interferon beta-1b Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5140 145155-23-3

Description:

MoleculeDescription

Synonyms:

  • interferon beta-1b
  • betaseron
A non-glycosylated form of interferon beta-1 that has a serine at position 17. It is used in the treatment of both RELAPSING-REMITTING MULTIPLE SCLEROSIS and CHRONIC PROGRESSIVE MULTIPLE SCLEROSIS. A possible role for IFNs in prophylaxis or early treatment of COVID-19 has been suggested to compensate for possibly insufficient endogenous IFN production. However, the efficacy and safety of IFNs for treatment or prevention of COVID-19 were not established.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
4 MU P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 23, 1993 FDA BAYER HEALTHCARE PHARMS

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 1154.50 14.48 521 23883 41604 46620054
Influenza like illness 956.82 14.48 506 23898 57064 46604594
Multiple sclerosis 889.09 14.48 371 24033 24420 46637238
Injection site erythema 887.61 14.48 526 23878 73901 46587757
Injection site pain 772.07 14.48 552 23852 106600 46555058
Injection site reaction 527.60 14.48 322 24082 47527 46614131
Injection site mass 511.74 14.48 217 24187 14823 46646835
Injection site bruising 393.07 14.48 240 24164 35396 46626262
Chills 243.96 14.48 275 24129 95757 46565901
Injection site scar 234.99 14.48 59 24345 721 46660937
Injection site rash 225.79 14.48 126 24278 15687 46645971
Injection site induration 220.87 14.48 100 24304 7979 46653679
Injection site necrosis 197.99 14.48 58 24346 1304 46660354
Hypoaesthesia 185.27 14.48 267 24137 118602 46543056
Gait disturbance 171.46 14.48 287 24117 144976 46516682
Injection site atrophy 163.21 14.48 41 24363 502 46661156
Product dose omission issue 144.47 14.48 290 24114 168230 46493428
Injection site abscess 138.45 14.48 41 24363 958 46660700
Depression 136.67 14.48 285 24119 169819 46491839
Injection site cellulitis 136.46 14.48 42 24362 1123 46660535
Injection site ulcer 122.95 14.48 33 24371 532 46661126
Gait inability 121.75 14.48 119 24285 35084 46626574
Injection site infection 119.78 14.48 41 24363 1546 46660112
Muscular weakness 117.04 14.48 188 24216 91656 46570002
Injection site discolouration 115.10 14.48 61 24343 6849 46654809
Off label use 108.71 14.48 32 24372 379809 46281849
Balance disorder 100.46 14.48 145 24259 64376 46597282
Injection site haematoma 99.11 14.48 53 24351 6059 46655599
Optic neuritis 93.30 14.48 53 24351 6818 46654840
Rheumatoid arthritis 88.05 14.48 11 24393 240204 46421454
Injection site inflammation 86.68 14.48 39 24365 3063 46658595
Injection site swelling 84.82 14.48 105 24299 40222 46621436
Toxicity to various agents 84.59 14.48 7 24397 211759 46449899
Central nervous system lesion 84.08 14.48 56 24348 9559 46652099
Acute kidney injury 79.08 14.48 14 24390 235841 46425817
Depressed mood 70.45 14.48 87 24317 33232 46628426
Injection site urticaria 68.70 14.48 54 24350 11913 46649745
Diarrhoea 67.11 14.48 119 24285 559483 46102175
Drug interaction 63.97 14.48 14 24390 203080 46458578
