cyclobenzaprine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
751 303-53-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cyclobenzaprine
  • proheptatrien
  • proheptatriene
  • cyclobenzaprine hydrochloride
  • cyclobenzaprine HCl
structurally related to tricyclic antidepressants relieves skeletal muscle spasm of local origin without interfering with muscle function, it is ineffective in muscle spasm due to central nervous system disease
  • Molecular weight: 275.40
  • Formula: C20H21N
  • CLOGP: 4.96
  • LIPINSKI: 1
  • HAC: 1
  • HDO: 0
  • TPSA: 3.24
  • ALOGS: -4.60
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 200 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.37 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 55 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma) 0.01 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK 49
kinase-selectivity-class ACVR2A,ACVR2B,AXL,BRAF,CDK4,EIF2AK3,ERBB2,MAPK7,STK33,TTK 10
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.630 Moderate 0.65
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
rat-kpuu-brain Rat brain Kpuu 1.227 % Moderate 0.65

Approvals:

DateAgencyCompanyOrphan
Aug. 26, 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
Completed suicide 1138.82 9.93 1245 135929 143813 90347460
Toxicity to various agents 741.43 9.93 1457 135717 286389 90204884
Sedation complication 619.72 9.93 361 136813 16583 90474690
Creatinine renal clearance decreased 593.42 9.93 365 136809 18534 90472739
Food allergy 591.16 9.93 407 136767 25071 90466202
Sedation 553.70 9.93 509 136665 47662 90443611
Temperature regulation disorder 544.81 9.93 315 136859 14264 90477009
Immunodeficiency 495.27 9.93 456 136718 42778 90448495
Drug abuse 492.18 9.93 615 136559 81732 90409541
Orthostatic hypotension 484.66 9.93 444 136730 41383 90449890
Blood calcium decreased 460.53 9.93 375 136799 29807 90461466
Constipation 408.75 9.93 1136 136038 279259 90212014
Cognitive disorder 385.69 9.93 500 136674 68907 90422366
Depressed level of consciousness 373.11 9.93 504 136670 72280 90418993
Balance disorder 346.23 9.93 567 136607 96513 90394760
Hyperhidrosis 333.40 9.93 676 136498 135629 90355644
Intentional product misuse 289.78 9.93 501 136673 89103 90402170
Rash erythematous 269.15 9.93 407 136767 64697 90426576
Coeliac disease 236.35 9.93 314 136860 44296 90446977
Upper respiratory tract infection 212.00 9.93 545 136629 127773 90363500
Back pain 208.28 9.93 991 136183 316184 90175089
Fluid retention 207.16 9.93 430 136744 87661 90403612
Pain 205.38 9.93 2355 134819 993986 89497287
Foetal death 192.78 9.93 195 136979 20528 90470745
Respiratory arrest 185.02 9.93 240 136934 33071 90458202
Bursitis 173.63 9.93 515 136659 131139 90360134
Overdose 164.37 9.93 569 136605 157140 90334133
Infusion site reaction 155.31 9.93 167 137007 18872 90472401
Cardio-respiratory arrest 154.07 9.93 313 136861 62827 90428446
Pemphigus 145.68 9.93 168 137006 326696 90164577
Blepharospasm 137.84 9.93 277 136897 55168 90436105
Prescribed overdose 134.55 9.93 388 136786 97237 90394036
Asthma 134.47 9.93 722 136452 241438 90249835
Systemic lupus erythematosus 131.16 9.93 216 136958 361680 90129593
Taste disorder 125.87 9.93 284 136890 61262 90430011
Fall 125.23 9.93 1195 135979 480615 90010658
Hand deformity 124.97 9.93 159 137015 296203 90195070
Psoriasis 123.80 9.93 497 136677 147257 90344016
Product dose omission issue 115.74 9.93 797 136377 290890 90200383
Rheumatoid factor positive 103.51 9.93 66 137108 171584 90319689
Neutropenia 101.89 9.93 114 137060 224790 90266483
Migraine 101.16 9.93 561 136613 189831 90301442
Rheumatoid arthritis 100.97 9.93 913 136261 361701 90129572
Pericarditis 99.94 9.93 159 137015 269992 90221281
Neck pain 97.58 9.93 386 136788 113577 90377696
Respiratory depression 97.27 9.93 119 137055 15456 90475817
Lower respiratory tract infection 97.07 9.93 143 137031 250516 90240757
Sleep disorder due to general medical condition, insomnia type 94.78 9.93 38 137136 128656 90362617
Glossodynia 90.88 9.93 222 136952 321557 90169716
Back injury 90.75 9.93 211 136963 46411 90444862
Wound 90.39 9.93 203 136971 302777 90188496
Synovitis 89.64 9.93 232 136942 329520 90161753
Drug hypersensitivity 89.23 9.93 1083 136091 462526 90028747
Gastrooesophageal reflux disease 88.94 9.93 491 136683 165846 90325427
Pulmonary malformation 88.44 9.93 30 137144 360 90490913
Anaemia 82.89 9.93 266 136908 352536 90138737
Arthropathy 82.70 9.93 281 136893 365961 90125312
C-reactive protein abnormal 82.46 9.93 45 137129 127384 90363889
Headache 82.17 9.93 1793 135381 860953 89630320
Acute kidney injury 81.38 9.93 233 136941 320154 90171119
Memory impairment 80.58 9.93 543 136631 196701 90294572
Gastrointestinal disorder 79.85 9.93 168 137006 256519 90234754
Alopecia 79.22 9.93 433 136741 494638 89996635
Hypotension 78.99 9.93 796 136378 324601 90166672
Febrile neutropenia 77.64 9.93 75 137099 158274 90332999
Discomfort 73.78 9.93 194 136980 274141 90217132
Decorticate posture 72.24 9.93 25 137149 320 90490953
Abdominal discomfort 68.63 9.93 432 136742 476896 90014377
Pancytopenia 67.49 9.93 50 137124 120213 90371060
Creatinine renal clearance increased 65.86 9.93 48 137126 3233 90488040
Poisoning 65.52 9.93 97 137077 15120 90476153
Epilepsy 62.90 9.93 269 136905 81937 90409336
Lung cyst 60.91 9.93 24 137150 451 90490822
Swelling 60.87 9.93 378 136796 418680 90072593
Cryopyrin associated periodic syndrome 60.11 9.93 25 137149 543 90490730
Multiple drug therapy 59.85 9.93 63 137111 6946 90484327
Overlap syndrome 59.45 9.93 69 137105 8479 90482794
Malignant neoplasm progression 57.96 9.93 46 137128 106824 90384449
Post-traumatic neck syndrome 57.91 9.93 40 137134 2474 90488799
Respiratory tract malformation 57.41 9.93 18 137156 165 90491108
Alanine aminotransferase increased 56.91 9.93 57 137117 118281 90372992
Drug-induced liver injury 55.43 9.93 34 137140 90284 90400989
Duodenal ulcer perforation 55.38 9.93 162 137012 221126 90270147
Renal function test abnormal 55.03 9.93 61 137113 7130 90484143
Mobility decreased 54.98 9.93 601 136573 250133 90241140
Muscle spasms 54.88 9.93 603 136571 251280 90239993
Anti-cyclic citrullinated peptide antibody positive 54.28 9.93 180 136994 236253 90255020
Cardiac arrest 53.57 9.93 306 136868 104629 90386644
Hyperkalaemia 53.30 9.93 16 137158 64948 90426325
Suspected suicide 53.22 9.93 69 137105 9499 90481774
Distributive shock 51.07 9.93 42 137132 3382 90487891
Libido increased 50.49 9.93 32 137142 1712 90489561
Soft tissue injury 49.88 9.93 34 137140 2058 90489215
Hostility 49.64 9.93 35 137139 2238 90489035
Erythema 48.65 9.93 546 136628 228700 90262573
Decreased appetite 48.48 9.93 352 136822 376188 90115085
General physical health deterioration 48.15 9.93 327 136847 354788 90136485
Electrocardiogram QT prolonged 47.73 9.93 25 137149 72431 90418842
Dyspnoea 47.54 9.93 995 136179 879960 89611313
Vascular malformation 47.28 9.93 23 137151 729 90490544
Spinal operation 46.81 9.93 67 137107 10129 90481144
Aspartate aminotransferase increased 46.78 9.93 52 137122 102885 90388388
Depression 46.41 9.93 675 136499 299926 90191347
Paranasal cyst 45.66 9.93 23 137151 787 90490486
