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

Stem definitionDrug idCAS RN
serotonin (5-HT1) receptor agonists, sumatriptan derivatives 2543 103628-46-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • GR43175
  • GR 43175
  • sumatriptan
  • sumatriptan succinate
A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.
  • Molecular weight: 295.40
  • Formula: C14H21N3O2S
  • CLOGP: 0.74
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 65.20
  • ALOGS: -3.37
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg N
50 mg O
6 mg P
25 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 21.40 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 22 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.68 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 14 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 19 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.83 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 28, 1992 FDA GLAXOSMITHKLINE

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
Product physical issue 4071.35 11.48 911 48705 4069 63435337
Product dose omission issue 1058.50 11.48 1097 48519 233216 63206190
Application site erythema 566.34 11.48 192 49424 4643 63434763
Migraine 536.74 11.48 523 49093 102823 63336583
Product quality issue 495.46 11.48 323 49293 35542 63403864
Application site burn 379.03 11.48 95 49521 739 63438667
Device deployment issue 334.96 11.48 123 49493 3779 63435627
Application site pain 326.65 11.48 123 49493 4059 63435347
Device malfunction 323.01 11.48 191 49425 17666 63421740
Application site discolouration 263.85 11.48 71 49545 750 63438656
Device issue 254.41 11.48 183 49433 23598 63415808
Application site paraesthesia 195.20 11.48 36 49580 39 63439367
Accidental exposure to product 151.98 11.48 144 49472 27261 63412145
Application site urticaria 139.91 11.48 34 49582 229 63439177
Application site rash 133.94 11.48 56 49560 2442 63436964
Medication overuse headache 133.73 11.48 42 49574 790 63438616
Headache 126.46 11.48 886 48730 632355 62807051
Application site irritation 124.18 11.48 48 49568 1702 63437704
Arteriospasm coronary 120.89 11.48 60 49556 3908 63435498
Colitis ischaemic 115.86 11.48 83 49533 10625 63428781
Application site warmth 113.22 11.48 27 49589 166 63439240
Application site pruritus 111.86 11.48 57 49559 3927 63435479
Coronary artery dissection 103.95 11.48 35 49581 827 63438579
Glossodynia 100.99 11.48 11 49605 178865 63260541
Anxiety 96.91 11.48 381 49235 217160 63222246
Systemic lupus erythematosus 93.45 11.48 24 49592 208894 63230512
Arthropathy 89.08 11.48 36 49580 234756 63204650
Serotonin syndrome 89.07 11.48 111 49505 28571 63410835
Injection site pain 88.31 11.48 262 49354 129538 63309868
Wound 85.03 11.48 13 49603 163250 63276156
Application site scar 83.48 11.48 22 49594 213 63439193
Needle issue 82.63 11.48 67 49549 10309 63429097
Contraindicated product administered 81.54 11.48 34 49582 217614 63221792
Death 81.37 11.48 104 49512 374277 63065129
Application site vesicles 79.73 11.48 33 49583 1402 63438004
Injection site haemorrhage 78.57 11.48 96 49520 24218 63415188
Infusion related reaction 76.19 11.48 49 49567 245472 63193934
Product complaint 74.25 11.48 69 49547 12740 63426666
Throat tightness 73.60 11.48 94 49522 24793 63414613
Application site swelling 71.80 11.48 24 49592 554 63438852
Reversible cerebral vasoconstriction syndrome 71.65 11.48 37 49579 2621 63436785
Drug ineffective 70.53 11.48 1175 48441 1043590 62395816
Product substitution issue 70.13 11.48 74 49542 15922 63423484
Depression 69.54 11.48 321 49295 196171 63243235
Wrong technique in product usage process 68.64 11.48 151 49465 62189 63377217
IIIrd nerve paresis 68.07 11.48 17 49599 130 63439276
Paraesthesia 66.70 11.48 271 49345 156695 63282711
Endometriosis 66.35 11.48 45 49571 5275 63434131
Treatment failure 64.13 11.48 38 49578 199005 63240401
Device power source issue 63.68 11.48 22 49594 563 63438843
Emotional distress 62.39 11.48 100 49516 32449 63406957
Acute kidney injury 61.62 11.48 69 49547 263346 63176060
Joint swelling 61.35 11.48 101 49515 327565 63111841
Cerebral vasoconstriction 61.16 11.48 26 49590 1182 63438224
Abdominal discomfort 59.99 11.48 99 49517 320786 63118620
Muscle twitching 59.29 11.48 75 49541 19593 63419813
Anaemia 58.20 11.48 87 49529 293343 63146063
Chest discomfort 55.86 11.48 201 49415 109768 63329638
Lower respiratory tract infection 55.78 11.48 17 49599 132290 63307116
Application site dryness 55.77 11.48 15 49601 158 63439248
Application site reaction 54.74 11.48 21 49595 729 63438677
Cholecystitis chronic 54.69 11.48 53 49563 10308 63429098
Swelling 54.27 11.48 82 49534 275296 63164110
Concussion 53.97 11.48 50 49566 9194 63430212
Rheumatoid arthritis 53.55 11.48 72 49544 253747 63185659
Application site exfoliation 53.04 11.48 18 49598 436 63438970
Injection site bruising 52.48 11.48 107 49509 41803 63397603
Product leakage 52.41 11.48 21 49595 820 63438586
Hepatic enzyme increased 51.83 11.48 49 49567 202279 63237127
Dizziness 51.69 11.48 538 49078 429387 63010019
Pituitary tumour benign 51.56 11.48 27 49589 1968 63437438
Alopecia 51.07 11.48 118 49498 337418 63101988
Post-traumatic neck syndrome 50.58 11.48 27 49589 2047 63437359
Incorrect dose administered by device 50.03 11.48 35 49581 4313 63435093
Application site scab 49.37 11.48 14 49602 182 63439224
Somnambulism 48.86 11.48 38 49578 5505 63433901
Clonus 48.02 11.48 35 49581 4601 63434805
Feeling abnormal 47.80 11.48 236 49380 148156 63291250
Hostility 47.43 11.48 25 49591 1847 63437559
Renal infarct 47.42 11.48 23 49593 1424 63437982
Drug specific antibody 47.37 11.48 27 49589 2328 63437078
Febrile neutropenia 46.81 11.48 17 49599 118432 63320974
Cardiac failure 46.62 11.48 7 49609 89135 63350271
Libido increased 45.96 11.48 22 49594 1323 63438083
Neutropenia 45.27 11.48 42 49574 174963 63264443
