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

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

Stem definition	Drug id	CAS RN
	4880	147245-92-9

Description:

Molecule	Description
Synonyms: glatiramer acetate copaxone protiramer	A random polymer of L-ALANINE, L-GLUTAMIC ACID, L-LYSINE, and L-TYROSINE that structurally resembles MYELIN BASIC PROTEIN. It is used in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS. Molecular weight: 559.66 Formula: C25H45N5O9 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 63.32 ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
20	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Dec. 20, 1996	FDA	TEVA PHARMS USA

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
Multiple sclerosis relapse	3602.95	15.48	1372	48457	47106	63392087
Injection site reaction	3124.55	15.48	1305	48524	57219	63381974
Injection site pain	1826.58	15.48	1181	48648	128619	63310574
Injection site erythema	1468.02	15.48	875	48954	82299	63356894
Injection site mass	1414.72	15.48	537	49292	18119	63421074
Immediate post-injection reaction	1104.52	15.48	203	49626	211	63438982
Injection site swelling	1015.62	15.48	567	49262	47005	63392188
Injection site pruritus	898.80	15.48	514	49315	44602	63394591
Injection site urticaria	745.70	15.48	313	49516	13760	63425433
Multiple sclerosis	573.46	15.48	310	49519	24062	63415131
Flushing	570.69	15.48	472	49357	74615	63364578
Injection site bruising	457.79	15.48	327	49502	41583	63397610
Fall	386.58	15.48	909	48920	391425	63047768
Urticaria	384.87	15.48	557	49272	165245	63273948
Chills	381.10	15.48	457	49372	112921	63326272
Injection site necrosis	360.89	15.48	101	49728	1243	63437950
Hypoaesthesia	324.60	15.48	519	49310	167874	63271319
Off label use	283.62	15.48	89	49740	674373	62764820
Injection site atrophy	280.76	15.48	71	49758	572	63438621
Injection site induration	247.04	15.48	128	49701	9098	63430095
Lipoatrophy	246.56	15.48	56	49773	267	63438926
Product dose omission issue	224.69	15.48	538	49291	233775	63205418
Therapy cessation	211.61	15.48	182	49647	30275	63408918
Central nervous system lesion	205.68	15.48	119	49710	10516	63428677
Influenza like illness	187.03	15.48	246	49583	66578	63372615
Chest discomfort	184.87	15.48	319	49510	109650	63329543
Gait disturbance	183.50	15.48	428	49401	182750	63256443
Injection site irritation	180.76	15.48	85	49744	4893	63434300
Palpitations	176.47	15.48	317	49512	112453	63326740
Injection site warmth	176.07	15.48	123	49706	15072	63424121
Lipodystrophy acquired	175.04	15.48	59	49770	1393	63437800
Balance disorder	171.78	15.48	267	49562	84155	63355038
Product substitution issue	170.38	15.48	123	49706	15873	63423320
Injection site scar	165.96	15.48	52	49777	966	63438227
Rheumatoid arthritis	165.86	15.48	8	49821	253811	63185382
Injection site haemorrhage	162.24	15.48	142	49687	24172	63415021
Memory impairment	155.40	15.48	287	49542	103971	63335222
Magnetic resonance imaging abnormal	154.62	15.48	66	49763	3019	63436174
Throat tightness	153.45	15.48	139	49690	24748	63414445
Contraindicated product administered	152.08	15.48	4	49825	217644	63221549
Acute kidney injury	147.63	15.48	17	49812	263398	63175795
Optic neuritis	146.36	15.48	88	49741	8347	63430846
Toxicity to various agents	146.24	15.48	13	49816	247237	63191956
Tremor	144.57	15.48	320	49509	131919	63307274
Embolia cutis medicamentosa	142.12	15.48	38	49791	389	63438804
Abortion	140.50	15.48	58	49771	2438	63436755
Infusion related reaction	139.72	15.48	15	49814	245506	63193687
Joint swelling	130.73	15.48	47	49782	327619	63111574
Injection related reaction	130.53	15.48	41	49788	768	63438425
Paraesthesia	129.85	15.48	341	49488	156625	63282568
Anaemia	126.02	15.48	37	49792	293393	63145800
Motor dysfunction	124.41	15.48	87	49742	10674	63428519
Injection site indentation	116.76	15.48	28	49801	176	63439017
Injection site rash	115.84	15.48	105	49724	18704	63420489
Glossodynia	115.66	15.48	6	49823	178870	63260323
Chest pain	109.20	15.48	395	49434	215564	63223629
Systemic lupus erythematosus	108.66	15.48	17	49812	208901	63230292
Depression	108.49	15.48	370	49459	196122	63243071
Dyspnoea	108.19	15.48	886	48943	660427	62778766
Diarrhoea	106.94	15.48	254	49575	715112	62724081
Injection site discolouration	106.34	15.48	70	49759	7778	63431415
Therapy change	104.36	15.48	63	49766	6018	63433175
Arthropathy	103.76	15.48	28	49801	234764	63204429
Burning sensation	98.19	15.48	163	49666	54244	63384949
Product use issue	96.13	15.48	27	49802	220493	63218700
Seizure	95.57	15.48	274	49555	132360	63306833
Muscle spasms	87.87	15.48	296	49533	155854	63283339
Neutropenia	87.10	15.48	16	49813	174989	63264204
Feeling hot	87.06	15.48	148	49681	50206	63388987