Helicobacter infection 44.66 9.93 184 136990 226666 90264607
Anxiety 44.49 9.93 687 136487 309085 90182188
Sternal fracture 44.29 9.93 36 137138 2851 90488422
Maternal exposure during pregnancy 44.25 9.93 341 136833 359722 90131551
Cardiac failure 43.80 9.93 61 137113 109435 90381838
Intervertebral disc protrusion 43.31 9.93 114 137060 27082 90464191
Ill-defined disorder 42.96 9.93 140 137034 184751 90306522
Hyponatraemia 42.68 9.93 86 137088 133452 90357821
Swollen joint count increased 42.47 9.93 64 137110 111142 90380131
Liver injury 41.85 9.93 126 137048 170441 90320832
Drug ineffective 41.74 9.93 1694 135480 1382604 89108669
Pleural effusion 41.29 9.93 66 137108 111925 90379348
Renal impairment 40.91 9.93 60 137114 105361 90385912
Surgery 39.17 9.93 153 137021 44734 90446539
Confusional state 38.92 9.93 385 136789 385820 90105453
Liver disorder 38.84 9.93 78 137096 121191 90370082
Middle insomnia 37.29 9.93 80 137094 16671 90474602
Blood creatinine increased 37.14 9.93 60 137114 101326 90389947
Concussion 37.11 9.93 63 137111 11028 90480245
Hepatic function abnormal 36.90 9.93 12 137162 46276 90444997
Dysphoria 36.78 9.93 46 137128 6108 90485165
Oedema peripheral 36.71 9.93 234 136940 257681 90233592
Stress 36.20 9.93 229 136945 81166 90410107
Disease progression 36.09 9.93 119 137055 156496 90334777
Myocardial depression 35.76 9.93 18 137156 615 90490658
Lactic acidosis 35.38 9.93 16 137158 50447 90440826
Toxic epidermal necrolysis 35.20 9.93 4 137170 32524 90458749
Hip arthroplasty 35.18 9.93 38 137136 76170 90415103
Decreased immune responsiveness 35.15 9.93 54 137120 8694 90482579
Lactation disorder 35.05 9.93 16 137158 438 90490835
Mastoiditis 34.82 9.93 25 137149 1645 90489628
Hypokalaemia 34.25 9.93 94 137080 131022 90360251
Mucosal inflammation 33.58 9.93 23 137151 57602 90433671
Ankylosing spondylitis 33.09 9.93 66 137108 13067 90478206
Dermatitis atopic 33.00 9.93 94 137080 23378 90467895
Paraesthesia 32.85 9.93 547 136627 249779 90241494
Therapeutic product effect decreased 32.64 9.93 266 136908 277305 90213968
Drug resistance 32.32 9.93 4 137170 30445 90460828
Exposure via ingestion 32.22 9.93 29 137145 2638 90488635
Hypoaesthesia 31.99 9.93 660 136514 313550 90177723
Pre-existing condition improved 31.90 9.93 53 137121 9116 90482157
Agranulocytosis 31.82 9.93 7 137167 34995 90456278
Therapy interrupted 31.65 9.93 155 137019 49953 90441320
Platelet count decreased 31.61 9.93 104 137070 136865 90354408
Product quality issue 31.53 9.93 217 136957 79108 90412165
Premature delivery 30.99 9.93 10 137164 38752 90452521
Condition aggravated 30.78 9.93 677 136497 594868 89896405
Neutrophil count decreased 30.50 9.93 38 137136 71494 90419779
Drug eruption 30.38 9.93 8 137166 35399 90455874
Blood bilirubin increased 30.14 9.93 14 137160 43456 90447817
Gamma-glutamyltransferase increased 29.97 9.93 10 137164 37942 90453331
Cytomegalovirus infection 29.48 9.93 3 137171 26599 90464674
Pruritus 29.31 9.93 611 136563 540914 89950359
Illness 28.98 9.93 218 136956 81751 90409522
Oedema 28.86 9.93 181 136993 200114 90291159
Atrial fibrillation 28.44 9.93 105 137069 133506 90357767
Fear of disease 28.29 9.93 21 137153 1455 90489818
Product administration interrupted 28.20 9.93 60 137114 12432 90478841
Bone marrow failure 28.19 9.93 7 137167 32214 90459059
Ascites 27.89 9.93 19 137155 47721 90443552
International normalised ratio increased 27.42 9.93 19 137155 47297 90443976
Device expulsion 27.09 9.93 14 137160 40872 90450401
Poor sucking reflex 26.16 9.93 13 137161 432 90490841
Red blood cell sedimentation rate abnormal 26.13 9.93 3 137171 24201 90467072
Folliculitis 25.80 9.93 192 136982 204161 90287112
Muscle injury 25.78 9.93 159 137015 176495 90314778
Rash maculo-papular 25.69 9.93 15 137159 40918 90450355
Tubulointerstitial nephritis 25.32 9.93 4 137170 25339 90465934
Irritability 25.22 9.93 114 137060 35548 90455725
Macular degeneration 25.16 9.93 13 137161 37957 90453316
Foot fracture 25.12 9.93 93 137081 26513 90464760
Leukopenia 24.98 9.93 74 137100 100636 90390637
Rheumatic fever 24.93 9.93 133 137041 152988 90338285
Jaundice 24.93 9.93 9 137165 32508 90458765
Cholestasis 24.69 9.93 12 137162 36287 90454986
Sepsis 24.63 9.93 165 137009 179649 90311624
Rib fracture 24.62 9.93 92 137082 26343 90464930
Interstitial lung disease 24.59 9.93 49 137125 76356 90414917
Knee arthroplasty 24.55 9.93 56 137118 83126 90408147
Multiple organ dysfunction syndrome 24.51 9.93 41 137133 68295 90422978
Blood lactate dehydrogenase increased 23.95 9.93 5 137169 25927 90465346
Pulmonary fibrosis 23.87 9.93 83 137091 107420 90383853
Exposure via breast milk 23.78 9.93 23 137151 2292 90488981
Anti-cyclic citrullinated peptide antibody 23.65 9.93 6 137168 27215 90464058
Unresponsive to stimuli 23.42 9.93 117 137057 38004 90453269
Hepatotoxicity 23.30 9.93 21 137153 45821 90445452
Mycobacterium tuberculosis complex test positive 23.24 9.93 24 137150 2588 90488685
Nasal discharge discolouration 23.22 9.93 25 137149 2828 90488445
Hypoglycaemia 23.16 9.93 44 137130 69804 90421469
Deep vein thrombosis postoperative 23.14 9.93 45 137129 70764 90420509
Drug tolerance decreased 22.82 9.93 10 137164 32120 90459153
Stevens-Johnson syndrome 22.75 9.93 8 137166 29368 90461905
Bronchitis 22.63 9.93 341 136833 152586 90338687
Therapy cessation 22.63 9.93 112 137062 36249 90455024
Pneumocystis jirovecii pneumonia 22.55 9.93 3 137171 21613 90469660
Pregnancy 22.46 9.93 37 137137 62010 90429263
Emotional distress 22.16 9.93 112 137062 36550 90454723
Blood alkaline phosphatase increased 22.16 9.93 24 137150 48055 90443218
Hypocalcaemia 22.02 9.93 19 137155 42349 90448924
Gastrointestinal haemorrhage 21.89 9.93 67 137107 90181 90401092
Impaired healing 21.72 9.93 238 136936 233961 90257312
Myelodysplastic syndrome 21.57 9.93 3 137171 20900 90470373
Bedridden 21.50 9.93 53 137121 12095 90479178
Melaena 21.49 9.93 13 137161 34784 90456489
Transaminases increased 21.46 9.93 15 137159 37177 90454096
Hyperaesthesia 21.44 9.93 49 137125 10653 90480620
Myalgia 21.27 9.93 378 136796 174747 90316526
Dental restoration failure 21.06 9.93 16 137158 1148 90490125
Neck injury 21.02 9.93 22 137152 2410 90488863
Abortion spontaneous 20.74 9.93 31 137143 54025 90437248
Opiates positive 20.58 9.93 10 137164 316 90490957
Nightmare 20.56 9.93 76 137098 21649 90469624
Feeling abnormal 20.32 9.93 361 136813 166874 90324399
Type 2 diabetes mellitus 20.28 9.93 203 136971 203041 90288232
Onychomadesis 20.19 9.93 129 137045 45869 90445404
Neurotoxicity 20.12 9.93 4 137170 21463 90469810
Drug reaction with eosinophilia and systemic symptoms 20.09 9.93 21 137153 42737 90448536
Stomatitis 19.94 9.93 294 136880 274404 90216869
Pyrexia 19.82 9.93 808 136366 659677 89831596
Meniscus injury 19.10 9.93 40 137134 8197 90483076
Poor quality sleep 19.03 9.93 81 137093 24612 90466661
Gluten sensitivity 18.95 9.93 13 137161 795 90490478
Circulatory collapse 18.91 9.93 7 137167 24897 90466376
Urinary incontinence 18.80 9.93 109 137065 37457 90453816
Coccydynia 18.22 9.93 19 137155 2072 90489201
Blister 18.13 9.93 274 136900 254724 90236549
Peritonitis 17.79 9.93 4 137170 19701 90471572
Liver function test abnormal 17.78 9.93 31 137143 50814 90440459