Expired product administered 45.22 11.48 38 49578 6143 63433263
Disease progression 44.63 11.48 20 49596 122738 63316668
Device leakage 44.59 11.48 40 49576 7056 63432350
Soft tissue injury 44.54 11.48 23 49593 1629 63437777
Stress cardiomyopathy 43.72 11.48 45 49571 9405 63430001
Synovitis 43.65 11.48 49 49567 186869 63252537
Folliculitis 43.26 11.48 3 49613 70314 63369092
General physical health deterioration 42.60 11.48 57 49559 201345 63238061
Incorrect route of product administration 41.61 11.48 76 49540 27376 63412030
Suicidal ideation 41.46 11.48 125 49491 62296 63377110
Peripheral swelling 40.18 11.48 93 49523 265849 63173557
Application site inflammation 39.92 11.48 14 49602 375 63439031
Swollen tongue 39.09 11.48 85 49531 34715 63404691
Application site bruise 38.22 11.48 13 49603 317 63439089
Off label use 37.94 11.48 341 49275 674121 62765285
Sternal fracture 37.86 11.48 23 49593 2231 63437175
Pre-existing condition improved 37.68 11.48 39 49577 8205 63431201
Product use issue 37.60 11.48 72 49544 220448 63218958
Vasospasm 37.25 11.48 16 49600 746 63438660
Nausea 36.33 11.48 898 48718 853573 62585833
Angle closure glaucoma 35.63 11.48 22 49594 2197 63437209
Nightmare 35.46 11.48 58 49558 19136 63420270
Hot flush 35.45 11.48 104 49512 51055 63388351
Atrial fibrillation 33.85 11.48 25 49591 116611 63322795
Impaired healing 33.83 11.48 19 49597 102523 63336883
Pancytopenia 33.39 11.48 17 49599 96916 63342490
Secondary adrenocortical insufficiency 33.17 11.48 18 49598 1410 63437996
Renal impairment 32.74 11.48 14 49602 88341 63351065
Therapeutic response unexpected 32.40 11.48 55 49561 18704 63420702
Haemoglobin decreased 31.96 11.48 40 49576 145445 63293961
Tremor 31.61 11.48 194 49422 132045 63307361
Infection 31.59 11.48 84 49532 229089 63210317
Hyponatraemia 31.18 11.48 25 49591 111875 63327531
Muscle tightness 30.63 11.48 42 49574 11858 63427548
Diarrhoea 29.27 11.48 389 49227 714977 62724429
Rash 29.17 11.48 289 49327 560582 62878824
Pharyngeal swelling 28.74 11.48 30 49586 6374 63433032
Neonatal respiratory distress 28.62 11.48 11 49605 384 63439022
Hyperprolactinaemia 28.58 11.48 24 49592 3876 63435530
Application site discomfort 28.54 11.48 11 49605 387 63439019
Hypotension 28.49 11.48 113 49503 272491 63166915
Pneumonia 28.29 11.48 225 49391 456542 62982864
Tension headache 28.26 11.48 27 49589 5159 63434247
Chest pain 28.15 11.48 275 49341 215684 63223722
Interstitial lung disease 27.87 11.48 7 49609 61901 63377505
Application site erosion 27.86 11.48 9 49607 186 63439220
Dysgeusia 27.75 11.48 90 49526 46620 63392786
Renal tubular acidosis 27.74 11.48 17 49599 1675 63437731
Malignant neoplasm progression 27.40 11.48 15 49601 82106 63357300
Cerebral venous thrombosis 26.96 11.48 18 49598 2056 63437350
Hip arthroplasty 26.69 11.48 3 49613 47643 63391763
Hyperkalaemia 26.69 11.48 5 49611 54198 63385208
Stomatitis 26.63 11.48 42 49574 138683 63300723
Blood creatinine increased 26.58 11.48 18 49598 87826 63351580
Transient global amnesia 26.19 11.48 12 49604 653 63438753
Vision blurred 25.97 11.48 141 49475 91783 63347623
Cluster headache 25.66 11.48 12 49604 685 63438721
Eyelid ptosis 25.62 11.48 30 49586 7237 63432169
Narcolepsy 25.59 11.48 15 49601 1363 63438043
Drug-disease interaction 25.53 11.48 11 49605 517 63438889
Device defective 25.43 11.48 17 49599 1945 63437461
Platelet count decreased 25.43 11.48 32 49584 116090 63323316
Migraine without aura 25.14 11.48 10 49606 383 63439023
Liver injury 25.10 11.48 8 49608 60512 63378894
Poor quality sleep 25.07 11.48 51 49565 19884 63419522
Pleural effusion 24.53 11.48 22 49594 93188 63346218
Photophobia 24.45 11.48 47 49569 17588 63421818
Vasoconstriction 24.25 11.48 11 49605 585 63438821
Somnolence 24.00 11.48 229 49387 178456 63260950
Nipple pain 23.83 11.48 9 49607 299 63439107
Injection site laceration 23.82 11.48 7 49609 104 63439302
Multiple sclerosis 23.46 11.48 56 49560 24316 63415090
Swelling face 23.37 11.48 105 49511 63370 63376036
C-reactive protein abnormal 23.24 11.48 4 49612 46092 63393314
Oxygen saturation decreased 23.20 11.48 21 49595 88564 63350842
Gastrointestinal haemorrhage 22.79 11.48 18 49598 81158 63358248
Sepsis 22.74 11.48 54 49562 153069 63286337
Hypoaesthesia 22.70 11.48 216 49400 168177 63271229
Discomfort 22.56 11.48 62 49554 167312 63272094
Blister 22.45 11.48 42 49574 129772 63309634
Palpitations 22.42 11.48 158 49458 112612 63326794
Muscle spasms 21.90 11.48 202 49414 155948 63283458
Red blood cell sedimentation rate increased 21.78 11.48 4 49612 43978 63395428
Hyperreflexia 21.76 11.48 25 49591 5909 63433497
Application site papules 21.60 11.48 6 49610 72 63439334
Hyperhidrosis 21.38 11.48 151 49465 107685 63331721
Septic shock 21.05 11.48 13 49603 66616 63372790
Decreased appetite 20.92 11.48 113 49503 250939 63188467
Drug hypersensitivity 20.91 11.48 350 49266 310337 63129069
Seizure 20.89 11.48 176 49440 132458 63306948
Blood testosterone increased 20.88 11.48 7 49609 163 63439243
Neck pain 20.72 11.48 108 49508 69210 63370196
Irritability 20.60 11.48 63 49553 31631 63407775
Personality disorder 20.50 11.48 24 49592 5787 63433619
Middle insomnia 20.43 11.48 36 49580 12607 63426799
Thrombocytopenia 20.37 11.48 56 49560 151101 63288305
Migraine with aura 20.36 11.48 17 49599 2723 63436683
Pyrexia 20.23 11.48 253 49363 470225 62969181
Major depression 20.19 11.48 28 49588 7990 63431416
Injection site injury 20.08 11.48 10 49606 656 63438750
Dependence 19.98 11.48 15 49601 2062 63437344
Meningoradiculitis 19.84 11.48 6 49610 99 63439307
Cardiac failure congestive 19.69 11.48 26 49590 92407 63346999
Knee arthroplasty 19.43 11.48 9 49607 54197 63385209
Optic ischaemic neuropathy 19.33 11.48 12 49604 1210 63438196
Large intestinal ulcer haemorrhage 19.25 11.48 6 49610 110 63439296
Product adhesion issue 19.22 11.48 21 49595 4698 63434708
Post-traumatic stress disorder 19.05 11.48 22 49594 5229 63434177
