cyclobenzaprine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/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

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 1058.82 10.72 1166 89320 144507 63254029
Toxicity to various agents 768.92 10.72 1311 89175 245939 63152597
Sedation complication 617.52 10.72 329 90157 13493 63385043
Sedation 568.49 10.72 459 90027 38350 63360186
Creatinine renal clearance decreased 561.33 10.72 327 90159 15981 63382555
Orthostatic hypotension 492.54 10.72 410 90076 35750 63362786
Drug abuse 450.63 10.72 536 89950 71982 63326554
Blood calcium decreased 437.19 10.72 336 90150 26115 63372421
Cognitive disorder 424.07 10.72 458 90028 55357 63343179
Constipation 370.33 10.72 918 89568 224025 63174511
Balance disorder 357.92 10.72 517 89969 83905 63314631
Temperature regulation disorder 343.44 10.72 170 90316 5962 63392574
Depressed level of consciousness 342.15 10.72 432 90054 61646 63336890
Food allergy 259.70 10.72 176 90310 11225 63387311
Coeliac disease 230.09 10.72 171 90315 12626 63385910
Immunodeficiency 212.29 10.72 198 90288 20056 63378480
Glossodynia 186.91 10.72 19 90467 178857 63219679
Hand deformity 180.22 10.72 12 90474 159445 63239091
Respiratory arrest 177.90 10.72 226 90260 32419 63366117
Pain 174.37 10.72 1713 88773 738915 62659621
Systemic lupus erythematosus 173.86 10.72 42 90444 208876 63189660
Fall 172.11 10.72 1050 89436 391284 63007252
Cardio-respiratory arrest 157.44 10.72 296 90190 59663 63338873
Mobility decreased 152.21 10.72 448 90038 120711 63277825
Maternal exposure during pregnancy 151.48 10.72 62 90424 220000 63178536
Pericarditis 151.38 10.72 9 90477 131570 63266966
Synovitis 150.84 10.72 40 90446 186878 63211658
Back pain 149.77 10.72 758 89728 263387 63135149
Anti-cyclic citrullinated peptide antibody positive 143.27 10.72 5 90481 116207 63282329
Hyperhidrosis 141.46 10.72 405 90081 107431 63291105
Bursitis 135.66 10.72 212 90274 36829 63361707
Fluid retention 121.37 10.72 265 90221 59421 63339115
Product dose omission issue 118.06 10.72 651 89835 233662 63164874
Migraine 112.88 10.72 364 90122 102982 63295554
Upper respiratory tract infection 111.34 10.72 312 90174 81735 63316801
Rash erythematous 106.81 10.72 206 90280 42304 63356232
Rheumatoid factor positive 106.30 10.72 3 90483 84403 63314133
Wound 104.46 10.72 51 90435 163212 63235324
Hypotension 100.58 10.72 699 89787 271905 63126631
Lower respiratory tract infection 99.94 10.72 32 90454 132275 63266261
Drug hypersensitivity 98.31 10.72 768 89718 309919 63088617
Therapeutic product effect decreased 89.46 10.72 86 90400 193101 63205435
Blepharospasm 87.89 10.72 71 90415 5925 63392611
Pulmonary malformation 85.45 10.72 27 90459 272 63398264
Intentional product misuse 83.96 10.72 233 90253 60684 63337852
Respiratory depression 79.57 10.72 98 90388 13617 63384919
Anxiety 77.36 10.72 553 89933 216988 63181548
Arthropathy 77.31 10.72 135 90351 234657 63163879
Alopecia 75.90 10.72 238 90248 337298 63061238
Asthma 75.63 10.72 371 90115 127190 63271346
Psoriasis 75.58 10.72 284 90202 86673 63311863
Poisoning 74.86 10.72 95 90391 13605 63384931
Cardiac arrest 74.51 10.72 295 90191 92250 63306286
Decorticate posture 72.55 10.72 24 90462 283 63398253
Muscle injury 70.72 10.72 6 90480 65339 63333197
Taste disorder 67.28 10.72 90 90396 13572 63384964
Hyponatraemia 67.06 10.72 38 90448 111862 63286674
Headache 66.74 10.72 1269 89217 631972 62766564
Memory impairment 65.97 10.72 309 90177 103949 63294587
Neutropenia 65.80 10.72 92 90394 174913 63223623
Discomfort 63.92 10.72 87 90399 167287 63231249
Folliculitis 62.79 10.72 12 90474 70305 63328231
C-reactive protein increased 58.43 10.72 31 90455 94676 63303860
Abdominal discomfort 58.42 10.72 247 90239 320638 63077898
Lung cyst 58.40 10.72 21 90465 323 63398213
Respiratory tract malformation 57.54 10.72 18 90468 175 63398361
Drug ineffective 56.78 10.72 1100 89386 1043665 62354871
General physical health deterioration 56.62 10.72 127 90359 201275 63197261
Exposure during pregnancy 56.28 10.72 84 90402 155463 63243073
Febrile neutropenia 55.66 10.72 52 90434 118397 63280139
Liver injury 50.62 10.72 12 90474 60508 63338028
Impaired healing 48.20 10.72 45 90441 102497 63296039
Joint swelling 47.65 10.72 273 90213 327393 63071143
Blister 46.09 10.72 71 90415 129743 63268793
Swelling 45.88 10.72 219 90267 275159 63123377
Anaemia 45.66 10.72 239 90247 293191 63105345
Leukopenia 45.23 10.72 27 90459 77263 63321273
Gastrointestinal disorder 44.50 10.72 74 90412 131165 63267371
Acute kidney injury 44.16 10.72 209 90277 263206 63135330
Contraindicated product administered 43.74 10.72 161 90325 217487 63181049
Alanine aminotransferase increased 43.72 10.72 50 90436 103720 63294816
Cardiac failure 43.23 10.72 38 90448 89104 63309432
Spinal operation 43.06 10.72 56 90430 8215 63390321
Cryopyrin associated periodic syndrome 43.02 10.72 17 90469 343 63398193
Post-traumatic neck syndrome 42.48 10.72 30 90456 2044 63396492
Myocardial depression 40.70 10.72 18 90468 486 63398050
Pancytopenia 40.52 10.72 47 90439 96886 63301650
Suspected suicide 39.83 10.72 48 90438 6520 63392016
