38.90	21.85	118	66053	169986	46449905
Eyelid disorder	38.50	21.85	23	66148	1183	46618708
Glossodynia	38.42	21.85	8	66163	44365	46575526
Asthma	38.22	21.85	44	66127	91498	46528393
Accidental exposure to product	38.05	21.85	89	66082	20992	46598899
Cataract	37.69	21.85	9	66162	45406	46574485
Abdominal pain upper	37.54	21.85	95	66076	145210	46474681
Rhabdomyolysis	37.45	21.85	7	66164	41902	46577989
Product packaging issue	37.11	21.85	21	66150	975	46618916
Mental status changes	37.11	21.85	5	66166	38083	46581808
Lower respiratory tract infection	36.75	21.85	16	66155	55073	46564818
Cerebrovascular accident	36.60	21.85	54	66117	100985	46518906
Depressed level of consciousness	36.50	21.85	11	66160	47558	46572333
Muscle contractions involuntary	36.48	21.85	27	66144	1991	46617900
Haematochezia	36.34	21.85	5	66166	37488	46582403
Encephalopathy	36.33	21.85	3	66168	33586	46586305
White blood cell count increased	36.23	21.85	9	66162	44210	46575681
Dyspnoea exertional	36.18	21.85	13	66158	50276	46569615
Blood pressure increased	35.76	21.85	79	66092	126587	46493304
Femur fracture	35.70	21.85	5	66166	36992	46582899
Urticaria	35.45	21.85	287	65884	117605	46502286
Muscle atrophy	35.29	21.85	43	66128	5941	46613950
Epistaxis	35.15	21.85	24	66147	64281	46555610
Lung disorder	35.12	21.85	9	66162	43295	46576596
Drug effect less than expected	35.03	21.85	10	66161	69	46619822
Torticollis	35.03	21.85	25	66146	1742	46618149
Product temperature excursion issue	34.60	21.85	7	66164	6	46619885
Blood alkaline phosphatase increased	34.59	21.85	7	66164	39602	46580289
Blood bilirubin increased	34.49	21.85	4	66167	34180	46585711
Hypoaesthesia eye	34.43	21.85	10	66161	74	46619817
Gastrointestinal disorder	34.25	21.85	21	66150	59555	46560336
Sinusitis	34.17	21.85	84	66087	129684	46490207
Colitis	33.89	21.85	6	66165	37341	46582550
Gamma-glutamyltransferase increased	33.88	21.85	3	66168	31737	46588154
Delirium	33.74	21.85	6	66165	37222	46582669
Pancreatitis	33.64	21.85	10	66161	43617	46576274
Hepatic failure	33.49	21.85	4	66167	33412	46586479
Haemorrhage	33.46	21.85	18	66153	54851	46565040
Injection site indentation	33.29	21.85	11	66160	130	46619761
Lip swelling	33.22	21.85	95	66076	25300	46594591
Eye irritation	33.16	21.85	73	66098	16541	46603350
Impaired healing	33.13	21.85	6	66165	36737	46583154
Chest pain	33.13	21.85	133	66038	176191	46443700
Hospitalisation	32.89	21.85	25	66146	63360	46556531
Wound	32.66	21.85	10	66161	42792	46577099
Product use issue	31.98	21.85	53	66118	94591	46525300
Blood pressure decreased	31.69	21.85	21	66150	57138	46562753
Liver disorder	31.66	21.85	7	66164	37239	46582652
Cutis laxa	31.47	21.85	11	66160	156	46619735
Cholelithiasis	31.44	21.85	8	66163	38673	46581218
Choking	30.94	21.85	48	66123	8328	46611563
Application site acne	30.93	21.85	6	66165	3	46619888
Rectal haemorrhage	30.93	21.85	8	66163	38247	46581644
Diverticulitis	30.66	21.85	5	66166	33034	46586857
Facial discomfort	30.62	21.85	7	66164	16	46619875
Pregnancy	30.30	21.85	96	66075	27041	46592850
Injection site anaesthesia	30.21	21.85	8	66163	40	46619851
Red blood cell count decreased	30.13	21.85	5	66166	32618	46587273
Jaundice	30.06	21.85	3	66168	28842	46591049
Ocular hyperaemia	30.04	21.85	78	66093	19632	46600259
Haematemesis	30.01	21.85	3	66168	28803	46591088
Lip disorder	29.86	21.85	19	66152	1094	46618797
Skin disorder	29.82	21.85	84	66087	22179	46597712
Nerve injury	29.65	21.85	45	66126	7660	46612231
Blood cholesterol increased	29.38	21.85	10	66161	40003	46579888
Eye contusion	29.12	21.85	21	66150	1487	46618404
Haematocrit decreased	28.98	21.85	7	66164	35050	46584841
Syncope	28.25	21.85	67	66104	104736	46515155
Diaphragmatic rupture	28.22	21.85	11	66160	215	46619676
Malaise	28.16	21.85	317	65854	330915	46288976
Eyelid thickening	27.81	21.85	8	66163	57	46619834
Intranasal hypoaesthesia	27.80	21.85	5	66166	0	46619891
Tachycardia	27.40	21.85	63	66108	99559	46520332
Hypocalcaemia	27.36	21.85	3	66168	26782	46593109
Oedema	27.18	21.85	33	66138	67038	46552853
Cellulitis	27.01	21.85	36	66135	70252	46549639
Psoriatic arthropathy	26.87	21.85	9	66162	36370	46583521
Gastrooesophageal reflux disease	26.66	21.85	40	66131	74304	46545587
Occupational exposure to product	26.65	21.85	21	66150	1700	46618191
Haemoptysis	26.58	21.85	3	66168	26186	46593705
Treatment noncompliance	26.49	21.85	5	66166	29726	46590165
Skin indentation	26.47	21.85	6	66165	13	46619878
Intestinal obstruction	26.43	21.85	3	66168	26072	46593819
Injection site pruritus	26.36	21.85	119	66052	39624	46580267
Pericardial effusion	25.74	21.85	3	66168	25540	46594351
Drug withdrawal syndrome	25.73	21.85	4	66167	27380	46592511
Drooling	25.64	21.85	27	66144	3182	46616709
Erythema	25.50	21.85	312	65859	142508	46477383
Dermatochalasis	25.46	21.85	5	66166	3	46619888
Blepharochalasis	25.46	21.85	5	66166	3	46619888
Flatulence	25.43	21.85	5	66166	28873	46591018
Alopecia	25.42	21.85	131	66040	162283	46457608
Blood pressure systolic increased	25.32	21.85	5	66166	28782	46591109
Acute myocardial infarction	25.20	21.85	7	66164	31917	46587974
Angina pectoris	24.96	21.85	4	66167	26771	46593120
Pancreatitis acute	24.87	21.85	3	66168	24869	46595022
Cerebral haemorrhage	24.80	21.85	5	66166	28366	46591525
Muscle spasms	24.66	21.85	275	65896	122838	46497053
Prescribed overdose	24.45	21.85	49	66122	10400	46609491
Dry mouth	24.33	21.85	147	66024	54779	46565112
Upper respiratory tract infection	23.97	21.85	33	66138	63523	46556368
Patient dissatisfaction with treatment	23.96	21.85	7	66164	53	46619838
Product quality control issue	23.94	21.85	6	66165	23	46619868
Blood potassium decreased	23.93	21.85	12	66159	38051	46581840
Injection site pallor	23.85	21.85	7	66164	54	46619837
Hepatic steatosis	23.79	21.85	3	66168	24039	46595852
Product supply issue	23.59	21.85	15	66156	863	46619028
Ophthalmoplegia	23.46	21.85	15	66156	871	46619020
Injury	23.31	21.85	17	66154	44010	46575881
Application site papules	23.09	21.85	7	66164	61	46619830
Wheezing	23	21.85	25	66146	53361	46566530
Cerebral infarction	22.92	21.85	3	66168	23363	46596528
Sensation of foreign body	22.90	21.85	28	66143	3883	46616008
Eyelids pruritus	22.77	21.85	13	66158	614	46619277
Dyspepsia	22.52	21.85	39	66132	68433	46551458
Skin ulcer	22.33	21.85	9	66162	32449	46587442
Eyelid contusion	22.24	21.85	4	66167	0	46619891
Dyspnoea	22.20	21.85	559	65612	514989	46104902
Procedural anxiety	22.09	21.85	12	66159	514	46619377
Unresponsive to stimuli	22.01	21.85	9	66162	32165	46587726
Hallucination	21.96	21.85	23	66148	49928	46569963

