baclofen Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
282 1134-47-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • baclofen
  • baclon
  • lioresal
  • DL-Baclofen
A GAMMA-AMINOBUTYRIC ACID derivative that is a specific agonist of GABA-B RECEPTORS. It is used in the treatment of MUSCLE SPASTICITY, especially that due to SPINAL CORD INJURIES. Its therapeutic effects result from actions at spinal and supraspinal sites, generally the reduction of excitatory transmission.
  • Molecular weight: 213.66
  • Formula: C10H12ClNO2
  • CLOGP: -0.62
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 63.32
  • ALOGS: -2.48
  • ROTB: 4

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O
0.55 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2.10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 69 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.22 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.65 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.69 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.24 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 22, 1977 FDA

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
Muscle spasticity 2213.73 10.10 834 90021 10606 46584601
Hypertonia 1560.55 10.10 506 90349 3960 46591247
Multiple sclerosis relapse 1400.06 10.10 924 89931 41201 46554006
Drug withdrawal syndrome 1137.70 10.10 692 90163 26692 46568515
Multiple sclerosis 784.91 10.10 528 90327 24263 46570944
Implant site infection 532.10 10.10 154 90701 777 46594430
Implant site extravasation 502.34 10.10 130 90725 390 46594817
Hypotonia 409.83 10.10 234 90621 7995 46587212
Coma 339.32 10.10 489 90366 57860 46537347
Muscle spasms 297.76 10.10 706 90149 122407 46472800
Overdose 289.14 10.10 623 90232 101356 46493851
Somnolence 273.60 10.10 795 90060 155726 46439481
Urinary tract infection 266.56 10.10 987 89868 219279 46375928
Cerebrospinal fluid leakage 266.07 10.10 89 90766 774 46594433
Gait disturbance 250.16 10.10 734 90121 144529 46450678
Seizure 225.56 10.10 636 90219 122418 46472789
Muscular weakness 215.77 10.10 521 90334 91323 46503884
Complication associated with device 196.15 10.10 193 90662 15248 46579959
Pneumonia aspiration 194.12 10.10 272 90583 31333 46563874
Withdrawal syndrome 191.13 10.10 205 90650 17929 46577278
Device failure 179.13 10.10 123 90732 5836 46589371
Device infusion issue 169.39 10.10 68 90787 1031 46594176
Mental status changes 169.17 10.10 282 90573 37806 46557401
Fall 167.41 10.10 1154 89701 327943 46267264
Implant site erosion 163.35 10.10 37 90818 48 46595159
Muscle tightness 161.99 10.10 145 90710 10160 46585047
Diarrhoea 152.82 10.10 568 90287 559034 46036173
Unresponsive to stimuli 152.05 10.10 245 90610 31929 46563278
Device power source issue 143.50 10.10 47 90808 380 46594827
Intracranial hypotension 142.77 10.10 44 90811 285 46594922
Implant site discharge 137.54 10.10 35 90820 96 46595111
Anaemia 131.20 10.10 184 90671 255595 46339612
Therapy non-responder 129.99 10.10 263 90592 40889 46554318
Febrile neutropenia 124.45 10.10 18 90837 94609 46500598
Underdose 121.08 10.10 169 90686 19389 46575818
Device physical property issue 117.20 10.10 57 90798 1392 46593815
Device malfunction 116.63 10.10 137 90718 13237 46581970
Implant site swelling 114.83 10.10 41 90814 441 46594766
Secondary progressive multiple sclerosis 113.99 10.10 53 90802 1167 46594040
Medical device site pain 113.83 10.10 34 90821 195 46595012
Medical device site infection 108.84 10.10 31 90824 146 46595061
Device connection issue 108.20 10.10 43 90812 634 46594573
White blood cell count abnormal 104.90 10.10 84 90771 5048 46590159
Pain 104.41 10.10 1399 89456 475549 46119658
Neutropenia 102.87 10.10 77 90778 143127 46452080
Completed suicide 102.63 10.10 557 90298 145363 46449844
Decubitus ulcer 100.96 10.10 110 90745 9788 46585419
Implant site pain 100.47 10.10 59 90796 2125 46593082
Musculoskeletal stiffness 99.45 10.10 416 90439 97577 46497630
Balance disorder 95.01 10.10 309 90546 64212 46530995
Post lumbar puncture syndrome 92.59 10.10 37 90818 554 46594653
Hypoaesthesia 91.99 10.10 466 90389 118403 46476804
Dyspnoea 91.64 10.10 608 90247 514940 46080267
Therapeutic response decreased 90.95 10.10 235 90620 42910 46552297
Central nervous system lesion 89.72 10.10 102 90753 9513 46585694
Device dislocation 89.62 10.10 156 90699 21646 46573561
Acute kidney injury 89.12 10.10 205 90650 235650 46359557
Progressive multiple sclerosis 88.56 10.10 39 90816 753 46594454
Rash 87.41 10.10 377 90478 356135 46239072
Rheumatoid arthritis 86.62 10.10 214 90641 240001 46355206
Device inversion 86.39 10.10 17 90838 3 46595204
Joint swelling 83.54 10.10 121 90734 165952 46429255
Influenza like illness 81.44 10.10 272 90583 57298 46537909
Exposure during pregnancy 79.23 10.10 57 90798 108155 46487052
Cough 78.49 10.10 211 90644 230038 46365169
Urine analysis abnormal 76.04 10.10 64 90791 4126 46591081
Device kink 75.80 10.10 47 90808 1871 46593336
Wound dehiscence 75.40 10.10 66 90789 4488 46590719
Malignant neoplasm progression 75.32 10.10 17 90838 64909 46530298
Pseudomeningocele 73.62 10.10 15 90840 6 46595201
Medical device site swelling 73.42 10.10 14 90841 0 46595207
Thrombocytopenia 73.19 10.10 83 90772 126498 46468709
Lymphocyte count decreased 71.99 10.10 156 90699 25433 46569774
Pancytopenia 70.24 10.10 39 90816 85019 46510188
Memory impairment 69.79 10.10 317 90538 77020 46518187
Dystonia 69.27 10.10 97 90758 11160 46584047
Progressive multifocal leukoencephalopathy 68.67 10.10 97 90758 11249 46583958
Interstitial lung disease 67.01 10.10 12 90843 53937 46541270
Toxic encephalopathy 65.63 10.10 64 90791 4998 46590209
Respiratory depression 65.57 10.10 96 90759 11504 46583703
Medical device site discharge 65.12 10.10 16 90839 36 46595171
Infusion site mass 59.26 10.10 31 90824 887 46594320
Muscle rigidity 58.58 10.10 84 90771 9877 46585330
Infusion related reaction 57.81 10.10 67 90788 101141 46494066
Seroma 57.51 10.10 41 90814 2066 46593141
Clonus 57.47 10.10 54 90801 4026 46591181
Arthralgia 55.46 10.10 449 90406 364154 46231053
Pocket erosion 55.04 10.10 11 90844 3 46595204
Cardiac failure 54.83 10.10 45 90810 79903 46515304
Paraesthesia 54.30 10.10 403 90452 117034 46478173
Pleural effusion 54.08 10.10 49 90806 82903 46512304
Medical device site erythema 53.94 10.10 13 90842 26 46595181
Gastrointestinal haemorrhage 53.75 10.10 43 90812 77330 46517877
Glossodynia 52.72 10.10 11 90844 44362 46550845
Sedation 52.68 10.10 129 90726 22781 46572426
Device alarm issue 52.26 10.10 33 90822 1357 46593850
Immune reconstitution inflammatory syndrome 52.18 10.10 60 90795 5665 46589542
Device leakage 51.91 10.10 58 90797 5307 46589900
Abdominal discomfort 51.86 10.10 138 90717 151027 46444180
Lethargy 51.68 10.10 217 90638 50954 46544253
Off label use 51.02 10.10 483 90372 379358 46215849
Tremor 50.75 10.10 392 90463 115247 46479960
Neurogenic bladder 49.84 10.10 43 90812 2867 46592340
Renal impairment 49.60 10.10 43 90812 74329 46520878
Asphyxia 48.85 10.10 56 90799 5270 46589937
Diplopia 48.65 10.10 113 90742 19292 46575915
Implant site haematoma 48.47 10.10 14 90841 70 46595137