Secondary progressive multiple sclerosis	86.60	15.48	35	49794	1392	63437801
Coronavirus infection	85.73	15.48	49	49780	4229	63434964
Urinary tract infection	83.87	15.48	420	49409	264264	63174929
Muscular weakness	83.56	15.48	248	49581	122105	63317088
Erythema	83.37	15.48	315	49514	175436	63263757
Abdominal discomfort	80.40	15.48	80	49749	320805	63118388
Pericarditis	80.29	15.48	6	49823	131573	63307620
Swelling face	78.98	15.48	162	49667	63313	63375880
Lower respiratory tract infection	78.06	15.48	7	49822	132300	63306893
Completed suicide	77.69	15.48	11	49818	145662	63293531
Stomatitis	77.54	15.48	9	49820	138716	63300477
General physical health deterioration	76.73	15.48	31	49798	201371	63237822
Needle fatigue	75.49	15.48	18	49811	110	63439083
Injection site inflammation	74.29	15.48	43	49786	3800	63435393
Drug interaction	74.07	15.48	44	49785	229087	63210106
Wound	71.11	15.48	20	49809	163243	63275950
Arthralgia	70.91	15.48	221	49608	569489	62869704
Injection site nodule	69.10	15.48	41	49788	3794	63435399
Loss of consciousness	67.38	15.48	225	49604	117896	63321297
Feeling cold	66.87	15.48	88	49741	23800	63415393
Thrombocytopenia	66.79	15.48	18	49811	151139	63288054
Decreased appetite	65.88	15.48	60	49769	250992	63188201
Hypotension	61.58	15.48	74	49755	272530	63166663
Product use in unapproved indication	61.31	15.48	32	49797	179048	63260145
Therapeutic product effect decreased	61.17	15.48	38	49791	193149	63246044
Breast cancer	59.61	15.48	123	49706	48260	63390933
Blood creatinine increased	56.58	15.48	3	49826	87841	63351352
Platelet count decreased	54.87	15.48	12	49817	116110	63323083
Intentional product use issue	53.26	15.48	17	49812	127875	63311318
Pneumonia	52.75	15.48	183	49646	456584	62982609
Pancytopenia	52.42	15.48	7	49822	96926	63342267
Bladder disorder	51.31	15.48	48	49781	8898	63430295
Visual impairment	50.96	15.48	164	49665	84282	63354911
Dizziness	50.35	15.48	537	49292	429388	63009805
Muscle spasticity	50.07	15.48	73	49756	21721	63417472
Hyponatraemia	50.05	15.48	13	49816	111887	63327306
Malignant neoplasm progression	49.37	15.48	4	49825	82117	63357076
Psoriatic arthropathy	48.57	15.48	7	49822	91513	63347680
Immune reconstitution inflammatory syndrome	47.69	15.48	39	49790	6045	63433148
Injection site vesicles	46.38	15.48	29	49800	2948	63436245
Cough	45.91	15.48	101	49728	292642	63146551
Haemoglobin decreased	45.51	15.48	29	49800	145456	63293737
Normal newborn	44.50	15.48	43	49786	8298	63430895
Irritable bowel syndrome	44.45	15.48	6	49823	82406	63356787
C-reactive protein increased	44.31	15.48	10	49819	94697	63344496
Injection site infection	43.68	15.48	24	49805	1919	63437274
Drug abuse	42.32	15.48	4	49825	72514	63366679
Peroneal nerve palsy	42.18	15.48	33	49796	4802	63434391
Injection site scab	42.12	15.48	15	49814	419	63438774
Blister	41.82	15.48	25	49804	129789	63309404
JC polyomavirus test positive	41.32	15.48	21	49808	1432	63437761
Intentional overdose	40.95	15.48	5	49824	74147	63365046
Osteoarthritis	40.91	15.48	12	49817	95331	63343862
Sinusitis	40.88	15.48	72	49757	226581	63212612
Folliculitis	40.72	15.48	4	49825	70313	63368880
Fatigue	40.61	15.48	946	48883	887082	62552111
Hyperhidrosis	40.56	15.48	180	49649	107656	63331537
Hepatic enzyme increased	40.50	15.48	60	49769	202268	63236925
Skin reaction	40.47	15.48	54	49775	14795	63424398
Injection site hypoaesthesia	40.13	15.48	15	49814	482	63438711
Blood cholesterol increased	40.04	15.48	12	49817	94020	63345173
Therapeutic product effect incomplete	39.01	15.48	25	49804	125031	63314162
Autonomic dysreflexia	37.94	15.48	13	49816	323	63438870
Pleural effusion	37.73	15.48	13	49816	93197	63345996
Constipation	37.44	15.48	75	49754	224868	63214325
Insurance issue	37.35	15.48	34	49795	6087	63433106
Paralysis	36.65	15.48	42	49787	9858	63429335
Progressive multifocal leukoencephalopathy	36.63	15.48	48	49781	12923	63426270
Fibromyalgia	36.62	15.48	9	49820	80411	63358782
Hemiparesis	35.78	15.48	65	49764	23217	63415976
Hypertension	35.60	15.48	107	49722	279196	63159997
Electrocardiogram QT prolonged	35.50	15.48	3	49826	59527	63379666
Band sensation	35.10	15.48	16	49813	857	63438336
Interstitial lung disease	34.62	15.48	4	49825	61904	63377289
Injection site haematoma	34.17	15.48	34	49795	6798	63432395
Atrial fibrillation	34.14	15.48	25	49804	116611	63322582
Impaired healing	34.09	15.48	19	49810	102523	63336670
Expanded disability status scale score increased	34.05	15.48	14	49815	582	63438611
Injection site ulcer	34.01	15.48	14	49815	584	63438609
Anaphylactic shock	33.83	15.48	64	49765	23569	63415624
Demyelination	33.80	15.48	34	49795	6886	63432307
Dyspnoea exertional	33.46	15.48	4	49825	60298	63378895
Anxiety	33.45	15.48	288	49541	217253	63221940