Sleep talking 18.91 11.48 11 49605 985 63438421
Phonophobia 18.89 11.48 8 49608 360 63439046
Spleen congestion 18.81 11.48 6 49610 119 63439287
Basilar migraine 18.74 11.48 5 49611 51 63439355
Renal failure 18.68 11.48 40 49576 117612 63321794
Biliary dyskinesia 18.38 11.48 16 49600 2713 63436693
Plasma cell myeloma 18.36 11.48 3 49613 35902 63403504
Underdose 18.24 11.48 55 49561 27401 63412005
Sunburn 18.08 11.48 16 49600 2772 63436634
Multiple organ dysfunction syndrome 18.03 11.48 11 49605 56741 63382665
Hyperacusis 17.58 11.48 14 49602 2099 63437307
Incorrect product administration duration 17.54 11.48 32 49584 11514 63427892
Device use error 17.41 11.48 22 49594 5739 63433667
Gastrointestinal disorder 17.40 11.48 49 49567 131190 63308216
Gastrooesophageal reflux disease 17.29 11.48 131 49485 95508 63343898
Complement factor C4 decreased 17.24 11.48 7 49609 283 63439123
Drug dependence 17.17 11.48 50 49566 24433 63414973
Pharyngeal oedema 17.13 11.48 35 49581 13686 63425720
Complement factor C3 decreased 17.06 11.48 7 49609 291 63439115
Meconium in amniotic fluid 17.03 11.48 7 49609 292 63439114
Burns third degree 16.97 11.48 7 49609 295 63439111
Subclavian artery thrombosis 16.69 11.48 6 49610 173 63439233
Application site dermatitis 16.47 11.48 6 49610 180 63439226
Cough 16.38 11.48 148 49468 292595 63146811
Depressive symptom 16.27 11.48 18 49598 4084 63435322
Multiple sclerosis relapse 16.23 11.48 78 49538 48400 63391006
Paraesthesia oral 16.17 11.48 42 49574 19214 63420192
Bipolar disorder 16.00 11.48 25 49591 7935 63431471
Ischaemic cerebral infarction 15.87 11.48 11 49605 1335 63438071
Osteonecrosis of jaw 15.75 11.48 4 49612 35119 63404287
Superior sagittal sinus thrombosis 15.72 11.48 9 49607 782 63438624
Transverse sinus thrombosis 15.71 11.48 8 49608 550 63438856
Rash maculo-papular 15.58 11.48 3 49613 31893 63407513
Ill-defined disorder 15.45 11.48 25 49591 81730 63357676
Pulmonary fibrosis 15.24 11.48 6 49610 39803 63399603
Hepatotoxicity 15.17 11.48 5 49611 37036 63402370
Withdrawal syndrome 15.16 11.48 42 49574 19955 63419451
Illness 15.05 11.48 77 49539 48982 63390424
Neoplasm progression 14.78 11.48 5 49611 36423 63402983
Inflammation 14.77 11.48 26 49590 82247 63357159
International normalised ratio increased 14.74 11.48 9 49607 46416 63392990
Therapeutic product effect decreased 14.46 11.48 90 49526 193097 63246309
Burning sensation 14.39 11.48 82 49534 54325 63385081
Injury associated with device 14.39 11.48 16 49600 3650 63435756
Lichen planus 14.34 11.48 13 49603 2325 63437081
Pericardial effusion 14.32 11.48 3 49613 30055 63409351
Lactic acidosis 14.29 11.48 6 49610 38281 63401125
Peripheral nerve injury 14.27 11.48 7 49609 444 63438962
Hypotonia neonatal 14.27 11.48 10 49606 1236 63438170
Cerebral venous sinus thrombosis 14.17 11.48 12 49604 1960 63437446
Teratogenicity 14.15 11.48 6 49610 271 63439135
Potassium wasting nephropathy 14.11 11.48 4 49612 52 63439354
Nasal discomfort 14.10 11.48 18 49598 4742 63434664
Influenza like illness 14.09 11.48 95 49521 66729 63372677
Loss of personal independence in daily activities 13.90 11.48 35 49581 97255 63342151
Cholestasis 13.90 11.48 3 49613 29431 63409975
Drug ineffective for unapproved indication 13.80 11.48 58 49558 34005 63405401
Bone marrow failure 13.80 11.48 3 49613 29287 63410119
Pancreatic failure 13.75 11.48 9 49607 994 63438412
Loss of consciousness 13.74 11.48 147 49469 117974 63321432
Gallbladder disorder 13.72 11.48 39 49577 18803 63420603
Trismus 13.63 11.48 16 49600 3869 63435537
Hepatic function abnormal 13.57 11.48 6 49610 37136 63402270
Pneumonia aspiration 13.57 11.48 5 49611 34535 63404871
Psoriasis 13.48 11.48 115 49501 86842 63352564
Post viral fatigue syndrome 13.37 11.48 6 49610 311 63439095
Body temperature increased 13.30 11.48 61 49555 37131 63402275
Nasopharyngitis 13.17 11.48 131 49485 254126 63185280
Angioedema 13.15 11.48 73 49543 47892 63391514
Gallbladder injury 13.08 11.48 10 49606 1413 63437993
Toxicity to various agents 12.97 11.48 127 49489 247123 63192283
Injection site erythema 12.89 11.48 110 49506 83064 63356342
Dysphonia 12.75 11.48 72 49544 47542 63391864
Sensory disturbance 12.71 11.48 31 49585 13641 63425765
Melaena 12.61 11.48 4 49612 30361 63409045
Premature delivery 12.56 11.48 4 49612 30277 63409129
Flushing 12.54 11.48 101 49515 74986 63364420
Oedema 12.53 11.48 37 49579 97585 63341821
Arterial intramural haematoma 12.50 11.48 3 49613 19 63439387
Slow speech 12.44 11.48 10 49606 1519 63437887
Tinnitus 12.42 11.48 58 49558 35570 63403836
Meningitis aseptic 12.38 11.48 17 49599 4806 63434600
Product administration interrupted 12.34 11.48 17 49599 4819 63434587
Osteoarthritis 12.34 11.48 36 49580 95307 63344099
Memory impairment 12.24 11.48 130 49486 104128 63335278
Therapeutic response shortened 12.18 11.48 28 49588 11860 63427546
Mobility decreased 12.15 11.48 51 49565 121108 63318298
Alanine aminotransferase increased 12.15 11.48 41 49575 103729 63335677
Rib fracture 12.05 11.48 42 49574 22555 63416851
Ovarian neoplasm 12.05 11.48 8 49608 905 63438501
Deep vein thrombosis 12.04 11.48 109 49507 83691 63355715
Foetal heart rate abnormal 12.00 11.48 7 49609 630 63438776
Maternal exposure during pregnancy 11.98 11.48 112 49504 219950 63219456
Product storage error 11.92 11.48 32 49584 14924 63424482
Device difficult to use 11.88 11.48 29 49587 12767 63426639
Blood cholesterol increased 11.81 11.48 36 49580 93996 63345410
Dysmenorrhoea 11.73 11.48 15 49601 3958 63435448
Chemical burn 11.70 11.48 6 49610 419 63438987
Type 2 diabetes mellitus 11.63 11.48 20 49596 63848 63375558
Arthralgia 11.58 11.48 348 49268 569362 62870044
Drug effect less than expected 11.57 11.48 10 49606 1679 63437727
Cholelithiasis 11.48 11.48 66 49550 43859 63395547

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
Product physical issue 967.79 17.42 199 7703 2342 34946687
