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

Stem definitionDrug idCAS RN
4880 147245-92-9

Description:

MoleculeDescription

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:

DoseUnitRoute
20 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 20, 1996 FDA TEVA PHARMS USA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 3316.54 14.89 1307 45466 41657 50516694
Injection site reaction 2993.06 14.89 1268 45505 48764 50509587
Injection site pain 1726.40 14.89 1143 45630 109881 50448470
Injection site mass 1384.12 14.89 527 46246 15153 50543198
Injection site erythema 1357.07 14.89 850 45923 74086 50484265
Immediate post-injection reaction 1038.27 14.89 196 46577 196 50558155
Injection site swelling 955.11 14.89 551 46222 41222 50517129
Injection site pruritus 826.37 14.89 496 46277 39915 50518436
Injection site urticaria 712.57 14.89 305 46468 11912 50546439
Flushing 527.98 14.89 461 46312 66554 50491797
Multiple sclerosis 472.36 14.89 272 46501 20221 50538130
Injection site bruising 416.78 14.89 313 46460 36455 50521896
Urticaria 391.95 14.89 538 46235 129023 50429328
Injection site necrosis 348.69 14.89 100 46673 1133 50557218
Fall 347.19 14.89 875 45898 334057 50224294
Chills 345.68 14.89 436 46337 96251 50462100
Hypoaesthesia 322.59 14.89 486 46287 126771 50431580
Injection site atrophy 285.02 14.89 71 46702 443 50557908
Product dose omission issue 233.99 14.89 521 46252 183317 50375034
Off label use 227.22 14.89 78 46695 474348 50084003
Injection site induration 224.76 14.89 123 46650 8274 50550077
Lipoatrophy 213.10 14.89 51 46722 262 50558089
Therapy cessation 198.65 14.89 176 46597 25835 50532516
Gait disturbance 175.06 14.89 411 46362 149594 50408757
Central nervous system lesion 174.55 14.89 109 46664 9380 50548971
Injection site irritation 169.34 14.89 82 46691 4268 50554083
Injection site scar 166.88 14.89 52 46721 797 50557554
Chest discomfort 164.59 14.89 302 46471 92420 50465931
Injection site warmth 163.60 14.89 121 46652 13745 50544606
Influenza like illness 163.51 14.89 232 46541 57227 50501124
Lipodystrophy acquired 162.99 14.89 57 46716 1272 50557079
Palpitations 159.23 14.89 301 46472 94205 50464146
Balance disorder 156.86 14.89 254 46519 70336 50488015
Memory impairment 155.62 14.89 270 46503 79090 50479261
Rheumatoid arthritis 154.33 14.89 8 46765 202542 50355809
Acute kidney injury 151.39 14.89 17 46756 228041 50330310
Product substitution issue 148.87 14.89 115 46658 13942 50544409
Toxicity to various agents 148.47 14.89 13 46760 212486 50345865
Throat tightness 143.35 14.89 133 46640 20714 50537637
Injection site haemorrhage 142.58 14.89 134 46639 21212 50537139
Magnetic resonance imaging abnormal 142.54 14.89 63 46710 2655 50555696
Paraesthesia 131.09 14.89 321 46452 119922 50438429
Anaemia 130.47 14.89 36 46737 252420 50305931
Injection related reaction 127.25 14.89 39 46734 564 50557787
Optic neuritis 126.36 14.89 79 46694 6811 50551540
Tremor 123.39 14.89 305 46468 114598 50443753
Motor dysfunction 122.46 14.89 82 46691 7949 50550402
Infusion related reaction 122.24 14.89 9 46764 169548 50388803
Embolia cutis medicamentosa 120.35 14.89 32 46741 267 50558084
Contraindicated product administered 119.72 14.89 4 46769 148954 50409397
Injection site indentation 117.12 14.89 28 46745 143 50558208
Diarrhoea 111.89 14.89 236 46537 588240 49970111
Injection site rash 108.89 14.89 102 46671 16075 50542276
Chest pain 108.77 14.89 385 46388 176497 50381854
Joint swelling 107.69 14.89 46 46727 245240 50313111
Therapy change 101.12 14.89 62 46711 5163 50553188
Injection site discolouration 101.06 14.89 69 46704 6905 50551446
Dyspnoea 96.51 14.89 847 45926 546761 50011590
Depression 95.68 14.89 353 46420 165070 50393281
Muscle spasms 91.06 14.89 289 46484 125264 50433087
Feeling hot 86.94 14.89 141 46632 39061 50519290
Glossodynia 86.62 14.89 5 46768 115564 50442787
Neutropenia 86.59 14.89 16 46757 147949 50410402
Completed suicide 84.58 14.89 11 46762 131878 50426473
Burning sensation 84.34 14.89 151 46622 45295 50513056