Gastrointestinal haemorrhage	33.42	15.48	11	49818	81165	63358028
Cognitive disorder	33.30	15.48	108	49721	55707	63383486
Movement disorder	32.69	15.48	60	49769	21601	63417592
Therapy interrupted	32.58	15.48	76	49753	32379	63406814
Injection site injury	32.55	15.48	14	49815	652	63438541
Respiratory failure	32.27	15.48	20	49809	101838	63337355
Incorrect dose administered by device	32.27	15.48	27	49802	4321	63434872
No reaction on previous exposure to drug	32.21	15.48	9	49820	110	63439083
Maternal exposure during pregnancy	32.11	15.48	288	49541	219774	63219419
Infection	32.00	15.48	84	49745	229089	63210104
Therapeutic response decreased	31.97	15.48	5	49824	61520	63377673
Bradycardia	31.81	15.48	9	49820	73218	63365975
Anaphylactic reaction	31.72	15.48	119	49710	65981	63373212
Hyperkalaemia	31.60	15.48	3	49826	54200	63384993
Product storage error	31.35	15.48	48	49781	14908	63424285
Hypokalaemia	30.70	15.48	22	49807	103782	63335411
Neutrophil count decreased	30.67	15.48	4	49825	56402	63382791
Hypersensitivity	30.28	15.48	357	49472	292328	63146865
White blood cell count decreased	30.08	15.48	39	49790	139065	63300128
Injection site anaesthesia	30.06	15.48	7	49822	38	63439155
Wheezing	29.96	15.48	19	49810	95576	63343617
Renal impairment	29.91	15.48	16	49813	88339	63350854
Skin indentation	29.76	15.48	7	49822	40	63439153
Septic shock	29.29	15.48	8	49821	66621	63372572
Leukopenia	29.24	15.48	12	49817	77278	63361915
Lymphadenopathy	29.17	15.48	81	49748	38377	63400816
Muscle tightness	29.00	15.48	41	49788	11859	63427334
Cardiac failure	28.94	15.48	17	49812	89125	63350068
Productive cough	28.92	15.48	7	49822	63201	63375992
Heart rate increased	28.68	15.48	148	49681	94090	63345103
Weight decreased	28.57	15.48	116	49713	276682	63162511
Gait inability	28.52	15.48	99	49730	52860	63386333
Trigeminal neuralgia	28.52	15.48	23	49806	3496	63435697
Abdominal pain	28.43	15.48	126	49703	293330	63145863
Peripheral swelling	28.36	15.48	110	49719	265832	63173361
Lip swelling	28.23	15.48	70	49759	30993	63408200
Arthritis	27.73	15.48	30	49799	115891	63323302
Pregnancy	26.39	15.48	76	49753	36760	63402433
Confusional state	26.36	15.48	96	49733	236284	63202909
Upper respiratory tract infection	26.14	15.48	16	49813	82031	63357162
Haemorrhagic adrenal infarction	26.02	15.48	6	49823	31	63439162
Oxygen saturation decreased	25.90	15.48	19	49810	88566	63350627
Wrong device used	25.70	15.48	6	49823	33	63439160
Cardiac failure congestive	25.54	15.48	21	49808	92412	63346781
Speech disorder	25.50	15.48	80	49749	40549	63398644
Head injury	25.18	15.48	62	49767	27334	63411859
Progressive multiple sclerosis	24.97	15.48	14	49815	1164	63438029
Urinary incontinence	24.85	15.48	68	49761	31946	63407247
Maternal exposure during breast feeding	24.79	15.48	23	49806	4218	63434975
Hypoxia	24.79	15.48	8	49821	59784	63379409
Oedema	24.79	15.48	24	49805	97598	63341595
Ill-defined disorder	24.61	15.48	17	49812	81738	63357455
Pharyngeal oedema	24.59	15.48	41	49788	13680	63425513
Oedema peripheral	24.56	15.48	72	49757	189439	63249754
Depressed level of consciousness	24.54	15.48	9	49820	62069	63377124
Abortion spontaneous	24.35	15.48	87	49742	47108	63392085
Vision blurred	24.35	15.48	139	49690	91785	63347408
Discomfort	23.62	15.48	61	49768	167313	63271880
Wrong schedule	23.61	15.48	8	49821	192	63439001
Neuropathy peripheral	23.42	15.48	33	49796	113634	63325559
Hypoglycaemia	23.25	15.48	9	49820	60056	63379137
Cardiac arrest	23.21	15.48	23	49806	92522	63346671
Injection site discomfort	23.08	15.48	23	49806	4607	63434586
Limb discomfort	22.94	15.48	63	49766	29653	63409540
Gastrooesophageal reflux disease	22.60	15.48	25	49804	95614	63343579
Feeling abnormal	22.55	15.48	196	49633	148196	63290997
Psoriasis	22.52	15.48	21	49808	86936	63352257
Renal failure	22.46	15.48	36	49793	117616	63321577
Death	22.44	15.48	187	49642	374194	63064999
Loss of personal independence in daily activities	22.37	15.48	26	49803	97264	63341929
Injury	22.35	15.48	15	49814	73232	63365961
Delirium	22.35	15.48	6	49823	50535	63388658
Wrong technique in device usage process	21.98	15.48	20	49809	3578	63435615
Alopecia	21.89	15.48	165	49664	337371	63101822
Rhabdomyolysis	21.89	15.48	4	49825	43947	63395246
Condition aggravated	21.87	15.48	206	49623	402011	63037182
Kinematic imbalances due to suboccipital strain	21.83	15.48	4	49825	4	63439189
Somnolence	21.65	15.48	70	49759	178615	63260578
Cardio-respiratory arrest	21.58	15.48	10	49819	59949	63379244
Nephrolithiasis	21.33	15.48	77	49752	41907	63397286
Relapsing-remitting multiple sclerosis	21.19	15.48	10	49819	580	63438613
Pruritus	20.92	15.48	399	49430	361054	63078139
Asthma	20.81	15.48	43	49786	127518	63311675
Gastrointestinal disorder	20.77	15.48	45	49784	131194	63307999