Acute hepatic failure 17.72 9.93 6 137168 22555 90468718
Intervertebral disc degeneration 17.68 9.93 62 137112 17212 90474061
Serum sickness-like reaction 17.55 9.93 11 137163 577 90490696
Multiple sclerosis 17.50 9.93 86 137088 27754 90463519
Arthropod sting 17.47 9.93 15 137159 1282 90489991
Musculoskeletal stiffness 17.39 9.93 330 136844 296202 90195071
Pre-eclampsia 17.27 9.93 46 137128 11002 90480271
Hot flush 17.12 9.93 151 137023 59337 90431936
Rectal haemorrhage 16.98 9.93 66 137108 82678 90408595
Cardiogenic shock 16.78 9.93 8 137166 24460 90466813
Cytokine release syndrome 16.52 9.93 11 137163 27962 90463311
Bradycardia 16.49 9.93 68 137106 83779 90407494
Disseminated intravascular coagulation 16.45 9.93 6 137168 21532 90469741
Lymphopenia 16.44 9.93 7 137167 22874 90468399
Medication error 16.44 9.93 69 137105 84583 90406690
Somnolence 16.24 9.93 423 136751 208661 90282612
Hepatic enzyme increased 16.20 9.93 684 136490 360052 90131221
Rotator cuff syndrome 16.18 9.93 57 137117 15862 90475411
Hepatic failure 16.02 9.93 22 137152 39706 90451567
Ejection fraction decreased 15.94 9.93 10 137164 26243 90465030
Lymphatic system neoplasm 15.93 9.93 5 137169 46 90491227
Cardiac failure congestive 15.91 9.93 86 137088 98608 90392665
Muscle strain 15.83 9.93 41 137133 9646 90481627
Poor venous access 15.79 9.93 65 137109 19462 90471811
Temperature intolerance 15.78 9.93 47 137127 11983 90479290
Suicidal ideation 15.69 9.93 176 136998 73679 90417594
Blood cholesterol increased 15.66 9.93 221 136953 207791 90283482
Tenderness 15.48 9.93 81 137093 26787 90464486
Malaise 15.47 9.93 727 136447 585259 89906014
Toxicologic test abnormal 15.36 9.93 11 137163 721 90490552
Vomiting 15.30 9.93 1008 136166 787285 89703988
C-reactive protein 15.20 9.93 15 137159 31352 90459921
Basal cell carcinoma 15.02 9.93 17 137157 33372 90457901
Exposure during pregnancy 14.84 9.93 469 136705 237941 90253332
Amphetamines positive 14.77 9.93 7 137167 209 90491064
Pallor 14.72 9.93 18 137156 34147 90457126
Ligament sprain 14.60 9.93 52 137122 14547 90476726
Priapism 14.48 9.93 6 137168 129 90491144
Haemoglobin decreased 14.45 9.93 166 137008 161790 90329483
Colitis ulcerative 14.43 9.93 45 137129 60221 90431052
Substance use 14.41 9.93 13 137161 1186 90490087
Posterior reversible encephalopathy syndrome 14.28 9.93 8 137166 22331 90468942
Drug withdrawal syndrome 14.15 9.93 83 137091 28640 90462633
Respiratory failure 14.12 9.93 113 137061 118305 90372968
Catheter site pain 14.01 9.93 28 137146 5551 90485722
Proctitis 13.97 9.93 3 137171 15256 90476017
Muscle twitching 13.97 9.93 73 137101 24129 90467144
Angioedema 13.79 9.93 51 137123 64825 90426448
Withdrawal syndrome 13.74 9.93 69 137105 22455 90468818
Seasonal allergy 13.74 9.93 70 137104 22913 90468360
Tremor 13.73 9.93 316 136858 152857 90338416
Metastases to liver 13.70 9.93 14 137160 28793 90462480
Infrequent bowel movements 13.63 9.93 14 137160 1500 90489773
Female genital tract fistula 13.61 9.93 5 137169 17863 90473410
Panic attack 13.52 9.93 77 137097 26288 90464985
Cholecystitis chronic 13.47 9.93 39 137135 9787 90481486
Therapy non-responder 13.44 9.93 137 137037 136567 90354706
Clonus 13.42 9.93 28 137146 5722 90485551
Uterine perforation 13.41 9.93 33 137141 7521 90483752
Injection site pain 13.37 9.93 351 136823 173348 90317925
Retching 13.36 9.93 61 137113 19098 90472175
Purpura 13.34 9.93 3 137171 14775 90476498
Occipital neuralgia 13.26 9.93 10 137164 710 90490563
Appetite disorder 13.25 9.93 37 137137 9096 90482177
Multiple sclerosis relapse 13.16 9.93 129 137045 52176 90439097
Spinal cord neoplasm 13.07 9.93 8 137166 402 90490871
Catheter site bruise 12.77 9.93 9 137165 575 90490698
Muscle neoplasm 12.73 9.93 4 137170 37 90491236
Proteinuria 12.66 9.93 10 137164 23281 90467992
Osteonecrosis of jaw 12.65 9.93 25 137149 39078 90452195
Anticholinergic syndrome 12.56 9.93 18 137156 2725 90488548
Gallbladder neoplasm 12.54 9.93 4 137170 39 90491234
Skin necrosis 12.47 9.93 5 137169 16936 90474337
Foetal exposure timing unspecified 12.41 9.93 8 137166 441 90490832
Peripheral venous disease 12.36 9.93 187 136987 83734 90407539
Acute myeloid leukaemia 12.34 9.93 8 137166 20632 90470641
Injection site injury 12.34 9.93 11 137163 988 90490285
Skin ulcer 12.27 9.93 37 137137 50038 90441235
Disturbance in attention 12.25 9.93 117 137057 46992 90444281
Cerebral haemorrhage 12.11 9.93 21 137153 34501 90456772
Abdominal pain 12.08 9.93 483 136691 395238 90096035
Congenital cystic lung 12.03 9.93 4 137170 45 90491228
Maternal exposure during breast feeding 11.93 9.93 28 137146 6192 90485081
Haematochezia 11.87 9.93 61 137113 70852 90420421
Gingival abscess 11.84 9.93 11 137163 1042 90490231
Bladder discomfort 11.83 9.93 10 137164 836 90490437
Peripheral coldness 11.83 9.93 47 137127 13845 90477428
Syncope 11.82 9.93 136 137038 132527 90358746
Rheumatoid nodule 11.81 9.93 8 137166 20158 90471115
Narcolepsy 11.73 9.93 13 137161 1519 90489754
Pneumonia aspiration 11.73 9.93 28 137146 40912 90450361
Extrapyramidal disorder 11.70 9.93 5 137169 16298 90474975
Essential hypertension 11.65 9.93 28 137146 6287 90484986
Septic shock 11.63 9.93 77 137097 84083 90407190
Bronchiectasis 11.62 9.93 10 137164 22320 90468953
Sacroiliitis 11.60 9.93 22 137152 4197 90487076
Vertebral lateral recess stenosis 11.56 9.93 7 137167 345 90490928
Anuria 11.53 9.93 4 137170 14814 90476459
Copper deficiency 11.52 9.93 5 137169 121 90491152
Cerebral infarction 11.47 9.93 14 137160 26582 90464691
Electric shock sensation 11.47 9.93 13 137161 1557 90489716
Bone density decreased 11.40 9.93 6 137168 17339 90473934
Haematemesis 11.40 9.93 21 137153 33705 90457568
Paraesthesia oral 11.35 9.93 19 137155 31640 90459633
Drug interaction 11.34 9.93 325 136849 276128 90215145
Metastases to lung 11.32 9.93 5 137169 15986 90475287
Osteoarthropathy 11.28 9.93 7 137167 361 90490912
Product temperature excursion issue 11.27 9.93 10 137164 893 90490380
Adjustment disorder with depressed mood 11.18 9.93 46 137128 56707 90434566
Lower respiratory tract congestion 11.15 9.93 19 137155 3337 90487936
Ligamentum flavum hypertrophy 11.12 9.93 7 137167 370 90490903
Upper gastrointestinal haemorrhage 11.12 9.93 11 137163 22965 90468308
Exposure via inhalation 11.10 9.93 4 137170 58 90491215
Foetal exposure during pregnancy 11.08 9.93 31 137143 42944 90448329
Pneumonia 11.03 9.93 824 136350 637235 89854038
Fracture pain 11.01 9.93 11 137163 1140 90490133
Seronegative arthritis 11.00 9.93 7 137167 18227 90473046
Incorrect route of product administration 10.91 9.93 121 137053 50505 90440768
Dry mouth 10.91 9.93 360 136814 183699 90307574
Polyneuropathy 10.90 9.93 8 137166 19333 90471940
Toe operation 10.88 9.93 11 137163 1157 90490116
Vasculitis 10.83 9.93 11 137163 22682 90468591
Serotonin syndrome 10.82 9.93 96 137078 37791 90453482
Otitis media 10.80 9.93 26 137148 5844 90485429
Ankle fracture 10.78 9.93 60 137114 20310 90470963
Accidental poisoning 10.74 9.93 10 137164 950 90490323
Subarachnoid haemorrhage 10.63 9.93 7 137167 17897 90473376
Abdominal pain upper 10.58 9.93 610 136564 332064 90159209
Wheezing 10.51 9.93 277 136897 237803 90253470