Muscular weakness 83.38 14.89 234 46539 94779 50463572
Arthropathy 78.78 14.89 24 46749 157882 50400469
Systemic lupus erythematosus 78.53 14.89 17 46756 140605 50417746
Drug interaction 77.64 14.89 44 46729 199577 50358774
Coronavirus infection 75.88 14.89 42 46731 2887 50555464
Secondary progressive multiple sclerosis 75.06 14.89 32 46741 1234 50557117
Swelling face 73.46 14.89 155 46618 52440 50505911
Erythema 72.85 14.89 298 46475 146116 50412235
Seizure 72.74 14.89 257 46516 117617 50440734
Injection site inflammation 72.35 14.89 42 46731 3163 50555188
Injection site nodule 68.05 14.89 41 46732 3307 50555044
Hypotension 67.34 14.89 71 46702 235398 50322953
Product use issue 67.21 14.89 27 46746 149448 50408903
Thrombocytopenia 66.27 14.89 18 46755 127655 50430696
Lower respiratory tract infection 65.95 14.89 6 46767 95195 50463156
Feeling cold 64.80 14.89 85 46688 19446 50538905
Hyponatraemia 64.14 14.89 7 46766 96132 50462219
Stomatitis 63.66 14.89 9 46764 101335 50457016
General physical health deterioration 63.60 14.89 26 46747 142408 50415943
Arthralgia 63.17 14.89 202 46571 438500 50119851
Abdominal discomfort 61.69 14.89 74 46699 231567 50326784
Urinary tract infection 60.57 14.89 384 46389 223636 50334715
Decreased appetite 60.39 14.89 58 46715 200865 50357486
Blood creatinine increased 57.98 14.89 3 46770 76157 50482194
Platelet count decreased 56.58 14.89 12 46761 100714 50457637
Insurance issue 56.48 14.89 33 46740 2515 50555836
Pneumonia 56.02 14.89 172 46601 378229 50180122
Pericarditis 54.39 14.89 5 46768 78684 50479667
Pancytopenia 53.88 14.89 7 46766 84023 50474328
Needle fatigue 53.19 14.89 13 46760 74 50558277
Product use in unapproved indication 51.92 14.89 21 46752 115798 50442553
Loss of consciousness 50.77 14.89 211 46562 104142 50454209
Dizziness 50.39 14.89 515 46258 345854 50212497
Haemoglobin decreased 49.49 14.89 28 46745 127188 50431163
Malignant neoplasm progression 47.98 14.89 4 46769 68120 50490231
Cough 47.97 14.89 94 46679 241170 50317181
Bladder disorder 47.78 14.89 46 46727 7497 50550854
Breast cancer 47.18 14.89 115 46658 42775 50515576
Respiratory failure 47.03 14.89 13 46760 91168 50467183
Wound 46.11 14.89 20 46753 105774 50452577
Visual impairment 43.93 14.89 151 46622 68124 50490227
Hypersensitivity 43.61 14.89 344 46429 214817 50343534
Injection site infection 43.32 14.89 24 46749 1652 50556699
Injection site vesicles 43.11 14.89 28 46745 2577 50555774
Gastrointestinal haemorrhage 42.71 14.89 8 46765 73313 50485038
Therapeutic product effect decreased 42.36 14.89 38 46735 136012 50422339
Fatigue 41.69 14.89 899 45874 706702 49851649
Injection site scab 41.59 14.89 15 46758 367 50557984
Immune reconstitution inflammatory syndrome 41.44 14.89 37 46736 5479 50552872
Pleural effusion 41.29 14.89 12 46761 81442 50476909
Peroneal nerve palsy 40.95 14.89 33 46740 4250 50554101
Drug abuse 40.84 14.89 4 46769 59842 50498509
Intentional overdose 40.57 14.89 5 46768 62499 50495852
Hyperhidrosis 39.77 14.89 176 46597 89250 50469101
Muscle spasticity 39.71 14.89 63 46710 17121 50541230
Hypokalaemia 39.36 14.89 16 46757 87976 50470375
Atrial fibrillation 38.71 14.89 23 46750 101722 50456629
Constipation 38.08 14.89 71 46702 185637 50372714
Renal failure 37.97 14.89 26 46747 106607 50451744
Injection site hypoaesthesia 37.88 14.89 14 46759 368 50557983
Electrocardiogram QT prolonged 36.66 14.89 3 46770 51883 50506468
Skin reaction 36.30 14.89 49 46724 11519 50546832
Band sensation 36.20 14.89 16 46757 674 50557677
Autonomic dysreflexia 36.05 14.89 13 46760 318 50558033
Normal newborn 35.38 14.89 37 46736 6654 50551697
Sinusitis 35.15 14.89 65 46708 170493 50387858
Interstitial lung disease 35.14 14.89 4 46769 53172 50505179
Anxiety 34.89 14.89 282 46491 177324 50381027
Therapeutic product effect incomplete 34.37 14.89 21 46752 91494 50466857
Gait inability 34.23 14.89 93 46680 36934 50521417
Incorrect dose administered by device 33.70 14.89 27 46746 3448 50554903