Mucosal inflammation 47.69 10.10 9 90846 38967 46556240
Peroneal nerve palsy 47.25 10.10 49 90806 4119 46591088
Motor dysfunction 46.68 10.10 64 90791 7218 46587989
Escherichia urinary tract infection 46.57 10.10 77 90778 10246 46584961
Incision site oedema 45.53 10.10 10 90845 10 46595197
Atrial fibrillation 45.02 10.10 83 90772 103507 46491700
Osteonecrosis of jaw 44.16 10.10 7 90848 34395 46560812
Insomnia 44.13 10.10 503 90352 164421 46430786
Urinary incontinence 44.12 10.10 139 90716 28391 46566816
Generalised tonic-clonic seizure 43.66 10.10 134 90721 26988 46568219
Drug delivery device placement 43.66 10.10 14 90841 105 46595102
Renal failure 43.43 10.10 98 90757 113496 46481711
Paralysis 43.37 10.10 68 90787 8653 46586554
Systemic lupus erythematosus 43.09 10.10 38 90817 65142 46530065
Implant site reaction 43.07 10.10 15 90840 149 46595058
Platelet count decreased 42.71 10.10 81 90774 99943 46495264
Device computer issue 42.61 10.10 9 90846 6 46595201
Hyporeflexia 42.60 10.10 33 90822 1889 46593318
Areflexia 42.56 10.10 40 90815 2983 46592224
Contraindicated product administered 42.42 10.10 56 90799 79891 46515316
Toxicity to various agents 42.34 10.10 612 90243 211154 46384053
Device occlusion 42.32 10.10 55 90800 5890 46589317
Implant site erythema 42.21 10.10 20 90835 460 46594747
Cardiac failure congestive 42.14 10.10 71 90784 91679 46503528
Gait inability 41.75 10.10 157 90698 35046 46560161
Ascites 41.59 10.10 10 90845 36574 46558633
Decreased appetite 41.50 10.10 215 90640 193621 46401586
Status epilepticus 41.36 10.10 87 90768 13892 46581315
Drug intolerance 41.35 10.10 147 90708 146902 46448305
Agitation 41.25 10.10 215 90640 55200 46540007
Maternal exposure during pregnancy 41.24 10.10 86 90769 102463 46492744
Meningitis 40.96 10.10 55 90800 6081 46589126
Focal dyscognitive seizures 40.93 10.10 38 90817 2790 46592417
Burning sensation 40.76 10.10 183 90672 44228 46550979
Bone marrow failure 40.52 10.10 5 90850 29664 46565543
Medical device site fibrosis 39.41 10.10 8 90847 3 46595204
JC polyomavirus test positive 39.21 10.10 24 90831 933 46594274
Trigeminal neuralgia 39.14 10.10 38 90817 2951 46592256
Confusional state 38.95 10.10 479 90376 159413 46435794
Haemoglobin decreased 38.92 10.10 125 90730 128824 46466383
Lymphopenia 38.27 10.10 89 90766 15204 46580003
Magnetic resonance imaging abnormal 38.13 10.10 36 90819 2700 46592507
Urosepsis 38.04 10.10 89 90766 15264 46579943
Optic neuritis 37.59 10.10 56 90799 6815 46588392
Blood creatinine increased 37.08 10.10 57 90798 76346 46518861
Metabolic encephalopathy 36.94 10.10 49 90806 5354 46589853
Peripheral swelling 36.90 10.10 170 90685 157901 46437306
Device expulsion 36.75 10.10 5 90850 27537 46567670
Synovitis 36.43 10.10 39 90816 61036 46534171
Hepatic function abnormal 36.13 10.10 11 90844 34410 46560797
Paraparesis 35.97 10.10 30 90825 1909 46593298
Pericarditis 35.35 10.10 3 90852 23924 46571283
Product use issue 35.08 10.10 83 90772 94561 46500646
Urine leukocyte esterase positive 34.65 10.10 33 90822 2502 46592705
Hand deformity 34.61 10.10 12 90843 34562 46560645
Gastrooesophageal reflux disease 34.27 10.10 255 90600 74089 46521118
Cognitive disorder 33.86 10.10 152 90703 36731 46558476
Device extrusion 33.83 10.10 9 90846 31 46595176
Dyspnoea exertional 33.62 10.10 29 90826 50260 46544947
Multiple organ dysfunction syndrome 33.16 10.10 31 90824 51679 46543528
Hyperkalaemia 32.99 10.10 30 90825 50679 46544528
Hyponatraemia 32.88 10.10 95 90760 101237 46493970
Toxic epidermal necrolysis 32.35 10.10 3 90852 22275 46572932
Laboratory test abnormal 32.33 10.10 108 90747 22739 46572468
Implant site scar 32.33 10.10 13 90842 198 46595009
Red blood cells urine positive 32.01 10.10 32 90823 2575 46592632
Dehydration 31.90 10.10 181 90674 159359 46435848
Medical device site reaction 31.87 10.10 7 90848 7 46595200
Muscle contracture 31.77 10.10 24 90831 1323 46593884
Erythema 31.35 10.10 157 90698 142663 46452544
Hallucination 31.30 10.10 185 90670 49766 46545441
Gait spastic 30.61 10.10 13 90842 229 46594978
Electroencephalogram abnormal 30.34 10.10 37 90818 3717 46591490
Scoliosis 30.30 10.10 48 90807 6162 46589045
Disease progression 30.05 10.10 85 90770 91215 46503992
Arthropathy 30.04 10.10 76 90779 84624 46510583
Muscle twitching 29.96 10.10 79 90776 14593 46580614
Encephalopathy 29.77 10.10 137 90718 33452 46561755
Abdominal pain 29.76 10.10 295 90560 229736 46365471
Plasma cell myeloma 29.31 10.10 26 90829 44452 46550755
Nausea 28.98 10.10 1071 89784 686383 45908824
Neoplasm progression 28.98 10.10 8 90847 26675 46568532
Medical device change 28.82 10.10 14 90841 341 46594866
Psoriasis 28.29 10.10 70 90785 78534 46516673
Enthesopathy 28.24 10.10 40 90815 4650 46590557
Neuralgia 27.57 10.10 98 90757 21285 46573922
Lactic acidosis 27.33 10.10 16 90839 33893 46561314
Drug interaction 26.87 10.10 259 90596 202835 46392372
Lower respiratory tract infection 26.82 10.10 41 90814 55048 46540159
Medical device site discomfort 26.82 10.10 13 90842 315 46594892
Prescribed underdose 26.79 10.10 67 90788 11986 46583221
Epistaxis 26.64 10.10 53 90802 64252 46530955
Palmar-plantar erythrodysaesthesia syndrome 26.62 10.10 4 90851 20447 46574760
CSF pressure decreased 26.22 10.10 5 90850 0 46595207
Therapy cessation 26.16 10.10 112 90743 26517 46568690
Device breakage 26.02 10.10 58 90797 9634 46585573
Urinary retention 25.90 10.10 110 90745 25951 46569256
Depression 25.88 10.10 470 90385 169634 46425573
Melaena 25.55 10.10 11 90844 27761 46567446
Monocyte percentage increased 25.53 10.10 19 90836 1024 46594183
Nasopharyngitis 25.52 10.10 185 90670 153813 46441394
Asthma 25.39 10.10 92 90763 91450 46503757
Medical device discomfort 25.33 10.10 25 90830 1981 46593226
Hypothermia 25.29 10.10 66 90789 12117 46583090
Premature delivery 25.15 10.10 6 90849 22063 46573144
Concussion 24.82 10.10 47 90808 6956 46588251
White blood cells urine positive 24.73 10.10 35 90820 4065 46591142
Speech disorder 24.65 10.10 137 90718 36030 46559177
Ankle fracture 24.37 10.10 76 90779 15435 46579772
Hypokinesia 24.19 10.10 62 90793 11260 46583947
Alopecia 24.16 10.10 201 90654 162213 46432994
Mobility decreased 24.15 10.10 201 90654 60393 46534814
Hypoglycaemia 24.09 10.10 43 90812 54306 46540901
Metabolic acidosis 23.99 10.10 24 90831 38756 46556451
Medical device site erosion 23.70 10.10 6 90849 16 46595191
Stiff person syndrome 23.60 10.10 10 90845 175 46595032
Product use in unapproved indication 23.56 10.10 93 90762 90180 46505027
Band neutrophil count increased 23.37 10.10 12 90843 330 46594877
Cerebral palsy 23.33 10.10 9 90846 122 46595085
Myoclonus 23.18 10.10 71 90784 14281 46580926
Depressed level of consciousness 22.96 10.10 165 90690 47404 46547803
Device programming error 22.89 10.10 7 90848 44 46595163
Device issue 22.77 10.10 88 90767 19892 46575315
International normalised ratio increased 22.72 10.10 35 90820 46848 46548359
Productive cough 22.59 10.10 40 90815 50675 46544532
Hemiparesis 22.56 10.10 88 90767 19981 46575226
Therapeutic response unexpected 22.26 10.10 74 90781 15542 46579665
Temperature intolerance 22.11 10.10 47 90808 7560 46587647