Manufacturing product shipping issue	20.66	15.48	6	49823	85	63439108
Adverse reaction	20.34	15.48	32	49797	10171	63429022
Overdose	20.33	15.48	37	49792	115041	63324152
Blood pressure systolic increased	20.26	15.48	6	49823	47391	63391802
Injection site coldness	20.22	15.48	6	49823	92	63439101
Medication error	19.97	15.48	8	49821	52276	63386917
Monoplegia	19.96	15.48	18	49811	3183	63436010
Dyspepsia	19.76	15.48	31	49798	102165	63337028
Injury associated with device	19.74	15.48	19	49810	3647	63435546
Blood glucose increased	19.67	15.48	22	49807	83734	63355459
Sensory disturbance	19.54	15.48	37	49792	13635	63425558
Pulmonary hypertension	19.32	15.48	3	49826	37120	63402073
Sepsis	19.24	15.48	59	49770	153064	63286129
Ankle fracture	19.23	15.48	43	49786	17812	63421381
Injection site cellulitis	19.00	15.48	12	49817	1242	63437951
Chronic kidney disease	18.95	15.48	6	49823	45392	63393801
Weight increased	18.60	15.48	124	49705	260668	63178525
Needle issue	18.59	15.48	31	49798	10345	63428848
Pulmonary oedema	18.48	15.48	10	49819	54863	63384330
Injection site paraesthesia	18.46	15.48	9	49820	561	63438632
Wrong technique in product usage process	18.34	15.48	97	49732	62243	63376950
Skin mass	18.33	15.48	23	49806	5932	63433261
Epistaxis	18.32	15.48	18	49811	72707	63366486
Uterine leiomyosarcoma	17.98	15.48	4	49825	17	63439176
Panic attack	17.90	15.48	48	49781	22283	63416910
Anaplastic large cell lymphoma T- and null-cell types	17.83	15.48	5	49824	62	63439131
Haematochezia	17.68	15.48	10	49819	53534	63385659
Liver injury	17.67	15.48	13	49816	60507	63378686
Injection site fibrosis	17.62	15.48	4	49825	19	63439174
Vertigo	17.49	15.48	93	49736	59794	63379399
Fluid retention	17.19	15.48	13	49816	59673	63379520
Pulmonary fibrosis	17.09	15.48	5	49824	39804	63399389
Hypoaesthesia oral	17.07	15.48	34	49795	12999	63426194
Neoplasm progression	16.73	15.48	4	49825	36424	63402769
Hot flush	16.72	15.48	82	49747	51077	63388116
Hyperglycaemia	16.66	15.48	6	49823	41861	63397332
Necrosis	16.58	15.48	21	49808	5466	63433727
Nonspecific reaction	16.53	15.48	14	49815	2278	63436915
Nasal sinus cancer	16.43	15.48	4	49825	27	63439166
Plasma cell myeloma	16.38	15.48	4	49825	35901	63403292
Asthenia	16.28	15.48	405	49424	383199	63055994
Relapsing multiple sclerosis	16.26	15.48	6	49823	186	63439007
Nasopharyngitis	16.14	15.48	125	49704	254132	63185061
Coma	16.13	15.48	16	49813	64348	63374845
Alanine aminotransferase increased	16.07	15.48	36	49793	103734	63335459
Skin irritation	16.00	15.48	28	49801	9713	63429480
Spinal cord operation	15.91	15.48	3	49826	4	63439189
Type 2 diabetes mellitus	15.87	15.48	16	49813	63852	63375341
Drug administered in wrong device	15.73	15.48	4	49825	33	63439160
Exposure during pregnancy	15.52	15.48	66	49763	155481	63283712

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
Multiple sclerosis relapse	1156.52	23.72	336	10485	12797	34933313
Injection site reaction	880.76	23.72	272	10549	12761	34933349
Injection site pain	577.91	23.72	268	10553	38737	34907373
Injection site erythema	481.47	23.72	182	10639	15717	34930393
Immediate post-injection reaction	316.07	23.72	48	10773	31	34946079
Injection site swelling	271.22	23.72	110	10711	11417	34934693
Injection site mass	219.10	23.72	81	10740	6545	34939565
Injection site necrosis	210.35	23.72	44	10777	397	34945713
Multiple sclerosis	204.26	23.72	77	10744	6568	34939542
Injection site pruritus	204.13	23.72	78	10743	6905	34939205
Fall	147.38	23.72	241	10580	202644	34743466
Injection site urticaria	147.02	23.72	45	10776	2027	34944083
Flushing	135.72	23.72	98	10723	32322	34913788
Injection site bruising	120.05	23.72	57	10764	8606	34937504
Hypoaesthesia	113.20	23.72	116	10705	61328	34884782
Gait disturbance	101.12	23.72	128	10693	85012	34861098
Balance disorder	97.95	23.72	89	10732	40565	34905545
Urticaria	92.46	23.72	105	10716	62272	34883838
Central nervous system lesion	87.93	23.72	42	10779	6421	34939689
Embolia cutis medicamentosa	75.52	23.72	17	10804	222	34945888
Product dose omission issue	69.36	23.72	129	10692	119582	34826528
Magnetic resonance imaging abnormal	65.02	23.72	23	10798	1633	34944477
Secondary progressive multiple sclerosis	62.20	23.72	16	10805	377	34945733
Expanded disability status scale score increased	59.64	23.72	15	10806	322	34945788
Off label use	57.86	23.72	29	10792	419495	34526615
Product substitution issue	57.62	23.72	37	10784	10058	34936052
Motor dysfunction	56.48	23.72	32	10789	6942	34939168
Injection site discolouration	55.83	23.72	20	10801	1473	34944637
Injection site irritation	54.90	23.72	19	10802	1264	34944846
Urinary tract infection	52.95	23.72	94	10727	83987	34862123
Progressive multiple sclerosis	52.85	23.72	13	10808	254	34945856