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
Drug ineffective	2203.01	25.37	1281	7295	339106	29604796
Off label use	1012.31	25.37	708	7868	248582	29695320
Product preparation error	693.67	25.37	147	8429	1559	29942343
Therapeutic response decreased	608.80	25.37	237	8339	24112	29919790
Injection site pain	370.09	25.37	178	8398	30132	29913770
Eyelid ptosis	365.70	25.37	110	8466	5078	29938824
Wrong technique in product usage process	353.43	25.37	174	8402	30981	29912921
Multiple use of single-use product	269.53	25.37	44	8532	80	29943822
Dysphagia	251.65	25.37	172	8404	56526	29887376
Muscular weakness	200.47	25.37	157	8419	63488	29880414
Migraine	116.88	25.37	62	8514	12812	29931090
Botulism	107.94	25.37	22	8554	188	29943714
Product storage error	104.27	25.37	46	8530	6345	29937557
Neuromuscular toxicity	98.38	25.37	16	8560	28	29943874
Product preparation issue	70.93	25.37	15	8561	156	29943746
Injection site swelling	59.75	25.37	35	8541	8745	29935157
Poor quality product administered	58.94	25.37	21	8555	1648	29942254
Facial paresis	58	25.37	24	8552	2826	29941076
Acute kidney injury	54.79	25.37	7	8569	273835	29670067
Brow ptosis	50.11	25.37	7	8569	0	29943902
Drug ineffective for unapproved indication	45.71	25.37	32	8544	10848	29933054
Therapeutic product effect decreased	42.76	25.37	47	8529	29029	29914873
Anaemia	42.34	25.37	5	8571	207987	29735915
Headache	42.10	25.37	131	8445	182175	29761727
Diplopia	41.10	25.37	33	8543	13739	29930163
Neck pain	34.57	25.37	36	8540	20908	29922994
Toxicity to various agents	32.04	25.37	6	8570	177177	29766725
Drug interaction	31.64	25.37	9	8567	199559	29744343
Eyelid oedema	28.87	25.37	18	8558	5027	29938875
Injection site rash	26.45	25.37	15	8561	3524	29940378
Muscle spasticity	25.94	25.37	17	8559	5171	29938731

Pharmacologic Action:

Source	Code	Description
FDA MoA	N0000175770	Acetylcholine Release Inhibitors
FDA EPC	N0000175771	Acetylcholine Release Inhibitor

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Rhytidectomy of glabellar frown lines	indication	14667004

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Synaptosomal-associated protein 25	Cytosolic other	P60880	SNP25_HUMAN	BLOCKER				SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

ID	Source
E211KPY694	UNII
93384-43-1	SECONDARY_CAS_RN
4020561	VANDF
C0006050	UMLSCUI
CHEBI:3160	CHEBI
CHEMBL4297862	ChEMBL_ID
DB00083	DRUGBANK_ID
D00783	KEGG_DRUG
1712	RXNORM
4295	MMSL
d01227	MMSL
108890005	SNOMEDCT_US
427412002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BOTOX	HUMAN PRESCRIPTION DRUG LABEL	1	0023-1145	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 [USPU]	INTRADERMAL	BLA	30 sections
BOTOX Cosmetic	HUMAN PRESCRIPTION DRUG LABEL	1	0023-3919	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 [USPU]	INTRAMUSCULAR	BLA	30 sections
BOTOX	HUMAN PRESCRIPTION DRUG LABEL	1	0023-3921	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 [USPU]	INTRADERMAL	BLA	30 sections
BOTOX Cosmetic	HUMAN PRESCRIPTION DRUG LABEL	1	0023-9232	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 [USPU]	INTRAMUSCULAR	BLA	30 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	0259-1605	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 [USPU]	INTRAMUSCULAR	BLA	31 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	0259-1610	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 [USPU]	INTRAMUSCULAR	BLA	31 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	0259-1620	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 [USPU]	INTRAMUSCULAR	BLA	31 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	0259-4110	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 [USPU]	INTRAMUSCULAR	BLA	31 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	0259-4150	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 [USPU]	INTRAMUSCULAR	BLA	31 sections
Dysport	HUMAN PRESCRIPTION DRUG LABEL	1	0299-5962	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	300 U	INTRAMUSCULAR	BLA	33 sections
Dysport	HUMAN PRESCRIPTION DRUG LABEL	1	15054-0500	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 U	INTRAMUSCULAR	BLA	31 sections
Dysport	HUMAN PRESCRIPTION DRUG LABEL	1	15054-0530	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	300 U	INTRAMUSCULAR	BLA	31 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	46783-160	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 [USPU]	INTRAMUSCULAR	BLA	31 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	46783-161	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 [USPU]	INTRAMUSCULAR	BLA	31 sections
Xeomin	HUMAN PRESCRIPTION DRUG LABEL	1	46783-165	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 [USPU]	INTRAMUSCULAR	BLA	31 sections
Jeuveau	HUMAN PRESCRIPTION DRUG LABEL	1	72301-595	POWDER	100 [USPU]	INTRAMUSCULAR	BLA	28 sections