Incision site complication 22.05 10.10 14 90841 581 46594626
Irritability 22.01 10.10 113 90742 28833 46566374
C-reactive protein abnormal 21.96 10.10 7 90848 21263 46573944
Urinary sediment present 21.72 10.10 22 90833 1798 46593409
General physical health deterioration 21.72 10.10 134 90721 115635 46479572
Agranulocytosis 21.69 10.10 8 90847 22177 46573030
Fluid overload 21.67 10.10 13 90842 27172 46568035
Drug abuse 21.63 10.10 58 90797 63350 46531857
Tonic clonic movements 21.47 10.10 18 90837 1154 46594053
Drug resistance 21.27 10.10 4 90851 17364 46577843
Pulmonary oedema 21.27 10.10 42 90813 51063 46544144
Wheezing 21.26 10.10 45 90810 53341 46541866
Cholestasis 21.24 10.10 13 90842 26880 46568327
Implant site ulcer 20.98 10.10 4 90851 0 46595207
Incision site swelling 20.94 10.10 6 90849 29 46595178
Ataxia 20.74 10.10 67 90788 13863 46581344
Dyskinesia 20.68 10.10 111 90744 28814 46566393
Cytomegalovirus infection 20.54 10.10 5 90850 18139 46577068
Neutrophil count decreased 20.49 10.10 33 90822 43393 46551814
Stevens-Johnson syndrome 20.23 10.10 10 90845 23287 46571920
Pulmonary fibrosis 20.07 10.10 7 90848 20085 46575122
Intentional self-injury 20.06 10.10 11 90844 24155 46571052
Rash maculo-papular 19.97 10.10 15 90840 27859 46567348
Hepatotoxicity 19.88 10.10 12 90843 24997 46570210
Proteinuria 19.87 10.10 4 90851 16549 46578658
Relapsing-remitting multiple sclerosis 19.85 10.10 12 90843 456 46594751
Postoperative wound infection 19.81 10.10 49 90806 8704 46586503
Pneumocystis jirovecii pneumonia 19.80 10.10 3 90852 15245 46579962
Bladder spasm 19.74 10.10 19 90836 1460 46593747
Coronary artery disease 19.63 10.10 22 90833 33730 46561477
Rash pruritic 19.58 10.10 35 90820 44180 46551027
Flushing 19.53 10.10 202 90653 64412 46530795
Device related infection 19.52 10.10 87 90768 20954 46574253
Skin reaction 19.44 10.10 56 90799 10890 46584317
Coordination abnormal 19.43 10.10 56 90799 10893 46584314
Nitrite urine present 19.38 10.10 14 90841 720 46594487
Post procedural complication 19.36 10.10 71 90784 15658 46579549
Neutrophil percentage increased 19.35 10.10 25 90830 2662 46592545
Abdominal pain upper 19.33 10.10 185 90670 145120 46450087
Pulmonary hypertension 19.30 10.10 25 90830 35968 46559239
Band neutrophil percentage increased 19.24 10.10 9 90846 201 46595006
Culture urine positive 19.07 10.10 28 90827 3363 46591844
Delirium 19.06 10.10 131 90724 37097 46558110
Movement disorder 19.03 10.10 74 90781 16775 46578432
Swelling 19.01 10.10 153 90702 124358 46470849
Loss of control of legs 18.89 10.10 18 90837 1366 46593841
Arteriosclerosis coronary artery 18.82 10.10 46 90809 8110 46587097
Lower limb fracture 18.79 10.10 60 90795 12338 46582869
Medical device site cellulitis 18.74 10.10 4 90851 3 46595204
Incision site vesicles 18.74 10.10 4 90851 3 46595204
Apnoea 18.68 10.10 43 90812 7296 46587911
Dysarthria 18.64 10.10 131 90724 37367 46557840
Injection site scar 18.62 10.10 14 90841 766 46594441
Drug reaction with eosinophilia and systemic symptoms 18.61 10.10 18 90837 29530 46565677
Respiratory arrest 18.52 10.10 121 90734 33695 46561512
Primary progressive multiple sclerosis 18.48 10.10 7 90848 90 46595117
Bradypnoea 18.42 10.10 26 90829 3013 46592194
Neuropathy peripheral 18.22 10.10 103 90752 90790 46504417
Neurogenic bowel 18.21 10.10 7 90848 94 46595113
B-lymphocyte count decreased 18.15 10.10 14 90841 796 46594411
Haemorrhage 18.11 10.10 51 90804 54818 46540389
Dysstasia 17.89 10.10 75 90780 17593 46577614
Loss of consciousness 17.85 10.10 303 90552 107935 46487272
Myelocyte percentage increased 17.73 10.10 8 90847 164 46595043
CSF test abnormal 17.68 10.10 10 90845 335 46594872
Road traffic accident 17.68 10.10 92 90763 23599 46571608
Metastases to liver 17.63 10.10 8 90847 19577 46575630
Consciousness fluctuating 17.59 10.10 12 90843 563 46594644
Poisoning deliberate 17.55 10.10 44 90811 7882 46587325
Cataract 17.49 10.10 39 90816 45376 46549831
Nystagmus 17.48 10.10 36 90819 5663 46589544
Haematochezia 17.22 10.10 29 90826 37464 46557743
Disorientation 17.21 10.10 127 90728 36791 46558416
Rectal haemorrhage 17.19 10.10 30 90825 38225 46556982
Amnesia 17.07 10.10 139 90716 41492 46553715
Anaphylactic reaction 17.07 10.10 50 90805 53062 46542145
Liver disorder 16.93 10.10 29 90826 37217 46557990
Hypercalcaemia 16.86 10.10 10 90845 21036 46574171
Blood potassium increased 16.79 10.10 6 90849 16961 46578246
Hypersomnia 16.79 10.10 67 90788 15372 46579835
Incorrect drug administration rate 16.69 10.10 20 90835 1973 46593234
Migraine 16.68 10.10 209 90646 69817 46525390
Bone pain 16.68 10.10 42 90813 46848 46548359
Posturing 16.63 10.10 11 90844 490 46594717
Urine oxalate increased 16.50 10.10 8 90847 194 46595013
Incision site erythema 16.32 10.10 9 90846 287 46594920
Thyroid disorder 16.13 10.10 56 90799 12020 46583187
Blood bilirubin increased 16.11 10.10 26 90829 34158 46561049
Pulmonary arterial hypertension 16.09 10.10 16 90839 25912 46569295
Hypomagnesaemia 15.85 10.10 12 90843 22198 46573009
Conversion disorder 15.82 10.10 18 90837 1680 46593527
Medical device site bruise 15.73 10.10 3 90852 0 46595207
Medical device site scar 15.73 10.10 3 90852 0 46595207
CSF protein abnormal 15.73 10.10 3 90852 0 46595207
Urticaria 15.72 10.10 150 90705 117742 46477465
Suture rupture 15.42 10.10 8 90847 225 46594982
Right ventricular failure 15.41 10.10 6 90849 16087 46579120
Treatment failure 15.33 10.10 112 90743 92975 46502232
Neuromuscular toxicity 15.31 10.10 7 90848 148 46595059
Paraplegia 15.28 10.10 21 90834 2373 46592834
Quadriparesis 15.26 10.10 18 90837 1746 46593461
Muscle atrophy 15.16 10.10 35 90820 5949 46589258
Injection site infection 15.08 10.10 17 90838 1570 46593637
Angina pectoris 14.98 10.10 18 90837 26757 46568450
Pneumonitis 14.97 10.10 20 90835 28400 46566807
Pancreatitis chronic 14.86 10.10 18 90837 1795 46593412
Urinary tract infection bacterial 14.82 10.10 28 90827 4137 46591070
Myelodysplastic syndrome 14.81 10.10 6 90849 15705 46579502
Bacterial test 14.79 10.10 15 90840 1228 46593979
Lymphocyte percentage decreased 14.77 10.10 22 90833 2677 46592530
Soft tissue injury 14.70 10.10 13 90842 896 46594311
Pancreatitis acute 14.70 10.10 16 90839 24856 46570351
Abnormal behaviour 14.50 10.10 80 90775 20978 46574229
Haemoptysis 14.24 10.10 18 90837 26171 46569036
Death 14.22 10.10 522 90333 335026 46260181
Eosinophilia 14.21 10.10 10 90845 19207 46576000
Psoriatic arthropathy 14.21 10.10 31 90824 36348 46558859
Postoperative delirium 14.15 10.10 5 90850 52 46595155
Sinusitis 14.13 10.10 173 90682 129595 46465612
CD8 lymphocytes decreased 14.13 10.10 7 90848 178 46595029
Colitis microscopic 14.11 10.10 36 90819 6520 46588687
Retinal depigmentation 13.99 10.10 8 90847 274 46594933
Sensory disturbance 13.96 10.10 54 90801 12213 46582994
Migraine without aura 13.89 10.10 7 90848 185 46595022
Implant site oedema 13.85 10.10 4 90851 20 46595187
Hepatitis 13.82 10.10 26 90829 32189 46563018
Therapeutic product effect decreased 13.78 10.10 99 90756 82502 46512705
Respiratory rate decreased 13.76 10.10 23 90832 3087 46592120
Lung disorder 13.74 10.10 41 90814 43263 46551944