Product dose omission issue 243.30 17.42 207 7695 119504 34829525
Migraine 124.03 17.42 66 7836 17412 34931617
Product quality issue 122.79 17.42 65 7837 16970 34932059
Headache 91.76 17.42 163 7739 200472 34748557
Device deployment issue 91.23 17.42 18 7884 167 34948862
Arteriospasm coronary 80.91 17.42 30 7872 3352 34945677
Coronary artery dissection 60.29 17.42 14 7888 295 34948734
Device malfunction 59.18 17.42 34 7868 10387 34938642
Device issue 53.13 17.42 31 7871 9746 34939283
Throat tightness 52.14 17.42 29 7873 8329 34940700
Serotonin syndrome 51.93 17.42 40 7862 19893 34929136
Medication overuse headache 47.45 17.42 10 7892 132 34948897
IIIrd nerve paresis 43.89 17.42 9 7893 103 34948926
Hyperhidrosis 39.01 17.42 65 7837 75627 34873402
Accidental exposure to product 38.48 17.42 28 7874 12774 34936255
Brugada syndrome 34.36 17.42 11 7891 790 34948239
Cluster headache 33.72 17.42 10 7892 556 34948473
Injection site pain 32.45 17.42 42 7860 38963 34910066
Application site pain 31.72 17.42 13 7889 1895 34947134
Myofascial pain syndrome 28.43 17.42 8 7894 369 34948660
Xanthelasma 27.45 17.42 6 7896 95 34948934
Application site burn 27.43 17.42 7 7895 221 34948808
Foetal exposure during pregnancy 27.07 17.42 38 7864 38063 34910966
Acute kidney injury 26.94 17.42 18 7884 304970 34644059
Anophthalmos 26.81 17.42 4 7898 4 34949025
Drug ineffective 26.57 17.42 185 7717 456566 34492463
Congenital genital malformation male 25.19 17.42 4 7898 8 34949021
Gastrointestinal tract irritation 25.13 17.42 7 7895 311 34948718
Needle issue 24.46 17.42 16 7886 6149 34942880
Craniosynostosis 23.89 17.42 7 7895 373 34948656
Foetal malnutrition 23.52 17.42 5 7897 69 34948960
Death 23.09 17.42 34 7868 398015 34551014
Autonomic dysreflexia 23.07 17.42 5 7897 76 34948953
Chest pain 22.19 17.42 71 7831 126691 34822338
Electrocardiogram ST segment elevation 21.78 17.42 14 7888 5224 34943805
Capillaritis 20.99 17.42 5 7897 118 34948911
Anaemia 20.27 17.42 14 7888 233321 34715708
Muscle tightness 20.17 17.42 13 7889 4871 34944158
Application site erythema 19.95 17.42 10 7892 2326 34946703
Chest discomfort 19.46 17.42 40 7862 54490 34894539
Paraesthesia 19.39 17.42 44 7858 64128 34884901
Aphasia 19.25 17.42 24 7878 21430 34927599
Tobacco abuse 18.62 17.42 6 7896 440 34948589
Irritable bowel syndrome 18.34 17.42 11 7891 3632 34945397
Facial pain 18.17 17.42 11 7891 3693 34945336
Oromandibular dystonia 17.94 17.42 6 7896 495 34948534
Injection site haemorrhage 17.91 17.42 16 7886 9752 34939277
Cleft lip and palate 17.88 17.42 7 7895 905 34948124
Pityriasis lichenoides et varioliformis acuta 17.79 17.42 3 7899 10 34949019
Renal failure 17.56 17.42 4 7898 130553 34818476
Acute myocardial infarction 17.54 17.42 38 7864 53681 34895348

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
Product physical issue 1313.30 11.71 329 42716 3856 79697487
Migraine 557.66 11.71 425 42620 87068 79614275
Application site erythema 404.92 11.71 138 42907 4972 79696371
Product dose omission issue 339.91 11.71 533 42512 247004 79454339
Application site burn 285.44 11.71 71 42974 804 79700539
Application site pain 236.52 11.71 91 42954 4656 79696687
Product quality issue 231.79 11.71 172 42873 33768 79667575
Headache 195.28 11.71 782 42263 652990 79048353
Application site discolouration 188.92 11.71 51 42994 813 79700530
Arteriospasm coronary 186.86 11.71 85 42960 6631 79694712
Application site paraesthesia 182.88 11.71 32 43013 40 79701303
Device malfunction 179.39 11.71 123 42922 21325 79680018
Coronary artery dissection 157.26 11.71 47 42998 1097 79700246
Accidental exposure to product 148.16 11.71 128 42917 31194 79670149
Medication overuse headache 145.26 11.71 42 43003 870 79700473
Throat tightness 117.94 11.71 107 42938 27800 79673543
Serotonin syndrome 117.50 11.71 133 42912 44894 79656449
IIIrd nerve paresis 116.96 11.71 26 43019 172 79701171
Acute kidney injury 111.00 11.71 72 42973 519332 79182011
Colitis ischaemic 109.70 11.71 80 42965 15279 79686064
Anxiety 102.56 11.71 331 42714 248181 79453162
Application site pruritus 102.15 11.71 47 42998 3763 79697580
Application site irritation 99.80 11.71 37 43008 1707 79699636
Application site warmth 99.20 11.71 23 43022 188 79701155
Device deployment issue 96.82 11.71 43 43002 3169 79698174
Application site urticaria 90.38 11.71 22 43023 226 79701117
Application site rash 89.11 11.71 36 43009 2096 79699247
Death 86.90 11.71 107 42938 566407 79134936
Reversible cerebral vasoconstriction syndrome 86.01 11.71 39 43006 3018 79698325
Endometriosis 85.25 11.71 41 43004 3627 79697716
Paraesthesia 84.00 11.71 247 42798 176076 79525267
Wrong technique in product usage process 80.90 11.71 144 42901 73731 79627612
Anaemia 79.40 11.71 74 42971 444941 79256402
Device issue 77.48 11.71 84 42961 27024 79674319
Depression 77.28 11.71 275 42770 216515 79484828
Emotional distress 73.48 11.71 99 42946 39870 79661473
Application site swelling 70.24 11.71 23 43022 730 79700613
Application site scar 69.37 11.71 17 43028 180 79701163
Cerebral vasoconstriction 69.04 11.71 27 43018 1443 79699900
Dizziness 67.81 11.71 501 42544 525940 79175403
Chest discomfort 67.28 11.71 195 42850 137849 79563494
Drug ineffective 65.71 11.71 879 42166 1080034 78621309
Cardiac failure 61.85 11.71 6 43039 154836 79546507
Injection site pain 59.07 11.71 179 42866 129659 79571684
Muscle twitching 57.65 11.71 69 42976 24695 79676648
Pituitary tumour benign 57.47 11.71 28 43017 2548 79698795
Post-traumatic neck syndrome 56.66 11.71 26 43019 2068 79699275
Febrile neutropenia 56.49 11.71 27 43018 230972 79470371
Incorrect route of product administration 55.97 11.71 81 42964 34848 79666495
Application site vesicles 55.69 11.71 23 43022 1417 79699926
Concussion 53.57 11.71 43 43002 9460 79691883
Neutropenia 52.26 11.71 47 42998 287663 79413680
Cholecystitis chronic 52.00 11.71 43 43002 9863 79691480
Drug specific antibody 51.05 11.71 26 43019 2602 79698741