Mobility decreased 60.00 14.48 111 24293 60483 46601175
Feeling cold 54.92 14.48 58 24346 18713 46642945
Pyrexia 54.08 14.48 339 24065 348463 46313195
Memory impairment 53.32 14.48 122 24282 77215 46584443
Injection site calcification 53.30 14.48 9 24395 8 46661650
Coordination abnormal 51.50 14.48 44 24360 10905 46650753
Progressive multiple sclerosis 46.58 14.48 17 24387 775 46660883
Tremor 45.13 14.48 148 24256 115491 46546167
Injection site irritation 44.96 14.48 28 24376 4259 46657399
Hypotension 44.42 14.48 34 24370 232555 46429103
Hemianaesthesia 43.39 14.48 14 24390 438 46661220
Breast cancer female 43.34 14.48 31 24373 5932 46655726
Secondary progressive multiple sclerosis 42.77 14.48 18 24386 1202 46660456
Muscle spasticity 42.02 14.48 40 24364 11400 46650258
Hyponatraemia 41.41 14.48 3 24401 101329 46560329
Injection site scab 41.26 14.48 13 24391 376 46661282
Neutropenia 40.97 14.48 12 24392 143192 46518466
Injection site pruritus 40.84 14.48 74 24330 39669 46621989
Paraesthesia 39.45 14.48 143 24261 117294 46544364
Injection site haemorrhage 38.91 14.48 51 24353 20658 46641000
Pneumonia 35.02 14.48 92 24312 376228 46285430
Joint swelling 34.70 14.48 22 24382 166051 46495607
Fatigue 34.43 14.48 476 23928 608221 46053437
Seizure 34.11 14.48 141 24263 122913 46538745
Decreased interest 34.10 14.48 21 24383 3131 46658527
Muscle spasms 33.29 14.48 140 24264 122973 46538685
Neutralising antibodies positive 33.01 14.48 10 24394 253 46661405
Anti-interferon antibody positive 32.76 14.48 6 24398 12 46661646
Limb discomfort 32.26 14.48 49 24355 22727 46638931
Headache 32.03 14.48 386 24018 477966 46183692
Drug ineffective 31.82 14.48 216 24188 677622 45984036
Anaemia 31.79 14.48 53 24351 255726 46405932
Peroneal nerve palsy 31.06 14.48 22 24382 4146 46657512
Fall 30.66 14.48 284 24120 328813 46332845
Overdose 30.18 14.48 8 24396 101971 46559687
Dyspnoea 30.16 14.48 153 24251 515395 46146263
Pain in extremity 29.75 14.48 234 24170 258446 46403212
Expanded disability status scale score increased 29.47 14.48 9 24395 234 46661424
Paraparesis 29.16 14.48 16 24388 1923 46659735
Sensory disturbance 29.15 14.48 34 24370 12233 46649425
Abdominal discomfort 28.96 14.48 22 24382 151143 46510515
Migraine 28.54 14.48 91 24313 69935 46591723
Decreased appetite 27.13 14.48 37 24367 193799 46467859
Drug hypersensitivity 26.34 14.48 55 24349 243770 46417888
Injection site erosion 26.30 14.48 6 24398 47 46661611
Hypokalaemia 25.86 14.48 7 24397 88017 46573641
Urinary incontinence 25.43 14.48 50 24354 28480 46633178
Therapeutic product effect incomplete 25.38 14.48 5 24399 78148 46583510
Thrombocytopenia 24.78 14.48 18 24386 126563 46535095
Blood creatinine increased 24.57 14.48 5 24399 76398 46585260
Burning sensation 24.15 14.48 64 24340 44347 46617311
Device leakage 24.09 14.48 21 24383 5344 46656314
Lack of injection site rotation 22.89 14.48 7 24397 183 46661475
Hepatic enzyme increased 22.87 14.48 94 24310 81693 46579965
Injection site nerve damage 22.80 14.48 5 24399 32 46661626