Dysphagia 13.70 10.10 219 90636 77093 46518114
Injection site necrosis 13.65 10.10 15 90840 1347 46593860
Injection site abscess 13.65 10.10 13 90842 986 46594221
Urinary tract infection enterococcal 13.65 10.10 20 90835 2398 46592809
Major depression 13.64 10.10 36 90819 6654 46588553
Urine osmolarity increased 13.62 10.10 6 90849 116 46595091
Alcohol withdrawal syndrome 13.59 10.10 12 90843 825 46594382
Feeling abnormal 13.59 10.10 329 90526 124731 46470476
Neuropsychiatric syndrome 13.59 10.10 5 90850 59 46595148
Patient-device incompatibility 13.52 10.10 6 90849 118 46595089
Persistent depressive disorder 13.50 10.10 13 90842 999 46594208
Drug eruption 13.42 10.10 13 90842 21316 46573891
Product quality issue 13.41 10.10 31 90824 35617 46559590
Staphylococcal infection 13.37 10.10 117 90738 35654 46559553
Tibia fracture 13.35 10.10 28 90827 4461 46590746
Acute hepatic failure 13.27 10.10 6 90849 14715 46580492
Medical device site extravasation 13.20 10.10 3 90852 4 46595203
Incorrect route of product administration 13.19 10.10 65 90790 16318 46578889
Injection site ulcer 13.18 10.10 10 90845 555 46594652
Narcotic bowel syndrome 13.16 10.10 6 90849 126 46595081
Metastases to bone 13.05 10.10 9 90846 17467 46577740
Hyperhidrosis 12.95 10.10 245 90610 89063 46506144
Specific gravity urine decreased 12.94 10.10 9 90846 436 46594771
Hyperglycaemia 12.79 10.10 31 90824 35040 46560167
Pollakiuria 12.79 10.10 86 90769 24175 46571032
Reflexes abnormal 12.63 10.10 10 90845 591 46594616
Myocardial infarction 12.62 10.10 125 90730 97403 46497804
Athetosis 12.59 10.10 4 90851 29 46595178
Blood pressure systolic increased 12.55 10.10 23 90832 28764 46566443
Hepatocellular injury 12.51 10.10 24 90831 29498 46565709
Procedural headache 12.50 10.10 5 90850 75 46595132
Chest pain 12.48 10.10 255 90600 176069 46419138
Sports injury 12.47 10.10 4 90851 30 46595177
Congenital megacolon 12.45 10.10 3 90852 6 46595201
Invasive ductal breast carcinoma 12.38 10.10 33 90822 6135 46589072
Poisoning 12.34 10.10 57 90798 13937 46581270
Spinal cord disorder 12.26 10.10 13 90842 1121 46594086
Urobilinogen urine increased 12.24 10.10 6 90849 149 46595058
Myelocyte count increased 12.20 10.10 8 90847 351 46594856
Infective pulmonary exacerbation of cystic fibrosis 12.19 10.10 3 90852 10804 46584403
Red blood cell sedimentation rate increased 12.17 10.10 16 90839 22873 46572334
Hypokalaemia 12.16 10.10 111 90744 87913 46507294
Colitis ulcerative 12.13 10.10 10 90845 17722 46577485
Incoherent 12.11 10.10 27 90828 4485 46590722
Bursitis 12.11 10.10 73 90782 19769 46575438
Implant site abscess 12.04 10.10 4 90851 34 46595173
Affective disorder 12.02 10.10 28 90827 4787 46590420
Micturition urgency 12.00 10.10 38 90817 7779 46587428
Upper gastrointestinal haemorrhage 12 10.10 9 90846 16729 46578478
Lymphocyte count abnormal 11.98 10.10 10 90845 637 46594570
Oxygen saturation decreased 11.98 10.10 82 90773 69082 46526125
Tenosynovitis 11.97 10.10 37 90818 7478 46587729
Shock 11.89 10.10 15 90840 21830 46573377
CSF protein increased 11.85 10.10 9 90846 500 46594707
Device ineffective 11.82 10.10 6 90849 161 46595046
Klebsiella test positive 11.81 10.10 12 90843 985 46594222
Varicella virus test positive 11.67 10.10 5 90850 90 46595117
Injection site mass 11.63 10.10 59 90796 14981 46580226
Pulmonary renal syndrome 11.56 10.10 8 90847 384 46594823
T-lymphocyte count decreased 11.53 10.10 7 90848 268 46594939
Peritonitis 11.51 10.10 14 90841 20700 46574507
Aphasia 11.50 10.10 95 90760 28472 46566735
Decreased vibratory sense 11.49 10.10 7 90848 270 46594937
Spinal operation 11.49 10.10 30 90825 5510 46589697
Urinary tract infection pseudomonal 11.46 10.10 11 90844 842 46594365
Neurotoxicity 11.46 10.10 55 90800 13662 46581545
Eyelid oedema 11.44 10.10 3 90852 10354 46584853
Bladder disorder 11.42 10.10 35 90820 7043 46588164
Vomiting 11.38 10.10 744 90111 452050 46143157
Upper airway obstruction 11.38 10.10 9 90846 531 46594676
Foetal exposure during pregnancy 11.36 10.10 27 90828 30720 46564487
Injection site atrophy 11.34 10.10 9 90846 534 46594673
Oedema peripheral 11.29 10.10 231 90624 159475 46435732
Tuberculosis 11.29 10.10 3 90852 10262 46584945
Implant site warmth 11.29 10.10 4 90851 42 46595165
Rash erythematous 11.28 10.10 32 90823 34318 46560889
Occupational dermatitis 11.20 10.10 4 90851 43 46595164
Hypotension 11.19 10.10 356 90499 232233 46362974
Asthenia 11.19 10.10 725 90130 310350 46284857
Premature labour 11.17 10.10 4 90851 11295 46583912
Hypocalcaemia 11.15 10.10 22 90833 26763 46568444
Incision site pain 11.13 10.10 12 90843 1055 46594152
Chronic fatigue syndrome 11.09 10.10 12 90843 1059 46594148
Implant site fibrosis 11.09 10.10 6 90849 184 46595023
Vitamin D deficiency 11.07 10.10 47 90808 11087 46584120
Metastases to central nervous system 11.05 10.10 4 90851 11217 46583990
Basophil count decreased 11.01 10.10 5 90850 104 46595103
CSF culture positive 10.93 10.10 3 90852 12 46595195
Procedural pneumothorax 10.93 10.10 3 90852 12 46595195
Oropharyngeal pain 10.92 10.10 92 90763 74076 46521131
Tremor neonatal 10.88 10.10 5 90850 107 46595100
Aspiration 10.88 10.10 42 90813 9489 46585718
Coagulopathy 10.82 10.10 12 90843 18487 46576720
Autonomic nervous system imbalance 10.81 10.10 18 90837 2408 46592799
Cerebral infarction 10.80 10.10 18 90837 23348 46571859
Tonic convulsion 10.77 10.10 12 90843 1094 46594113
Neutralising antibodies 10.74 10.10 4 90851 49 46595158
Quadriplegia 10.73 10.10 15 90840 1722 46593485
Bladder dysfunction 10.73 10.10 10 90845 738 46594469
Chronic kidney disease 10.73 10.10 42 90813 40829 46554378
Pancreatitis 10.72 10.10 46 90809 43581 46551626
Neurosis 10.70 10.10 7 90848 306 46594901
Foot fracture 10.68 10.10 70 90785 19512 46575695
Upper motor neurone lesion 10.67 10.10 5 90850 112 46595095
Stitch abscess 10.66 10.10 4 90851 50 46595157
Vision blurred 10.65 10.10 216 90639 79492 46515715
Angioedema 10.60 10.10 40 90815 39302 46555905
Infected skin ulcer 10.58 10.10 17 90838 2208 46592999
Accidental overdose 10.50 10.10 71 90784 19995 46575212
Hyperlipasaemia 10.50 10.10 9 90846 595 46594612
Nodule 10.43 10.10 9 90846 15596 46579611
Limb discomfort 10.41 10.10 78 90777 22698 46572509
Infusion site macule 10.39 10.10 3 90852 15 46595192
Hypoventilation 10.37 10.10 24 90831 4086 46591121
Hostility 10.32 10.10 13 90842 1349 46593858
Premature baby 10.32 10.10 12 90843 18100 46577107
Bacterial test positive 10.29 10.10 25 90830 4391 46590816
Genital burning sensation 10.27 10.10 6 90849 214 46594993
Thyroxine decreased 10.26 10.10 8 90847 462 46594745
Knee arthroplasty 10.24 10.10 19 90836 23646 46571561
Implant site dehiscence 10.23 10.10 3 90852 16 46595191
Mean cell haemoglobin concentration abnormal 10.23 10.10 3 90852 16 46595191
Flatulence 10.16 10.10 26 90829 28852 46566355
Culture wound positive 10.14 10.10 6 90849 219 46594988
Polyneuropathy 10.11 10.10 5 90850 11639 46583568

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
Muscle spasticity 3965.14 11.13 1081 58622 4107 29888668
Hypertonia 2297.71 11.13 681 59022 3704 29889071
Drug withdrawal syndrome 1893.85 11.13 879 58824 18930 29873845
Implant site infection 1092.65 11.13 273 59430 656 29892119
Implant site extravasation 717.84 11.13 169 59534 280 29892495
Complication associated with device 549.32 11.13 255 59448 5465 29887310
Hypotonia 534.49 11.13 266 59437 6682 29886093
Muscle spasms 497.71 11.13 629 59074 64209 29828566
Device failure 490.03 11.13 178 59525 1970 29890805
Overdose 440.61 11.13 680 59023 83657 29809118
Multiple sclerosis relapse 378.80 11.13 248 59455 10614 29882161
Withdrawal syndrome 361.27 11.13 244 59459 11006 29881769
Multiple sclerosis 321.54 11.13 193 59510 7074 29885701
Therapy non-responder 290.46 11.13 325 59378 29128 29863647
Implant site swelling 286.58 11.13 61 59642 42 29892733
Therapeutic response decreased 279.23 11.13 291 59412 24058 29868717
Implant site erosion 260.52 11.13 56 59647 43 29892732
Intracranial hypotension 251.02 11.13 66 59637 208 29892567
Coma 245.08 11.13 350 59353 40099 29852676
Cerebrospinal fluid leakage 239.69 11.13 71 59632 383 29892392
Urinary tract infection 235.16 11.13 479 59224 73180 29819595
Mental status changes 233.74 11.13 327 59376 36752 29856023
Muscle tightness 227.66 11.13 131 59572 4432 29888343
Wound dehiscence 219.38 11.13 115 59588 3226 29889549
Device power source issue 217.94 11.13 60 59643 236 29892539
Implant site discharge 216.32 11.13 43 59660 9 29892766
Device physical property issue 212.07 11.13 71 59632 603 29892172
Somnolence 211.91 11.13 542 59161 96221 29796554
Medical device site infection 210.47 11.13 55 59648 168 29892607
Device infusion issue 205.11 11.13 66 59637 488 29892287
Pocket erosion 200.71 11.13 40 59663 9 29892766
Implant site erythema 197.85 11.13 43 59660 37 29892738
Pain 182.98 11.13 754 58949 171887 29720888
Device malfunction 176.35 11.13 139 59564 7972 29884803
Implant site pain 170.40 11.13 42 59661 93 29892682
Underdose 170.36 11.13 162 59541 11979 29880796
Clonus 170.35 11.13 88 59615 2393 29890382
Device breakage 167.32 11.13 76 59627 1544 29891231
Device dislocation 163.57 11.13 110 59593 4921 29887854
Device kink 159.07 11.13 55 59648 520 29892255
Device connection issue 154.66 11.13 52 59651 448 29892327
Anaemia 135.67 11.13 129 59574 207863 29684912
Seizure 135.55 11.13 468 59235 98007 29794768
Medical device site swelling 132.46 11.13 27 59676 10 29892765
Medical device site discharge 130.36 11.13 27 59676 13 29892762
Diarrhoea 127.85 11.13 300 59403 333803 29558972
Sedation 117.70 11.13 154 59549 16219 29876556
Infusion site mass 116.46 11.13 35 59668 200 29892575
Febrile neutropenia 114.78 11.13 35 59668 106658 29786117
Acute kidney injury 113.61 11.13 235 59468 273607 29619168
Medical device site erythema 110.78 11.13 24 59679 20 29892755
Respiratory depression 110.01 11.13 125 59578 11378 29881397
Meningitis 104.96 11.13 81 59622 4501 29888274
Implant site scar 104.40 11.13 20 59683 0 29892775
Unresponsive to stimuli 102.79 11.13 187 59516 26232 29866543
Decubitus ulcer 100.01 11.13 99 59604 7689 29885086
Device issue 99.71 11.13 99 59604 7717 29885058
Neutropenia 99.65 11.13 67 59636 128473 29764302
Medical device site pain 93.43 11.13 24 59679 67 29892708
Device alarm issue 91.57 11.13 40 59663 738 29892037
Dyspnoea 91.52 11.13 349 59354 332946 29559829
Medical device site erosion 89.47 11.13 21 59682 34 29892741
Device computer issue 87.36 11.13 18 59685 8 29892767
Gait disturbance 84.83 11.13 334 59369 74443 29818332
Cardiac failure 83.36 11.13 31 59672 83387 29809388
Seroma 83.22 11.13 35 59668 586 29892189
Toxic encephalopathy 81.37 11.13 70 59633 4539 29888236
Medical device site reaction 78.44 11.13 16 59687 6 29892769
Autonomic dysreflexia 77.81 11.13 20 59683 56 29892719
Device occlusion 77.10 11.13 77 59626 6043 29886732
Implant site haematoma 75.36 11.13 20 59683 66 29892709
Thrombocytopenia 73.94 11.13 99 59604 136945 29755830
Toxicity to various agents 72.21 11.13 601 59102 176582 29716193
Malignant neoplasm progression 71.99 11.13 27 59676 72260 29820515
Pancytopenia 71.91 11.13 40 59663 85012 29807763
Cardiac failure congestive 70.92 11.13 40 59663 84367 29808408
Dystonia 69.13 11.13 91 59612 9636 29883139
Interstitial lung disease 67.93 11.13 18 59685 60179 29832596
Autonomic nervous system imbalance 67.11 11.13 48 59655 2373 29890402
Agitation 65.78 11.13 247 59456 53826 29838949
Muscular weakness 65.59 11.13 276 59427 63369 29829406
Bradypnoea 64.84 11.13 43 59660 1878 29890897
Atrial fibrillation 64.75 11.13 72 59631 108052 29784723
Incision site erythema 64.55 11.13 18 59685 75 29892700
Renal failure 61.91 11.13 101 59602 128865 29763910
CSF culture positive 61.54 11.13 14 59689 18 29892757
Musculoskeletal stiffness 60.55 11.13 183 59520 35698 29857077
Secondary progressive multiple sclerosis 60.26 11.13 24 59679 347 29892428
Lethargy 59.74 11.13 194 59509 39325 29853450
Drug interaction 59.23 11.13 202 59501 199366 29693409
Rash 59.16 11.13 191 59512 191698 29701077
Arachnoiditis 58.55 11.13 23 59680 320 29892455
Post lumbar puncture syndrome 58.07 11.13 19 59684 149 29892626
Death 58.04 11.13 446 59257 356837 29535938
Encephalopathy 57.91 11.13 168 59535 32037 29860738
Medical device site fibrosis 57.42 11.13 11 59692 0 29892775
Renal impairment 57.38 11.13 50 59653 84134 29808641
Blood creatinine increased 56.76 11.13 59 59644 91316 29801459
Platelet count decreased 55.87 11.13 78 59625 106051 29786724
Hyperkalaemia 55.85 11.13 31 59672 65979 29826796
Rheumatoid arthritis 55.53 11.13 8 59695 41189 29851586
Gastrointestinal haemorrhage 55.15 11.13 51 59652 83395 29809380
Foetal exposure during pregnancy 55.09 11.13 5 59698 36866 29855909
Respiratory rate decreased 54.99 11.13 38 59665 1777 29890998
Infection 54.03 11.13 302 59401 77772 29815003
Depressed level of consciousness 53.65 11.13 183 59520 38039 29854736
Device related infection 53.39 11.13 110 59593 16905 29875870
Implant site cellulitis 52.09 11.13 12 59691 17 29892758
Confusional state 52.02 11.13 452 59251 134382 29758393
Device extrusion 52.02 11.13 11 59692 7 29892768
Status epilepticus 51.72 11.13 85 59618 10987 29881788
Drug ineffective 51.65 11.13 958 58745 339429 29553346
Device leakage 51.25 11.13 49 59654 3645 29889130
Implant site vesicles 49.58 11.13 10 59693 3 29892772
Neurogenic bladder 48.92 11.13 34 59669 1605 29891170
Myocardial infarction 47.65 11.13 113 59590 125512 29767263
Purulent discharge 47.35 11.13 42 59661 2837 29889938
Medical device site inflammation 46.98 11.13 9 59694 0 29892775
Urosepsis 45.63 11.13 79 59624 10653 29882122
Dyspnoea exertional 45.23 11.13 8 59695 35422 29857353
Implant site reaction 45.13 11.13 12 59691 40 29892735
Leukopenia 43.83 11.13 29 59674 56130 29836645
Staphylococcus test positive 43.61 11.13 41 59662 2986 29889789
Hyperhidrosis 43.44 11.13 255 59448 66835 29825940
Medical device site discomfort 42.40 11.13 9 59694 6 29892769
Medical device discomfort 42.11 11.13 12 59691 55 29892720
Intentional overdose 42.02 11.13 179 59524 41302 29851473
Medical device site cellulitis 41.76 11.13 8 59695 0 29892775
Pneumonia 41.70 11.13 446 59257 333860 29558915
Cough 40.12 11.13 123 59580 125519 29767256
Tremor 39.83 11.13 272 59431 75091 29817684