Irritable bowel syndrome 33.66 14.89 4 46769 51437 50506914
Bradycardia 33.57 14.89 9 46764 64417 50493934
Dyspnoea exertional 33.49 14.89 4 46769 51229 50507122
Renal impairment 33.45 14.89 14 46759 75647 50482704
Hyperkalaemia 33.38 14.89 3 46770 48086 50510265
C-reactive protein increased 33.31 14.89 10 46763 66464 50491887
Injection site ulcer 33.08 14.89 14 46759 530 50557821
Injection site haematoma 32.93 14.89 34 46739 6026 50552325
Product storage error 32.75 14.89 48 46725 12176 50546175
Injection site injury 32.54 14.89 14 46759 552 50557799
Movement disorder 31.95 14.89 58 46715 17574 50540777
Skin indentation 31.75 14.89 7 46766 23 50558328
Anaphylactic reaction 31.72 14.89 116 46657 53939 50504412
Osteoarthritis 31.46 14.89 12 46761 68594 50489757
Cognitive disorder 31.42 14.89 101 46672 44022 50514329
Demyelination 31.29 14.89 33 46740 5993 50552358
Paralysis 30.76 14.89 39 46734 8625 50549726
No reaction on previous exposure to drug 30.75 14.89 9 46764 110 50558241
Leukopenia 30.66 14.89 12 46761 67516 50490835
Cardiac failure 30.64 14.89 16 46757 76024 50482327
Therapeutic response decreased 30.11 14.89 4 46769 47227 50511124
Confusional state 30.01 14.89 81 46692 185847 50372504
Intentional product use issue 29.80 14.89 17 46756 76901 50481450
Septic shock 29.76 14.89 8 46765 57167 50501184
Abdominal pain 29.73 14.89 115 46658 236113 50322238
Epistaxis 29.64 14.89 11 46762 63943 50494408
Death 29.55 14.89 178 46595 325201 50233150
Cardiac failure congestive 29.47 14.89 21 46752 84361 50473990
White blood cell count decreased 29.25 14.89 39 46734 116683 50441668
Neutrophil count decreased 29.10 14.89 4 46769 46022 50512329
Wrong device used 29.02 14.89 6 46767 13 50558338
Cardiac arrest 28.98 14.89 21 46752 83630 50474721
Weight decreased 28.94 14.89 106 46667 221139 50337212
Injection site anaesthesia 28.92 14.89 7 46766 38 50558313
Oxygen saturation decreased 28.65 14.89 16 46757 73232 50485119
Productive cough 28.14 14.89 7 46766 52687 50505664
Hypertension 27.75 14.89 101 46672 211102 50347249
Heart rate increased 27.08 14.89 142 46631 77108 50481243
Muscle tightness 27.01 14.89 40 46733 10240 50548111
Hypoxia 26.90 14.89 7 46766 51116 50507235
Lip swelling 26.85 14.89 66 46707 24670 50533681
Pruritus 26.48 14.89 388 46385 283180 50275171
Progressive multifocal leukoencephalopathy 26.47 14.89 42 46731 11415 50546936
Upper respiratory tract infection 26.35 14.89 14 46759 65884 50492467
JC polyomavirus test positive 26.28 14.89 15 46758 1094 50557257
Pregnancy 26.06 14.89 73 46700 29504 50528847
Neuropathy peripheral 25.62 14.89 31 46742 96726 50461625
Rhabdomyolysis 25.62 14.89 3 46770 39024 50519327
Trigeminal neuralgia 25.62 14.89 22 46751 3093 50555258
Cardio-respiratory arrest 25.43 14.89 9 46764 53883 50504468
Somnolence 25.40 14.89 67 46706 154918 50403433
Anaphylactic shock 25.39 14.89 57 46716 20098 50538253
Infection 25.25 14.89 79 46694 172875 50385476
Blister 25.23 14.89 25 46748 85393 50472958
Hypoglycaemia 25.19 14.89 9 46764 53572 50504779
Arthritis 24.91 14.89 26 46747 86695 50471656
Oedema peripheral 24.60 14.89 70 46703 157891 50400460
Hepatic enzyme increased 24.38 14.89 57 46716 137323 50421028
Expanded disability status scale score increased 24.10 14.89 10 46763 360 50557991
Wrong schedule 24.03 14.89 8 46765 153 50558198
Depressed level of consciousness 23.97 14.89 9 46764 51944 50506407
Injection site discomfort 23.79 14.89 23 46750 3767 50554584
Sepsis 23.71 14.89 55 46718 132870 50425481
Psoriatic arthropathy 23.70 14.89 7 46766 47025 50511326
Folliculitis 23.45 14.89 4 46769 39221 50519130
Wrong technique in device usage process 23.44 14.89 19 46754 2467 50555884
Psoriasis 23.03 14.89 18 46755 68982 50489369
Progressive multiple sclerosis 22.84 14.89 12 46761 743 50557608
Impaired healing 22.30 14.89 19 46754 69767 50488584
Fibromyalgia 22.11 14.89 7 46766 44971 50513380
Blood glucose increased 22.09 14.89 20 46753 71304 50487047
Gastrooesophageal reflux disease 21.86 14.89 23 46750 76405 50481946