Chills	52.84	23.72	92	10729	80951	34865159
Injection site vesicles	52.16	23.72	16	10805	725	34945385
Acute kidney injury	52.11	23.72	15	10806	304973	34641137
Injection site rash	50.50	23.72	25	10796	4128	34941982
Injection site scar	50.47	23.72	13	10808	308	34945802
Tremor	50.30	23.72	91	10730	82496	34863614
Fatigue	49.63	23.72	236	10585	370417	34575693
Injection site induration	49.59	23.72	22	10799	2838	34943272
Chest discomfort	49.46	23.72	72	10749	54458	34891652
Toxicity to various agents	47.21	23.72	4	10817	200358	34745752
Depression	44.58	23.72	95	10726	97003	34849107
Muscle spasms	42.34	23.72	80	10741	74921	34871189
Influenza like illness	41.70	23.72	47	10774	27587	34918523
Injection site atrophy	40.82	23.72	8	10813	50	34946060
Muscular weakness	40.21	23.72	77	10744	72820	34873290
Anaemia	38.86	23.72	12	10809	233323	34712787
Therapy cessation	38.58	23.72	36	10785	16937	34929173
Injection site inflammation	36.99	23.72	13	10808	905	34945205
Therapy change	35.87	23.72	18	10803	3059	34943051
Hypersensitivity	35.55	23.72	66	10755	60969	34885141
Toxic neuropathy	34.85	23.72	11	10810	548	34945562
Memory impairment	34.71	23.72	54	10767	43264	34902846
Gait inability	34.24	23.72	37	10784	20721	34925389
Palpitations	33.66	23.72	51	10770	39935	34906175
Injection site warmth	33.00	23.72	15	10806	2047	34944063
Injection site haemorrhage	32.99	23.72	26	10795	9742	34936368
Burning sensation	32.49	23.72	34	10787	18360	34927750
Paraesthesia	32.01	23.72	65	10756	64107	34882003
Visual impairment	30.61	23.72	46	10775	35756	34910354
Injection site scab	30.54	23.72	6	10815	38	34946072
Coronavirus infection	30.20	23.72	18	10803	4289	34941821
Muscle spasticity	29.75	23.72	20	10801	5868	34940242
Hypotension	29.45	23.72	16	10805	221633	34724477
Drug interaction	29.03	23.72	17	10804	225929	34720181
Injection site haematoma	28.62	23.72	13	10808	1772	34944338
Thrombocytopenia	27.92	23.72	7	10814	156240	34789870
Swelling face	27.77	23.72	35	10786	23070	34923040
Pleurothotonus	26.60	23.72	11	10810	1194	34944916
Dyspnoea	24.82	23.72	200	10621	376582	34569528
Drug ineffective	24.67	23.72	232	10589	456519	34489591

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
Multiple sclerosis relapse	3039.22	16.93	1065	38998	45468	79658857
Injection site reaction	2672.00	16.93	1011	39052	53774	79650551
Injection site pain	1878.01	16.93	1026	39037	128812	79575513
Injection site erythema	1543.25	16.93	762	39301	77435	79626890
Injection site mass	1141.30	16.93	416	39647	19768	79684557
Injection site swelling	981.66	16.93	477	39586	46655	79657670
Injection site pruritus	913.94	16.93	439	39624	41844	79662481
Immediate post-injection reaction	756.01	16.93	134	39929	215	79704110
Injection site urticaria	734.64	16.93	267	39796	12559	79691766
Flushing	519.10	16.93	397	39666	87871	79616454
Injection site bruising	498.45	16.93	290	39773	40712	79663613
Hypoaesthesia	378.46	16.93	458	39605	178894	79525431
Multiple sclerosis	353.94	16.93	188	39875	22094	79682231
Fall	346.46	16.93	758	39305	486871	79217454
Chills	300.76	16.93	386	39677	159848	79544477
Urticaria	292.37	16.93	410	39653	184791	79519534
Product dose omission issue	278.08	16.93	468	39595	247069	79457256
Injection site necrosis	276.57	16.93	76	39987	1402	79702923
Therapy cessation	216.27	16.93	167	39896	37395	79666930
Off label use	213.44	16.93	95	39968	907120	78797205
Injection site atrophy	201.82	16.93	46	40017	375	79703950
Central nervous system lesion	193.29	16.93	106	39957	13262	79691063
Injection site induration	188.08	16.93	94	39969	9725	79694600
Acute kidney injury	182.79	16.93	23	40040	519381	79184944
Embolia cutis medicamentosa	177.99	16.93	45	40018	591	79703734
Influenza like illness	177.47	16.93	199	39864	71508	79632817
Product substitution issue	174.17	16.93	115	39948	20141	79684184
Balance disorder	168.02	16.93	227	39836	98630	79605695
Magnetic resonance imaging abnormal	164.99	16.93	63	40000	3396	79700929
Toxicity to various agents	163.00	16.93	13	40050	421527	79282798
Palpitations	160.36	16.93	253	39810	126357	79577968
Gait disturbance	158.64	16.93	333	39730	207173	79497152
Injection site warmth	151.97	16.93	94	39969	14713	79689612
Injection site haemorrhage	149.79	16.93	119	39944	27751	79676574
Chest discomfort	149.43	16.93	257	39806	137787	79566538
Injection site scar	147.41	16.93	41	40022	792	79703533
Tremor	146.68	16.93	287	39776	169796	79534529
Injection site irritation	145.52	16.93	59	40004	3731	79700594
Memory impairment	139.71	16.93	222	39841	111512	79592813
Anaemia	131.79	16.93	31	40032	444984	79259341
Paraesthesia	123.28	16.93	273	39790	176050	79528275
Optic neuritis	122.68	16.93	70	39993	9450	79694875
Therapy change	119.06	16.93	63	40000	7336	79696989