Hepatic function abnormal 39.57 11.13 17 59686 41928 29850847
Progressive multiple sclerosis 39.24 11.13 15 59688 193 29892582
Urinary incontinence 39.16 11.13 97 59606 16843 29875932
Muscle twitching 38.62 11.13 63 59640 8092 29884683
Medical device site bruise 38.53 11.13 8 59695 4 29892771
Central nervous system infection 38.45 11.13 19 59684 469 29892306
Incision site complication 38.36 11.13 17 59686 325 29892450
Decreased appetite 37.79 11.13 162 59541 149748 29743027
Completed suicide 37.54 11.13 332 59371 99160 29793615
Pneumonia aspiration 37.47 11.13 162 59541 37618 29855157
Pleural effusion 37.42 11.13 56 59647 74010 29818765
Implant site abscess 37.13 11.13 9 59694 18 29892757
Stomatitis 36.97 11.13 14 59689 37265 29855510
Medical device change 36.77 11.13 13 59690 132 29892643
Incision site vesicles 36.54 11.13 7 59696 0 29892775
Granuloma 35.62 11.13 33 59670 2359 29890416
Fall 35.60 11.13 534 59169 181338 29711437
Trigeminal neuralgia 35.22 11.13 22 59681 866 29891909
Weight decreased 35.10 11.13 168 59535 150753 29742022
Epistaxis 34.26 11.13 33 59670 52948 29839827
Implant site inflammation 34.05 11.13 7 59696 3 29892772
Implant site oedema 33.38 11.13 7 59696 4 29892771
Device material issue 33.34 11.13 8 59695 15 29892760
Cytomegalovirus infection 33.33 11.13 4 59699 23670 29869105
Apnoea 33.30 11.13 51 59652 6207 29886568
Coronary artery disease 33.28 11.13 30 59673 49682 29843093
Chest pain 32.87 11.13 122 59581 117505 29775270
Patient-device incompatibility 32.78 11.13 7 59696 5 29892770
Incorrect drug administration rate 32.59 11.13 23 59680 1113 29891662
Hypoaesthesia 32.47 11.13 202 59501 54028 29838747
Weight increased 32.02 11.13 63 59640 74850 29817925
Irritability 32.01 11.13 110 59593 22940 29869835
Medical device site haematoma 31.99 11.13 9 59694 39 29892736
Muscle rigidity 31.79 11.13 66 59637 10195 29882580
Implant site mass 31.70 11.13 7 59696 7 29892768
Infusion related reaction 31.57 11.13 21 59682 40543 29852232
Fatigue 31.56 11.13 450 59253 320223 29572552
Hypoglycaemia 31.54 11.13 33 59670 50948 29841827
Lymphocyte percentage decreased 31.49 11.13 29 59674 2057 29890718
White blood cell count decreased 31.42 11.13 76 59627 83871 29808904
Implant site ulcer 31.32 11.13 6 59697 0 29892775
Catheter site erosion 31.32 11.13 6 59697 0 29892775
General physical health deterioration 31.07 11.13 99 59604 99845 29792930
Staphylococcal infection 31.05 11.13 131 59572 30093 29862682
Wound infection staphylococcal 31.04 11.13 24 59679 1337 29891438
Macrophages increased 30.87 11.13 12 59691 162 29892613
Gait spastic 30.81 11.13 12 59691 163 29892612
Central nervous system lesion 30.47 11.13 43 59660 4863 29887912
Pseudomeningocele 30.35 11.13 7 59696 10 29892765
Drug delivery device placement 29.93 11.13 11 59692 126 29892649
Bone marrow failure 29.84 11.13 11 59692 29774 29863001
Abdominal pain 29.82 11.13 154 59549 135500 29757275
Skin erosion 29.68 11.13 26 59677 1727 29891048
Implant site dehiscence 29.57 11.13 7 59696 12 29892763
Mucosal inflammation 29.33 11.13 12 59691 30482 29862293
Dyskinesia 29.28 11.13 103 59600 21731 29871044
Hyperreflexia 29.11 11.13 32 59671 2807 29889968
Neurotoxicity 28.92 11.13 74 59629 13108 29879667
Haemoglobin decreased 28.92 11.13 123 59580 113975 29778800
Miosis 28.91 11.13 54 59649 7722 29885053
Chronic kidney disease 28.90 11.13 20 59683 37818 29854957
Poisoning deliberate 28.49 11.13 46 59657 5858 29886917
Dehydration 28.43 11.13 138 59565 123401 29769374
Plasma cell myeloma 28.40 11.13 39 59664 53423 29839352
White blood cells urine positive 28.32 11.13 21 59682 1098 29891677
Jaundice 27.84 11.13 15 59688 32471 29860304
Cognitive disorder 27.78 11.13 107 59596 23583 29869192
Movement disorder 27.66 11.13 61 59642 9822 29882953
Urinary retention 27.34 11.13 134 59569 32783 29859992
Rectal haemorrhage 27.31 11.13 18 59685 34921 29857854
Lipoma 27.15 11.13 23 59680 1460 29891315
Scoliosis 26.97 11.13 24 59679 1628 29891147
Areflexia 26.76 11.13 30 59673 2689 29890086
Electroencephalogram abnormal 26.52 11.13 28 59675 2346 29890429
Alcohol poisoning 26.41 11.13 35 59668 3729 29889046
Device ineffective 26.40 11.13 7 59696 23 29892752
Oedema peripheral 26.26 11.13 115 59588 105717 29787058
Infusion site fibrosis 26.10 11.13 5 59698 0 29892775
Device inversion 26.10 11.13 5 59698 0 29892775
Implant site fibrosis 26.10 11.13 5 59698 0 29892775
Motor dysfunction 25.82 11.13 44 59659 5858 29886917
Product use in unapproved indication 25.81 11.13 69 59634 73624 29819151
Sleep apnoea syndrome 25.68 11.13 83 59620 16774 29876001
Disease progression 25.61 11.13 78 59625 79796 29812979
Neuropathy peripheral 25.43 11.13 65 59638 70410 29822365
Delirium 25.36 11.13 153 59550 40478 29852297
Myalgia 25.21 11.13 74 59629 76593 29816182
Pre-existing disease 25.06 11.13 9 59694 96 29892679
Angina pectoris 24.75 11.13 14 59689 29504 29863271
Bacterial test positive 24.56 11.13 30 59673 2946 29889829
Hypothermia 24.49 11.13 57 59646 9510 29883265
Asphyxia 24.47 11.13 41 59662 5384 29887391
Anal incontinence 24.41 11.13 47 59656 6875 29885900
Asthma 24.01 11.13 22 59681 36152 29856623
Discomfort 24.00 11.13 73 59630 14283 29878492
Pneumocystis jirovecii pneumonia 23.84 11.13 3 59700 17117 29875658
Muscle contractions involuntary 23.62 11.13 23 59680 1750 29891025
Intestinal pseudo-obstruction 23.54 11.13 19 59684 1127 29891648
Haematuria 23.52 11.13 33 59670 44801 29847974
Delirium tremens 23.26 11.13 14 59689 515 29892260
Lactic acidosis 23.18 11.13 17 59686 31196 29861579
Infusion site granuloma 23.17 11.13 5 59698 4 29892771
Haemorrhage 23.11 11.13 35 59668 46044 29846731
Pneumonitis 23.05 11.13 13 59690 27441 29865334
Monocyte percentage increased 23.03 11.13 17 59686 883 29891892
Hypocalcaemia 22.98 11.13 7 59696 21369 29871406
Scar 22.93 11.13 41 59662 5670 29887105
Metabolic encephalopathy 22.91 11.13 33 59670 3802 29888973
Wound decomposition 22.46 11.13 7 59696 46 29892729
Seronegative arthritis 22.26 11.13 16 59687 797 29891978
Chronic obstructive pulmonary disease 22.21 11.13 36 59667 46090 29846685
Performance status decreased 22.12 11.13 33 59670 3924 29888851
Gait inability 22.01 11.13 85 59618 18756 29874019
Dysgeusia 21.92 11.13 11 59692 24790 29867985
Balance disorder 21.88 11.13 136 59567 36357 29856418
Multiple organ dysfunction syndrome 21.81 11.13 60 59643 63427 29829348
Pulmonary fibrosis 21.61 11.13 3 59700 15887 29876888
Angioedema 21.56 11.13 22 59681 34362 29858413
Muscle contracture 21.50 11.13 18 59685 1124 29891651
Arthralgia 21.22 11.13 171 59532 135620 29757155
Device deposit issue 20.88 11.13 4 59699 0 29892775
CSF pressure decreased 20.88 11.13 4 59699 0 29892775
Posture abnormal 20.85 11.13 22 59681 1842 29890933
Neutrophil percentage increased 20.85 11.13 22 59681 1842 29890933
Condition aggravated 20.75 11.13 388 59315 137478 29755297
Paralysis 20.73 11.13 40 59663 5861 29886914
Neutrophil count decreased 20.57 11.13 33 59670 42421 29850354
Cystitis 20.47 11.13 49 59654 8325 29884450
Urine leukocyte esterase positive 20.46 11.13 11 59692 325 29892450
Posturing 20.33 11.13 13 59690 533 29892242