Chronic kidney disease 21.80 14.89 5 46768 39766 50518585
Blood cholesterol increased 21.68 14.89 12 46761 55203 50503148
Needle issue 21.60 14.89 30 46743 7245 50551106
Lymphadenopathy 21.46 14.89 74 46699 33425 50524926
Overdose 21.44 14.89 37 46736 99690 50458661
Limb discomfort 21.34 14.89 60 46713 24297 50534054
Kinematic imbalances due to suboccipital strain 21.18 14.89 4 46769 4 50558347
Encephalopathy 21.15 14.89 3 46770 33708 50524643
Therapy interrupted 21.06 14.89 53 46720 20099 50538252
Pharyngeal oedema 20.98 14.89 41 46732 13124 50545227
Pulmonary hypertension 20.90 14.89 3 46770 33414 50524937
Adverse event 20.88 14.89 88 46685 43675 50514676
Peripheral swelling 20.65 14.89 109 46664 205827 50352524
Speech disorder 20.61 14.89 76 46697 35472 50522879
Adverse reaction 20.56 14.89 32 46741 8554 50549797
Blood pressure systolic increased 20.36 14.89 4 46769 35445 50522906
Injection site coldness 20.31 14.89 6 46767 76 50558275
Pulmonary oedema 20.15 14.89 10 46763 48928 50509423
Vision blurred 20.08 14.89 133 46640 78514 50479837
Coma 20.06 14.89 14 46759 56865 50501486
Manufacturing product shipping issue 19.89 14.89 6 46767 82 50558269
Injury associated with device 19.72 14.89 19 46754 3098 50555253
Hemiparesis 19.18 14.89 51 46722 19997 50538354
Plasma cell myeloma 19.16 14.89 3 46770 31319 50527032
Hyperglycaemia 19.12 14.89 5 46768 36400 50521951
Delirium 18.68 14.89 6 46767 38186 50520165
Condition aggravated 18.66 14.89 180 46593 296878 50261473
Wheezing 18.51 14.89 18 46755 62029 50496322
Relapsing-remitting multiple sclerosis 18.41 14.89 9 46764 478 50557873
Anaplastic large cell lymphoma T- and null-cell types 18.37 14.89 5 46768 46 50558305
Loss of personal independence in daily activities 17.96 14.89 23 46750 70027 50488324
Injection site cellulitis 17.92 14.89 12 46761 1163 50557188
Gastrointestinal disorder 17.72 14.89 38 46735 94418 50463933
Monoplegia 17.68 14.89 17 46756 2766 50555585
Abortion spontaneous 17.65 14.89 81 46692 41691 50516660
Nonspecific reaction 17.63 14.89 14 46759 1765 50556586
Panic attack 17.30 14.89 48 46725 19294 50539057
Maternal exposure during breast feeding 17.22 14.89 18 46755 3236 50555115
Fluid retention 17.17 14.89 13 46760 50636 50507715
Head injury 17.11 14.89 55 46718 23965 50534386
Acute respiratory failure 17.06 14.89 3 46770 28779 50529572
Alanine aminotransferase increased 17.04 14.89 35 46738 88324 50470027
Oedema 17.02 14.89 24 46749 70157 50488194
Weight increased 16.98 14.89 113 46660 201778 50356573
Injection site fibrosis 16.97 14.89 4 46769 19 50558332
Ascites 16.90 14.89 6 46767 35855 50522496
Nephrolithiasis 16.73 14.89 70 46703 34623 50523728
Sensory disturbance 16.66 14.89 35 46738 11794 50546557
Hypoaesthesia oral 16.60 14.89 33 46740 10695 50547656
Skin mass 16.49 14.89 22 46751 5113 50553238
Necrosis 16.31 14.89 21 46752 4715 50553636
Injection site oedema 16.23 14.89 11 46762 1087 50557264
Haematemesis 16.20 14.89 3 46770 27722 50530629
Urinary incontinence 16.09 14.89 60 46713 28148 50530203
Nasal sinus cancer 15.91 14.89 4 46769 26 50558325
Alopecia 15.58 14.89 148 46625 244899 50313452
Injection site paraesthesia 15.50 14.89 8 46765 477 50557874
Hypocalcaemia 15.46 14.89 3 46770 26813 50531538
Spinal cord operation 15.42 14.89 3 46770 4 50558347
Acute myocardial infarction 15.42 14.89 4 46769 29269 50529082
Neoplasm progression 15.32 14.89 4 46769 29153 50529198
Drug administered in wrong device 15.30 14.89 4 46769 31 50558320
Thyroid cancer 15.17 14.89 19 46754 4150 50554201
Ankle fracture 15.04 14.89 40 46733 15682 50542669
Ill-defined disorder 15.01 14.89 17 46756 54637 50503714

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 1055.83 24.19 311 9907 11108 29553201
Injection site reaction 858.31 24.19 264 9954 10924 29553385
Injection site pain 571.67 24.19 260 9958 32186 29532123
Injection site erythema 467.01 24.19 177 10041 13779 29550530
Immediate post-injection reaction 299.53 24.19 46 10172 27 29564282
Injection site swelling 270.54 24.19 107 10111 9310 29554999