Motor dysfunction	117.89	16.93	80	39983	14653	79689672
Throat tightness	116.52	16.93	103	39960	27804	79676521
Injection related reaction	112.83	16.93	35	40028	1001	79703324
Injection site rash	108.08	16.93	82	39981	17872	79686453
Chest pain	105.82	16.93	347	39716	281957	79422368
Lipodystrophy acquired	102.77	16.93	48	40015	4277	79700048
Secondary progressive multiple sclerosis	102.55	16.93	35	40028	1362	79702963
Burning sensation	101.64	16.93	136	39927	58496	79645829
Lipoatrophy	99.77	16.93	29	40034	660	79703665
Muscle spasms	99.76	16.93	250	39813	174480	79529845
Completed suicide	96.55	16.93	7	40056	245760	79458565
Depression	94.62	16.93	281	39782	216509	79487816
Neutropenia	93.53	16.93	16	40047	287694	79416631
Injection site discolouration	92.82	16.93	54	40009	7560	79696765
Dyspnoea	89.80	16.93	735	39328	856290	78848035
Erythema	88.65	16.93	280	39783	223010	79481315
Drug interaction	84.66	16.93	52	40011	415131	79289194
Rheumatoid arthritis	84.65	16.93	5	40058	208465	79495860
Urinary tract infection	82.65	16.93	314	39749	274198	79430127
Hypotension	81.95	16.93	61	40002	440256	79264069
Thrombocytopenia	81.43	16.93	17	40046	265242	79439083
Feeling hot	80.63	16.93	123	39940	59611	79644714
Injection site indentation	76.22	16.93	18	40045	174	79704151
Fatigue	75.69	16.93	755	39308	928972	78775353
Diarrhoea	73.62	16.93	214	39849	880275	78824050
Injection site nodule	71.83	16.93	36	40027	3744	79700581
Swelling face	71.05	16.93	128	39935	71084	79633241
Product use in unapproved indication	71.01	16.93	19	40044	250340	79453985
Drug abuse	68.90	16.93	3	40060	162688	79541637
Decreased appetite	68.24	16.93	44	40019	342374	79361951
Infusion related reaction	68.14	16.93	16	40047	230221	79474104
Hyponatraemia	67.23	16.93	6	40057	177842	79526483
Injection site inflammation	67.23	16.93	35	40028	3941	79700384
Pancytopenia	67.20	16.93	4	40059	165741	79538584
Injection site vesicles	66.57	16.93	32	40031	3040	79701285
General physical health deterioration	65.71	16.93	28	40035	275210	79429115
Pneumonia	65.50	16.93	147	39916	660099	79044226
Visual impairment	64.71	16.93	143	39920	91988	79612337
Progressive multifocal leukoencephalopathy	62.99	16.93	64	39999	20536	79683789
Expanded disability status scale score increased	62.30	16.93	20	40043	641	79703684
Platelet count decreased	60.71	16.93	12	40051	194652	79509673
Blood creatinine increased	59.24	16.93	5	40058	155052	79549273
Dizziness	59.00	16.93	459	39604	525982	79178343
Malignant neoplasm progression	56.00	16.93	3	40060	135987	79568338
Muscle spasticity	55.49	16.93	61	40002	21414	79682911
Stomatitis	55.33	16.93	5	40058	146752	79557573
Insurance issue	55.31	16.93	35	40028	5698	79698627
Feeling cold	55.00	16.93	70	39993	28659	79675666
Death	54.64	16.93	128	39935	566386	79137939
Joint swelling	53.63	16.93	40	40023	288606	79415719
Loss of consciousness	52.05	16.93	194	39869	167749	79536576
Muscular weakness	51.77	16.93	188	39875	160541	79543784
Gastrointestinal haemorrhage	50.74	16.93	7	40056	147712	79556613
Immune reconstitution inflammatory syndrome	47.88	16.93	46	40017	13795	79690530
Haemoglobin decreased	47.81	16.93	26	40037	222093	79482232
Product use issue	47.48	16.93	23	40040	209799	79494526
Lower respiratory tract infection	47.15	16.93	5	40058	129215	79575110
Respiratory failure	45.46	16.93	17	40046	180894	79523431
Renal impairment	44.67	16.93	12	40051	157771	79546554
Therapeutic product effect incomplete	43.60	16.93	9	40054	141636	79562689
Pruritus	43.53	16.93	343	39720	394305	79310020
Injection site scab	42.44	16.93	13	40050	356	79703969
Renal failure	41.14	16.93	25	40038	200943	79503382
Pericarditis	40.82	16.93	3	40060	104233	79600092
Atrial fibrillation	39.98	16.93	25	40038	197861	79506464
Autonomic dysreflexia	39.96	16.93	13	40050	435	79703890
Intentional overdose	38.91	16.93	4	40059	105956	79598369
Product storage error	38.35	16.93	44	40019	16182	79688143
Hypersensitivity	38.28	16.93	244	39819	261995	79442330
Cardiac failure	38.15	16.93	15	40048	154827	79549498
Anxiety	38.00	16.93	234	39829	248278	79456047
Arthropathy	37.72	16.93	21	40042	177090	79527235
Sepsis	37.69	16.93	48	40015	269380	79434945
Overdose	37.58	16.93	23	40040	184183	79520142
Septic shock	37.39	16.93	8	40055	122793	79581532
Incorrect dose administered by device	37.33	16.93	26	40037	4963	79699362
Bradycardia	37.09	16.93	11	40052	135546	79568779
Intentional product use issue	37.04	16.93	15	40048	152097	79552228
Hyperhidrosis	36.58	16.93	162	39901	151330	79552995
Seizure	36.25	16.93	189	39874	188645	79515680
Neutrophil count decreased	35.96	16.93	3	40060	93956	79610369
Cardiac arrest	35.80	16.93	21	40042	172075	79532250
Hypoxia	35.20	16.93	5	40058	103238	79601087
White blood cell count decreased	35.07	16.93	26	40037	188262	79516063