Generalised tonic-clonic seizure 20.28 11.13 85 59618 19466 29873309
Drug eruption 20.22 11.13 5 59698 17521 29875254
Hallucination 20.21 11.13 167 59536 48892 29843883
Relapsing-remitting multiple sclerosis 20.15 11.13 10 59693 249 29892526
Culture wound positive 20.13 11.13 8 59695 115 29892660
Euphoric mood 20.12 11.13 33 59670 4257 29888518
Magnetic resonance imaging abnormal 20.02 11.13 20 59683 1570 29891205
Spinal cord injury 19.89 11.13 11 59692 344 29892431
Purulence 19.62 11.13 16 59687 963 29891812
Tachycardia 19.58 11.13 229 59474 73510 29819265
Abdominal pain upper 19.40 11.13 62 59641 62489 29830286
Postoperative wound infection 19.20 11.13 33 59670 4422 29888353
Victim of child abuse 19.09 11.13 10 59693 280 29892495
Tubulointerstitial nephritis 18.98 11.13 6 59697 17885 29874890
Stiff person syndrome 18.91 11.13 8 59695 136 29892639
Myoclonus 18.90 11.13 64 59639 13248 29879527
Ataxia 18.89 11.13 58 59645 11404 29881371
Incision site oedema 18.73 11.13 5 59698 17 29892758
Syringomyelia 18.73 11.13 5 59698 17 29892758
Therapeutic response unexpected 18.52 11.13 49 59654 8854 29883921
CSF white blood cell count increased 18.51 11.13 5 59698 18 29892757
Urticaria 18.46 11.13 52 59651 54554 29838221
Lymphadenopathy 18.46 11.13 13 59690 24363 29868412
Ascites 18.29 11.13 27 59676 35894 29856881
Radicular pain 18.18 11.13 7 59696 92 29892683
Dysstasia 18.11 11.13 54 59649 10451 29882324
Gout 18.02 11.13 6 59697 17309 29875466
International normalised ratio increased 18.02 11.13 43 59660 47696 29845079
Contraindicated product administered 17.88 11.13 6 59697 17225 29875550
Proteinuria 17.88 11.13 5 59698 16140 29876635
Hepatotoxicity 17.68 11.13 7 59696 18138 29874637
General symptom 17.61 11.13 14 59689 812 29891963
Agranulocytosis 17.56 11.13 11 59692 21931 29870844
Liver disorder 17.54 11.13 20 59683 29702 29863073
Pulmonary hypertension 17.50 11.13 8 59695 19028 29873747
Acute myeloid leukaemia 17.46 11.13 7 59696 17999 29874776
Insomnia 17.42 11.13 272 59431 93064 29799711
Hyperglycaemia 17.39 11.13 27 59676 35173 29857602
Toxic epidermal necrolysis 17.35 11.13 7 59696 17933 29874842
Respiratory disorder 17.32 11.13 75 59628 17419 29875356
Renal disorder 17.31 11.13 13 59690 23571 29869204
Blood bilirubin increased 17.26 11.13 29 59674 36607 29856168
Diabetes mellitus 17.20 11.13 36 59667 41829 29850946
Haemoptysis 17.19 11.13 22 59681 31056 29861719
Drug reaction with eosinophilia and systemic symptoms 16.99 11.13 19 59684 28469 29864306
Colitis 16.85 11.13 22 59681 30798 29861977
Blood ethanol increased 16.83 11.13 10 59693 359 29892416
Blood ketone body increased 16.71 11.13 10 59693 364 29892411
Respiratory acidosis 16.66 11.13 30 59673 4172 29888603
Chest discomfort 16.36 11.13 42 59661 45438 29847337
Psoriasis 16.27 11.13 38 59665 42468 29850307
Bladder dysfunction 16.26 11.13 9 59694 282 29892493
Tumour lysis syndrome 16.25 11.13 3 59700 12882 29879893
Drug resistance 16.24 11.13 10 59693 20123 29872652
Wound 16.19 11.13 58 59645 12344 29880431
Tethered cord syndrome 16.18 11.13 4 59699 9 29892766
Product use issue 16.17 11.13 43 59660 45973 29846802
Syncope 16.14 11.13 101 59602 84802 29807973
Alcohol withdrawal syndrome 16.06 11.13 18 59685 1613 29891162
Brain stem syndrome 16.02 11.13 10 59693 393 29892382
Central pain syndrome 15.98 11.13 7 59696 130 29892645
Melaena 15.91 11.13 25 59678 32412 29860363
Hallucination, visual 15.89 11.13 69 59634 16044 29876731
Medical device site oedema 15.66 11.13 3 59700 0 29892775
Ulcerative duodenitis 15.66 11.13 3 59700 0 29892775
Implant site calcification 15.66 11.13 3 59700 0 29892775
Fluctuance 15.66 11.13 3 59700 0 29892775
Neuromuscular blocking therapy 15.66 11.13 3 59700 0 29892775
Medical device site extravasation 15.66 11.13 3 59700 0 29892775
Device allergy 15.66 11.13 3 59700 0 29892775
Medical device site ulcer 15.62 11.13 4 59699 11 29892764
Myelodysplastic syndrome 15.61 11.13 9 59694 18769 29874006
Gram stain positive 15.53 11.13 5 59698 37 29892738
Cerebrovascular accident 15.51 11.13 100 59603 83377 29809398
Peritonitis 15.41 11.13 12 59691 21363 29871412
Premature baby 15.36 11.13 7 59696 16684 29876091
Device programming error 15.36 11.13 4 59699 12 29892763
Pancreatitis 15.31 11.13 31 59672 36459 29856316
Drug-induced liver injury 15.26 11.13 12 59691 21262 29871513
Brain injury 15.25 11.13 34 59669 5514 29887261
Procedural complication 15.21 11.13 30 59673 4467 29888308
Electric shock 15.20 11.13 7 59696 147 29892628
Urine abnormality 15.18 11.13 17 59686 1522 29891253
Treatment failure 14.95 11.13 29 59674 34650 29858125
Arrhythmia 14.95 11.13 27 59676 33142 29859633
Medical device removal 14.94 11.13 7 59696 153 29892622
Scratch 14.93 11.13 22 59681 2588 29890187
Streptococcus test positive 14.85 11.13 13 59690 863 29891912
Myocardial ischaemia 14.83 11.13 8 59695 17309 29875466
Athetosis 14.78 11.13 5 59698 44 29892731
Acute myocardial infarction 14.71 11.13 55 59648 52884 29839891
Rash pruritic 14.66 11.13 14 59689 22558 29870217
Tachyphrenia 14.63 11.13 14 59689 1042 29891733
Palpitations 14.54 11.13 28 59675 33545 29859230
Spinal cord infection 14.54 11.13 7 59696 163 29892612
Mobility decreased 14.41 11.13 95 59608 25904 29866871
Primary progressive multiple sclerosis 14.30 11.13 5 59698 49 29892726
Excessive granulation tissue 14.26 11.13 10 59693 479 29892296
Bradycardia 14.20 11.13 196 59507 65330 29827445
Accidental overdose 14.18 11.13 73 59630 18202 29874573
Narcissistic personality disorder 14.10 11.13 4 59699 18 29892757
Visual acuity reduced 14.04 11.13 7 59696 15839 29876936
Decreased vibratory sense 14.03 11.13 9 59694 371 29892404
Influenza B virus test positive 13.97 11.13 6 59697 106 29892669
Hypomagnesaemia 13.73 11.13 8 59695 16590 29876185
Band neutrophil percentage increased 13.72 11.13 6 59697 111 29892664
Blood sodium increased 13.70 11.13 22 59681 2789 29889986
Hallucination, olfactory 13.69 11.13 7 59696 186 29892589
Glossopharyngeal nerve disorder 13.59 11.13 4 59699 21 29892754
Ceruloplasmin decreased 13.59 11.13 3 59700 3 29892772
Lumbar puncture abnormal 13.59 11.13 3 59700 3 29892772
Haematochezia 13.58 11.13 30 59673 34192 29858583
Septic shock 13.51 11.13 73 59630 63534 29829241
Grimacing 13.45 11.13 8 59695 288 29892487
Intensive care 13.45 11.13 8 59695 288 29892487
Fluid overload 13.41 11.13 11 59692 19081 29873694
Sedation complication 13.38 11.13 12 59691 822 29891953
Influenza like illness 13.26 11.13 92 59611 25513 29867262
Hepatitis 13.24 11.13 15 59688 22341 29870434
Paraplegia 13.20 11.13 21 59682 2640 29890135
Wound infection 13.18 11.13 34 59669 6051 29886724
Incorrect route of product administration 13.17 11.13 51 59652 11264 29881511
Mitral valve incompetence 13.07 11.13 5 59698 13229 29879546
Disseminated intravascular coagulation 12.99 11.13 15 59688 22156 29870619
Mydriasis 12.97 11.13 34 59669 6109 29886666
Post laminectomy syndrome 12.95 11.13 7 59696 209 29892566
Loss of control of legs 12.95 11.13 10 59693 556 29892219
Red blood cells urine positive 12.86 11.13 16 59687 1601 29891174
Child abuse 12.80 11.13 7 59696 214 29892561
Haemorrhage intracranial 12.79 11.13 7 59696 15025 29877750