Injection site mass 225.81 24.19 81 10137 5374 29558935
Injection site pruritus 209.25 24.19 78 10140 5771 29558538
Injection site necrosis 194.82 24.19 41 10177 338 29563971
Multiple sclerosis 162.56 24.19 64 10154 5490 29558819
Injection site urticaria 153.74 24.19 45 10173 1551 29562758
Fall 134.40 24.19 228 9990 176950 29387359
Flushing 124.59 24.19 93 10125 28899 29535410
Injection site bruising 115.21 24.19 55 10163 7525 29556784
Hypoaesthesia 101.58 24.19 108 10110 53359 29510950
Gait disturbance 93.96 24.19 121 10097 73228 29491081
Balance disorder 88.80 24.19 84 10134 36086 29528223
Central nervous system lesion 79.83 24.19 39 10179 5609 29558700
Embolia cutis medicamentosa 76.42 24.19 17 10201 186 29564123
Urticaria 74.42 24.19 93 10125 54567 29509742
Product dose omission issue 71.41 24.19 123 10095 96260 29468049
Magnetic resonance imaging abnormal 64.32 24.19 23 10195 1508 29562801
Secondary progressive multiple sclerosis 61.67 24.19 16 10202 348 29563961
Injection site irritation 56.47 24.19 19 10199 1038 29563271
Motor dysfunction 55.31 24.19 31 10187 5899 29558410
Injection site vesicles 55.31 24.19 16 10202 528 29563781
Chills 52.76 24.19 91 10127 71209 29493100
Injection site discolouration 52.52 24.19 19 10199 1288 29563021
Product substitution issue 52.29 24.19 35 10183 9137 29555172
Acute kidney injury 51.64 24.19 14 10204 265253 29299056
Chest discomfort 49.84 24.19 70 10148 45913 29518396
Injection site rash 48.54 24.19 24 10194 3540 29560769
Progressive multiple sclerosis 48.09 24.19 12 10206 222 29564087
Injection site scar 46.38 24.19 12 10206 258 29564051
Fatigue 45.79 24.19 223 9995 316598 29247711
Toxicity to various agents 45.32 24.19 4 10214 173657 29390652
Depression 43.66 24.19 93 10125 85054 29479255
Tremor 43.23 24.19 85 10133 73453 29490856
Injection site induration 43.15 24.19 20 10198 2556 29561753
Off label use 42.20 24.19 26 10192 300774 29263535
Muscle spasms 41.66 24.19 78 10140 65004 29499305
Injection site atrophy 40.51 24.19 8 10210 46 29564263
Influenza like illness 40.45 24.19 46 10172 24424 29539885
Therapy cessation 40.14 24.19 36 10182 14426 29549883
Muscular weakness 38.01 24.19 73 10145 61979 29502330
Palpitations 37.36 24.19 51 10167 32553 29531756
Therapy change 36.88 24.19 18 10200 2580 29561729
Toxic neuropathy 36.63 24.19 11 10207 414 29563895
Anaemia 36.53 24.19 12 10206 200939 29363370
Urinary tract infection 35.89 24.19 78 10140 72276 29492033
Hypersensitivity 35.85 24.19 65 10153 52838 29511471
Memory impairment 35.82 24.19 53 10165 36417 29527892
Injection site inflammation 35.36 24.19 12 10206 673 29563636
Injection site haemorrhage 33.98 24.19 26 10192 8360 29555949
Injection site warmth 33.02 24.19 15 10203 1831 29562478
Gait inability 32.86 24.19 36 10182 18339 29545970
Paraesthesia 32.55 24.19 63 10155 53782 29510527
Visual impairment 31.83 24.19 45 10173 29663 29534646
Burning sensation 31.63 24.19 33 10185 15905 29548404
Muscle spasticity 31.16 24.19 20 10198 4863 29559446
Drug interaction 30.62 24.19 15 10203 197370 29366939
Injection site haematoma 29.21 24.19 13 10205 1512 29562797
Hypotension 28.33 24.19 16 10202 194338 29369971
Pleurothotonus 27.02 24.19 11 10207 1027 29563282
Swelling face 26.65 24.19 34 10184 20316 29543993
Thrombocytopenia 26.39 24.19 7 10211 134816 29429493
Injection site scab 25.58 24.19 5 10213 27 29564282
Testis cancer 24.81 24.19 10 10208 910 29563399

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 2800.02 17.10 1013 37200 40122 64420397
Injection site reaction 2657.33 17.10 1008 37205 45656 64414863
Injection site pain 1817.54 17.10 1008 37205 110400 64350119
Injection site erythema 1467.13 17.10 752 37461 70048 64390471
Injection site mass 1130.32 17.10 414 37799 16856 64443663
Injection site swelling 951.45 17.10 472 37741 40881 64419638
Injection site pruritus 873.83 17.10 433 37780 37393 64423126
Injection site urticaria 727.48 17.10 267 37946 10914 64449605
Immediate post-injection reaction 702.38 17.10 128 38085 202 64460317