Oral pain 10.49 9.93 85 137089 32598 90458675
Groin infection 10.48 9.93 8 137166 578 90490695
Bladder disorder 10.46 9.93 38 137136 10734 90480539
Thyrotoxic crisis 10.40 9.93 11 137163 1220 90490053
QRS axis abnormal 10.34 9.93 11 137163 1227 90490046
Chloasma 10.32 9.93 5 137169 157 90491116
Muscle spasticity 10.24 9.93 24 137150 35298 90455975
Cervical spinal stenosis 10.22 9.93 16 137158 2619 90488654
Neck surgery 10.20 9.93 14 137160 2036 90489237
Application site perspiration 10.16 9.93 3 137171 22 90491251
Tricuspid valve disease 10.15 9.93 6 137168 283 90490990
Economic problem 10.15 9.93 18 137156 3263 90488010
Rhinorrhoea 10.14 9.93 189 136985 88127 90403146
Hypercalcaemia 10.14 9.93 23 137151 34217 90457056
Delirium 10.09 9.93 105 137069 104254 90387019
White blood cell count decreased 10.09 9.93 185 136989 166924 90324349
Irritable bowel syndrome 10.06 9.93 238 136936 207210 90284063
Caesarean section 10.06 9.93 8 137166 18569 90472704
Schizophrenia 10.04 9.93 5 137169 14909 90476364
Anhedonia 10.00 9.93 39 137135 11392 90479881

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
Completed suicide 731.87 13.46 575 29062 95890 42495808
Drug abuse 303.99 13.46 369 29268 104402 42487296
Toxicity to various agents 238.92 13.46 505 29132 228631 42363067
Respiratory arrest 110.98 13.46 117 29520 28307 42563391
Cardio-respiratory arrest 77.39 13.46 143 29494 58493 42533205
Back pain 70.68 13.46 238 29399 141538 42450160
Product dose omission issue 55.97 13.46 234 29403 154131 42437567
Multiple organ dysfunction syndrome 55.21 13.46 3 29634 97032 42494666
Milk-alkali syndrome 54.61 13.46 20 29617 687 42591011
Pain 53.84 13.46 322 29315 244526 42347172
General physical health deterioration 53.78 13.46 19 29618 151227 42440471
Lymphocyte count abnormal 49.34 13.46 26 29611 2161 42589537
Suspected suicide 46.87 13.46 37 29600 6162 42585536
Lymphocyte count 43.79 13.46 13 29624 227 42591471
Back disorder 42.64 13.46 38 29599 7476 42584222
Interstitial lung disease 40.15 13.46 4 29633 78458 42513240
Asthma-chronic obstructive pulmonary disease overlap syndrome 36.50 13.46 19 29618 1540 42590158
Spinal operation 35.87 13.46 27 29610 4193 42587505
Bronchial hyperreactivity 35.39 13.46 20 29617 1909 42589789
Muscle spasms 34.78 13.46 135 29502 85909 42505789
Overdose 34.60 13.46 155 29482 105109 42486589
Off label use 33.94 13.46 283 29354 638052 41953646
C-reactive protein increased 33.16 13.46 3 29634 63557 42528141
Arthralgia 31.94 13.46 248 29389 204990 42386708
Anaemia 31.80 13.46 95 29542 280183 42311515
Intentional product misuse 31.74 13.46 105 29532 61795 42529903
Leukopenia 30.98 13.46 7 29630 74739 42516959
Cardiac arrest 30.84 13.46 154 29483 109166 42482532
Hyponatraemia 29.41 13.46 17 29620 101445 42490253
Pulmonary function test abnormal 29.24 13.46 20 29617 2674 42589024
Thrombocytopenia 29.13 13.46 55 29582 190224 42401474
Distributive shock 25.84 13.46 18 29619 2478 42589220
Back injury 24.69 13.46 22 29615 4326 42587372
Drug hypersensitivity 24.58 13.46 135 29502 99254 42492444
Intervertebral disc protrusion 24.21 13.46 34 29603 11038 42580660
Dermatitis atopic 24.08 13.46 36 29601 12368 42579330
Ankylosing spondylitis 23.96 13.46 27 29610 7029 42584669
Peripheral swelling 23.94 13.46 125 29512 90145 42501553
Antidepressant drug level increased 23.39 13.46 8 29629 224 42591474
Death 23.34 13.46 458 29179 470727 42120971
Product use in unapproved indication 21.27 13.46 62 29575 184394 42407304
Exposure via ingestion 21.26 13.46 15 29622 2107 42589591
Spinal fracture 21.26 13.46 29 29608 9161 42582537
Neck pain 21.16 13.46 57 29580 29957 42561741
Hepatic function abnormal 21.02 13.46 5 29632 51562 42540136
Ascites 20.33 13.46 7 29630 56671 42535027
Pain in extremity 20.18 13.46 176 29461 150428 42441270
Asthma 19.89 13.46 91 29546 62223 42529475
Febrile neutropenia 19.58 13.46 65 29572 185638 42406060
Feeling abnormal 19.45 13.46 98 29539 69688 42522010
Drug interaction 19.25 13.46 108 29529 266891 42324807
Anion gap 19.07 13.46 10 29627 823 42590875
Discomfort 18.90 13.46 49 29588 25170 42566528
Ischaemic cardiomyopathy 18.89 13.46 23 29614 6499 42585199
Respiratory failure 18.76 13.46 38 29599 128094 42463604
Nasopharyngitis 18.73 13.46 111 29526 83885 42507813
Bronchitis 18.20 13.46 73 29564 47128 42544570
Sciatica 18.17 13.46 24 29613 7353 42584345
Serotonin syndrome 18.14 13.46 49 29588 25796 42565902
Psoriasis 17.82 13.46 74 29563 48530 42543168
Disease progression 17.50 13.46 47 29590 143609 42448089
Melaena 17.37 13.46 3 29634 38743 42552955
Surgery 17.28 13.46 38 29599 17578 42574120
Fatigue 17.22 13.46 410 29227 435231 42156467
Neutropenia 17.04 13.46 76 29561 199355 42392343
Malignant neoplasm progression 16.87 13.46 31 29606 108369 42483329
Insomnia 16.79 13.46 140 29497 118113 42473585
Impaired quality of life 16.74 13.46 33 29604 14144 42577554
Rash maculo-papular 16.60 13.46 3 29634 37500 42554198
Therapeutic response shortened 16.55 13.46 32 29605 13522 42578176
Cardiac failure 16.24 13.46 31 29606 106825 42484873
Irritable bowel syndrome 16.04 13.46 18 29619 4663 42587035
Poisoning 15.91 13.46 33 29604 14666 42577032
Lactic acidosis 15.54 13.46 6 29631 45255 42546443
Cardiogenic shock 15.46 13.46 3 29634 35637 42556061
Neutrophil count increased 15.38 13.46 39 29598 19765 42571933
Mental status changes 15.34 13.46 64 29573 42051 42549647
Musculoskeletal stiffness 15.31 13.46 80 29557 57685 42534013
Joint swelling 15.23 13.46 90 29547 67932 42523766
Renal impairment 15.04 13.46 34 29603 110194 42481504
Tendinous contracture 14.65 13.46 5 29632 139 42591559
Septic shock 14.45 13.46 26 29611 91646 42500052
Unresponsive to stimuli 14.11 13.46 51 29586 31352 42560346
Bone pain 13.68 13.46 42 29595 23750 42567948

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
Completed suicide 1774.79 10.53 1830 136207 240551 110210711
Toxicity to various agents 896.64 10.53 1900 136137 478655 109972607
Drug abuse 684.81 10.53 969 137068 176442 110274820
Sedation complication 655.45 10.53 370 137667 19485 110431777
Creatinine renal clearance decreased 638.78 10.53 376 137661 21439 110429823
Temperature regulation disorder 534.65 10.53 279 137758 12547 110438715
Sedation 510.10 10.53 527 137510 69156 110382106
Blood calcium decreased 495.29 10.53 388 137649 35457 110415805
Food allergy 456.98 10.53 294 137743 19654 110431608
Orthostatic hypotension 409.18 10.53 458 137579 65791 110385471
Cognitive disorder 387.24 10.53 511 137526 87000 110364262
Constipation 383.31 10.53 1147 136890 356639 110094623
Immunodeficiency 363.28 10.53 336 137701 38502 110412760
Balance disorder 362.74 10.53 576 137461 115984 110335278
Pain 324.35 10.53 2168 135869 952787 109498475
Depressed level of consciousness 318.37 10.53 532 137505 111746 110339516
Coeliac disease 281.20 10.53 307 137730 42880 110408382
Back pain 252.85 10.53 1024 137013 369972 110081290
Respiratory arrest 247.98 10.53 334 137703 57965 110393297
Bursitis 221.08 10.53 496 137541 129422 110321840
Cardio-respiratory arrest 210.41 10.53 454 137583 115382 110335880
Intentional product misuse 208.07 10.53 491 137546 132413 110318849
Fluid retention 199.98 10.53 394 137643 93913 110357349