Cognitive disorder	34.68	16.93	95	39968	69831	79634494
Electrocardiogram QT prolonged	34.28	16.93	3	40060	90383	79613942
Feeling abnormal	33.84	16.93	164	39899	159035	79545290
Abortion spontaneous	33.28	16.93	56	40007	29451	79674874
Lip swelling	32.75	16.93	67	39996	40844	79663481
Pleural effusion	32.74	16.93	16	40047	145246	79559079
Dyspnoea exertional	32.73	16.93	3	40060	87070	79617255
JC polyomavirus test positive	32.64	16.93	16	40047	1586	79702739
C-reactive protein increased	32.62	16.93	12	40051	129015	79575310
Oedema peripheral	32.22	16.93	48	40015	252240	79452085
Gait inability	32.22	16.93	83	39980	58834	79645491
Cardio-respiratory arrest	31.19	16.93	8	40055	108502	79595823
Systemic lupus erythematosus	31.08	16.93	11	40052	121138	79583187
Bladder disorder	30.84	16.93	30	40033	9135	79695190
Injection site infection	30.49	16.93	17	40046	2195	79702130
Injection site ulcer	30.40	16.93	12	40051	707	79703618
Vision blurred	30.05	16.93	119	39944	105779	79598546
Coronavirus infection	29.96	16.93	27	40036	7470	79696855
Injection site injury	29.80	16.93	12	40051	745	79703580
Normal newborn	29.31	16.93	26	40037	7046	79697279
No reaction on previous exposure to drug	29.26	16.93	9	40054	250	79704075
Cough	29.18	16.93	91	39972	366698	79337627
Leukopenia	29.17	16.93	11	40052	116502	79587823
Injection site cellulitis	29.03	16.93	15	40048	1663	79702662
Injection site haematoma	28.94	16.93	22	40041	4805	79699520
Rhabdomyolysis	28.89	16.93	8	40055	103123	79601202
Therapeutic product effect decreased	28.78	16.93	24	40039	163839	79540486
Paralysis	28.26	16.93	34	40029	13143	79691182
Arthralgia	27.73	16.93	171	39892	571632	79132693
Constipation	27.18	16.93	64	39999	282986	79421339
Movement disorder	27.18	16.93	49	40014	27210	79677115
Muscle tightness	27.17	16.93	33	40030	12881	79691444
Abdominal pain	26.71	16.93	103	39960	389466	79314859
Hypokalaemia	26.68	16.93	20	40043	144020	79560305
Breast cancer	26.66	16.93	55	40008	33726	79670599
Skin reaction	25.90	16.93	36	40027	16032	79688293
Injection site coldness	25.90	16.93	7	40056	121	79704204
Hot flush	25.68	16.93	73	39990	54804	79649521
Injection site discomfort	25.51	16.93	21	40042	5145	79699180
Oxygen saturation decreased	25.11	16.93	17	40046	129030	79575295
Speech disorder	25.06	16.93	72	39991	54373	79649952
Headache	24.99	16.93	464	39599	653308	79051017
Vertigo	24.98	16.93	84	39979	68998	79635327
Productive cough	24.47	16.93	7	40056	88324	79616001
Maternal exposure during pregnancy	24.38	16.93	134	39929	136404	79567921
Progressive multiple sclerosis	24.34	16.93	12	40051	1205	79703120
Pain in extremity	23.86	16.93	284	39779	364254	79340071
Injection site abscess	23.69	16.93	13	40050	1627	79702698
Wrong technique in device usage process	23.37	16.93	18	40045	4010	79700315
Condition aggravated	23.19	16.93	152	39911	500972	79203353
Hypoglycaemia	23.18	16.93	11	40052	101583	79602742
Confusional state	23.15	16.93	82	39981	317915	79386410
Hypertension	23.01	16.93	87	39976	330905	79373420
Injection site oedema	22.98	16.93	12	40051	1359	79702966
Delirium	22.90	16.93	7	40056	84620	79619705
Trigeminal neuralgia	22.87	16.93	17	40046	3592	79700733
Demyelination	22.85	16.93	24	40039	7999	79696326
Injection site hypoaesthesia	22.72	16.93	9	40054	535	79703790
Peroneal nerve palsy	22.66	16.93	21	40042	6021	79698304
Pharyngeal oedema	22.64	16.93	34	40029	16238	79688087
Epistaxis	22.63	16.93	14	40049	111501	79592824
Cardiac failure congestive	22.47	16.93	23	40040	142379	79561946
Haematochezia	22.41	16.93	8	40055	87637	79616688
Temperature intolerance	22.40	16.93	26	40037	9679	79694646
Intentional product misuse	22.18	16.93	10	40053	95155	79609170
Somnolence	22.18	16.93	55	40008	238926	79465399
Upper respiratory tract infection	22.18	16.93	9	40054	91159	79613166
Anaphylactic shock	22.09	16.93	53	40010	35943	79668382
Primary progressive multiple sclerosis	22.02	16.93	6	40057	107	79704218
Psoriatic arthropathy	21.94	16.93	6	40057	77993	79626332
Heart rate increased	21.23	16.93	118	39945	120606	79583719
Rectal haemorrhage	21.22	16.93	6	40057	76294	79628031
Hepatic enzyme increased	21.18	16.93	37	40026	182573	79521752
Pulmonary oedema	21.00	16.93	9	40054	88245	79616080
Limb discomfort	20.84	16.93	49	40014	32801	79671524
Chronic kidney disease	20.78	16.93	4	40059	66150	79638175
Adverse event	20.71	16.93	72	39991	60142	79644183
Blister	20.37	16.93	18	40045	119458	79584867
Gastrointestinal disorder	20.13	16.93	19	40044	122186	79582139
Acute respiratory failure	20.02	16.93	3	40060	59538	79644787
Blood glucose increased	19.99	16.93	17	40046	114958	79589367
Hemiparesis	19.98	16.93	49	40014	33684	79670641
Coma	19.93	16.93	13	40050	100636	79603689
Back pain	19.91	16.93	237	39826	303943	79400382