Drug intolerance 22.74 14.48 26 24378 147023 46514635
Visual impairment 22.20 14.48 81 24323 66608 46595050
Rash 21.84 14.48 104 24300 356408 46305250
Asthenia 21.62 14.48 253 24151 310822 46350836
Condition aggravated 21.20 14.48 62 24342 244990 46416668
Feeling abnormal 20.83 14.48 124 24280 124936 46536722
Nausea 20.78 14.48 245 24159 687209 45974449
Product prescribing issue 20.71 14.48 10 24394 922 46660736
Seizure like phenomena 20.09 14.48 10 24394 985 46660673
Sepsis 20.01 14.48 25 24379 135989 46525669
Vomiting 19.84 14.48 147 24257 452647 46209011
Oxygen saturation decreased 19.40 14.48 6 24398 69158 46592500
Pain 19.30 14.48 353 24051 476595 46185063
Injection site injury 19.24 14.48 8 24396 518 46661140
Injection site fibrosis 19.24 14.48 4 24400 19 46661639
Skin necrosis 19.04 14.48 23 24381 8581 46653077
Lower respiratory tract infection 19.03 14.48 3 24401 55086 46606572
Product availability issue 18.93 14.48 10 24394 1115 46660543
Needle fatigue 18.84 14.48 5 24399 77 46661581
Hypoglycaemia 18.68 14.48 3 24401 54346 46607312
Fat necrosis 18.59 14.48 8 24396 564 46661094
Therapeutic product effect decreased 18.57 14.48 10 24394 82591 46579067
Treatment failure 18.53 14.48 13 24391 93074 46568584
Product leakage 18.34 14.48 7 24397 362 46661296
Wheezing 18.23 14.48 3 24401 53383 46608275
Septic shock 18.18 14.48 4 24400 57889 46603769
Bradycardia 18.15 14.48 6 24398 66292 46595366
Pancytopenia 18.12 14.48 11 24393 85047 46576611
Cough 17.98 14.48 61 24343 230188 46431470
Stomatitis 17.31 14.48 7 24397 68290 46593368
Cardio-respiratory arrest 17.14 14.48 5 24399 59864 46601794
Diplegia 16.68 14.48 9 24395 1047 46660611
Accident at home 16.45 14.48 5 24399 128 46661530
Cardiac arrest 16.25 14.48 14 24390 90385 46571273
Trigeminal neuralgia 16.11 14.48 13 24391 2976 46658682
Limb mass 15.94 14.48 12 24392 2482 46659176
Neutralising antibodies 15.92 14.48 4 24400 49 46661609
Neuromyelitis optica spectrum disorder 15.77 14.48 8 24396 820 46660838
Psoriasis 15.61 14.48 11 24393 78593 46583065
Multiple organ dysfunction syndrome 15.40 14.48 4 24400 51706 46609952
Injection site dryness 15.39 14.48 5 24399 160 46661498
Infection 15.38 14.48 29 24375 133563 46528095
Arthropathy 15.36 14.48 13 24391 84687 46576971
Thyroid function test abnormal 15.27 14.48 13 24391 3205 46658453
Neuropathy peripheral 15.24 14.48 15 24389 90878 46570780
Feeling hot 15.18 14.48 49 24355 37879 46623779
Lipoatrophy 15.18 14.48 6 24398 341 46661317
Peripheral swelling 15.15 14.48 38 24366 158033 46503625
Syringe issue 15.02 14.48 10 24394 1705 46659953
Magnetic resonance imaging abnormal 14.96 14.48 12 24392 2724 46658934
Quadriplegia 14.90 14.48 10 24394 1727 46659931
Skin mass 14.88 14.48 16 24388 5264 46656394
C-reactive protein increased 14.86 14.48 6 24398 58584 46603074
Underdose 14.75 14.48 32 24372 19526 46642132
Injection site nodule 14.74 14.48 13 24391 3358 46658300
Speech disorder 14.72 14.48 47 24357 36120 46625538
Osteoarthritis 14.71 14.48 7 24397 62018 46599640
Interstitial lung disease 14.56 14.48 5 24399 53944 46607714