Soft tissue injury 50.99 11.71 23 43022 1758 79699585
Hot flush 50.13 11.71 99 42946 54778 79646565
Stress cardiomyopathy 49.51 11.71 44 43001 11122 79690221
Cluster headache 49.28 11.71 19 43026 977 79700366
Chest pain 49.21 11.71 290 42755 282014 79419329
Disease progression 49.13 11.71 19 43026 184343 79517000
Hostility 48.23 11.71 24 43021 2286 79699057
Injection site haemorrhage 48.16 11.71 67 42978 27803 79673540
Clonus 47.42 11.71 35 43010 6805 79694538
Sepsis 46.60 11.71 46 42999 269382 79431961
Nausea 46.43 11.71 749 42296 956447 78744896
Muscle tightness 45.91 11.71 45 43000 12869 79688474
Libido increased 45.39 11.71 22 43023 1979 79699364
Feeling abnormal 45.23 11.71 188 42857 159011 79542332
Renal infarct 44.77 11.71 24 43021 2667 79698676
Pericarditis 44.50 11.71 3 43042 104233 79597110
Swollen tongue 44.07 11.71 81 42964 42489 79658854
Sternal fracture 43.32 11.71 23 43022 2507 79698836
Renal failure 42.63 11.71 28 43017 200940 79500403
Pneumonia 42.31 11.71 198 42847 660048 79041295
Application site dryness 42.28 11.71 12 43033 232 79701111
Vision blurred 41.75 11.71 139 42906 105759 79595584
Product substitution issue 41.61 11.71 53 42992 20203 79681140
Infusion related reaction 41.34 11.71 38 43007 230199 79471144
Pancytopenia 41.09 11.71 19 43026 165726 79535617
Renal impairment 40.83 11.71 17 43028 157766 79543577
Application site exfoliation 40.60 11.71 14 43031 522 79700821
Hyponatraemia 40.20 11.71 23 43022 177825 79523518
Treatment failure 40.06 11.71 21 43024 170465 79530878
Injection site bruising 39.93 11.71 76 42969 40926 79660417
Hyperkalaemia 39.55 11.71 7 43038 114391 79586952
Device power source issue 39.35 11.71 16 43029 947 79700396
Hypoaesthesia 39.17 11.71 196 42849 179156 79522187
Interstitial lung disease 38.68 11.71 7 43038 112593 79588750
Thrombocytopenia 38.61 11.71 52 42993 265207 79436136
Multiple organ dysfunction syndrome 38.16 11.71 9 43036 120237 79581106
Suicidal ideation 37.32 11.71 108 42937 76232 79625111
Angle closure glaucoma 37.19 11.71 22 43023 2954 79698389
Vasospasm 36.83 11.71 16 43029 1118 79700225
Glossodynia 36.43 11.71 6 43039 103331 79598012
Wound 36.27 11.71 9 43036 116170 79585173
Hyperhidrosis 35.55 11.71 169 42876 151323 79550020
Platelet count decreased 35.09 11.71 32 43013 194632 79506711
Swelling face 35.06 11.71 101 42944 71111 79630232
Application site inflammation 34.43 11.71 12 43033 462 79700881
Hypotension 33.81 11.71 123 42922 440194 79261149
Septic shock 32.14 11.71 13 43032 122788 79578555
Lower respiratory tract infection 31.73 11.71 15 43030 129205 79572138
Atrial fibrillation 31.72 11.71 36 43009 197850 79503493
Expired product administered 31.69 11.71 28 43017 7023 79694320
Pharyngeal swelling 31.44 11.71 29 43016 7690 79693653
Tension headache 31.15 11.71 28 43017 7183 79694160
Photophobia 30.57 11.71 46 42999 20482 79680861
Hyperprolactinaemia 30.35 11.71 23 43022 4653 79696690
Malignant neoplasm progression 30.14 11.71 18 43027 135972 79565371
Application site scab 30.03 11.71 9 43036 212 79701131
Pleural effusion 29.78 11.71 21 43024 145241 79556102
Palpitations 29.52 11.71 141 42904 126469 79574874
Gastrointestinal haemorrhage 29.45 11.71 22 43023 147697 79553646
Haemoglobin decreased 28.94 11.71 47 42998 222072 79479271
Hepatic function abnormal 28.75 11.71 3 43042 73104 79628239
Application site reaction 28.68 11.71 12 43033 764 79700579
Off label use 28.57 11.71 333 42712 906882 78794461
Blood creatinine increased 28.53 11.71 25 43020 155032 79546311
Drug hypersensitivity 28.46 11.71 266 42779 298650 79402693
Application site bruise 28.42 11.71 9 43036 256 79701087
Cerebral venous thrombosis 28.39 11.71 18 43027 2735 79698608
Subclavian artery thrombosis 27.94 11.71 6 43039 33 79701310
Tremor 27.86 11.71 172 42873 169911 79531432
General physical health deterioration 27.50 11.71 68 42977 275170 79426173
Systemic lupus erythematosus 26.90 11.71 16 43029 121133 79580210
Secondary adrenocortical insufficiency 26.90 11.71 18 43027 2996 79698347
Pain 26.64 11.71 530 42515 703272 78998071
Nightmare 26.50 11.71 49 42996 25812 79675531
Pharyngeal oedema 26.45 11.71 38 43007 16234 79685109
Pyrexia 26.33 11.71 237 42808 678472 79022871
Somnambulism 26.28 11.71 23 43022 5698 79695645
Product adhesion issue 26.20 11.71 17 43028 2687 79698656
Transient global amnesia 26.05 11.71 12 43033 963 79700380
Vasoconstriction 26.02 11.71 11 43034 719 79700624
Temperature intolerance 25.87 11.71 29 43016 9676 79691667
Respiratory failure 25.77 11.71 36 43009 180875 79520468
Hyperreflexia 25.75 11.71 27 43018 8358 79692985
Arthropathy 25.48 11.71 35 43010 177076 79524267
Application site discomfort 25.29 11.71 9 43036 369 79700974
Personality disorder 24.86 11.71 23 43022 6123 79695220
Incorrect dose administered by device 24.83 11.71 21 43024 4968 79696375
Therapeutic response unexpected 24.60 11.71 41 43004 19905 79681438
Electrocardiogram ST segment elevation 23.96 11.71 26 43019 8371 79692972
Middle insomnia 23.92 11.71 36 43009 16033 79685310
Cardiac failure congestive 23.82 11.71 25 43020 142377 79558966
Contraindicated product administered 23.82 11.71 30 43015 157508 79543835
Decreased appetite 23.49 11.71 100 42945 342318 79359025
Migraine without aura 23.31 11.71 8 43037 294 79701049
Poor quality sleep 23.22 11.71 43 43002 22679 79678664
Drug dependence 23.22 11.71 61 42984 40708 79660635
Injury 23.16 11.71 93 42952 77403 79623940
Product leakage 23.02 11.71 11 43034 959 79700384
Product complaint 22.92 11.71 32 43013 13317 79688026
Pre-existing condition improved 22.85 11.71 21 43024 5542 79695801
Muscle spasms 22.79 11.71 167 42878 174563 79526780
Phonophobia 22.56 11.71 9 43036 507 79700836
Body temperature increased 21.86 11.71 63 42982 44357 79656986
Impaired healing 21.79 11.71 10 43035 87645 79613698
Renal tubular acidosis 21.76 11.71 17 43028 3597 79697746
Infection 21.66 11.71 63 42982 241649 79459694