Foetal death 194.67 10.53 161 137876 15884 110435378
Upper respiratory tract infection 165.63 10.53 447 137590 130881 110320381
Hyperhidrosis 159.00 10.53 555 137482 186743 110264519
Rash erythematous 155.82 10.53 327 137710 81505 110369757
Infusion site reaction 153.87 10.53 147 137890 17535 110433727
Rheumatoid arthritis 153.46 10.53 760 137277 298853 110152409
Acute kidney injury 149.46 10.53 360 137677 635070 109816192
Anaemia 139.98 10.53 296 137741 546790 109904472
Blepharospasm 135.94 10.53 245 137792 54606 110396656
Neutropenia 135.28 10.53 161 137876 374459 110076803
Psoriasis 129.49 10.53 427 137610 139566 110311696
Neck pain 126.13 10.53 389 137648 122741 110328521
Overdose 125.36 10.53 601 137436 233193 110218069
Drug hypersensitivity 124.02 10.53 980 137057 453110 109998152
Febrile neutropenia 123.28 10.53 128 137909 316639 110134623
Migraine 119.27 10.53 477 137560 171175 110280087
Back injury 119.10 10.53 213 137824 47186 110404076
Taste disorder 118.37 10.53 256 137781 65131 110386131
Asthma 116.33 10.53 618 137419 249673 110201589
Mobility decreased 114.31 10.53 592 137445 236830 110214432
Fall 114.20 10.53 1203 136834 602279 109848983
Product dose omission issue 104.03 10.53 723 137314 321059 110130203
Gastrooesophageal reflux disease 96.70 10.53 463 137574 179513 110271749
Prescribed overdose 89.03 10.53 276 137761 87305 110363957
Headache 88.77 10.53 1570 136467 880807 109570455
Memory impairment 85.22 10.53 477 137560 196467 110254795
Pancytopenia 84.62 10.53 82 137955 209531 110241731
Multiple organ dysfunction syndrome 84.19 10.53 42 137995 151668 110299594
Suspected suicide 81.91 10.53 98 137939 15101 110436161
Malignant neoplasm progression 80.60 10.53 60 137977 174507 110276755
Pulmonary malformation 76.67 10.53 23 138014 222 110451040
Decorticate posture 75.65 10.53 25 138012 339 110450923
Hyponatraemia 73.86 10.53 98 137939 217555 110233707
Distributive shock 73.20 10.53 60 137977 5844 110445418
Renal impairment 70.11 10.53 79 137958 188366 110262896
Creatinine renal clearance increased 69.89 10.53 48 137989 3577 110447685
Cardiac failure 69.43 10.53 79 137958 187547 110263715
Overlap syndrome 68.93 10.53 70 137967 8989 110442273
Hepatic function abnormal 68.45 10.53 14 138023 89281 110361981
Poisoning 68.31 10.53 127 137910 28978 110422284
Cardiac arrest 66.45 10.53 447 137590 196306 110254956
Interstitial lung disease 65.48 10.53 47 137990 139287 110311975
Post-traumatic neck syndrome 63.79 10.53 40 137997 2555 110448707
Alanine aminotransferase increased 63.11 10.53 82 137955 183691 110267571
Pyrexia 63.07 10.53 768 137269 897497 109553765
Multiple drug therapy 62.95 10.53 63 137974 7951 110443311
Cryopyrin associated periodic syndrome 62.46 10.53 25 138012 600 110450662
Platelet count decreased 61.96 10.53 121 137916 230322 110220940
Drug interaction 60.99 10.53 370 137667 499813 109951449
Blood creatinine increased 60.38 10.53 84 137953 182805 110268457
Muscle spasms 59.95 10.53 570 137467 277587 110173675
Lactic acidosis 59.02 10.53 21 138016 92790 110358472
Sepsis 58.96 10.53 210 137827 327136 110124126
Ascites 57.33 10.53 22 138015 92786 110358476
C-reactive protein abnormal 56.81 10.53 47 137990 129648 110321614
Respiratory depression 56.44 10.53 124 137913 31877 110419385
Spinal operation 56.28 10.53 69 137968 10903 110440359
Disease progression 55.87 10.53 140 137897 243894 110207368
Pleural effusion 54.40 10.53 86 137951 177623 110273639
Lower respiratory tract infection 53.71 10.53 142 137895 242964 110208298
Electrocardiogram QT prolonged 53.53 10.53 35 138002 108925 110342337
Soft tissue injury 53.24 10.53 34 138003 2242 110449020
Drug-induced liver injury 53.22 10.53 43 137994 120024 110331238
Lung cyst 53.02 10.53 21 138016 490 110450772
Vascular malformation 52.91 10.53 24 138013 790 110450472
Toxic epidermal necrolysis 52.57 10.53 5 138032 56722 110394540
Rheumatoid factor positive 52.53 10.53 52 137985 131588 110319674
General physical health deterioration 51.10 10.53 316 137721 424979 110026283
Hepatocellular injury 51.08 10.53 3 138034 50639 110400623
Paranasal cyst 50.51 10.53 24 138013 880 110450382
Renal function test abnormal 50.39 10.53 59 137978 8887 110442375
Hostility 50.34 10.53 35 138002 2661 110448601
Hypoaesthesia 50.04 10.53 606 137431 313617 110137645
Hyperkalaemia 49.35 10.53 58 137979 135738 110315524
Concussion 48.88 10.53 66 137971 11472 110439790
Rash maculo-papular 48.57 10.53 16 138021 74206 110377056
Intervertebral disc protrusion 48.48 10.53 107 137930 27591 110423671
Melaena 48.31 10.53 13 138024 68744 110382518
Sternal fracture 48.19 10.53 37 138000 3279 110447983
Decreased appetite 48.07 10.53 372 137665 475474 109975788
Sleep disorder due to general medical condition, insomnia type 47.87 10.53 37 138000 105606 110345656
Cholestasis 47.65 10.53 11 138026 64507 110386755
Libido increased 47.49 10.53 33 138004 2506 110448756
Off label use 47.34 10.53 1470 136567 1498715 108952547
Tubulointerstitial nephritis 47.23 10.53 6 138031 54278 110396984
Drug resistance 47.23 10.53 7 138030 56367 110394895
Gastrointestinal disorder 47.12 10.53 150 137887 241802 110209460
Exposure via ingestion 46.98 10.53 43 137994 4857 110446405
Agranulocytosis 46.68 10.53 10 138027 61750 110389512
Drug eruption 46.52 10.53 6 138031 53653 110397609
Gamma-glutamyltransferase increased 46.19 10.53 10 138027 61299 110389963
Cardiogenic shock 46.05 10.53 8 138029 57330 110393932
Aspartate aminotransferase increased 45.62 10.53 81 137956 159855 110291407
Depression 45.00 10.53 599 137438 316736 110134526
Erythema 44.21 10.53 557 137480 290890 110160372
Product quality issue 43.78 10.53 202 137835 77097 110374165
Surgery 43.72 10.53 132 137905 41151 110410111
Neutrophil count decreased 43.57 10.53 52 137985 120889 110330373
Cytomegalovirus infection 42.85 10.53 8 138029 54436 110396826
Bone marrow failure 42.45 10.53 10 138027 57838 110393424
Hypokalaemia 42.27 10.53 104 137933 182344 110268918
Hypoglycaemia 41.75 10.53 50 137987 116054 110335208
Respiratory tract malformation 41.26 10.53 12 138025 103 110451159
Respiratory failure 40.88 10.53 135 137902 215197 110236065
Dyspnoea 40.84 10.53 1061 136976 1105811 109345451
Decreased immune responsiveness 40.78 10.53 55 137982 9551 110441711
Hypotension 40.04 10.53 895 137142 522954 109928308
International normalised ratio increased 39.82 10.53 30 138007 86742 110364520
Pericarditis 39.81 10.53 140 137897 218974 110232288
Poor sucking reflex 39.18 10.53 12 138025 125 110451137
Epilepsy 38.96 10.53 236 137801 99973 110351289
Septic shock 38.73 10.53 87 137950 157441 110293821
Oedema peripheral 38.53 10.53 246 137791 328414 110122848
Leukopenia 38.38 10.53 80 137957 148711 110302551
Lactation disorder 37.26 10.53 14 138023 282 110450980
Liver disorder 37.10 10.53 76 137961 142167 110309095
Atrial fibrillation 37.03 10.53 154 137883 229488 110221774
Cytokine release syndrome 36.74 10.53 21 138016 70285 110380977
Anxiety 36.69 10.53 620 137417 344458 110106804
Myocardial depression 36.57 10.53 18 138019 714 110450548
Pneumocystis jirovecii pneumonia 36.51 10.53 5 138032 42730 110408532
Ankylosing spondylitis 36.48 10.53 68 137969 15544 110435718
Blood lactate dehydrogenase increased 36.02 10.53 6 138031 44328 110406934