Acute myocardial infarction	19.75	16.93	7	40056	77029	79627296
Weight decreased	19.47	16.93	102	39961	355096	79349229
Wrong technique in product usage process	19.36	16.93	81	39982	73794	79630531
Sensory loss	19.31	16.93	28	40035	12963	79691362
Migraine	19.20	16.93	91	39972	87402	79616923
Ascites	19.14	16.93	7	40056	75555	79628770
Osteoarthritis	19.09	16.93	10	40053	87299	79617026
Neuropathy peripheral	18.90	16.93	26	40037	141279	79563046
Sensory disturbance	18.87	16.93	30	40033	15047	79689278
Hyperglycaemia	18.71	16.93	6	40057	70329	79633996
Abdominal discomfort	18.68	16.93	64	39999	250663	79453662
Wheezing	18.23	16.93	19	40044	116645	79587680
Manufacturing product shipping issue	17.91	16.93	5	40058	98	79704227
Urinary incontinence	17.77	16.93	53	40010	40856	79663469
Hypoaesthesia oral	17.54	16.93	28	40035	14096	79690229
Panic attack	17.45	16.93	38	40025	24178	79680147
Gastrooesophageal reflux disease	17.42	16.93	16	40047	104230	79600095
Maternal exposure during breast feeding	17.38	16.93	13	40050	2772	79701553
Scar	17.35	16.93	29	40034	15167	79689158
Contusion	17.29	16.93	131	39932	148645	79555680
Therapeutic response decreased	17.26	16.93	6	40057	66847	79637478
Depressed level of consciousness	17.16	16.93	14	40049	96638	79607687
Diplopia	17.12	16.93	46	40017	33420	79670905
Irritable bowel syndrome	17.11	16.93	5	40058	62236	79642089
Alanine aminotransferase increased	17.04	16.93	35	40028	162535	79541790
Oedema	17.02	16.93	21	40042	119559	79584766
Pregnancy	16.98	16.93	40	40023	26811	79677514

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L03AX13	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSTIMULANTS IMMUNOSTIMULANTS Other immunostimulants
MeSH PA	D000276	Adjuvants, Immunologic
MeSH PA	D018501	Antirheumatic Agents
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents

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

Disease	Relation	SNOMED_ID	DOID
Multiple sclerosis	indication	24700007	DOID:2377

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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:

None

External reference:

ID	Source
5M691HL4BO	UNII
D04318	KEGG_DRUG
4020989	VUID
N0000179467	NUI
4020989	VANDF
C0289884	UMLSCUI
CHEMBL1201507	ChEMBL_ID
3081884	PUBCHEM_CID
D000068717	MESH_DESCRIPTOR_UI
135779	RXNORM
10204	MMSL
262778	MMSL
4781	MMSL
006395	NDDF
108755008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Glatiramer Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6960	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatiramer Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6960	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatiramer Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6960	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatiramer Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6961	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Glatiramer Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6961	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Glatiramer Acetate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6961	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3234	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3234	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3234	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3250	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3250	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3250	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8815	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8815	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8816	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Glatopa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8816	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	ANDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-317	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	NDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-317	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	NDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-317	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	NDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-317	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	NDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-325	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	NDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-325	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	NDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-325	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	NDA	26 sections
Copaxone	HUMAN PRESCRIPTION DRUG LABEL	1	68546-325	INJECTION, SOLUTION	40 mg	SUBCUTANEOUS	NDA	26 sections