Device leakage 21.66 11.71 28 43017 10828 79690515
Blood pressure systolic increased 21.28 11.71 5 43040 66981 79634362
Loss of consciousness 21.04 11.71 159 42886 167784 79533559
Meconium in amniotic fluid 20.90 11.71 6 43039 121 79701222
Head discomfort 20.89 11.71 32 43013 14470 79686873
Irritability 20.87 11.71 59 42986 41085 79660258
Hepatic enzyme increased 20.78 11.71 42 43003 182568 79518775
Dysgeusia 20.73 11.71 73 42972 57104 79644239
Neck pain 20.57 11.71 88 42957 75329 79626014
Withdrawal syndrome 20.48 11.71 45 43000 26809 79674534
Brugada syndrome 20.48 11.71 11 43034 1227 79700116
Gallbladder disorder 20.27 11.71 37 43008 19303 79682040
Myofascial pain syndrome 20.21 11.71 13 43032 2024 79699319
Burns third degree 20.01 11.71 8 43037 453 79700890
Burning sensation 19.68 11.71 73 42972 58559 79642784
Flushing 19.63 11.71 97 42948 88171 79613172
Basilar migraine 19.54 11.71 5 43040 64 79701279
Joint swelling 19.36 11.71 85 42960 288561 79412782
Epistaxis 19.30 11.71 19 43026 111496 79589847
Major depression 19.24 11.71 24 43021 8956 79692387
Post-traumatic stress disorder 19.23 11.71 18 43027 4863 79696480
Hyperacusis 19.18 11.71 13 43032 2210 79699133
Xanthelasma 19.14 11.71 6 43039 165 79701178
Migraine with aura 19.11 11.71 14 43031 2691 79698652
Blood bilirubin increased 19.05 11.71 6 43039 66226 79635117
Plasma cell myeloma 18.98 11.71 3 43042 53256 79648087
Meningoradiculitis 18.94 11.71 6 43039 171 79701172
Application site papules 18.93 11.71 5 43040 73 79701270
Device difficult to use 18.53 11.71 29 43016 13356 79687987
Complement factor C4 decreased 18.48 11.71 7 43038 343 79701000
Insomnia 18.46 11.71 208 42837 244962 79456381
Diarrhoea 18.37 11.71 350 42695 880139 78821204
Eyelid ptosis 18.26 11.71 26 43019 11018 79690325
Multiple sclerosis relapse 18.26 11.71 61 42984 46472 79654871
Rheumatoid arthritis 18.19 11.71 55 42990 208415 79492928
Dependence 18.17 11.71 13 43032 2409 79698934
Injection site erythema 18.16 11.71 87 42958 78110 79623233
Aphasia 18.11 11.71 61 42984 46671 79654672
Optic ischaemic neuropathy 17.98 11.71 14 43031 2947 79698396
Complement factor C3 decreased 17.95 11.71 7 43038 371 79700972
Foetal heart rate abnormal 17.85 11.71 7 43038 377 79700966
Ovarian neoplasm 17.72 11.71 8 43037 613 79700730
International normalised ratio increased 17.69 11.71 12 43033 84709 79616634
Memory impairment 17.67 11.71 112 42933 111622 79589721
Biliary dyskinesia 17.59 11.71 13 43032 2532 79698811
Paraesthesia oral 17.58 11.71 36 43009 20435 79680908
Nipple pain 17.52 11.71 9 43036 917 79700426
Gastrooesophageal reflux disease 17.43 11.71 106 42939 104140 79597203
Meningitis aseptic 17.28 11.71 20 43025 6908 79694435
Transverse sinus thrombosis 17.19 11.71 8 43037 657 79700686
Teratogenicity 16.88 11.71 6 43039 245 79701098
Sunburn 16.79 11.71 15 43030 3818 79697525
Tinnitus 16.41 11.71 57 42988 44276 79657067
Superior sagittal sinus thrombosis 16.35 11.71 9 43036 1054 79700289
Injection site laceration 16.29 11.71 5 43040 128 79701215
Application site erosion 16.12 11.71 6 43039 280 79701063
Peripheral coldness 16.04 11.71 30 43015 15940 79685403
Folliculitis 15.96 11.71 5 43040 55375 79645968
Bone marrow failure 15.87 11.71 4 43041 51103 79650240
Hypoglycaemia 15.72 11.71 19 43026 101575 79599768
Abortion spontaneous 15.64 11.71 43 43002 29464 79671879
Hormone level abnormal 15.61 11.71 11 43034 1991 79699352
Visual impairment 15.60 11.71 94 42951 92037 79609306
Seizure 15.50 11.71 163 42882 188671 79512672
Vertigo 15.42 11.71 76 42969 69006 79632337
Oxygen saturation decreased 15.26 11.71 29 43016 129018 79572325
Large intestinal ulcer haemorrhage 15.21 11.71 6 43039 328 79701015
Pancreatic failure 15.20 11.71 10 43035 1618 79699725
Gallbladder injury 15.19 11.71 9 43036 1212 79700131
Toxicity to various agents 15.11 11.71 150 42895 421390 79279953
Inflammation 15.08 11.71 17 43028 93736 79607607
Post viral fatigue syndrome 14.96 11.71 6 43039 343 79701000
Liver injury 14.80 11.71 6 43039 56608 79644735
Lactic acidosis 14.64 11.71 10 43035 70349 79630994
C-reactive protein abnormal 14.61 11.71 4 43041 48363 79652980
Torsade de pointes 14.32 11.71 32 43013 19280 79682063
Neoplasm progression 14.31 11.71 5 43040 51677 79649666
Cerebral venous sinus thrombosis 14.28 11.71 11 43034 2280 79699063
Asthma 14.25 11.71 123 42922 134972 79566371
Incorrect disposal of product 14.22 11.71 8 43037 977 79700366
Illness 14.04 11.71 56 42989 46455 79654888
Acute myocardial infarction 13.95 11.71 80 42965 76956 79624387
Gastrointestinal tract irritation 13.95 11.71 7 43038 679 79700664
Cytomegalovirus infection 13.91 11.71 3 43042 42641 79658702
Dysphonia 13.73 11.71 64 42981 56808 79644535
Peripheral nerve injury 13.68 11.71 7 43038 707 79700636
Pericardial effusion 13.64 11.71 4 43041 46233 79655110
Product dispensing error 13.43 11.71 25 43020 13238 79688105
Anger 13.36 11.71 29 43016 17133 79684210
Hyperglycaemia 13.35 11.71 11 43034 70324 79631019
Stomatitis 13.32 11.71 38 43007 146719 79554624
Product storage error 13.30 11.71 28 43017 16198 79685145
Ischaemic cerebral infarction 13.30 11.71 11 43034 2524 79698819
Injection site injury 13.30 11.71 7 43038 750 79700593
Aspartate aminotransferase increased 13.26 11.71 35 43010 138606 79562737
Haemorrhage 13.10 11.71 18 43027 91100 79610243
Neutrophil count decreased 13.08 11.71 19 43026 93940 79607403
Psoriasis 13.06 11.71 88 42957 89499 79611844
Mucosal inflammation 12.94 11.71 13 43032 75567 79625776
Therapeutic product effect incomplete 12.93 11.71 125 42920 141520 79559823
Injection site urticaria 12.76 11.71 24 43021 12802 79688541
Choking sensation 12.76 11.71 13 43032 3893 79697450
Product use issue 12.76 11.71 64 42981 209758 79491585
Alanine aminotransferase increased 12.72 11.71 45 43000 162525 79538818
Deep vein thrombosis 12.71 11.71 110 42935 120809 79580534