Hepatotoxicity 36.00 10.53 17 138020 63383 110387879
Blood bilirubin increased 35.20 10.53 26 138011 75946 110375316
Hypocalcaemia 34.92 10.53 19 138018 65347 110385915
Bronchitis 34.91 10.53 324 137713 156708 110294554
Back disorder 34.57 10.53 79 137958 20843 110430419
Fatigue 33.38 10.53 1845 136192 1214113 109237149
Transaminases increased 33.03 10.53 19 138018 63371 110387891
Fear of disease 33.03 10.53 21 138016 1374 110449888
Hand deformity 32.52 10.53 151 137886 218355 110232907
Circulatory collapse 32.41 10.53 7 138030 42986 110408276
Jaundice 31.96 10.53 17 138020 59219 110392043
Paraesthesia 31.68 10.53 503 137534 276018 110175244
Pemphigus 31.51 10.53 149 137888 214421 110236841
Fibromyalgia 31.40 10.53 339 137698 170570 110280692
Mastoiditis 31.25 10.53 26 138011 2585 110448677
Dermatitis atopic 31.23 10.53 86 137951 25455 110425807
Mucosal inflammation 30.89 10.53 45 137992 96096 110355166
Exposure via breast milk 30.82 10.53 18 138019 1010 110450252
Disseminated intravascular coagulation 30.57 10.53 7 138030 41279 110409983
Systemic lupus erythematosus 29.99 10.53 190 137847 254148 110197114
Hepatic failure 29.99 10.53 25 138012 68714 110382548
Hypercholesterolaemia 29.23 10.53 204 137833 90633 110360629
Middle insomnia 29.12 10.53 73 137964 20429 110430833
Therapy cessation 29.03 10.53 122 137915 44735 110406527
Thrombocytopenia 28.89 10.53 287 137750 348598 110102664
Unresponsive to stimuli 28.56 10.53 156 137881 63634 110387628
Blood alkaline phosphatase increased 28.32 10.53 28 138009 70907 110380355
Hyperaesthesia 28.19 10.53 59 137978 14668 110436594
Condition aggravated 27.93 10.53 701 137336 734135 109717127
Onychomadesis 27.86 10.53 122 137915 45541 110405721
Lymphopenia 27.46 10.53 8 138029 40162 110411100
Acute hepatic failure 27.37 10.53 6 138031 36462 110414800
Renal failure 27.36 10.53 168 137869 226406 110224856
Pneumonia aspiration 27.11 10.53 37 138000 81196 110370066
Hepatic enzyme increased 26.97 10.53 556 137481 320336 110130926
Myocarditis 26.94 10.53 3 138034 30052 110421210
Neck injury 26.92 10.53 26 138011 3142 110448120
Polyneuropathy 26.76 10.53 4 138033 32008 110419254
Gastrointestinal haemorrhage 26.67 10.53 111 137926 165407 110285855
Intervertebral disc degeneration 26.33 10.53 65 137972 18020 110433242
Stevens-Johnson syndrome 25.99 10.53 13 138024 46888 110404374
Feeling abnormal 25.96 10.53 342 137695 180369 110270893
Pre-existing condition improved 25.65 10.53 36 138001 6490 110444772
Synovitis 25.48 10.53 219 137818 273873 110177389
Dysphoria 24.58 10.53 35 138002 6393 110444869
Emotional distress 24.51 10.53 116 137921 44731 110406531
Illness 24.40 10.53 181 137856 81990 110369272
Bronchopulmonary aspergillosis 24.35 10.53 4 138033 29859 110421403
Milk-alkali syndrome 24.07 10.53 20 138017 1985 110449277
Gluten sensitivity 23.81 10.53 12 138025 501 110450761
Wound 23.77 10.53 183 137854 234254 110217008
Abdominal pain upper 23.73 10.53 587 137450 348524 110102738
Bronchiectasis 23.64 10.53 8 138029 36485 110414777
Injection site pain 23.62 10.53 332 137705 177590 110273672
Syncope 23.51 10.53 152 137885 202384 110248878
Meniscus injury 23.51 10.53 38 137999 7755 110443507
Cerebral haemorrhage 23.33 10.53 28 138009 64940 110386322
Stress 23.22 10.53 217 137820 105131 110346131
Haemoglobin decreased 23 10.53 199 137838 248528 110202734
Myelodysplastic syndrome 22.96 10.53 9 138028 37475 110413787
Foetal exposure timing unspecified 22.85 10.53 7 138030 73 110451189
Rib fracture 22.75 10.53 93 137944 33677 110417585
Mycobacterium tuberculosis complex test positive 22.49 10.53 24 138013 3264 110447998
Poor quality sleep 21.92 10.53 81 137956 27996 110423266
Foot fracture 21.90 10.53 76 137961 25470 110425792
Dental restoration failure 21.67 10.53 15 138022 1132 110450130
Bradycardia 21.66 10.53 110 137927 155407 110295855
Muscle strain 21.59 10.53 45 137992 11157 110440105
Arthralgia 21.52 10.53 1184 136853 778448 109672814
Neurotoxicity 21.50 10.53 13 138024 42194 110409068
Pain in extremity 21.42 10.53 776 137261 486342 109964920
Nasal discharge discolouration 21.25 10.53 23 138014 3178 110448084
Extrapyramidal disorder 21.16 10.53 5 138032 28862 110422400
Therapy interrupted 21.08 10.53 120 137917 49702 110401560
Serotonin syndrome 20.92 10.53 136 137901 59017 110392245
Haematemesis 20.67 10.53 26 138011 59082 110392180
Confusional state 20.62 10.53 437 137600 468243 109983019
Purpura 20.49 10.53 3 138034 24385 110426877
Uterine perforation 20.16 10.53 33 138004 6807 110444455
Cerebral infarction 20.08 10.53 21 138016 51817 110399445
Breast cancer stage III 20.04 10.53 168 137869 78949 110372313
Withdrawal syndrome 20.03 10.53 85 137952 31295 110419967
Medication error 20.03 10.53 66 137971 105300 110345962
Multiple sclerosis 19.94 10.53 74 137963 25624 110425638
Drug reaction with eosinophilia and systemic symptoms 19.64 10.53 46 137991 82049 110369213
Liver function test abnormal 19.58 10.53 35 138002 68915 110382347
Altered state of consciousness 19.48 10.53 26 138011 57600 110393662
Haematuria 19.47 10.53 47 137990 82958 110368304
Proteinuria 19.46 10.53 13 138024 40005 110411257
Bronchial hyperreactivity 19.34 10.53 23 138014 3521 110447741
Osteonecrosis of jaw 19.11 10.53 19 138018 47998 110403264
Acute myeloid leukaemia 19.05 10.53 12 138025 38098 110413164
Drug ineffective 18.92 10.53 1638 136399 1518902 108932360
Rectal haemorrhage 18.91 10.53 81 137956 119752 110331510
Upper gastrointestinal haemorrhage 18.62 10.53 21 138016 50075 110401187
Ligament sprain 18.56 10.53 53 137984 16015 110435247
Accidental poisoning 18.53 10.53 19 138018 2468 110448794
Torsade de pointes 18.49 10.53 3 138034 22597 110428665
Red blood cell sedimentation rate abnormal 18.46 10.53 4 138033 24505 110426757
Anuria 18.28 10.53 4 138033 24337 110426925
Blood creatine phosphokinase increased 18.25 10.53 40 137997 73037 110378225
Hot flush 18.22 10.53 143 137894 65893 110385369
Cardiac failure congestive 18.21 10.53 112 137925 150888 110300374
Ischaemic stroke 18.01 10.53 15 138022 41248 110410014
Pulmonary fibrosis 17.99 10.53 66 137971 101976 110349286
Miosis 17.80 10.53 3 138034 21980 110429282
Ejection fraction decreased 17.67 10.53 15 138022 40865 110410397
Schizophrenia 17.63 10.53 3 138034 21823 110429439
Catheter site pain 17.53 10.53 30 138007 6416 110444846
Peripheral venous disease 17.42 10.53 171 137866 83946 110367316
Pulmonary function test abnormal 17.34 10.53 26 138011 4974 110446288
Bedridden 17.21 10.53 46 137991 13379 110437883
Nerve injury 17.20 10.53 40 137997 10673 110440589
Status epilepticus 17.12 10.53 9 138028 31562 110419700
Opiates positive 17.09 10.53 12 138025 927 110450335
Electrocardiogram QRS complex prolonged 17.08 10.53 45 137992 12976 110438286
Haematochezia 17.08 10.53 80 137957 115444 110335818
Aggression 16.87 10.53 30 138007 59180 110392082
Intentional overdose 16.69 10.53 245 137792 132256 110319006
Peritonitis 16.67 10.53 10 138027 32597 110418665
Serum sickness-like reaction 16.54 10.53 11 138026 777 110450485
Metastases to liver 16.54 10.53 12 138025 35374 110415888
Posterior reversible encephalopathy syndrome 16.46 10.53 11 138026 33850 110417412