Flushing 484.62 17.10 389 37824 78259 64382260
Injection site bruising 478.55 17.10 287 37926 36086 64424433
Hypoaesthesia 371.03 17.10 434 37779 138674 64321845
Fall 322.28 17.10 740 37473 416086 64044433
Multiple sclerosis 311.80 17.10 173 38040 18768 64441751
Product dose omission issue 295.91 17.10 462 37751 194285 64266234
Urticaria 291.40 17.10 396 37817 146921 64313598
Chills 276.05 17.10 372 37841 136892 64323627
Injection site necrosis 258.73 17.10 73 38140 1252 64459267
Therapy cessation 204.74 17.10 163 38050 32326 64428193
Injection site atrophy 199.32 17.10 46 38167 331 64460188
Acute kidney injury 190.09 17.10 22 38191 449218 64011301
Central nervous system lesion 170.12 17.10 99 38114 11750 64448769
Off label use 167.88 17.10 83 38130 632723 63827796
Injection site induration 167.58 17.10 89 38124 8843 64451676
Toxicity to various agents 166.41 17.10 13 38200 363500 64097019
Product substitution issue 160.61 17.10 111 38102 17750 64442769
Influenza like illness 160.02 17.10 190 38023 61512 64399007
Balance disorder 158.77 17.10 221 37992 83705 64376814
Magnetic resonance imaging abnormal 154.13 17.10 61 38152 3062 64457457
Embolia cutis medicamentosa 152.03 17.10 39 38174 456 64460063
Palpitations 151.63 17.10 243 37970 104245 64356274
Gait disturbance 148.51 17.10 320 37893 171835 64288684
Injection site scar 146.86 17.10 41 38172 675 64459844
Injection site warmth 145.96 17.10 94 38119 13368 64447151
Injection site irritation 145.06 17.10 59 38154 3181 64457338
Memory impairment 140.71 17.10 211 38002 85471 64375048
Injection site haemorrhage 140.67 17.10 116 38097 24162 64436357
Chest discomfort 137.96 17.10 247 37966 115859 64344660
Anaemia 132.49 17.10 31 38182 378649 64081870
Paraesthesia 126.37 17.10 259 37954 134263 64326256
Tremor 126.04 17.10 274 37939 147956 64312563
Therapy change 114.78 17.10 62 38151 6372 64454147
Injection related reaction 113.43 17.10 33 38180 634 64459885
Motor dysfunction 112.53 17.10 75 38138 11298 64449221
Throat tightness 106.52 17.10 97 38116 23063 64437456
Injection site rash 105.65 17.10 82 38131 15660 64444859
Completed suicide 105.56 17.10 7 38206 224407 64236112
Optic neuritis 103.94 17.10 63 38150 8053 64452466
Muscle spasms 103.55 17.10 246 37967 140777 64319742
Chest pain 103.38 17.10 341 37872 235639 64224880
Lipoatrophy 96.94 17.10 29 38184 616 64459903
Lipodystrophy acquired 95.50 17.10 47 38166 3980 64456539
Secondary progressive multiple sclerosis 93.23 17.10 33 38180 1210 64459309
Drug interaction 92.06 17.10 50 38163 362033 64098486
Neutropenia 91.25 17.10 16 38197 239608 64220911
Burning sensation 89.74 17.10 128 38085 49536 64410983
Injection site discolouration 89.67 17.10 54 38159 6821 64453698
Hypotension 87.92 17.10 59 38154 380915 64079604
Thrombocytopenia 80.85 17.10 17 38196 223784 64236735
Depression 80.33 17.10 265 37948 183026 64277493
Feeling hot 80.03 17.10 116 38097 45547 64414972
Dyspnoea 78.35 17.10 707 37506 717967 63742552
Rheumatoid arthritis 77.61 17.10 5 38208 164289 64296230
Diarrhoea 77.39 17.10 199 38014 722505 63738014
Erythema 76.28 17.10 264 37949 186806 64273713
Injection site indentation 75.88 17.10 18 38195 148 64460371
Fatigue 75.81 17.10 725 37488 748005 63712514
Injection site nodule 71.57 17.10 36 38177 3194 64457325
Pneumonia 71.32 17.10 140 38073 559436 63901083
Insurance issue 70.06 17.10 34 38179 2792 64457727
Pancytopenia 68.77 17.10 4 38209 143305 64317214
Decreased appetite 68.36 17.10 41 38172 281248 64179271
Urinary tract infection 68.35 17.10 295 37918 231301 64229218
Infusion related reaction 67.11 17.10 9 38204 164458 64296061
Product use in unapproved indication 66.76 17.10 12 38201 176606 64283913
Injection site vesicles 66.17 17.10 32 38181 2608 64457911
Hyponatraemia 65.87 17.10 6 38207 148333 64312186
Drug abuse 65.71 17.10 3 38210 132371 64328148
Swelling face 64.06 17.10 121 38092 59045 64401474
Injection site inflammation 62.98 17.10 33 38180 3188 64457331