Muscle spasms 37.26 10.72 363 90123 155787 63242749
Overdose 37.13 10.72 286 90200 114792 63283744
Stomatitis 36.95 10.72 90 90396 138635 63259901
Bronchitis 36.76 10.72 304 90182 124631 63273905
Depression 36.75 10.72 435 90051 196057 63202479
Pyrexia 36.68 10.72 462 90024 470016 62928520
Hyperkalaemia 36.08 10.72 16 90470 54187 63344349
Infusion related reaction 35.96 10.72 204 90282 245317 63153219
Hypoaesthesia 35.20 10.72 381 90105 168012 63230524
Neck pain 35.09 10.72 193 90293 69125 63329411
Lactation disorder 34.99 10.72 15 90471 375 63398161
Electrocardiogram QT prolonged 34.54 10.72 21 90465 59509 63339027
Malignant neoplasm progression 34.13 10.72 40 90446 82081 63316455
Hostility 33.61 10.72 25 90461 1847 63396689
Libido increased 33.61 10.72 22 90464 1323 63397213
Aspartate aminotransferase increased 33.37 10.72 48 90438 90229 63308307
Confusional state 33.23 10.72 199 90287 236181 63162355
Multiple drug therapy 33.20 10.72 33 90453 3613 63394923
Intervertebral disc protrusion 32.96 10.72 91 90395 23618 63374918
Renal impairment 32.64 10.72 47 90439 88308 63310228
Type 2 diabetes mellitus 32.47 10.72 26 90460 63842 63334694
Fibromyalgia 32.43 10.72 211 90275 80209 63318327
Soft tissue injury 31.78 10.72 23 90463 1629 63396907
Surgery 31.77 10.72 118 90368 35794 63362742
Exposure via ingestion 31.56 10.72 29 90457 2880 63395656
Stress 31.35 10.72 183 90303 66984 63331552
Irritable bowel syndrome 31.28 10.72 43 90443 82369 63316167
Hyperaesthesia 30.75 10.72 51 90435 9307 63389229
Foot fracture 30.53 10.72 89 90397 23825 63374711
Blood creatinine increased 30.26 10.72 49 90437 87795 63310741
Gamma-glutamyltransferase increased 29.97 10.72 6 90480 34025 63364511
Pre-existing condition improved 29.91 10.72 47 90439 8197 63390339
Drug-induced liver injury 29.88 10.72 10 90476 40212 63358324
Dysphoria 29.64 10.72 36 90450 4930 63393606
Treatment failure 29.35 10.72 165 90321 198878 63199658
International normalised ratio increased 28.92 10.72 15 90471 46410 63352126
Concussion 28.54 10.72 49 90437 9195 63389341
Gastrooesophageal reflux disease 28.28 10.72 233 90253 95406 63303130
Poor sucking reflex 27.99 10.72 12 90474 300 63398236
Therapy cessation 27.72 10.72 101 90385 30356 63368180
Decreased appetite 27.61 10.72 227 90259 250825 63147711
Sternal fracture 27.48 10.72 24 90462 2230 63396306
Unresponsive to stimuli 27.36 10.72 108 90378 33708 63364828
Therapy interrupted 27.35 10.72 105 90381 32350 63366186
Erythema 27.30 10.72 376 90110 175375 63223161
Rash 26.59 10.72 603 89883 560268 62838268
Drug intolerance 26.35 10.72 297 90189 308364 63090172
Pleural effusion 25.99 10.72 59 90427 93151 63305385
Back disorder 25.98 10.72 52 90434 10965 63387571
Thrombocytopenia 25.86 10.72 119 90367 151038 63247498
Vascular malformation 25.72 10.72 12 90474 368 63398168
Hypokalaemia 25.59 10.72 70 90416 103734 63294802
Off label use 25.13 10.72 751 89735 673711 62724825
Paranasal cyst 24.94 10.72 12 90474 395 63398141
Bedridden 24.68 10.72 51 90435 11000 63387536
Bone marrow failure 24.11 10.72 6 90480 29284 63369252
Emotional distress 23.99 10.72 101 90385 32448 63366088
Toxic epidermal necrolysis 23.31 10.72 4 90482 25330 63373206
Exposure via breast milk 23.28 10.72 21 90465 2036 63396500
Hepatic function abnormal 23.14 10.72 12 90474 37130 63361406
Infection 23.07 10.72 212 90274 228961 63169575
Therapy non-responder 22.86 10.72 46 90440 75855 63322681
Gluten sensitivity 22.84 10.72 13 90473 607 63397929
Blood lactate dehydrogenase increased 22.76 10.72 3 90483 23113 63375423
Mucosal inflammation 22.75 10.72 20 90466 46908 63351628
Drug resistance 22.53 10.72 3 90483 22930 63375606
Irritability 22.32 10.72 97 90389 31597 63366939
Jaundice 22.21 10.72 7 90479 29244 63369292
Middle insomnia 22.21 10.72 53 90433 12590 63385946
Dental restoration failure 21.91 10.72 15 90471 972 63397564
Interstitial lung disease 21.83 10.72 34 90452 61874 63336662
Urinary incontinence 21.80 10.72 97 90389 31917 63366619
Pulmonary fibrosis 21.79 10.72 15 90471 39794 63358742
Blood bilirubin increased 21.69 10.72 13 90473 37127 63361409
Feeling abnormal 21.25 10.72 313 90173 148079 63250457
Blood alkaline phosphatase increased 21.21 10.72 18 90468 42949 63355587
Atrial fibrillation 21.04 10.72 90 90396 116546 63281990
Meniscus injury 21.04 10.72 37 90449 7077 63391459
Ankylosing spondylitis 20.70 10.72 46 90440 10428 63388108
Dermatitis atopic 20.70 10.72 44 90442 9680 63388856
Abortion spontaneous 20.69 10.72 22 90464 47173 63351363
Multiple sclerosis 20.66 10.72 79 90407 24293 63374243
Liver disorder 20.38 10.72 28 90458 53659 63344877
Dyspnoea 20.23 10.72 755 89731 660558 62737978
Lactic acidosis 20.21 10.72 15 90471 38272 63360264
Drug eruption 19.85 10.72 8 90478 28686 63369850
Paraesthesia 19.77 10.72 324 90162 156642 63241894
Serum sickness-like reaction 19.61 10.72 11 90475 499 63398037
Device expulsion 19.33 10.72 13 90473 34909 63363627
Agranulocytosis 19.11 10.72 6 90480 25128 63373408
Ascites 18.98 10.72 18 90468 40710 63357826
Hip arthroplasty 18.96 10.72 24 90462 47622 63350914
Rib fracture 18.95 10.72 73 90413 22524 63376012
Neck injury 18.95 10.72 19 90467 2102 63396434
Knee arthroplasty 18.89 10.72 30 90456 54176 63344360
Ill-defined disorder 18.78 10.72 57 90429 81698 63316838
Mastoiditis 18.74 10.72 14 90472 1041 63397495
Panic attack 18.61 10.72 72 90414 22259 63376277
Premature delivery 18.54 10.72 10 90476 30271 63368265
Product use issue 18.10 10.72 214 90272 220306 63178230
Neutrophil count decreased 18.02 10.72 33 90453 56373 63342163
Maternal exposure during breast feeding 17.98 10.72 26 90460 4215 63394321
Fear of disease 17.89 10.72 15 90471 1319 63397217
Nasal discharge discolouration 17.87 10.72 19 90467 2252 63396284
Oedema peripheral 17.50 10.72 179 90307 189332 63209204
Suicidal ideation 17.35 10.72 150 90336 62271 63336265
Somnolence 17.31 10.72 354 90132 178331 63220205
Platelet count decreased 17.24 10.72 96 90390 116026 63282510
Disease progression 16.89 10.72 104 90382 122654 63275882
Opiates positive 16.70 10.72 9 90477 377 63398159
Lymphatic system neoplasm 16.63 10.72 5 90481 42 63398494
Uterine perforation 16.58 10.72 33 90453 6930 63391606
Tubulointerstitial nephritis 16.53 10.72 4 90482 19899 63378637
Liver function test abnormal 16.48 10.72 27 90459 48154 63350382
Withdrawal syndrome 16.28 10.72 64 90422 19933 63378603
Infrequent bowel movements 16.15 10.72 14 90472 1288 63397248
Blood cholesterol increased 16.09 10.72 74 90412 93958 63304578
Hypothyroidism 16.06 10.72 110 90376 42522 63356014
Muscle strain 15.97 10.72 36 90450 8238 63390298
Hypoglycaemia 15.96 10.72 39 90447 60026 63338510
Multiple sclerosis relapse 15.91 10.72 121 90365 48357 63350179
Melaena 15.89 10.72 12 90474 30353 63368183
Myalgia 15.78 10.72 295 90191 146234 63252302
Sepsis 15.68 10.72 141 90345 152982 63245554
Fracture pain 15.66 10.72 11 90475 743 63397793
Stevens-Johnson syndrome 15.63 10.72 8 90478 24942 63373594
Poor quality sleep 15.59 10.72 63 90423 19872 63378664
Circulatory collapse 15.37 10.72 6 90480 21932 63376604
Nightmare 15.28 10.72 61 90425 19133 63379403
Muscle twitching 15.25 10.72 62 90424 19606 63378930
Electrocardiogram QRS complex prolonged 15.18 10.72 29 90457 5909 63392627
Peritonitis 15.16 10.72 3 90483 17151 63381385
Rash maculo-papular 14.98 10.72 14 90472 31882 63366654
Cholestasis 14.94 10.72 12 90474 29422 63369114
Epilepsy 14.81 10.72 77 90409 26988 63371548
Hypocalcaemia 14.80 10.72 14 90472 31699 63366837
Illness 14.75 10.72 120 90366 48939 63349597
Catheter site bruise 14.69 10.72 9 90477 482 63398054
Seasonal allergy 14.66 10.72 64 90422 20886 63377650
Myelodysplastic syndrome 14.66 10.72 3 90483 16751 63381785
Insomnia 14.60 10.72 406 90080 214846 63183690
Cardiac failure congestive 14.51 10.72 75 90411 92358 63306178
Hepatotoxicity 14.38 10.72 19 90467 37022 63361514
Hot flush 14.25 10.72 123 90363 51036 63347500
Thyrotoxic crisis 14.19 10.72 11 90475 865 63397671
Intervertebral disc degeneration 14.17 10.72 52 90434 15680 63382856
Obstructive airways disorder 13.95 10.72 6 90480 20693 63377843
Drug withdrawal syndrome 13.94 10.72 76 90410 27118 63371418
Toxicologic test abnormal 13.78 10.72 10 90476 711 63397825
Foetal exposure timing unspecified 13.69 10.72 7 90479 263 63398273
Cholecystitis chronic 13.65 10.72 39 90447 10322 63388214
Ankle fracture 13.62 10.72 56 90430 17799 63380737
Transaminases increased 13.33 10.72 15 90471 31352 63367184
Lower limb fracture 13.31 10.72 69 90417 24152 63374384
Personality disorder 13.19 10.72 27 90459 5784 63392752
Medication error 13.08 10.72 35 90451 52249 63346287
Lip dry 13.07 10.72 3 90483 15467 63383069
Neurotoxicity 13.01 10.72 4 90482 16986 63381550
Muscle neoplasm 12.96 10.72 4 90482 37 63398499
Acute hepatic failure 12.86 10.72 5 90481 18322 63380214
Rheumatoid arthritis 12.82 10.72 462 90024 253357 63145179
Ejection fraction decreased 12.78 10.72 8 90478 22324 63376212
Gallbladder neoplasm 12.78 10.72 4 90482 39 63398497
Respiratory acidosis 12.72 10.72 29 90457 6686 63391850
Lower respiratory tract congestion 12.69 10.72 18 90468 2868 63395668
Gastrointestinal haemorrhage 12.66 10.72 66 90420 81110 63317426
Amphetamines positive 12.51 10.72 6 90480 196 63398340
Spinal cord neoplasm 12.47 10.72 7 90479 318 63398218
Pelvic pain 12.44 10.72 45 90441 13474 63385062
Haematemesis 12.43 10.72 15 90471 30397 63368139
Choroid melanoma 12.34 10.72 4 90482 44 63398492
Vitamin B6 deficiency 12.34 10.72 5 90481 108 63398428
Basal cell carcinoma 12.32 10.72 13 90473 27978 63370558
Injection site mass 12.31 10.72 56 90430 18600 63379936
Anhedonia 12.28 10.72 39 90447 10935 63387601
Pregnancy 12.26 10.72 21 90465 36815 63361721
Congenital cystic lung 12.26 10.72 4 90482 45 63398491
Tooth abscess 12.26 10.72 48 90438 14921 63383615
Tenderness 12.19 10.72 64 90422 22514 63376022
Injection site pain 12.19 10.72 256 90230 129544 63268992
Disseminated intravascular coagulation 12.10 10.72 6 90480 19045 63379491
Anaphylactic shock 12.09 10.72 66 90420 23567 63374969
Sleep apnoea syndrome 12.08 10.72 77 90409 29056 63369480
Drug interaction 12.08 10.72 242 90244 228889 63169647
Multiple organ dysfunction syndrome 12.04 10.72 41 90445 56711 63341825
Upper gastrointestinal haemorrhage 11.88 10.72 6 90480 18846 63379690
Spinal disorder 11.83 10.72 36 90450 9866 63388670
Poor venous access 11.78 10.72 47 90439 14738 63383798
Prescribed underdose 11.76 10.72 15 90471 29674 63368862
Rotator cuff syndrome 11.64 10.72 44 90442 13458 63385078
Liver function test increased 11.58 10.72 18 90468 32793 63365743
Drug reaction with eosinophilia and systemic symptoms 11.53 10.72 19 90467 33817 63364719
Lymphopenia 11.30 10.72 6 90480 18321 63380215
Exposure via inhalation 11.28 10.72 4 90482 59 63398477
Bladder discomfort 11.28 10.72 9 90477 738 63397798
Hepatic failure 11.26 10.72 21 90465 35635 63362901
Condition aggravated 11.21 10.72 464 90022 401753 62996783
Fatigue 11.15 10.72 1436 89050 886592 62511944
Prescribed overdose 11.07 10.72 85 90401 34068 63364468
Pruritus 10.93 10.72 413 90073 361040 63037496
Cardiogenic shock 10.86 10.72 6 90480 17926 63380610
Electric shock sensation 10.85 10.72 9 90477 779 63397757
Proteinuria 10.77 10.72 7 90479 19138 63379398
Body height increased 10.76 10.72 4 90482 68 63398468

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 580.81 13.00 508 23969 97660 34834794
Drug abuse 264.86 13.00 336 24141 98760 34833694
Toxicity to various agents 239.54 13.00 469 24008 199893 34732561
Respiratory arrest 108.09 13.00 115 24362 27928 34904526
Cardio-respiratory arrest 63.97 13.00 128 24349 55145 34877309
Back pain 61.26 13.00 206 24271 121583 34810871
Milk-alkali syndrome 57.52 13.00 20 24457 585 34931869
Product dose omission issue 56.29 13.00 198 24279 119513 34812941
General physical health deterioration 49.91 13.00 14 24463 128255 34804199
Intentional product misuse 46.17 13.00 100 24377 45511 34886943
Back disorder 42.30 13.00 36 24441 6615 34925839
Multiple organ dysfunction syndrome 42.02 13.00 3 24474 76563 34855891
Spinal operation 39.46 13.00 25 24452 2919 34929535
Cardiac arrest 39.25 13.00 152 24325 96007 34836447
Pain 36.09 13.00 256 24221 204419 34728035
Suspected suicide 32.89 13.00 27 24450 4721 34927733
Lymphocyte count abnormal 32.02 13.00 16 24461 1182 34931272
Interstitial lung disease 32.00 13.00 4 24473 65278 34867176
Asthma-chronic obstructive pulmonary disease overlap syndrome 30.93 13.00 16 24461 1271 34931183
Bronchial hyperreactivity 29.31 13.00 17 24460 1692 34930762
C-reactive protein increased 27.30 13.00 3 24474 54095 34878359
Leukopenia 26.09 13.00 6 24471 62850 34869604
Back injury 25.96 13.00 22 24455 4019 34928435
Serotonin syndrome 25.27 13.00 48 24429 19885 34912569
Drug hypersensitivity 24.87 13.00 117 24360 80412 34852042
Overdose 24.35 13.00 127 24350 90932 34841522
Spinal fracture 24.13 13.00 28 24449 7470 34924984
Anaemia 22.97 13.00 85 24392 233250 34699204
Thrombocytopenia 22.77 13.00 47 24430 156200 34776254
Death 22.44 13.00 397 24080 397652 34534802
Product communication issue 22.21 13.00 9 24468 405 34932049
Arthralgia 21.39 13.00 197 24280 169844 34762610
Hyponatraemia 21.36 13.00 16 24461 82675 34849779
Exposure via ingestion 20.80 13.00 15 24462 2166 34930288
Pulmonary function test abnormal 20.55 13.00 16 24461 2594 34929860
Muscle spasms 20.32 13.00 105 24372 74896 34857558
Poisoning 20.10 13.00 33 24444 12193 34920261
Ankylosing spondylitis 19.86 13.00 22 24455 5582 34926872
Cardiac failure 19.56 13.00 21 24456 91227 34841227
Peripheral swelling 19.26 13.00 105 24372 76436 34856018
Respiratory failure 19.12 13.00 29 24448 108543 34823911
Anion gap 18.63 13.00 10 24467 857 34931597
Neck pain 18.53 13.00 49 24428 25300 34907154
Product use in unapproved indication 18.28 13.00 34 24443 117465 34814989
Ascites 18.25 13.00 5 24472 46566 34885888
Pain in extremity 18.20 13.00 151 24326 126362 34806092
Feeling abnormal 17.46 13.00 89 24388 63146 34869308
Hepatic function abnormal 16.94 13.00 5 24472 44358 34888096
Postoperative delirium 16.84 13.00 6 24471 189 34932265
Off label use 16.28 13.00 202 24275 419322 34513132
Blood creatinine increased 16.12 13.00 26 24451 94950 34837504
Vasoplegia syndrome 15.98 13.00 12 24465 1844 34930610
Metabolic alkalosis 15.88 13.00 11 24466 1490 34930964
Psoriasis 15.52 13.00 61 24416 38751 34893703
Melaena 15.45 13.00 3 24474 35377 34897077
Intervertebral disc protrusion 15.20 13.00 26 24451 9930 34922524
Pyrexia 15.01 13.00 155 24322 332858 34599596
Ischaemic cardiomyopathy 14.43 13.00 20 24457 6369 34926085
Tremor 14.33 13.00 103 24374 82484 34849970
Unresponsive to stimuli 14.14 13.00 47 24430 27522 34904932
Irritable bowel syndrome 14.13 13.00 15 24462 3628 34928826
Renal impairment 14.12 13.00 28 24449 94485 34837969
Febrile neutropenia 14.00 13.00 49 24428 136800 34795654
Accidental poisoning 13.93 13.00 8 24469 782 34931672
Painful ejaculation 13.66 13.00 4 24473 66 34932388
Neutropenia 13.58 13.00 60 24417 156718 34775736
Respiratory depression 13.53 13.00 33 24444 16212 34916242
Insomnia 13.35 13.00 121 24356 103786 34828668
Adverse drug reaction 13.29 13.00 48 24429 29294 34903160
Anion gap abnormal 13.12 13.00 5 24472 191 34932263

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 1599.16 11.07 1690 91754 244077 79406867
Toxicity to various agents 944.44 11.07 1733 91711 419807 79231137
Sedation complication 671.28 11.07 340 93104 15329 79635615
Drug abuse 631.71 11.07 862 92582 161829 79489115
Creatinine renal clearance decreased 606.87 11.07 339 93105 18663 79632281
Sedation 556.95 11.07 472 92972 51423 79599521
Blood calcium decreased 467.10 11.07 348 93096 31471 79619473
Orthostatic hypotension 434.25 11.07 425 93019 55739 79595205
Cognitive disorder 430.23 11.07 468 92976 69458 79581486
Balance disorder 383.60 11.07 524 92920 98333 79552611
Temperature regulation disorder 360.42 11.07 163 93281 5690 79645254
Constipation 349.06 11.07 917 92527 282133 79368811
Depressed level of consciousness 324.27 11.07 478 92966 96174 79554770
Pain 309.44 11.07 1631 91813 702171 78948773
Food allergy 278.87 11.07 168 93276 10656 79640288
Coeliac disease 261.40 11.07 164 93280 11187 79639757
Respiratory arrest 252.33 11.07 324 93120 57226 79593718
Cardio-respiratory arrest 211.86 11.07 422 93022 108088 79542856
Immunodeficiency 211.18 11.07 187 93257 21581 79629363
Mobility decreased 207.89 11.07 449 92995 121726 79529218
Back pain 179.66 11.07 769 92675 303411 79347533
Fall 159.07 11.07 1046 92398 486583 79164361
Bursitis 157.39 11.07 202 93242 35642 79615302
Intentional product misuse 128.03 11.07 319 93125 94846 79556098
Migraine 123.77 11.07 299 93145 87194 79563750
Fluid retention 120.32 11.07 258 93186 69551 79581393
Product dose omission issue 115.92 11.07 585 92859 246952 79403992
Drug hypersensitivity 110.20 11.07 662 92782 298254 79352690
Upper respiratory tract infection 109.63 11.07 293 93151 90875 79560069
Cardiac arrest 100.59 11.07 434 93010 171662 79479282
Hand deformity 94.85 11.07 7 93437 103912 79547032
General physical health deterioration 92.30 11.07 112 93332 275126 79375818
Rash erythematous 92.17 11.07 207 93237 57562 79593382
Neutropenia 90.36 11.07 123 93321 287587 79363357
Hyperhidrosis 90.03 11.07 384 93060 151108 79499836
Pericarditis 89.74 11.07 9 93435 104227 79546717
Acute kidney injury 88.63 11.07 312 93132 519092 79131852
Hyponatraemia 88.60 11.07 49 93395 177799 79473145
Synovitis 85.08 11.07 35 93409 150699 79500245
Poisoning 84.67 11.07 125 93319 25147 79625797
Asthma 83.04 11.07 346 93098 134749 79516195
Febrile neutropenia 82.86 11.07 89 93355 230910 79420034
Headache 82.40 11.07 1146 92298 652626 78998318
Anaemia 80.88 11.07 260 93184 444755 79206189
Decorticate posture 74.62 11.07 24 93420 318 79650626
C-reactive protein increased 72.75 11.07 30 93414 128997 79521947
Pulmonary malformation 70.47 11.07 21 93423 212 79650732
Systemic lupus erythematosus 68.58 11.07 28 93416 121121 79529823
Cardiac failure 67.09 11.07 50 93394 154792 79496152
Lower respiratory tract infection 65.23 11.07 35 93409 129185 79521759
Glossodynia 65.13 11.07 20 93424 103317 79547627
Psoriasis 63.53 11.07 240 93204 89347 79561597
Pyrexia 62.32 11.07 503 92941 678206 78972738
Blepharospasm 60.22 11.07 52 93392 5799 79645145
Leukopenia 59.63 11.07 31 93413 116482 79534462
Respiratory depression 59.41 11.07 112 93332 27518 79623426
Thrombocytopenia 58.53 11.07 141 93303 265118 79385826
Suspected suicide 58.48 11.07 67 93377 10509 79640435
Overdose 57.91 11.07 392 93052 183814 79467130
Hypotension 57.85 11.07 778 92666 439539 79211405
Spinal operation 57.60 11.07 58 93386 7859 79643085
Renal impairment 55.23 11.07 62 93382 157721 79493223
Interstitial lung disease 53.26 11.07 33 93411 112567 79538377
Maternal exposure during pregnancy 53.08 11.07 49 93395 136489 79514455
Anxiety 51.78 11.07 481 92963 248031 79402913
Lung cyst 51.46 11.07 18 93426 313 79650631
Blood creatinine increased 50.99 11.07 64 93380 154993 79495951
Malignant neoplasm progression 50.31 11.07 51 93393 135939 79515005
Memory impairment 50.07 11.07 261 93183 111473 79539471
Alanine aminotransferase increased 49.50 11.07 71 93373 162499 79488445
Neck pain 49.36 11.07 197 93247 75220 79575724
Multiple organ dysfunction syndrome 48.12 11.07 42 93402 120204 79530740
Rheumatoid arthritis 47.78 11.07 412 93032 208058 79442886
Exposure via ingestion 47.31 11.07 43 93401 5131 79645813
Pancytopenia 46.99 11.07 76 93368 165669 79485275
Taste disorder 46.98 11.07 74 93370 15749 79635195
Hepatic function abnormal 46.33 11.07 14 93430 73093 79577851
Fibromyalgia 46.13 11.07 173 93271 64167 79586777
Wound 45.98 11.07 41 93403 116138 79534806
Back disorder 45.79 11.07 62 93382 11516 79639428
Post-traumatic neck syndrome 45.08 11.07 29 93415 2065 79648879
Drug interaction 44.63 11.07 294 93150 414889 79236055
Cryopyrin associated periodic syndrome 44.56 11.07 17 93427 382 79650562
Hepatocellular injury 44.02 11.07 3 93441 47590 79603354
Gamma-glutamyltransferase increased 43.88 11.07 6 93438 54674 79596270
Off label use 43.26 11.07 776 92668 906439 78744505
Myocardial depression 43.26 11.07 18 93426 511 79650433
Respiratory tract malformation 41.21 11.07 12 93432 111 79650833
Ascites 40.33 11.07 19 93425 75543 79575401
Hyperaesthesia 38.86 11.07 59 93385 12163 79638781
International normalised ratio increased 38.47 11.07 26 93418 84695 79566249
Electrocardiogram QT prolonged 38.10 11.07 30 93414 90356 79560588
Melaena 37.98 11.07 12 93432 60878 79590066
Bone marrow failure 37.88 11.07 7 93437 51100 79599844
Decreased appetite 37.53 11.07 241 93203 342177 79308767
Muscle injury 37.42 11.07 6 93438 48555 79602389
Hypoaesthesia 37.26 11.07 347 93097 179005 79471939
Platelet count decreased 37.23 11.07 111 93333 194553 79456391
Bronchitis 36.93 11.07 271 93173 130373 79520571
Lactation disorder 36.80 11.07 13 93431 233 79650711
Concussion 36.24 11.07 50 93394 9453 79641491
Aspartate aminotransferase increased 36.16 11.07 67 93377 138574 79512370
Poor sucking reflex 35.82 11.07 11 93433 124 79650820
Multiple drug therapy 35.55 11.07 33 93411 4045 79646899
Toxic epidermal necrolysis 35.52 11.07 5 93439 44576 79606368
Unresponsive to stimuli 35.13 11.07 144 93300 55644 79595300
Soft tissue injury 34.28 11.07 23 93421 1758 79649186
Lactic acidosis 34.14 11.07 20 93424 70339 79580605
Sepsis 34.11 11.07 181 93263 269247 79381697
Therapy cessation 33.88 11.07 109 93335 37453 79613491
Intervertebral disc protrusion 33.67 11.07 81 93363 23540 79627404
Hostility 33.29 11.07 25 93419 2285 79648659
Therapeutic product effect decreased 33.12 11.07 91 93353 163772 79487172
Pleural effusion 32.98 11.07 76 93368 145186 79505758
Fatigue 32.64 11.07 1365 92079 928362 78722582
Surgery 32.24 11.07 98 93346 32668 79618276
Blood lactate dehydrogenase increased 32.15 11.07 4 93440 39166 79611778
Gastrointestinal disorder 31.92 11.07 59 93385 122146 79528798
Libido increased 31.86 11.07 23 93421 1978 79648966
Milk-alkali syndrome 31.40 11.07 20 93424 1400 79649544
Hypoglycaemia 31.28 11.07 44 93400 101550 79549394
Sternal fracture 31.27 11.07 25 93419 2505 79648439
Cholestasis 31.22 11.07 11 93433 52098 79598846
Drug eruption 30.53 11.07 7 93437 43928 79607016
Cardiogenic shock 30.51 11.07 6 93438 41908 79609036
Drug-induced liver injury 30.41 11.07 20 93424 66097 79584847
Death 30.19 11.07 873 92571 565641 79085303
Hyperkalaemia 30.09 11.07 55 93389 114343 79536601
Hypokalaemia 29.85 11.07 79 93365 143961 79506983
Cytomegalovirus infection 29.22 11.07 7 93437 42637 79608307
Tubulointerstitial nephritis 28.85 11.07 5 93439 38230 79612714
Drug resistance 28.79 11.07 7 93437 42206 79608738
Rash maculo-papular 28.57 11.07 15 93429 56063 79594881
Stomatitis 28.55 11.07 83 93361 146674 79504270
Blood alkaline phosphatase increased 28.29 11.07 20 93424 63644 79587300
Ankylosing spondylitis 28.15 11.07 51 93393 12154 79638790
Folliculitis 27.94 11.07 15 93429 55365 79595579
Blood bilirubin increased 27.89 11.07 22 93422 66210 79584734
Atrial fibrillation 27.88 11.07 128 93316 197758 79453186
Agranulocytosis 27.86 11.07 9 93435 45021 79605923
Liver injury 27.60 11.07 16 93428 56598 79594346
Jaundice 27.58 11.07 14 93430 53335 79597609
Depression 27.55 11.07 381 93063 216409 79434535
Pneumocystis jirovecii pneumonia 27.48 11.07 3 93441 32505 79618439
Vascular malformation 27.44 11.07 12 93432 386 79650558
Exposure via breast milk 27.06 11.07 16 93428 980 79649964
Muscle spasms 26.82 11.07 318 93126 174412 79476532
Gluten sensitivity 26.74 11.07 12 93432 411 79650533
Erythema 26.61 11.07 388 93056 222902 79428042
Circulatory collapse 26.17 11.07 6 93438 37662 79613282
Impaired healing 25.97 11.07 39 93405 87616 79563328
Hypocalcaemia 25.96 11.07 13 93431 49911 79601033
Paranasal cyst 25.90 11.07 12 93432 443 79650501
Neutrophil count decreased 25.77 11.07 44 93400 93915 79557029
Foot fracture 25.75 11.07 70 93374 21911 79629033
Neck injury 25.21 11.07 23 93421 2758 79648186
Serotonin syndrome 25.08 11.07 112 93332 44915 79606029
Feeling abnormal 25.00 11.07 291 93153 158908 79492036
Meniscus injury 24.90 11.07 35 93409 6733 79644211
Gastrooesophageal reflux disease 24.37 11.07 207 93237 104039 79546905
Hepatotoxicity 24.35 11.07 15 93429 51337 79599607
Disease progression 23.80 11.07 123 93321 184239 79466705
Uterine perforation 23.79 11.07 33 93411 6270 79644674
Emotional distress 23.47 11.07 101 93343 39868 79611076
Maternal exposure during breast feeding 23.25 11.07 22 93422 2763 79648181
Respiratory failure 22.63 11.07 122 93322 180789 79470155
Oedema peripheral 22.59 11.07 188 93256 252100 79398844
Disseminated intravascular coagulation 22.46 11.07 7 93437 35835 79615109
Prescribed overdose 22.45 11.07 96 93348 37787 79613157
Stress 22.41 11.07 165 93279 79447 79571497
Pre-existing condition improved 22.32 11.07 30 93414 5533 79645411
Multiple sclerosis 22.26 11.07 67 93377 22215 79628729
Electrocardiogram QRS complex prolonged 22.16 11.07 43 93401 10790 79640154
Dental restoration failure 22.11 11.07 14 93430 970 79649974
Injection site pain 22.04 11.07 241 93203 129597 79521347
Therapy non-responder 22.01 11.07 47 93397 92258 79558686
Confusional state 21.75 11.07 253 93191 317744 79333200
Withdrawal syndrome 21.62 11.07 75 93369 26779 79624165
Fear of disease 20.92 11.07 15 93429 1277 79649667
Foetal exposure timing unspecified 20.65 11.07 6 93438 55 79650889
Pneumonia aspiration 20.62 11.07 29 93415 66938 79584006
Back injury 20.60 11.07 41 93403 10482 79640462
Acute hepatic failure 20.52 11.07 5 93439 30108 79620836
Hepatic failure 20.39 11.07 25 93419 61187 79589757
Infection 20.36 11.07 183 93261 241529 79409415
Dyspnoea 20.34 11.07 810 92634 856215 78794729
Intervertebral disc degeneration 20.25 11.07 52 93392 15733 79635211
Bedridden 20.06 11.07 44 93400 12035 79638909
Septic shock 20.05 11.07 75 93369 122726 79528218
Therapy interrupted 19.81 11.07 81 93363 31260 79619684
Transaminases increased 19.59 11.07 19 93425 51724 79599220
Serum sickness-like reaction 19.37 11.07 11 93433 624 79650320
Nasal discharge discolouration 19.32 11.07 19 93425 2502 79648442
Arthropathy 19.20 11.07 125 93319 176986 79473958
Painful ejaculation 18.96 11.07 4 93440 7 79650937
Rhinorrhoea 18.82 11.07 153 93291 75921 79575023
Personality disorder 18.60 11.07 29 93415 6117 79644827
Application site burn 18.55 11.07 12 93432 863 79650081
Dysphoria 18.19 11.07 25 93419 4709 79646235
Bronchial hyperreactivity 18.07 11.07 20 93424 3020 79647924
Fracture pain 17.87 11.07 11 93433 725 79650219
Haematemesis 17.78 11.07 21 93423 52243 79598701
Cerebral haemorrhage 17.73 11.07 25 93419 57648 79593296
Gastrointestinal haemorrhage 17.71 11.07 101 93343 147618 79503326
Lymphopenia 17.39 11.07 7 93437 30550 79620394
Muscle strain 17.25 11.07 36 93408 9519 79641425
Blood creatine phosphokinase increased 17.17 11.07 32 93412 66058 79584886
Liver disorder 17.16 11.07 37 93407 72380 79578564
Upper gastrointestinal haemorrhage 17.10 11.07 14 93430 41366 79609578
Renal failure 16.99 11.07 152 93292 200816 79450128
Liver function test abnormal 16.95 11.07 31 93413 64444 79586500
Pulmonary fibrosis 16.93 11.07 16 93428 44096 79606848
Catheter site bruise 16.91 11.07 9 93435 449 79650495
Mucosal inflammation 16.78 11.07 40 93404 75540 79575404
Cardiac failure congestive 16.73 11.07 98 93346 142304 79508640
Rib fracture 16.70 11.07 71 93373 27876 79623068
Middle insomnia 16.70 11.07 49 93395 16020 79634924
Ischaemic stroke 16.67 11.07 9 93435 33122 79617822
Bronchopulmonary aspergillosis 16.63 11.07 3 93441 22291 79628653
Foetal death 16.54 11.07 32 93412 8012 79642932
Stevens-Johnson syndrome 16.50 11.07 13 93431 39153 79611791
Polyneuropathy 16.48 11.07 4 93440 24147 79626797
Panic attack 16.44 11.07 64 93380 24152 79626792
Syncope 16.39 11.07 133 93311 179316 79471628
Pneumonia 16.29 11.07 621 92823 659625 78991319
Lower limb fracture 16.29 11.07 62 93382 23153 79627791
Haemoglobin decreased 16.25 11.07 174 93270 221945 79428999
Proteinuria 16.11 11.07 9 93435 32493 79618451
Lung disorder 16.07 11.07 45 93399 80512 79570432
Myocarditis 16.05 11.07 3 93441 21730 79629214
Lymphatic system neoplasm 16.00 11.07 5 93439 60 79650884
Cerebral infarction 15.91 11.07 18 93426 45658 79605286
Application site perspiration 15.86 11.07 4 93440 20 79650924
Hyperglycaemia 15.80 11.07 37 93407 70298 79580646
Allodynia 15.67 11.07 14 93430 1634 79649310
Road traffic accident 15.59 11.07 96 93348 43568 79607376
Tremor 15.57 11.07 283 93161 169800 79481144
Spinal disorder 15.51 11.07 36 93408 10224 79640720
Sinusitis 15.42 11.07 318 93126 195183 79455761
Poor quality sleep 15.38 11.07 60 93384 22662 79628282
Mastoiditis 15.26 11.07 14 93430 1690 79649254
Pain in extremity 15.26 11.07 546 92898 363992 79286952
Cholecystitis chronic 15.24 11.07 35 93409 9871 79641073
Peritonitis 15.03 11.07 7 93437 28029 79622915
Basal cell carcinoma 15.01 11.07 13 93431 37362 79613582
Extrapyramidal disorder 15.00 11.07 4 93440 22675 79628269
Dermatitis atopic 14.89 11.07 35 93409 10021 79640923
Opiates positive 14.77 11.07 11 93433 993 79649951
Throat irritation 14.60 11.07 90 93354 40856 79610088
Drug ineffective 14.34 11.07 1082 92362 1079831 78571113
Injection site mass 14.24 11.07 54 93390 20130 79630814
Insomnia 14.18 11.07 382 93062 244788 79406156
Myelodysplastic syndrome 14.16 11.07 9 93435 30292 79620652
Osteonecrosis of jaw 14.04 11.07 18 93426 43208 79607736
Abdominal discomfort 14.00 11.07 208 93236 250519 79400425
Hot flush 13.91 11.07 111 93333 54766 79596178
Asthma-chronic obstructive pulmonary disease overlap syndrome 13.89 11.07 18 93426 3203 79647741
Thrombosis 13.76 11.07 155 93289 83945 79566999
Altered state of consciousness 13.47 11.07 19 93425 43803 79607141
Discomfort 13.44 11.07 89 93355 125528 79525416
Arthralgia 13.42 11.07 808 92636 570995 79079949
Rash 13.38 11.07 548 92896 577810 79073134
Anuria 13.31 11.07 4 93440 20959 79629985
Injury 13.22 11.07 144 93300 77352 79573592
Product prescribing error 13.21 11.07 20 93424 44793 79606151
Blister 13.11 11.07 84 93360 119392 79531552
Catheter site pain 13.02 11.07 23 93421 5373 79645571
Paraesthesia 12.99 11.07 284 93160 176039 79474905
Type 2 diabetes mellitus 12.87 11.07 30 93414 57092 79593852
Urinary incontinence 12.80 11.07 87 93357 40822 79610122
Rotator cuff syndrome 12.80 11.07 41 93403 14054 79636890
Exposure during pregnancy 12.75 11.07 68 93376 101064 79549880
Cytokine release syndrome 12.75 11.07 14 93430 35984 79614960
Ejection fraction decreased 12.74 11.07 13 93431 34564 79616380
Myocardial ischaemia 12.74 11.07 7 93437 25512 79625432
Hypophagia 12.66 11.07 21 93423 45346 79605598
Seasonal allergy 12.50 11.07 45 93399 16361 79634583
Thyrotoxic crisis 12.39 11.07 11 93433 1273 79649671
Skin necrosis 12.33 11.07 3 93441 18084 79632860
Status epilepticus 12.31 11.07 7 93437 25034 79625910
Muscle neoplasm 12.30 11.07 4 93440 55 79650889
Illness 12.30 11.07 95 93349 46416 79604528
Lower respiratory tract congestion 12.29 11.07 19 93425 3978 79646966
Irritable bowel syndrome 12.24 11.07 35 93409 62206 79588738
Neurotoxicity 12.24 11.07 12 93432 32506 79618438
Pelvic pain 12.22 11.07 39 93405 13342 79637602
Rectal haemorrhage 12.19 11.07 47 93397 76253 79574691
Aggression 12.10 11.07 26 93418 50932 79600012
Insurance issue 12.03 11.07 23 93421 5710 79645234
Product communication issue 12.03 11.07 10 93434 1059 79649885
Irritability 11.99 11.07 86 93358 41058 79609886
Nightmare 11.99 11.07 61 93383 25800 79625144
Tooth abscess 11.96 11.07 44 93400 16166 79634778
Major depression 11.96 11.07 30 93414 8950 79641994
Haematuria 11.93 11.07 41 93403 68795 79582149
Choroid melanoma 11.92 11.07 4 93440 61 79650883
Priapism 11.92 11.07 20 93424 4485 79646459
Toxicologic test abnormal 11.85 11.07 11 93433 1349 79649595
Medication error 11.81 11.07 41 93403 68601 79582343
Multiple sclerosis relapse 11.73 11.07 94 93350 46439 79604505
Prostate cancer 11.71 11.07 13 93431 33255 79617689
Ankle fracture 11.64 11.07 45 93399 16924 79634020
Vaginal infection 11.62 11.07 23 93421 5857 79645087
Poor venous access 11.54 11.07 47 93397 18102 79632842
Pallor 11.51 11.07 26 93418 50036 79600908
Blood urea increased 11.50 11.07 25 93419 48765 79602179
Oropharyngeal pain 11.47 11.07 186 93258 109167 79541777
Sinus headache 11.43 11.07 21 93423 5059 79645885
Gait disturbance 11.34 11.07 321 93123 207185 79443759
Bradycardia 11.24 11.07 103 93341 135454 79515490
Hyperthyroidism 11.22 11.07 6 93438 22203 79628741
Muscle twitching 11.19 11.07 58 93386 24706 79626238
Ligament sprain 11.18 11.07 38 93406 13426 79637518
Hypomagnesaemia 11.09 11.07 24 93420 46887 79604057

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 D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35473 tranquilizing drugs
CHEBI has role CHEBI:51371 muscle relaxants
FDA PE N0000175730 Centrally-mediated Muscle Relaxation
FDA EPC N0000175737 Muscle Relaxant

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
15MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 7544372 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
15MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 7829121 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
15MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 8877245 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
15MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 9375410 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
15MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 9399025 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
30MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 7544372 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
30MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 7829121 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
30MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 8877245 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
30MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 9375410 Nov. 14, 2023 RELIEF OF MUSCLE SPASM
30MG AMRIX TEVA PHARMS INTL N021777 Feb. 1, 2007 RX CAPSULE, EXTENDED RELEASE ORAL 9399025 Nov. 14, 2023 RELIEF OF MUSCLE SPASM

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.54 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.73 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 6.97 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Ki 7.44 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
5-hydroxytryptamine receptor 2B GPCR Ki 6.81 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
4017956 VANDF
4019699 VANDF
C0056732 UMLSCUI
CHEBI:3996 CHEBI
CHEMBL669 ChEMBL_ID
DB00924 DRUGBANK_ID
CHEMBL1200636 ChEMBL_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

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 0093-1920 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA authorized generic 30 sections
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 0093-1921 CAPSULE, EXTENDED RELEASE 30 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 0115-1436 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 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 0591-3256 TABLET, FILM COATED 5 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-3330 TABLET, FILM COATED 7.50 mg ORAL ANDA 20 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0591-5658 TABLET, FILM COATED 10 mg ORAL ANDA 20 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 0615-8084 TABLET, FILM COATED 10 mg ORAL ANDA 21 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8182 TABLET, FILM COATED 5 mg ORAL ANDA 14 sections
Cyclobenzaprine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7809 TABLET, FILM COATED 10 mg ORAL ANDA 20 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