Antidepressant drug level increased 16.42 10.53 10 138027 606 110450656
Vomiting 16.38 10.53 950 137087 909725 109541537
Diabetic ketoacidosis 16.33 10.53 17 138020 42041 110409221
Seasonal allergy 16.33 10.53 58 137979 19664 110431598
Rhinorrhoea 16.31 10.53 198 137839 102468 110348794
Haemoptysis 16.27 10.53 41 137996 71313 110379949
Abdominal pain 16.22 10.53 502 137535 512487 109938775
Swollen joint count increased 16.18 10.53 52 137985 83609 110367653
Angioedema 15.90 10.53 66 137971 98434 110352828
Basal cell carcinoma 15.74 10.53 20 138017 45250 110406012
Pallor 15.73 10.53 29 138008 56438 110394824
Retching 15.71 10.53 63 137974 22619 110428643
White blood cell count decreased 15.69 10.53 197 137840 229193 110222069
Haemophagocytic lymphohistiocytosis 15.69 10.53 10 138027 31549 110419713
Pneumonia 15.68 10.53 915 137122 875799 109575463
Application site perspiration 15.61 10.53 4 138033 20 110451242
Dehydration 15.60 10.53 250 137787 279261 110172001
Myocardial ischaemia 15.39 10.53 7 138030 26677 110424585
Dry mouth 15.35 10.53 342 137695 199606 110251656
Subarachnoid haemorrhage 15.34 10.53 9 138028 29693 110421569
Poor venous access 15.33 10.53 66 137971 24456 110426806
Rotator cuff syndrome 15.31 10.53 51 137986 16743 110434519
Skin necrosis 15.24 10.53 4 138033 21508 110429754
Occipital neuralgia 15.20 10.53 10 138027 694 110450568
Inappropriate antidiuretic hormone secretion 15.15 10.53 12 138025 33839 110417423
Bladder disorder 15.14 10.53 39 137998 11098 110440164
Death 14.92 10.53 1038 136999 697831 109753431
Malaise 14.89 10.53 686 137351 671133 109780129
Prostate cancer 14.86 10.53 15 138022 37626 110413636
Premature delivery 14.83 10.53 10 138027 30622 110420640
Cholecystitis chronic 14.74 10.53 35 138002 9465 110441797
Lymphatic system neoplasm 14.73 10.53 5 138032 74 110451188
Maternal exposure during breast feeding 14.65 10.53 22 138015 4216 110447046
Product prescribing error 14.63 10.53 26 138011 51305 110399957
Tremor 14.62 10.53 343 137694 201889 110249373
Arthropod sting 14.55 10.53 13 138024 1423 110449839
Osteoarthritis 14.54 10.53 314 137723 182309 110268953
Oedema 14.48 10.53 180 137857 209796 110241466
Immune thrombocytopenia 14.45 10.53 5 138032 22489 110428773
Colitis ulcerative 14.33 10.53 49 137988 77314 110373948
Catheter site bruise 14.25 10.53 9 138028 582 110450680
Epstein-Barr virus infection 14.23 10.53 3 138034 18735 110432527
Rhabdomyolysis 14.15 10.53 90 137947 120311 110330951
Appetite disorder 14.10 10.53 35 138002 9734 110441528
Toe operation 14.05 10.53 11 138026 1003 110450259
Enterococcal infection 14.03 10.53 4 138033 20362 110430900
Application site burn 14.02 10.53 11 138026 1006 110450256
Chronic sinusitis 13.83 10.53 7 138030 25077 110426185
Amphetamines positive 13.81 10.53 7 138030 296 110450966
Panic attack 13.79 10.53 72 137965 28868 110422394
Neck surgery 13.69 10.53 15 138022 2102 110449160
Myalgia 13.66 10.53 369 137668 222012 110229250
Economic problem 13.65 10.53 21 138016 4110 110447152
Liver injury 13.61 10.53 121 137916 150292 110300970
Acute myocardial infarction 13.61 10.53 56 137981 83721 110367541
Injection site bruising 13.59 10.53 110 137927 51153 110400109
Toxicologic test abnormal 13.58 10.53 12 138025 1295 110449967
Hyperthyroidism 13.57 10.53 10 138027 29251 110422011
Hyperbilirubinaemia 13.57 10.53 11 138026 30660 110420602
Pre-eclampsia 13.57 10.53 32 138005 8618 110442644
Arthropathy 13.55 10.53 265 137772 287257 110164005
Blood uric acid increased 13.47 10.53 5 138032 21524 110429738
Skin ulcer 13.43 10.53 38 137999 63607 110387655
Gingival abscess 13.38 10.53 11 138026 1076 110450186
Liver function test increased 13.30 10.53 169 137868 88379 110362883
Therapy non-responder 13.18 10.53 129 137908 157178 110294084
Ataxia 13.07 10.53 11 138026 30097 110421165
Coccydynia 13.07 10.53 16 138021 2525 110448737
Contraindicated product administered 13.06 10.53 404 137633 247863 110203399
Erythema multiforme 13.03 10.53 5 138032 21092 110430170
Ear pain 12.94 10.53 112 137925 53114 110398148
Oropharyngeal pain 12.91 10.53 239 137798 135037 110316225
Spinal disorder 12.89 10.53 38 137999 11690 110439572
Fracture pain 12.85 10.53 11 138026 1137 110450125
Vertebral lateral recess stenosis 12.82 10.53 7 138030 345 110450917
Product administration interrupted 12.81 10.53 37 138000 11255 110440007
Enteritis 12.76 10.53 4 138033 19152 110432110
Drug intolerance 12.73 10.53 625 137412 405887 110045375
Activated partial thromboplastin time prolonged 12.70 10.53 6 138031 22362 110428900
Hepatic encephalopathy 12.67 10.53 10 138027 28246 110423016
Escherichia infection 12.61 10.53 7 138030 23809 110427453
Metabolic acidosis 12.54 10.53 73 137964 99671 110351591
Ligamentum flavum hypertrophy 12.40 10.53 7 138030 368 110450894
Limb injury 12.39 10.53 85 137952 37551 110413711
Osteoarthropathy 12.33 10.53 7 138030 372 110450890
Left ventricular dysfunction 12.30 10.53 7 138030 23486 110427776
Progressive multifocal leukoencephalopathy 12.28 10.53 8 138029 24948 110426314
Proctitis 12.27 10.53 3 138034 16924 110434338
Hypophagia 12.18 10.53 30 138007 52596 110398666
Allodynia 12.17 10.53 14 138023 2069 110449193
Rales 12.08 10.53 8 138029 24731 110426531
Drug tolerance decreased 12.03 10.53 10 138027 27530 110423732
Hypogammaglobulinaemia 12.00 10.53 5 138032 20071 110431191
Hyperglycaemia 11.95 10.53 60 137977 85030 110366232
Metastases to lung 11.89 10.53 7 138030 23056 110428206
Pruritus 11.86 10.53 599 137438 580961 109870301
Muscle neoplasm 11.86 10.53 4 138033 58 110451204
Irritability 11.83 10.53 101 137936 47708 110403554
Haemodynamic instability 11.73 10.53 7 138030 22881 110428381
Personality disorder 11.72 10.53 39 137998 12798 110438464
Pelvic floor dysfunction 11.71 10.53 3 138034 15 110451247
Urinary incontinence 11.68 10.53 102 137935 48485 110402777
Metastases to central nervous system 11.66 10.53 7 138030 22810 110428452
Second primary malignancy 11.64 10.53 4 138033 18064 110433198
Duodenal ulcer perforation 11.64 10.53 154 137883 177546 110273716
Osteonecrosis 11.63 10.53 15 138022 33726 110417536
Nail disorder 11.62 10.53 117 137920 57818 110393444
Sneezing 11.59 10.53 74 137963 31910 110419352
Intestinal ischaemia 11.48 10.53 3 138034 16176 110435086
Pericardial effusion 11.46 10.53 35 138002 57182 110394080
Full blood count abnormal 11.43 10.53 34 138003 56018 110395244
Ill-defined disorder 11.37 10.53 133 137904 156720 110294542
Hypomagnesaemia 11.34 10.53 38 137999 60332 110390930
Muscle twitching 11.31 10.53 70 137967 29865 110421397
Clonus 11.31 10.53 30 138007 8686 110442576
Major depression 11.28 10.53 34 138003 10587 110440675
Hip arthroplasty 11.28 10.53 34 138003 55779 110395483
Eye irritation 11.28 10.53 76 137961 33376 110417886
Thinking abnormal 11.25 10.53 43 137994 15097 110436165
Tenderness 11.23 10.53 69 137968 29368 110421894
Presyncope 11.21 10.53 28 138009 48859 110402403
Injection site injury 11.20 10.53 10 138027 1094 110450168
Angina pectoris 11.17 10.53 40 137997 62255 110389007
Pregnancy 11.14 10.53 30 138007 51037 110400225
Renal tubular necrosis 11.08 10.53 13 138024 30462 110420800
Parkinsonism 11.07 10.53 7 138030 22180 110429082