Wound secretion 12.73 11.13 20 59683 2488 29890287
Anaphylactic shock 12.68 11.13 6 59697 13987 29878788
JC polyomavirus test positive 12.64 11.13 10 59693 576 29892199
Suicide attempt 12.57 11.13 120 59583 36577 29856198
Palmar-plantar erythrodysaesthesia syndrome 12.54 11.13 7 59696 14863 29877912
Medical device site haemorrhage 12.45 11.13 6 59697 140 29892635
Urine cannabinoids increased 12.38 11.13 3 59700 6 29892769
Implant site rash 12.38 11.13 3 59700 6 29892769
Allergy to metals 12.38 11.13 3 59700 6 29892769
Pituitary cyst 12.38 11.13 3 59700 6 29892769
Urinary tract infection pseudomonal 12.34 11.13 11 59692 748 29892027
Neuromyelitis optica spectrum disorder 12.33 11.13 6 59697 143 29892632
Meningitis staphylococcal 12.33 11.13 5 59698 76 29892699
Cerebral infarction 12.31 11.13 21 59682 26352 29866423
Respiratory arrest 12.26 11.13 100 59603 29158 29863617
Myopathy 12.25 11.13 3 59700 10583 29882192
Feeling of body temperature change 12.22 11.13 14 59689 1285 29891490
Spinal cord injury cauda equina 12.22 11.13 6 59697 146 29892629
Hiccups 12.21 11.13 44 59659 9390 29883385
Gastrointestinal tract mucosal pigmentation 12.21 11.13 7 59696 235 29892540
Neurodegenerative disorder 12.21 11.13 7 59696 235 29892540
Analgesic drug level above therapeutic 12.13 11.13 7 59696 238 29892537
Bone pain 12.12 11.13 12 59691 19014 29873761
Rash maculo-papular 12.08 11.13 20 59683 25398 29867377
Ventricular tachycardia 12.08 11.13 18 59685 23844 29868931
Somatosensory evoked potentials abnormal 12.07 11.13 6 59697 150 29892625
Nausea 12.07 11.13 477 59226 296480 29596295
Uhthoff's phenomenon 12.06 11.13 3 59700 7 29892768
Acute coronary syndrome 12.02 11.13 6 59697 13567 29879208
Coma scale abnormal 12.00 11.13 23 59680 3353 29889422
Needle fatigue 11.98 11.13 5 59698 82 29892693
B-lymphocyte count decreased 11.96 11.13 9 59694 481 29892294
Quadriplegia 11.91 11.13 15 59688 1520 29891255
Colitis ulcerative 11.88 11.13 7 59696 14427 29878348
Neutropenic sepsis 11.79 11.13 4 59699 11405 29881370
Glomerular filtration rate decreased 11.72 11.13 4 59699 11358 29881417
Pericardial effusion 11.66 11.13 15 59688 21129 29871646
Cerebral palsy 11.61 11.13 5 59698 89 29892686
Hyperbilirubinaemia 11.61 11.13 10 59693 16932 29875843
Angina unstable 11.59 11.13 5 59698 12305 29880470
Cholestasis 11.52 11.13 20 59683 24930 29867845
Graft versus host disease 11.51 11.13 3 59700 10147 29882628
Swollen tongue 11.43 11.13 6 59697 13186 29879589
Gun shot wound 11.42 11.13 13 59690 1185 29891590
Arteriosclerosis coronary artery 11.41 11.13 4 59699 11172 29881603
Mental disorder 11.34 11.13 55 59648 13394 29879381
Opisthotonus 11.28 11.13 8 59695 390 29892385
Medical device site warmth 11.28 11.13 3 59700 10 29892765
CSF shunt operation 11.28 11.13 3 59700 10 29892765
Hypoventilation 11.25 11.13 21 59682 3002 29889773
Neuralgia 11.24 11.13 46 59657 10420 29882355
Vitamin B6 deficiency 11.14 11.13 6 59697 178 29892597

Pharmacologic Action:

SourceCodeDescription
ATC M03BX01 MUSCULO-SKELETAL SYSTEM
MUSCLE RELAXANTS
MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
Other centrally acting agents
FDA MoA N0000000116 GABA B Agonists
FDA MoA N0000000196 GABA A Agonists
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist
CHEBI has role CHEBI:35488 cns depressants
CHEBI has role CHEBI:51371 muscle relaxants
CHEBI has role CHEBI:51373 gamma-aminobutyric acid receptor agonists
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018682 GABA Agents
MeSH PA D018755 GABA Agonists
MeSH PA D058786 GABA-B Receptor Agonists
MeSH PA D009125 Muscle Relaxants, Central
MeSH PA D009465 Neuromuscular Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Muscle spasticity of spinal origin indication 416830008
Muscle Spasticity of Cerebral Origin indication
Trigeminal neuralgia off-label use 31681005 DOID:12098
Alcohol withdrawal syndrome off-label use 191480000
Gastroesophageal reflux disease off-label use 235595009 DOID:8534
Disorder of autonomic nervous system contraindication 15241006
Schizophrenia contraindication 58214004 DOID:5419
Psychotic disorder contraindication 69322001
Epilepsy contraindication 84757009 DOID:1826
Kidney disease contraindication 90708001 DOID:557
Autonomic dysreflexia contraindication 129618003
Cerebrovascular accident contraindication 230690007
Functional disorder of bladder neck and sphincter mechanism contraindication 236644005
Impaired cognition contraindication 386806002
Central nervous system depression contraindication 418072004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.95 acidic
pKa2 9.54 Basic

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
GABA-B receptor GPCR AGONIST IC50 7.46 CHEMBL CHEMBL
Adenosine receptor A3 GPCR IC50 7.30 CHEMBL
GABA B receptor GPCR IC50 7.52 CHEMBL
GABA-A receptor; anion channel Ion channel IC50 7.52 CHEMBL

External reference:

IDSource
H789N3FKE8 UNII
4018392 VUID
N0000146719 NUI
D00241 KEGG_DRUG
4018392 VANDF
C0004609 UMLSCUI
CHEBI:2972 CHEBI
2C0 PDB_CHEM_ID
CHEMBL701 ChEMBL_ID
DB00181 DRUGBANK_ID
D001418 MESH_DESCRIPTOR_UI
2284 PUBCHEM_CID
2956 INN_ID
1084 IUPHAR_LIGAND_ID
1292 RXNORM
1959 MMSL
4243 MMSL
709 MMSL
d00967 MMSL
001677 NDDF
387342009 SNOMEDCT_US
6102009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1010 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1012 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4096 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4097 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1330 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1337 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2406 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2407 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3541 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3542 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1024 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1025 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1054 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1055 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6475 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6476 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-532 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-533 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10544-172 TABLET 10 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-026 TABLET 10 mg ORAL ANDA 11 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-027 TABLET 20 mg ORAL ANDA 11 sections
Baclofen Human Prescription Drug Label 1 16714-071 TABLET 10 mg ORAL ANDA 12 sections
Baclofen Human Prescription Drug Label 1 16714-072 TABLET 20 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 17856-0319 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 17856-1024 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 21695-014 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 21695-015 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 29300-343 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 29300-344 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 31722-998 TABLET 10 mg ORAL ANDA 11 sections