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 499.50 23.24 158 6819 10704 29934797
Multiple sclerosis 441.60 23.24 131 6846 7136 29938365
Influenza like illness 424.35 23.24 175 6802 25430 29920071
Injection site pain 357.52 23.24 163 6814 30147 29915354
Injection site erythema 250.86 23.24 101 6876 13733 29931768
Injection site mass 162.78 23.24 56 6921 4897 29940604
Injection site reaction 162.58 23.24 69 6908 10691 29934810
Injection site cellulitis 120.21 23.24 27 6950 473 29945028
Gait disturbance 116.37 23.24 113 6864 74664 29870837
Chills 115.74 23.24 111 6866 72227 29873274
Injection site infection 110.67 23.24 28 6949 829 29944672
Injection site induration 81.87 23.24 28 6949 2401 29943100
Injection site abscess 80.98 23.24 21 6956 687 29944814
Hypoaesthesia 73.30 23.24 76 6901 54154 29891347
Injection site scar 71.90 23.24 16 6961 268 29945233
Gait inability 71.35 23.24 48 6929 18793 29926708
Depression 69.55 23.24 95 6882 90342 29855159
Injection site rash 61.17 23.24 25 6952 3514 29941987
Balance disorder 58.24 23.24 56 6921 36437 29909064
Expanded disability status scale score increased 54.67 23.24 12 6965 188 29945313
Injection site inflammation 53.68 23.24 15 6962 654 29944847
Muscular weakness 50.61 23.24 68 6909 63577 29881924
Injection site swelling 50 23.24 29 6948 8751 29936750
Secondary progressive multiple sclerosis 47.30 23.24 12 6965 359 29945142
Injection site bruising 46.52 23.24 26 6951 7312 29938189
Mobility decreased 43.56 23.24 41 6936 25958 29919543
Injection site necrosis 41.64 23.24 11 6966 387 29945114
Depressed mood 40.94 23.24 33 6944 16996 29928505
Muscle spasticity 40.20 23.24 21 6956 5167 29940334
Optic neuritis 36.75 23.24 17 6960 3217 29942284
Injection site discolouration 33.13 23.24 12 6965 1216 29944285
Muscle spasms 32.61 23.24 56 6921 64782 29880719
Acute kidney injury 31.93 23.24 12 6965 273830 29671671
Product dose omission issue 31.14 23.24 67 6910 91564 29853937
Injection site haematoma 30.67 23.24 12 6965 1505 29943996
Hemianaesthesia 28.03 23.24 6 6971 83 29945418
Skin necrosis 27.94 23.24 16 6961 4711 29940790
Headache 27.49 23.24 99 6878 182207 29763294
Visual impairment 26.44 23.24 34 6943 30404 29915097
Injection site atrophy 24.67 23.24 5 6972 52 29945449
Pain 24.54 23.24 92 6885 172549 29772952
Drug interaction 24.52 23.24 8 6969 199560 29745941
Toxicity to various agents 23.79 23.24 6 6971 177177 29768324
Hepatitis toxic 23.76 23.24 11 6966 2086 29943415
Decreased interest 23.28 23.24 11 6966 2184 29943317

Pharmacologic Action:

SourceCodeDescription
ATC L03AB08 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSTIMULANTS
IMMUNOSTIMULANTS
Interferons
FDA CS M0018641 Recombinant Proteins
FDA CS M0025715 Interferon-beta
FDA EPC N0000175747 Recombinant Human Interferon beta
MeSH PA D000276 Adjuvants, Immunologic
MeSH PA D007155 Immunologic Factors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Relapsing remitting multiple sclerosis indication 426373005 DOID:2378

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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Interferon alpha/beta receptor Membrane receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
4023900 VANDF
C0284968 UMLSCUI
CHEBI:5938 CHEBI
D00746 KEGG_DRUG
CHEMBL1201563 ChEMBL_ID
DB00068 DRUGBANK_ID
D000068576 MESH_DESCRIPTOR_UI
TTD90R31WZ UNII
72257 RXNORM
304 MMSL
4896 MMSL
d03051 MMSL
004370 NDDF
108751004 SNOMEDCT_US
386903009 SNOMEDCT_US

Pharmaceutical products:

None