Knee operation 11.04 10.53 26 138011 6996 110444266
Anion gap 11.03 10.53 13 138024 1972 110449290
Otitis media 11.02 10.53 27 138010 7449 110443813
Hypoalbuminaemia 10.93 10.53 12 138025 28962 110422300
Haemolysis 10.90 10.53 3 138034 15636 110435626
Feeling hot 10.90 10.53 167 137870 90939 110360323
Enterocolitis 10.88 10.53 5 138032 18944 110432318
Total lung capacity 10.85 10.53 3 138034 21 110451241
Oral pain 10.84 10.53 82 137955 37362 110413900
Subdural haematoma 10.81 10.53 18 138019 36436 110414826
Lymphocyte count decreased 10.78 10.53 36 138001 57207 110394055
Colitis 10.78 10.53 79 137958 102244 110349018
Graft versus host disease 10.74 10.53 5 138032 18801 110432461
Blood urea increased 10.74 10.53 34 138003 54923 110396339
Rheumatoid nodule 10.69 10.53 6 138031 20290 110430972
Akathisia 10.66 10.53 4 138033 17109 110434153
Right ventricular failure 10.64 10.53 10 138027 25944 110425318
Impaired quality of life 10.61 10.53 69 137968 29948 110421314
Paraesthesia oral 10.58 10.53 16 138021 33655 110417607
Macular degeneration 10.58 10.53 7 138030 21652 110429610
Acute pulmonary oedema 10.54 10.53 4 138033 16992 110434270

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M03BX08 MUSCULO-SKELETAL SYSTEM
MUSCLE RELAXANTS
MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
Other centrally acting agents
MeSH PA D000928 Antidepressive Agents
MeSH PA D000929 Antidepressive Agents, Tricyclic
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009125 Muscle Relaxants, Central
MeSH PA D009465 Neuromuscular Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
MeSH PA D018373 Peripheral Nervous System Agents
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35473 tranquilizing drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:51371 muscle relaxant
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:53784 antispasmodic drug
FDA PE N0000175730 Centrally-mediated Muscle Relaxation
FDA EPC N0000175737 Muscle Relaxant

Related Drugs by ATC class:

M03BX Other centrally acting agents 9 drugs
baclofeneperisonefenyramidolmephenesinpridinoltetrazepamthiocolchicosidetizanidinetolperisone

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

DiseaseRelationSNOMED_IDDOID
Spasticity indication 221360009
Fibromyalgia off-label use 203082005 DOID:631
Sinus tachycardia contraindication 11092001
Glaucoma contraindication 23986001 DOID:1686
Hyperthyroidism contraindication 34486009 DOID:7998
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Hepatic failure contraindication 59927004
Open-angle glaucoma contraindication 84494001 DOID:1067
Heart block contraindication 233916004
Retention of urine contraindication 267064002
Myocardial infarction in recovery phase contraindication 418044006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.66 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2.8MG TONMYA TONIX N219428 Aug. 15, 2025 RX TABLET SUBLINGUAL Aug. 15, 2028 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.54 WOMBAT-PK CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 6.97 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Ki 7.44 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 6.81 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 7.24 WOMBAT-PK
5-hydroxytryptamine receptor 6 GPCR Ki 6.84 WOMBAT-PK
5-hydroxytryptamine receptor 7 GPCR Ki 6.82 WOMBAT-PK
Histamine H1 receptor GPCR Ki 8.83 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR IC50 6.95 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 7.22 PDSP
Muscarinic acetylcholine receptor M3 GPCR Ki 8.22 PDSP
Aldehyde oxidase Enzyme IC50 5.51 WOMBAT-PK
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase IC50 6.52 CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.73 WOMBAT-PK
Voltage-dependent N-type calcium channel subunit alpha-1B Ion channel IC50 5 CHEMBL

External reference:

IDSource
4019699 VUID
N0000147791 NUI
D00772 KEGG_DRUG
6202-23-9 SECONDARY_CAS_RN
21949 RXNORM
C0056732 UMLSCUI
CHEBI:3996 CHEBI
CHEMBL669 ChEMBL_ID
CHEMBL1200636 ChEMBL_ID
DB00924 DRUGBANK_ID
C004704 MESH_SUPPLEMENTAL_RECORD_UI
2895 PUBCHEM_CID
7152 IUPHAR_LIGAND_ID
791 INN_ID
69O5WQQ5TI UNII
217 MMSL
4517 MMSL
d00963 MMSL
001678 NDDF
004680 NDDF
373779004 SNOMEDCT_US
63083007 SNOMEDCT_US
80802008 SNOMEDCT_US
4017956 VANDF
4019699 VANDF
69O5WQQ5TI INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1920 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA authorized generic 30 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1921 CAPSULE, EXTENDED RELEASE 30 mg ORAL NDA authorized generic 30 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-3420 TABLET, FILM COATED 5 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-3421 TABLET, FILM COATED 7.50 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-3422 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1436 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA authorized generic 28 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1437 CAPSULE, EXTENDED RELEASE 30 mg ORAL NDA authorized generic 28 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-1350 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-7350 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8084 TABLET, FILM COATED 10 mg ORAL ANDA 21 sections
Cyclobenzaprine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8508 TABLET, FILM COATED 5 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7400 TABLET, FILM COATED 5 mg ORAL ANDA 23 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7401 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-072 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-159 TABLET 10 mg ORAL ANDA 13 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-200 TABLET, FILM COATED 5 mg ORAL ANDA 13 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-006 TABLET, FILM COATED 5 mg ORAL ANDA 13 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10702-007 TABLET, FILM COATED 10 mg ORAL ANDA 13 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 12634-528 TABLET 10 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride Human Prescription Drug Label 1 16571-782 TABLET, FILM COATED 5 mg ORAL ANDA 23 sections
Cyclobenzaprine Hydrochloride Human Prescription Drug Label 1 16571-783 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
CYCLOBENZAPRINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-065 TABLET 10 mg ORAL ANDA 12 sections
CYCLOBENZAPRINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-544 TABLET 5 mg ORAL ANDA 12 sections
Amrix HUMAN PRESCRIPTION DRUG LABEL 1 16590-596 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA 13 sections
FEXMID HUMAN PRESCRIPTION DRUG LABEL 1 16590-699 TABLET, FILM COATED 7.50 mg ORAL ANDA 22 sections
Amrix HUMAN PRESCRIPTION DRUG LABEL 1 16590-810 CAPSULE, EXTENDED RELEASE 30 mg ORAL NDA 13 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-036 TABLET 5 mg ORAL ANDA 13 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-037 TABLET 10 mg ORAL ANDA 13 sections
AMRIX HUMAN PRESCRIPTION DRUG LABEL 1 21695-723 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA 22 sections
Fexmid HUMAN PRESCRIPTION DRUG LABEL 1 21695-830 TABLET, FILM COATED 7.50 mg ORAL ANDA 22 sections