Platelet count decreased 62.10 17.10 12 38201 167699 64292820
Visual impairment 61.82 17.10 136 38077 73941 64386578
Blood creatinine increased 61.63 17.10 5 38208 135777 64324742
General physical health deterioration 60.03 17.10 23 38190 204402 64256117
Death 59.55 17.10 123 38090 482582 63977937
Dizziness 58.93 17.10 446 37767 429717 64030802
Muscular weakness 56.54 17.10 185 38028 127153 64333366
Malignant neoplasm progression 54.61 17.10 3 38210 112868 64347651
Gastrointestinal haemorrhage 54.55 17.10 7 38206 132305 64328214
Progressive multifocal leukoencephalopathy 52.00 17.10 59 38154 18173 64442346
Respiratory failure 50.99 17.10 16 38197 161167 64299352
Haemoglobin decreased 50.89 17.10 26 38187 195037 64265482
Feeling cold 50.27 17.10 66 38147 23612 64436907
Pruritus 48.55 17.10 334 37879 312066 64148453
Hypersensitivity 48.12 17.10 237 37976 196215 64264304
Renal failure 47.72 17.10 24 38189 181664 64278855
Muscle spasticity 47.64 17.10 54 38159 16615 64443904
Renal impairment 47.23 17.10 11 38202 135006 64325513
Stomatitis 47.16 17.10 5 38208 109600 64350919
Cardiac arrest 44.12 17.10 18 38195 154046 64306473
Immune reconstitution inflammatory syndrome 43.71 17.10 45 38168 12425 64448094
Joint swelling 43.68 17.10 38 38175 215344 64245175
Atrial fibrillation 42.87 17.10 24 38189 171065 64289454
Cardiac failure 42.12 17.10 13 38200 132360 64328159
Sepsis 41.65 17.10 45 38168 230296 64230223
Product storage error 39.52 17.10 44 38169 13274 64447245
Loss of consciousness 39.21 17.10 183 38030 148182 64312337
Overdose 39.09 17.10 23 38190 159543 64300976
Anxiety 39.09 17.10 229 37984 202420 64258099
Gait inability 39.04 17.10 81 38132 42287 64418232
Lower respiratory tract infection 39.01 17.10 5 38208 94609 64365910
Intentional overdose 38.96 17.10 4 38209 89940 64370579
Autonomic dysreflexia 38.89 17.10 13 38200 400 64460119
Bradycardia 38.72 17.10 11 38202 118208 64342311
Septic shock 38.07 17.10 8 38205 105429 64355090
Injection site scab 37.93 17.10 12 38201 309 64460210
Hyperhidrosis 36.69 17.10 159 38054 124761 64335758
Cardio-respiratory arrest 36.49 17.10 7 38206 98386 64362133
Pleural effusion 35.89 17.10 15 38198 126544 64333975
Electrocardiogram QT prolonged 35.84 17.10 3 38210 79445 64381074
Incorrect dose administered by device 35.74 17.10 25 38188 4072 64456447
Product use issue 35.59 17.10 23 38190 151692 64308827
Hypoxia 35.52 17.10 5 38208 88144 64372375
Hypokalaemia 35.30 17.10 14 38199 121889 64338630
Rhabdomyolysis 35.15 17.10 6 38207 91720 64368799
Therapeutic product effect incomplete 35.08 17.10 9 38204 103473 64357046
Neutrophil count decreased 34.59 17.10 3 38210 77193 64383326
White blood cell count decreased 34.29 17.10 26 38187 157811 64302708
Cognitive disorder 33.97 17.10 90 38123 54997 64405522
Dyspnoea exertional 32.67 17.10 3 38210 73727 64386792
Adverse event 32.36 17.10 72 38141 39417 64421102
Oedema peripheral 31.86 17.10 47 38166 210270 64250249
Lip swelling 31.77 17.10 63 38150 31844 64428675
Cough 30.82 17.10 85 38128 302063 64158456
Injection site infection 30.58 17.10 17 38196 1848 64458671
Leukopenia 30.36 17.10 11 38202 101231 64359288
Injection site haematoma 29.71 17.10 22 38191 3914 64456605
Injection site injury 29.57 17.10 12 38201 643 64459876
Injection site ulcer 29.36 17.10 12 38201 655 64459864
Bladder disorder 29.00 17.10 29 38184 7738 64452781
Skin reaction 28.68 17.10 36 38177 12316 64448203
Oxygen saturation decreased 28.36 17.10 14 38199 107162 64353357
Injection site cellulitis 28.09 17.10 15 38198 1506 64459013
No reaction on previous exposure to drug 28.04 17.10 9 38204 243 64460276
Feeling abnormal 27.72 17.10 154 38059 133448 64327071
Movement disorder 27.62 17.10 48 38165 21952 64438567
Arthropathy 27.48 17.10 19 38194 120948 64339571
Seizure 27.40 17.10 181 38032 166711 64293808
Vision blurred 27.31 17.10 116 38097 90200 64370319
Muscle tightness 26.78 17.10 33 38180 11082 64449437
Abortion spontaneous 26.68 17.10 51 38162 25092 64435427
Maternal exposure during pregnancy 26.60 17.10 120 38093 95764 64364755