Incorrect product administration duration 12.60 11.71 23 43022 11999 79689344
Panic attack 12.55 11.71 35 43010 24181 79677162
Capillaritis 12.53 11.71 5 43040 282 79701061
Bradycardia 12.38 11.71 35 43010 135522 79565821
Lichen planus 12.38 11.71 11 43034 2780 79698563
Nasal oedema 12.35 11.71 9 43036 1715 79699628
Trismus 12.34 11.71 15 43030 5452 79695891
Multiple sclerosis 12.34 11.71 33 43012 22249 79679094
Hypomagnesaemia 12.22 11.71 5 43040 46906 79654437
Rib fracture 12.20 11.71 38 43007 27909 79673434
Facial pain 12.15 11.71 23 43022 12327 79689016
Somnolence 11.85 11.71 188 42857 238793 79462550
Red blood cell sedimentation rate increased 11.80 11.71 5 43040 45937 79655406
Abdominal discomfort 11.79 11.71 83 42962 250644 79450699
Drug-induced liver injury 11.75 11.71 11 43034 66106 79635237

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02CC01 NERVOUS SYSTEM
ANALGESICS
ANTIMIGRAINE PREPARATIONS
Selective serotonin (5HT1) agonists
CHEBI has role CHEBI:35941 serotonin agonists
FDA MoA N0000175763 Serotonin 1b Receptor Agonists
FDA MoA N0000175764 Serotonin 1d Receptor Agonists
FDA EPC N0000175765 Serotonin-1b and Serotonin-1d Receptor Agonist
MeSH PA D002317 Cardiovascular Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D058825 Serotonin 5-HT1 Receptor Agonists
MeSH PA D018490 Serotonin Agents
MeSH PA D017366 Serotonin Receptor Agonists
MeSH PA D014662 Vasoconstrictor Agents

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

DiseaseRelationSNOMED_IDDOID
Migraine indication 37796009 DOID:6364
Cluster headache syndrome indication 193031009
Tachyarrhythmia contraindication 6285003
Alcoholism contraindication 7200002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Hemiplegic migraine contraindication 59292006
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Vascular insufficiency of intestine contraindication 82196007
Epilepsy contraindication 84757009 DOID:1826
Prinzmetal angina contraindication 87343002
Kidney disease contraindication 90708001 DOID:557
Liver function tests abnormal contraindication 166603001
Angina pectoris contraindication 194828000
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Cerebral ischemia contraindication 287731003
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Serotonin syndrome contraindication 371089000
Cardiovascular event risk contraindication 395112001
Peripheral vascular disease contraindication 400047006
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002




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 11.23 acidic
pKa2 13.42 acidic
pKa3 8.28 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 8327844 Oct. 3, 2023 METHOD OF DRUG DELIVERY VIA THE NASAL CAVITY
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 7975690 Aug. 18, 2025 METHOD OF DRUG DELIVERY VIA THE NASAL CAVITY
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 8590530 Sept. 15, 2025 METHOD OF DRUG DELIVERY VIA THE NASAL CAVITY
500MG;EQ 85MG BASE TREXIMET CURRAX N021926 April 15, 2008 RX TABLET ORAL 7332183 Oct. 2, 2025 TREATMENT OF MIGRAINE
60MG;EQ 10MG BASE TREXIMET CURRAX N021926 May 14, 2015 DISCN TABLET ORAL 7332183 Oct. 2, 2025 ACUTE TREATMENT OF MIGRAINE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 11571531 Feb. 23, 2026 METHOD OF DRUG DELIVERY VIA THE NASAL CAVITY
10MG/SPRAY TOSYMRA TONIX MEDS N210884 Jan. 25, 2019 RX SPRAY NASAL 8440631 May 9, 2026 ACUTE TREATMENT OF MIGRAINE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 10124132 March 6, 2027 ACUTE TREATMENT OF MIGRAINE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 10124132 March 6, 2027 ACUTE TREATMENT OF MIGRAINE BY DELIVERING A POWDERED SUBSTANCE COMPRISING SUMATRIPTAN VIA A BREATH-POWERED DELIVERY DEVICE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 10124132 March 6, 2027 TREATMENT OF MIGRAINE VIA DELIVERY OF SUMATRIPTAN VIA THE NASAL CAVITY
EQ 6.5MG BASE/4HR ZECUITY TEVA BRANDED PHARM N202278 Jan. 17, 2013 DISCN SYSTEM IONTOPHORESIS 7973058 April 12, 2027 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
EQ 6.5MG BASE/4HR ZECUITY TEVA BRANDED PHARM N202278 Jan. 17, 2013 DISCN SYSTEM IONTOPHORESIS 8155737 April 12, 2027 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
EQ 6.5MG BASE/4HR ZECUITY TEVA BRANDED PHARM N202278 Jan. 17, 2013 DISCN SYSTEM IONTOPHORESIS 8470853 April 12, 2027 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
EQ 6.5MG BASE/4HR ZECUITY TEVA BRANDED PHARM N202278 Jan. 17, 2013 DISCN SYSTEM IONTOPHORESIS 9427578 April 12, 2027 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) ALSUMA MERIDIAN MEDCL N022377 June 29, 2010 DISCN INJECTABLE SUBCUTANEOUS 7811254 Aug. 26, 2027 ACUTE TREATMENT OF MIGRAINE ATTACKS, WITH OR WITHOUT AURA, AND THE TREATMENT OF CLUSTER HEADACHE EPISODES
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 8875704 April 7, 2028 METHOD OF DRUG DELIVERY VIA THE NASAL CAVITY
EQ 6.5MG BASE/4HR ZECUITY TEVA BRANDED PHARM N202278 Jan. 17, 2013 DISCN SYSTEM IONTOPHORESIS 8366600 April 21, 2029 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF, USING A FLOWABLE HYDROGEL FORMULATION
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 10076615 July 30, 2029 ACUTE TREATMENT OF MIGRAINE BY DELIVERING A POWDERED SUBSTANCE COMPRISING SUMATRIPTAN VIA A BREATH-POWERED DELIVERY DEVICE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 10076615 July 30, 2029 METHOD OF DELIVERING SUMATRIPTAN TO A NASAL CAVITY
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 10076615 July 30, 2029 TREATMENT OF MIGRAINE VIA DELIVERY OF SUMATRIPTAN VIA THE NASAL CAVITY
10MG/SPRAY TOSYMRA TONIX MEDS N210884 Jan. 25, 2019 RX SPRAY NASAL 10603305 June 16, 2030 ACUTE TREATMENT OF MIGRAINE
10MG/SPRAY TOSYMRA TONIX MEDS N210884 Jan. 25, 2019 RX SPRAY NASAL 11337962 June 16, 2030 ACUTE TREATMENT OF MIGRAINE
10MG/SPRAY TOSYMRA TONIX MEDS N210884 Jan. 25, 2019 RX SPRAY NASAL 9610280 June 16, 2030 ACUTE TREATMENT OF MIGRAINE