Cardiac failure congestive 26.50 17.10 23 38190 130557 64329962
Arthralgia 26.33 17.10 154 38059 442106 64018413
Injection site discomfort 26.10 17.10 21 38192 4220 64456299
Injection site coldness 25.99 17.10 7 38206 100 64460419
Migraine 25.97 17.10 89 38124 62588 64397931
C-reactive protein increased 25.72 17.10 12 38201 94897 64365622
Productive cough 25.52 17.10 6 38207 73197 64387322
Headache 25.23 17.10 447 37766 529020 63931499
Hypoglycaemia 24.93 17.10 11 38202 89881 64370638
Normal newborn 24.80 17.10 23 38190 5594 64454925
Abdominal pain 24.23 17.10 99 38114 312276 64148243
Epistaxis 24.23 17.10 14 38199 98117 64362402
Progressive multiple sclerosis 24.12 17.10 11 38202 785 64459734
Confusional state 24.07 17.10 77 38136 261067 64199452
Injection site oedema 23.82 17.10 12 38201 1068 64459451
Constipation 23.76 17.10 64 38149 229273 64231246
Acute myocardial infarction 23.75 17.10 6 38207 69712 64390807
Injection site hypoaesthesia 23.69 17.10 9 38204 404 64460115
Injection site abscess 23.62 17.10 13 38200 1385 64459134
Somnolence 23.30 17.10 54 38159 203591 64256928
Coronavirus infection 23.18 17.10 22 38191 5508 64455011
Pulmonary oedema 22.83 17.10 9 38204 78665 64381854
Paralysis 22.59 17.10 31 38182 11564 64448955
Expanded disability status scale score increased 22.49 17.10 9 38204 465 64460054
Coma 22.35 17.10 12 38201 87603 64372916
Primary progressive multiple sclerosis 22.07 17.10 6 38207 89 64460430
JC polyomavirus test positive 22.06 17.10 12 38201 1250 64459269
Peroneal nerve palsy 21.98 17.10 21 38192 5300 64455219
Chronic kidney disease 21.73 17.10 4 38209 57915 64402604
Rectal haemorrhage 21.68 17.10 5 38208 61812 64398707
Upper respiratory tract infection 21.66 17.10 8 38205 72777 64387742
Limb discomfort 21.65 17.10 49 38164 27126 64433393
Delirium 21.64 17.10 7 38206 69187 64391332
Intentional product use issue 21.63 17.10 15 38198 95349 64365170
Wrong technique in device usage process 21.51 17.10 16 38197 2866 64457653
Blood glucose increased 21.49 17.10 16 38197 98057 64362462
Hyperglycaemia 21.25 17.10 5 38208 60963 64399556
Demyelination 21.01 17.10 23 38190 6811 64453708
Temperature intolerance 20.68 17.10 25 38188 8230 64452289
Trigeminal neuralgia 20.43 17.10 16 38197 3093 64457426
Vertigo 20.39 17.10 79 38134 58932 64401587
Hot flush 20.34 17.10 67 38146 46168 64414351
Haematochezia 20.26 17.10 7 38206 66366 64394153
Speech disorder 20.25 17.10 69 38144 48372 64412147
Pain in extremity 20.21 17.10 271 37942 302814 64157705
Neuropathy peripheral 20.09 17.10 24 38189 117501 64343018
Back pain 19.81 17.10 231 37982 249940 64210579
Acute respiratory failure 19.73 17.10 3 38210 49931 64410588
Pharyngeal oedema 19.65 17.10 34 38179 15497 64445022
Sensory loss 19.53 17.10 27 38186 10142 64450377
Breast cancer 19.39 17.10 49 38164 29099 64431420
Heart rate increased 19.31 17.10 112 38101 98563 64361956
Systemic lupus erythematosus 19.26 17.10 11 38202 77601 64382918
Therapeutic product effect decreased 19.25 17.10 24 38189 115327 64345192
Weight decreased 18.90 17.10 96 38117 285643 64174876
Thyroid cancer 18.90 17.10 17 38196 3974 64456545
Hypertension 18.37 17.10 85 38128 259176 64201343
Alanine aminotransferase increased 18.32 17.10 34 38179 138997 64321522
Intentional product misuse 18.30 17.10 10 38203 72285 64388234
Sensory disturbance 18.15 17.10 30 38183 13178 64447341
Ascites 18.14 17.10 7 38206 61994 64398525
Contusion 17.73 17.10 122 38091 113843 64346676
Gastrooesophageal reflux disease 17.66 17.10 14 38199 83129 64377390
Manufacturing product shipping issue 17.24 17.10 5 38208 95 64460424
Dehydration 17.24 17.10 68 38145 216695 64243824

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
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 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 68546-325 INJECTION, SOLUTION 40 mg SUBCUTANEOUS NDA 26 sections
Copaxone HUMAN PRESCRIPTION DRUG LABEL 1 68546-325 INJECTION, SOLUTION 40 mg SUBCUTANEOUS NDA 26 sections