10MG/SPRAY TOSYMRA TONIX MEDS N210884 Jan. 25, 2019 RX SPRAY NASAL 9974770 June 16, 2030 ACUTE TREATMENT OF MIGRAINE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 9649456 Oct. 21, 2030 ACUTE TREATMENT OF MIGRAINE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 9649456 Oct. 21, 2030 ACUTE TREATMENT OF MIGRAINE BY DELIVERING A POWDERED SUBSTANCE COMPRISING SUMATRIPTAN VIA A BREATH-POWERED DELIVERY DEVICE
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 9649456 Oct. 21, 2030 TREATMENT OF MIGRAINE VIA DELIVERY OF SUMATRIPTAN VIA THE NASAL CAVITY
EQ 6.5MG BASE/4HR ZECUITY TEVA BRANDED PHARM N202278 Jan. 17, 2013 DISCN SYSTEM IONTOPHORESIS 8983594 Nov. 19, 2030 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
10MG/SPRAY TOSYMRA TONIX MEDS N210884 Jan. 25, 2019 RX SPRAY NASAL 9211282 July 19, 2031 ACUTE TREATMENT OF MIGRAINE
EQ 6.5MG BASE/4HR ZECUITY TEVA BRANDED PHARM N202278 Jan. 17, 2013 DISCN SYSTEM IONTOPHORESIS 9327114 Oct. 8, 2032 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
EQ 11MG BASE ONZETRA XSAIL CURRAX N206099 Jan. 27, 2016 RX POWDER NASAL 10478574 Nov. 4, 2033 METHOD OF DELIVERING SUMATRIPTAN TO A NASAL CAVITY
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) ZEMBRACE SYMTOUCH TONIX MEDS N208223 Jan. 28, 2016 RX SOLUTION SUBCUTANEOUS 10537554 Jan. 29, 2036 TREATMENT OF MIGRAINE
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) ZEMBRACE SYMTOUCH TONIX MEDS N208223 Jan. 28, 2016 RX SOLUTION SUBCUTANEOUS 11364224 Jan. 29, 2036 TREATMENT OF MIGRAINE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 1D GPCR AGONIST Ki 8.92 CHEMBL CHEMBL
5-hydroxytryptamine receptor 1B GPCR AGONIST Ki 8.26 CHEMBL CHEMBL
5-hydroxytryptamine receptor 2C GPCR IC50 8.14 CHEMBL
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 5.60 IUPHAR
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 6 IUPHAR
5-hydroxytryptamine receptor 3A Ion channel IC50 8.03 CHEMBL
5-hydroxytryptamine receptor 5A GPCR IC50 6.30 CHEMBL
5-hydroxytryptamine receptor 1F GPCR Ki 7.59 CHEMBL
5-hydroxytryptamine receptor 1E GPCR IC50 5.26 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.17 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 6.64 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 6.42 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 7.64 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 6.19 CHEMBL
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 6.60 IUPHAR
5-hydroxytryptamine receptor 1D GPCR IC50 7.70 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 6.35 CHEMBL
5-hydroxytryptamine receptor 1D GPCR IC50 7.21 CHEMBL
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 5.20 IUPHAR
5-hydroxytryptamine receptor 1B GPCR Ki 8.19 CHEMBL
5-hydroxytryptamine 1D receptor Unclassified IC50 7.23 CHEMBL
5-hydroxytryptamine receptor 5A GPCR AGONIST Ki 4.80 IUPHAR

External reference:

IDSource
4021050 VUID
N0000148514 NUI
D00451 KEGG_DRUG
103628-48-4 SECONDARY_CAS_RN
4020790 VANDF
4021050 VANDF
C0075632 UMLSCUI
CHEBI:10650 CHEBI
CHEMBL128 ChEMBL_ID
DB00669 DRUGBANK_ID
CHEMBL1201150 ChEMBL_ID
D018170 MESH_DESCRIPTOR_UI
5358 PUBCHEM_CID
54 IUPHAR_LIGAND_ID
6125 INN_ID
8R78F6L9VO UNII
37418 RXNORM
158892 MMSL
166806 MMSL
25268 MMSL
31925 MMSL
5536 MMSL
d03160 MMSL
004044 NDDF
004045 NDDF
322822007 SNOMEDCT_US
395892000 SNOMEDCT_US
96215002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sumatriptan HUMAN PRESCRIPTION DRUG LABEL 1 0093-2013 INJECTION 4 mg SUBCUTANEOUS ANDA 28 sections
Sumatriptan HUMAN PRESCRIPTION DRUG LABEL 1 0093-2013 INJECTION 4 mg SUBCUTANEOUS ANDA 28 sections
Sumatriptan HUMAN PRESCRIPTION DRUG LABEL 1 0093-2014 INJECTION 6 mg SUBCUTANEOUS ANDA 28 sections
Sumatriptan HUMAN PRESCRIPTION DRUG LABEL 1 0093-2014 INJECTION 6 mg SUBCUTANEOUS ANDA 28 sections
SUMATRIPTAN HUMAN PRESCRIPTION DRUG LABEL 1 0143-9638 INJECTION 6 mg SUBCUTANEOUS ANDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0478 INJECTION 6 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0478 INJECTION 6 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0478 INJECTION 6 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0479 INJECTION 6 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0479 INJECTION 6 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0479 INJECTION 6 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0523 SPRAY 20 mg NASAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0523 SPRAY 20 mg NASAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0524 SPRAY 5 mg NASAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0524 SPRAY 5 mg NASAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0735 TABLET, FILM COATED 25 mg ORAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0735 TABLET, FILM COATED 25 mg ORAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0736 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0736 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0737 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0737 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0739 INJECTION 4 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0739 INJECTION 4 mg SUBCUTANEOUS NDA 28 sections
IMITREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0739 INJECTION 4 mg SUBCUTANEOUS NDA 28 sections
ZEMBRACE SYMTOUCH HUMAN PRESCRIPTION DRUG LABEL 1 0245-0809 INJECTION, SOLUTION 3 mg SUBCUTANEOUS NDA 31 sections
ZEMBRACE SYMTOUCH HUMAN PRESCRIPTION DRUG LABEL 1 0245-0809 INJECTION, SOLUTION 3 mg SUBCUTANEOUS NDA 31 sections
TOSYMRA HUMAN PRESCRIPTION DRUG LABEL 1 0245-0812 SPRAY 10 mg NASAL NDA 31 sections
TOSYMRA HUMAN PRESCRIPTION DRUG LABEL 1 0245-0812 SPRAY 10 mg NASAL NDA 31 sections
Sumatriptan Succinate HUMAN PRESCRIPTION DRUG LABEL 1 0378-5630 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Sumatriptan Succinate HUMAN PRESCRIPTION DRUG LABEL 1 0378-5630 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections