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

Stem definitionDrug idCAS RN
mucolytics 66 616-91-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • N-Acetylcysteine
  • acetylcysteine
  • acetadote
  • acetilcysteina
  • L-Acetylcysteine
The N-acetyl derivative of CYSTEINE. It is used as a mucolytic agent to reduce the viscosity of mucous secretions. It has also been shown to have antiviral effects in patients with HIV due to inhibition of viral stimulation by reactive oxygen intermediates. N-Acetylcystene (NAC) as a precursor to the antioxidant glutathione modulates glutamatergic, neurotrophic, and inflammatory pathways. The potential applications of NAC to facilitate recovery after traumatic brain injury, cerebral ischemia, and in treatment of cerebrovascular vasospasm after subarachnoid hemorrhage.
  • Molecular weight: 163.19
  • Formula: C5H9NO3S
  • CLOGP: -0.62
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 66.40
  • ALOGS: -1.51
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.60 g Inhal.solution
0.50 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 61.28 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 5 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.55 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.17 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.50 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -3.971 Moderate 0.69
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.407 Moderate 0.69
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 1.489 10^-6 cm/s Moderate 0.69
dh-clint Dog hepatocyte intrinsic clearance 1.816 uL/min/10^6 cells Moderate 0.69
dppb Dog plasma protein binding (% unbound) 87.650 % Moderate 0.69
fcs-ppb Fetal calf serum protein binding (% unbound) 84.900 % Moderate 0.69
herg hERG pIC50 4.399 pIC50 Moderate 0.69
hh-clint Human hepatocyte intrinsic clearance 1.315 uL/min/10^6 cells Moderate 0.69
hlm-clint Human liver microsomal intrinsic clearance 3.648 uL/min/mg protein Moderate 0.69
hppb Human plasma protein binding (% unbound) 81.600 % Moderate 0.69
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,IGF1R,ITK,JAK1,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 57
kinase-selectivity-class ACVR2B,AXL,BRAF,CDK4,CDK9,EIF2AK3,EPHB4,GRK2,MAP2K6,MAP3K14,MAPK7,PIK3CD,PIK3CG,PRKDC,STK33,TEK,TGFBR1 17
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.292 Moderate 0.69
mh-clint Mouse hepatocyte intrinsic clearance 0.948 Moderate 0.69
mppb Mouse plasma protein binding (% unbound) 98.280 Moderate 0.69
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.381 Moderate 0.69
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 84.450 % Moderate 0.69
rh-clint Rat hepatocyte intrinsic clearance 1.514 uL/min/10^6 cells Moderate 0.69
rh-fuinc Rat hepatocyte fraction unbound in incubation 95.560 % Moderate 0.69
rppb Rat plasma protein binding (% unbound) 90.790 % Moderate 0.69
solubility-dd Solubility at pH 7.4 in DMSO 866.962 uM Moderate 0.69

Approvals:

DateAgencyCompanyOrphan
Sept. 14, 1963 FDA APOTHECON
March 27, 2023 PMDA Maruho Co., Ltd.

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
Contraindicated product administered 178.79 10.55 8 60201 320131 90248107
Systemic lupus erythematosus 171.10 10.55 20 60189 361876 90206362
Glossodynia 154.06 10.55 17 60192 321762 90246476
Pericarditis 153.34 10.55 6 60203 270145 90298093
Wound 147.62 10.55 15 60194 302965 90265273
Treatment failure 145.64 10.55 16 60193 303912 90264326
Infusion related reaction 141.74 10.55 50 60159 416730 90151508
Helicobacter infection 132.37 10.55 4 60205 226846 90341392
Body tinea 115.20 10.55 46 60163 2102 90566136
Folliculitis 114.40 10.55 5 60204 204348 90363890
Product use issue 113.13 10.55 39 60170 329880 90238358
Arthropathy 109.84 10.55 53 60156 366189 90202049
Drug intolerance 107.55 10.55 84 60125 447507 90120731
Maternal exposure during pregnancy 105.12 10.55 54 60155 360009 90208229
Hepatic enzyme increased 102.52 10.55 56 60153 360680 90207558
Inhibitory drug interaction 95.00 10.55 45 60164 3118 90565120
Lower respiratory tract infection 94.29 10.55 25 60184 250634 90317604
Type 2 diabetes mellitus 91.72 10.55 13 60196 203231 90365007
Therapeutic product effect decreased 91.43 10.55 35 60174 277536 90290702
Joint swelling 90.76 10.55 121 60088 503179 90065059
Infection susceptibility increased 88.64 10.55 46 60163 3880 90564358
Glucose tolerance impaired 76.62 10.55 54 60155 7931 90560307
Pneumonia 74.64 10.55 698 59511 637361 89930877
Poor quality sleep 74.59 10.55 87 60122 24606 90543632
Drug hypersensitivity 74.24 10.55 121 60088 463488 90104750
Intentional product use issue 71.99 10.55 27 60182 216865 90351373
Discomfort 71.71 10.55 47 60162 274288 90293950
C-reactive protein abnormal 71.69 10.55 3 60206 127426 90440812
Ill-defined disorder 68.46 10.55 19 60190 184872 90383366
Rheumatoid arthritis 66.52 10.55 86 60123 362528 90205710
Off label use 65.82 10.55 446 59763 1101806 89466432
Irritable bowel syndrome 65.29 10.55 28 60181 207420 90360818
Product use in unapproved indication 63.49 10.55 78 60131 336158 90232080
Sinobronchitis 63.29 10.55 22 60187 679 90567559
Unevaluable event 63.14 10.55 123 60086 54725 90513513
Impaired healing 62.74 10.55 39 60170 234160 90334078
Blister 62.27 10.55 47 60162 254951 90313287
Fibromyalgia 60.06 10.55 31 60178 206238 90362000
Joint range of motion decreased 58.18 10.55 10 60199 135633 90432605
Bone density decreased 57.28 10.55 64 60145 17281 90550957
Diarrhoea 55.40 10.55 903 59306 938287 89629951
Product dose omission issue 53.91 10.55 355 59854 291332 90276906
Therapeutic product effect incomplete 53.74 10.55 31 60178 193865 90374373
Prescribed overdose 52.67 10.55 3 60206 97622 90470616
Hypercholesterolaemia 51.79 10.55 4 60205 100888 90467350
Dyspnoea 50.44 10.55 843 59366 880112 89688126
Flatulence 50.35 10.55 95 60114 41272 90526966
Swelling 49.59 10.55 130 60079 418928 90149310
Blood cholesterol increased 48.68 10.55 40 60169 207972 90360266
Completed suicide 48.22 10.55 18 60191 145040 90423198
Device expulsion 47.43 10.55 92 60117 40794 90527444
Mobility decreased 46.44 10.55 59 60150 250675 90317563
Toxic epidermal necrolysis 46.35 10.55 80 60129 32448 90535790
Fall 46.09 10.55 506 59703 481304 90086934
Alopecia 45.61 10.55 172 60037 494899 90073339
Stevens-Johnson syndrome 45.51 10.55 75 60134 29301 90538937
Facet joint syndrome 45.07 10.55 6 60203 98383 90469855
Deep vein thrombosis 44.43 10.55 148 60061 91472 90476766
C-reactive protein increased 43.55 10.55 34 60175 181355 90386883
Constipation 43.45 10.55 327 59882 280068 90288170
Abdominal discomfort 43.21 10.55 167 60042 477161 90091077
Liver injury 42.19 10.55 31 60178 170536 90397702
Grip strength decreased 41.57 10.55 6 60203 92570 90475668
Peripheral venous disease 41.24 10.55 4 60205 83917 90484321
Purpura 41.22 10.55 50 60159 14728 90553510
Infective pulmonary exacerbation of cystic fibrosis 41.13 10.55 42 60167 10237 90558001
Bursitis 41.05 10.55 18 60191 131636 90436602
Full blood count decreased 40.98 10.55 72 60137 29617 90538621
Cellulitis 39.47 10.55 142 60067 91195 90477043
Gastrointestinal disorder 39.18 10.55 69 60140 256618 90311620
Respiratory failure 38.96 10.55 169 60040 118249 90449989
Device dislocation 37.94 10.55 72 60137 31410 90536828
Hyperlipidaemia 37.53 10.55 60 60149 22856 90545382
Leukocytosis 37.51 10.55 71 60138 30919 90537319
Hypoxia 36.94 10.55 119 60090 72280 90495958
Impaired work ability 36.42 10.55 54 60155 19272 90548966
Neuropathy peripheral 35.92 10.55 183 60026 136787 90431451
Wound infection 35.70 10.55 13 60196 106389 90461849
Chronic obstructive pulmonary disease 35.56 10.55 119 60090 73710 90494528
Hypersensitivity 35.07 10.55 169 60040 454508 90113730
Hypotension 34.97 10.55 350 59859 325047 90243191
Impaired quality of life 34.40 10.55 58 60151 23086 90545152
Therapy cessation 34.15 10.55 75 60134 36286 90531952
Coagulopathy 34.13 10.55 58 60151 23231 90545007
Nausea 33.72 10.55 970 59239 1109346 89458892
Musculoskeletal stiffness 32.80 10.55 95 60114 296437 90271801
Allergic sinusitis 31.91 10.55 19 60190 2094 90566144
Live birth 31.46 10.55 7 60202 79100 90489138
Fatigue 31.23 10.55 994 59215 1153029 89415209
Platelet count decreased 29.85 10.55 174 60035 136795 90431443
Hepatic encephalopathy 29.65 10.55 41 60168 13731 90554507
Atrial fibrillation 29.29 10.55 170 60039 133441 90434797
Psoriatic arthropathy 29.19 10.55 68 60141 228267 90339971
Cataract 28.56 10.55 109 60100 71983 90496255
Plasma cell myeloma 28.42 10.55 75 60134 40753 90527485
Pulmonary embolism 28.38 10.55 166 60043 130654 90437584
Pulmonary fibrosis 27.28 10.55 19 60190 107484 90460754
Skin disorder 27.17 10.55 69 60140 36637 90531601
Anaphylactoid reaction 27.06 10.55 23 60186 4445 90563793
Feeling abnormal 27.00 10.55 197 60012 167038 90401200
Sleep disorder 26.93 10.55 57 60152 197973 90370265
Oral herpes 26.91 10.55 65 60144 33459 90534779
Haemoglobin decreased 26.85 10.55 192 60017 161764 90406474
Pain 26.66 10.55 484 59725 995857 89572381
Night sweats 26.30 10.55 28 60181 128738 90439500
Brain herniation 26.22 10.55 22 60187 4178 90564060
Tremor 26.21 10.55 183 60026 152990 90415248
International normalised ratio increased 26.18 10.55 80 60129 47236 90521002
Urinary tract infection 26.04 10.55 314 59895 305318 90262920
Cough 25.57 10.55 365 59844 368597 90199641
Back pain 25.36 10.55 322 59887 316853 90251385
Exposure during pregnancy 25.19 10.55 78 60131 238332 90329906
Flushing 25.16 10.55 121 60088 88370 90479868
Brain oedema 25.08 10.55 43 60166 17342 90550896
Red blood cell sedimentation rate increased 24.65 10.55 12 60197 82583 90485655
Adverse event 24.58 10.55 25 60184 117393 90450845
Arthralgia 24.49 10.55 367 59842 778155 89790083
Metabolic acidosis 24.42 10.55 87 60122 55589 90512649
Tachycardia 23.90 10.55 183 60026 157490 90410748
Aspartate aminotransferase increased 23.89 10.55 133 60076 102804 90465434
Osteoarthritis 23.67 10.55 60 60149 195670 90372568
Hot flush 23.61 10.55 90 60119 59398 90508840
Model for end stage liver disease score increased 23.55 10.55 5 60204 20 90568218
Prothrombin time ratio decreased 23.45 10.55 12 60197 983 90567255
Autoimmune disorder 23.13 10.55 11 60198 76733 90491505
Muscle spasms 22.88 10.55 262 59947 251621 90316617
Acute respiratory failure 22.30 10.55 71 60138 42847 90525391
Infection 22.23 10.55 145 60064 361949 90206289
Dizziness 21.89 10.55 529 59680 588755 89979483
Blepharospasm 21.86 10.55 5 60204 55440 90512798
Congenital central hypoventilation syndrome 21.74 10.55 5 60204 31 90568207
Confusional state 21.57 10.55 159 60050 386046 90182192
Dyspnoea exertional 21.39 10.55 100 60109 72188 90496050
Drug ineffective 21.36 10.55 730 59479 1383568 89184670
Pleural effusion 21.07 10.55 137 60072 111854 90456384
Anaemia 20.95 10.55 340 59869 352462 90215776
Respiratory tract oedema 20.85 10.55 10 60199 712 90567526
Dehydration 20.79 10.55 209 60000 194238 90374000
Wheezing 20.43 10.55 85 60124 237995 90330243
Drug abuse 20.31 10.55 15 60194 82332 90485906
Junctional ectopic tachycardia 20.20 10.55 7 60202 214 90568024
Asthenia 20.07 10.55 480 59729 533271 90034967
Liver disorder 19.98 10.55 31 60178 121238 90447000
Hip arthroplasty 19.97 10.55 13 60196 76195 90492043
Immune-mediated pancreatitis 19.94 10.55 8 60201 370 90567868
Mental impairment 19.85 10.55 38 60171 16682 90551556
Nasopharyngitis 19.79 10.55 174 60035 406930 90161308
Postresuscitation encephalopathy 19.73 10.55 4 60205 12 90568226
Tongue oedema 19.53 10.55 21 60188 5433 90562805
Stomatitis 19.51 10.55 105 60104 274593 90293645
Acute hepatic failure 19.47 10.55 45 60164 22516 90545722
Hepatitis viral 18.77 10.55 9 60200 641 90567597
Injection site haemorrhage 18.68 10.55 51 60158 28267 90539971
Nail disorder 18.53 10.55 8 60201 59059 90509179
Inflammation 18.46 10.55 59 60150 178533 90389705
Injury 17.85 10.55 69 60140 197280 90370958
Face oedema 17.43 10.55 44 60165 23274 90544964
Foramen magnum stenosis 17.33 10.55 6 60203 183 90568055
Blood potassium decreased 17.16 10.55 70 60139 47657 90520581
Pelvic pain 17.13 10.55 34 60175 15323 90552915
Brain death 17.13 10.55 17 60192 4004 90564234
Lower limb fracture 16.79 10.55 19 60190 84994 90483244
Influenza like illness 16.65 10.55 101 60108 80510 90487728
Epilepsy 16.65 10.55 18 60191 82188 90486050
Pulmonary hypertension 16.60 10.55 64 60145 42459 90525779
Hip fracture 16.53 10.55 54 60155 33023 90535215
Iliotibial band syndrome 16.51 10.55 7 60202 373 90567865
Herpes simplex hepatitis 16.42 10.55 8 60201 590 90567648
Chest discomfort 16.40 10.55 152 60057 138213 90430025
Lupus-like syndrome 16.33 10.55 6 60203 48840 90519398
Breast conserving surgery 16.21 10.55 10 60199 1175 90567063
Tongue exfoliation 16.20 10.55 5 60204 105 90568133
Productive cough 16.20 10.55 97 60112 76966 90491272
Hypercapnia 16.09 10.55 21 60188 6656 90561582
Hypervolaemia 15.95 10.55 53 60156 32704 90535534
Thrombosis 15.91 10.55 93 60116 73158 90495080
Eyelid myoclonus 15.86 10.55 5 60204 113 90568125
Sciatica 15.69 10.55 27 60182 101355 90466883
Chills 15.65 10.55 145 60064 131836 90436402
Myalgia 15.37 10.55 181 60028 174944 90393294
Nasal congestion 15.06 10.55 101 60108 83313 90484925
Herpes simplex sepsis 14.97 10.55 4 60205 49 90568189
Biopsy liver abnormal 14.84 10.55 6 60203 283 90567955
Foot deformity 14.54 10.55 11 60198 59640 90508598
Bronchospasm 14.37 10.55 38 60171 20671 90547567
Dysgeusia 14.32 10.55 71 60138 52489 90515749
Pulmonary arterial hypertension 14.23 10.55 44 60165 26143 90542095
Abscess rupture 14.16 10.55 6 60203 319 90567919
Sepsis 14.12 10.55 182 60027 179632 90388606
COVID-19 14.04 10.55 61 60148 168782 90399456
Neuroleptic malignant syndrome 14.02 10.55 31 60178 15065 90553173
Product complaint 14.01 10.55 29 60180 13471 90554767
Knee arthroplasty 13.95 10.55 21 60188 83161 90485077
Herpes zoster 13.86 10.55 109 60100 94535 90473703
Road traffic accident 13.79 10.55 32 60177 107594 90460644
Nail avulsion 13.70 10.55 6 60203 346 90567892
Disability 13.63 10.55 5 60204 40740 90527498
Chronic hepatitis C 13.63 10.55 5 60204 181 90568057
Pulmonary oedema 13.60 10.55 79 60130 62001 90506237
Prothrombin level abnormal 13.49 10.55 4 60205 73 90568165
White blood cell count decreased 13.49 10.55 170 60039 166939 90401299
Lymphocytosis 13.38 10.55 13 60196 2984 90565254
Autoimmune thyroiditis 13.38 10.55 18 60191 5875 90562363
Gait inability 13.37 10.55 51 60158 146405 90421833
Osteoporosis postmenopausal 13.37 10.55 6 60203 367 90567871
Superior vena cava occlusion 13.24 10.55 4 60205 78 90568160
Acute kidney injury 13.22 10.55 292 59917 320095 90248143
Alcohol withdrawal syndrome 13.15 10.55 8 60201 916 90567322
Respiratory distress 13.12 10.55 56 60153 38890 90529348
Seizure 13.06 10.55 157 60052 152472 90415766
Alanine aminotransferase increased 13.03 10.55 128 60081 118210 90450028
Epistaxis 13.00 10.55 99 60110 85026 90483212
Vaginal haemorrhage 12.98 10.55 48 60161 31223 90537015
Lip pain 12.97 10.55 11 60198 2119 90566119
Pneumonia necrotising 12.96 10.55 7 60202 640 90567598
Autoimmune hepatitis 12.88 10.55 24 60185 10327 90557911
Necrotising colitis 12.72 10.55 9 60200 1329 90566909
Ageusia 12.72 10.55 31 60178 16045 90552193
General physical health deterioration 12.70 10.55 163 60046 354952 90213286
Laboratory test interference 12.64 10.55 7 60202 673 90567565
Prothrombin time prolonged 12.59 10.55 23 60186 9749 90558489
Joint dislocation 12.53 10.55 7 60202 44575 90523663
Post procedural haematoma 12.52 10.55 9 60200 1363 90566875
Laboratory test abnormal 12.46 10.55 58 60151 41796 90526442
Cervical vertebral fracture 12.36 10.55 13 60196 3280 90564958
Blood creatinine increased 12.33 10.55 112 60097 101274 90466964
Biliary fistula 12.27 10.55 3 60206 25 90568213
Haemolysis 12.21 10.55 21 60188 8489 90559749
Intestinal dilatation 12.20 10.55 11 60198 2299 90565939
Haemolytic uraemic syndrome 12.19 10.55 12 60197 2799 90565439
Skin discolouration 12.17 10.55 60 60149 44255 90523983
Activated partial thromboplastin time prolonged 12.15 10.55 20 60189 7805 90560433
Eye swelling 12.11 10.55 45 60164 29341 90538897
Swelling face 12.08 10.55 94 60115 81258 90486980
Peripheral nerve lesion 11.96 10.55 6 60203 471 90567767
Mydriasis 11.93 10.55 29 60180 14983 90553255
Urogenital haemorrhage 11.87 10.55 5 60204 262 90567976
Administration site swelling 11.81 10.55 9 60200 1490 90566748
Vertebral lesion 11.81 10.55 7 60202 765 90567473
Patellofemoral pain syndrome 11.74 10.55 7 60202 773 90567465
Myelosuppression 11.69 10.55 11 60198 53580 90514658
Sputum increased 11.68 10.55 12 60197 2945 90565293
Bronchitis 11.67 10.55 154 60055 152773 90415465
Body height decreased 11.62 10.55 25 60184 11924 90556314
International normalised ratio decreased 11.61 10.55 15 60194 4709 90563529
Anion gap 11.60 10.55 8 60201 1134 90567104
Laryngitis 11.57 10.55 10 60199 50743 90517495
Pathological fracture 11.52 10.55 22 60187 9638 90558600
Exostosis 11.48 10.55 11 60198 53123 90515115
Encephalopathy 11.44 10.55 61 60148 46383 90521855
Abdominal pain lower 11.44 10.55 45 60164 30132 90538106
Meniscus injury 11.40 10.55 20 60189 8217 90560021
Psoriasis 11.37 10.55 149 60060 147605 90420633
Decerebrate posture 11.31 10.55 4 60205 130 90568108
Bone pain 11.16 10.55 75 60134 61908 90506330
Flank pain 11.10 10.55 33 60176 19189 90549049
Full blood count abnormal 11.10 10.55 51 60158 36546 90531692
Ammonia increased 10.97 10.55 15 60194 4971 90563267
Multiple sclerosis 10.95 10.55 42 60167 27798 90540440
Oedema peripheral 10.94 10.55 236 59973 257679 90310559
Thrombocytopenia 10.87 10.55 197 60012 208528 90359710
Cardiac pacemaker insertion 10.84 10.55 14 60195 4393 90563845
Rotator cuff syndrome 10.83 10.55 29 60180 15890 90552348
Obesity 10.80 10.55 35 60174 105472 90462766
Heavy menstrual bleeding 10.70 10.55 34 60175 20496 90547742
Nasal turbinate hypertrophy 10.67 10.55 7 60202 914 90567324
Product quality issue 10.64 10.55 23 60186 79302 90488936
Defaecation disorder 10.62 10.55 7 60202 922 90567316
Nocturia 10.60 10.55 22 60187 10233 90558005
Injection site erythema 10.58 10.55 106 60103 98396 90469842
Radial nerve palsy 10.57 10.55 6 60203 605 90567633
Dose calculation error 10.56 10.55 5 60204 346 90567892

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
Congenital hiatus hernia 170.89 10.71 95 42556 6079 42572605
Malignant melanoma in situ 168.68 10.71 73 42578 2694 42575990
Breath sounds abnormal 153.91 10.71 114 42537 11979 42566705
Bronchiectasis 105.24 10.71 109 42542 17910 42560774
Transient ischaemic attack 100.23 10.71 145 42506 33594 42545090
Chronic obstructive pulmonary disease 97.40 10.71 203 42448 62911 42515773
Benign prostatic hyperplasia 84.81 10.71 105 42546 20947 42557737
Micturition urgency 82.46 10.71 79 42572 11819 42566865
Pneumonia 79.97 10.71 706 41945 421443 42157241
Joint injury 75.49 10.71 83 42568 14593 42564091
Productive cough 72.80 10.71 160 42491 51407 42527277
Product use in unapproved indication 72.15 10.71 48 42603 184408 42394276
Hypercholesterolaemia 71.94 10.71 76 42575 12773 42565911
Off label use 68.71 10.71 368 42283 637967 41940717
Drug abuse 66.93 10.71 12 42639 104759 42473925
Dyspnoea 66.42 10.71 705 41946 441916 42136768
Full blood count abnormal 61.97 10.71 109 42542 29767 42548917
Completed suicide 61.73 10.71 11 42640 96454 42482230
Dyspnoea exertional 52.89 10.71 139 42512 50009 42528675
Gastrooesophageal reflux disease 45.66 10.71 123 42528 44900 42533784
Stevens-Johnson syndrome 42.27 10.71 78 42573 22100 42556584
Empyema 41.44 10.71 34 42617 4146 42574538
Toxic epidermal necrolysis 41.18 10.71 86 42565 26664 42552020
Obstructive airways disorder 38.58 10.71 80 42571 24679 42554005
Abdominal abscess 35.63 10.71 34 42617 5059 42573625
Laboratory test abnormal 34.36 10.71 73 42578 22905 42555779
Klebsiella infection 34.07 10.71 49 42602 11283 42567401
Dermatillomania 33.92 10.71 9 42642 68 42578616
Hemianopia 33.29 10.71 17 42634 915 42577769
Wheezing 32.91 10.71 125 42526 54656 42524028
Cyanosis 32.68 10.71 56 42595 14975 42563709
Toxicity to various agents 29.82 10.71 123 42528 229013 42349671
Oral mucosal eruption 29.01 10.71 12 42639 395 42578289
Coronary artery disease 28.58 10.71 118 42533 53602 42525082
Device related sepsis 25.41 10.71 25 42626 3862 42574822
COVID-19 24.84 10.71 49 42602 115899 42462785
Drug ineffective 23.97 10.71 466 42185 629731 41948953
Vascular device infection 23.84 10.71 30 42621 6080 42572604
Plasma cell myeloma 22.60 10.71 101 42550 47477 42531207
Asthma 22.28 10.71 122 42529 62192 42516492
Fatigue 21.79 10.71 580 42071 435061 42143623
Full blood count decreased 20.66 10.71 56 42595 20504 42558180
Drug interaction 20.43 10.71 170 42481 266829 42311855
Staphylococcal sepsis 20.32 10.71 39 42612 11375 42567309
Impaired healing 19.76 10.71 49 42602 17004 42561680
Intentional product use issue 19.47 10.71 26 42625 71807 42506877
Febrile neutropenia 19.29 10.71 108 42543 185595 42393089
Product use issue 18.63 10.71 30 42621 76721 42501963
Clostridium difficile infection 18.23 10.71 57 42594 22602 42556082
Bilirubin conjugated abnormal 18.21 10.71 6 42645 102 42578582
Asthenia 18.00 10.71 387 42264 280406 42298278
Inappropriate schedule of product administration 17.69 10.71 44 42607 95858 42482826
Skin odour abnormal 16.48 10.71 12 42639 1227 42577457
Drug resistance 16.16 10.71 7 42644 34241 42544443
Wrong dose 15.57 10.71 11 42640 1073 42577611
Cytokine release syndrome 15.56 10.71 13 42638 44514 42534170
Influenza like illness 15.43 10.71 68 42583 31772 42546912
Sinusitis 15.20 10.71 90 42561 47202 42531482
Brain oedema 14.96 10.71 43 42608 16284 42562400
Stress 14.15 10.71 14 42637 44198 42534486
Rheumatoid arthritis 14.09 10.71 13 42638 42427 42536257
Drug intolerance 13.99 10.71 38 42613 80386 42498298
Mucosal erosion 13.98 10.71 10 42641 995 42577689
Cell death 13.96 10.71 16 42635 2943 42575741
Prothrombin time ratio decreased 13.46 10.71 8 42643 581 42578103
Enterococcal infection 13.33 10.71 34 42617 12005 42566679
Anion gap 13.25 10.71 9 42642 824 42577860
Laryngitis bacterial 12.99 10.71 4 42647 54 42578630
Oedema peripheral 12.72 10.71 199 42452 135877 42442807
Skin irritation 12.42 10.71 25 42626 7549 42571135
Prader-Willi syndrome 12.20 10.71 3 42648 16 42578668
Staphylococcal bacteraemia 11.89 10.71 31 42620 11090 42567594
Dizziness 11.88 10.71 330 42321 248924 42329760
Cardiogenic shock 11.73 10.71 11 42640 35629 42543055
Bronchitis 11.61 10.71 84 42567 47117 42531567
Therapeutic response decreased 11.52 10.71 12 42639 37000 42541684
Chronic hepatitis C 11.48 10.71 7 42644 532 42578152
Hyperlactacidaemia 11.40 10.71 18 42633 4498 42574186
Acute respiratory failure 11.25 10.71 72 42579 38786 42539898
Cough 11.24 10.71 245 42406 177858 42400826
Acute hepatic failure 11.12 10.71 40 42611 17033 42561651
Serotonin syndrome 11.10 10.71 6 42645 25839 42552845
Leukopenia 11.08 10.71 38 42613 74708 42503976
Fall 11.03 10.71 310 42341 234210 42344474
Eosinophilia 11.01 10.71 10 42641 32889 42545795
Kidney rupture 11.01 10.71 5 42646 207 42578477
Foetal exposure during pregnancy 11.01 10.71 19 42632 47292 42531392
White blood cell count decreased 10.91 10.71 163 42488 110233 42468451
Altered state of consciousness 10.91 10.71 8 42643 29251 42549433
Viral infection 10.88 10.71 48 42603 22435 42556249
Weight 10.75 10.71 3 42648 28 42578656

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
Congenital hiatus hernia 196.24 10.36 96 84897 6163 110498143
Malignant melanoma in situ 173.15 10.36 74 84919 3468 110500838
Systemic lupus erythematosus 142.15 10.36 15 84978 254323 110249983
Chronic obstructive pulmonary disease 136.79 10.36 276 84717 108882 110395424
Pneumonia 135.63 10.36 1142 83851 875572 109628734
Benign prostatic hyperplasia 120.53 10.36 105 84888 18129 110486177
Dyspnoea 120.07 10.36 1338 83655 1105534 109398772
Contraindicated product administered 119.31 10.36 23 84970 248244 110256062
Breath sounds abnormal 119.31 10.36 121 84872 25283 110479023
Duodenal ulcer perforation 118.55 10.36 4 84989 177696 110326610
Helicobacter infection 118.24 10.36 5 84988 181872 110322434
Drug intolerance 117.08 10.36 85 84908 406427 110097879
Infusion related reaction 114.68 10.36 76 84917 381086 110123220
Product use in unapproved indication 111.09 10.36 108 84885 447269 110057037
Treatment failure 109.74 10.36 38 84955 277196 110227110
Product use issue 108.33 10.36 52 84941 311643 110192663
Pericarditis 105.92 10.36 20 84973 219094 110285212
Completed suicide 105.37 10.36 28 84965 242353 110261953
Glossodynia 103.69 10.36 22 84971 221982 110282324
Joint swelling 103.06 10.36 113 84880 442732 110061574
Body tinea 102.77 10.36 44 84949 2071 110502235
Folliculitis 101.55 10.36 7 84986 167646 110336660
Arthropathy 98.34 10.36 49 84944 287473 110216833
Stevens-Johnson syndrome 92.95 10.36 145 84848 46756 110457550
Transient ischaemic attack 92.63 10.36 172 84821 63810 110440496
Drug hypersensitivity 90.90 10.36 130 84863 453960 110050346
Hepatic enzyme increased 87.40 10.36 71 84922 320821 110183485
Micturition urgency 87.06 10.36 90 84903 19230 110485076
Toxic epidermal necrolysis 86.55 10.36 156 84837 56571 110447735
Dyspnoea exertional 85.77 10.36 223 84770 103837 110400469
Inhibitory drug interaction 85.23 10.36 51 84942 4896 110499410
Lower respiratory tract infection 82.27 10.36 42 84951 243064 110261242
Intentional product use issue 80.71 10.36 45 84948 247861 110256445
Infection susceptibility increased 80.11 10.36 47 84946 4351 110499955
C-reactive protein abnormal 79.77 10.36 5 84988 129690 110374616
Bronchiectasis 79.64 10.36 118 84875 36375 110467931
Productive cough 79.33 10.36 230 84763 114075 110390231
Off label use 78.41 10.36 757 84236 1499428 109004878
Fibromyalgia 77.65 10.36 18 84975 170891 110333415
Maternal exposure during pregnancy 76.38 10.36 51 84942 254832 110249474
Type 2 diabetes mellitus 76.03 10.36 21 84972 177211 110327095
Wound 75.68 10.36 43 84950 234394 110269912
Irritable bowel syndrome 75.20 10.36 17 84976 164198 110340108
Rheumatoid arthritis 73.55 10.36 73 84920 299540 110204766
Drug abuse 70.73 10.36 24 84969 177387 110326919
Therapeutic product effect decreased 69.11 10.36 52 84941 244264 110260042
Glucose tolerance impaired 67.75 10.36 58 84935 9779 110494527
Full blood count abnormal 64.63 10.36 137 84856 55915 110448391
Mobility decreased 64.05 10.36 53 84940 237369 110266937
Bursitis 60.39 10.36 13 84980 129905 110374401
Venoocclusive disease 57.65 10.36 44 84949 6306 110498000
Ill-defined disorder 56.27 10.36 25 84968 156828 110347478
Discomfort 55.39 10.36 50 84943 214657 110289649
Joint range of motion decreased 55.00 10.36 13 84980 121819 110382487
Peripheral venous disease 49.54 10.36 4 84989 84113 110420193
Respiratory failure 48.93 10.36 308 84685 215024 110289282
Device expulsion 48.46 10.36 86 84907 30805 110473501
Poor quality sleep 47.74 10.36 81 84912 27996 110476310
Grip strength decreased 46.70 10.36 4 84989 80170 110424136
Hypoxia 45.64 10.36 209 84784 129306 110375000
Brain oedema 45.50 10.36 84 84909 31014 110473292
Leukocytosis 45.00 10.36 116 84877 53712 110450594
Sinobronchitis 44.62 10.36 16 84977 466 110503840
Aspartate aminotransferase increased 43.59 10.36 240 84753 159696 110344610
Joint injury 42.96 10.36 95 84898 39899 110464407
Empyema 42.83 10.36 35 84958 5535 110498771
Bone density decreased 42.61 10.36 57 84936 15985 110488321
Prescribed overdose 42.29 10.36 8 84985 87573 110416733
Swelling 42.13 10.36 134 84859 350907 110153399
Plasma cell myeloma 41.14 10.36 124 84869 62812 110441494
Psoriatic arthropathy 40.65 10.36 55 84938 196706 110307600
Acute respiratory failure 39.88 10.36 138 84855 75122 110429184
Blood cholesterol increased 39.87 10.36 50 84943 184735 110319571
Alopecia 39.19 10.36 146 84847 364607 110139699
Unevaluable event 38.06 10.36 116 84877 59111 110445195
Prothrombin time ratio decreased 37.11 10.36 20 84973 1572 110502734
Gastrointestinal disorder 36.88 10.36 82 84911 241870 110262436
Arthralgia 36.57 10.36 403 84590 779229 109725077
Abdominal abscess 36.03 10.36 39 84954 8780 110495526
Coronary artery disease 35.87 10.36 129 84864 71561 110432745
Musculoskeletal stiffness 35.57 10.36 104 84889 279718 110224588
COVID-19 34.99 10.36 86 84907 244974 110259332
Cellulitis 34.94 10.36 190 84803 125826 110378480
Deep vein thrombosis 34.88 10.36 205 84788 139682 110364624
Fall 34.42 10.36 653 84340 602829 109901477
Atrial fibrillation 34.15 10.36 297 84696 229345 110274961
Infective pulmonary exacerbation of cystic fibrosis 34.02 10.36 49 84944 14722 110489584
Therapeutic response decreased 33.65 10.36 16 84977 96483 110407823
Night sweats 33.60 10.36 32 84961 133951 110370355
Blister 33.09 10.36 79 84914 227297 110277009
Hypersensitivity 33.01 10.36 179 84814 403819 110100487
Anaphylactoid reaction 32.94 10.36 33 84960 6793 110497513
Abdominal discomfort 32.46 10.36 174 84819 393684 110110622
Cyanosis 32.34 10.36 71 84922 29670 110474636
Impaired healing 32.22 10.36 64 84929 196653 110307653
Live birth 32.19 10.36 7 84986 69477 110434829
Klebsiella infection 31.76 10.36 56 84937 19953 110484353
Sleep disorder 31.36 10.36 66 84927 198578 110305728
Obstructive airways disorder 31.18 10.36 92 84901 46057 110458249
Coagulopathy 30.99 10.36 85 84908 40826 110463480
Oral herpes 30.41 10.36 78 84915 36002 110468304
Anaemia 30.17 10.36 589 84404 546497 109957809
Liver injury 30.11 10.36 43 84950 150370 110353936
Wound infection 29.29 10.36 19 84974 96446 110407860
Pleural effusion 29.17 10.36 235 84758 177474 110326832
Therapy cessation 28.96 10.36 88 84905 44769 110459537
Product dose omission issue 28.94 10.36 376 84617 321406 110182900
Blepharospasm 28.74 10.36 4 84989 54847 110449459
Full blood count decreased 28.74 10.36 71 84922 32028 110472278
Flushing 28.41 10.36 157 84836 104579 110399727
Hypervolaemia 28.24 10.36 93 84900 49367 110454939
Liver disorder 28.14 10.36 41 84952 142202 110362104
Sepsis 27.98 10.36 379 84614 326967 110177339
Flatulence 27.95 10.36 96 84897 52053 110452253
Dizziness 27.89 10.36 718 84275 697475 109806831
International normalised ratio increased 27.63 10.36 136 84857 86636 110417670
Autoimmune disorder 27.63 10.36 8 84985 65475 110438831
Skin disorder 27.53 10.36 84 84909 42829 110461477
Red blood cell sedimentation rate increased 27.27 10.36 13 84980 78289 110426017
Device dislocation 27.20 10.36 69 84924 31635 110472671
Allergic sinusitis 27.20 10.36 17 84976 1764 110502542
Osteoarthritis 26.92 10.36 63 84930 182560 110321746
Acute hepatic failure 26.86 10.36 75 84918 36393 110467913
Pain 26.04 10.36 548 84445 954407 109549899
Inflammation 25.90 10.36 70 84923 193168 110311138
Platelet count decreased 25.88 10.36 281 84712 230162 110274144
Chronic hepatitis C 25.78 10.36 12 84981 689 110503617
Anion gap 25.51 10.36 17 84976 1968 110502338
Stomatitis 25.36 10.36 114 84879 270128 110234178
Asthenia 25.35 10.36 701 84292 688298 109816008
Dehydration 25.29 10.36 327 84666 279184 110225122
Oral mucosal eruption 25.26 10.36 14 84979 1163 110503143
Bone erosion 25.22 10.36 3 84990 46368 110457938
Haemoglobin decreased 25.09 10.36 297 84696 248430 110255876
Alanine aminotransferase increased 24.93 10.36 233 84760 183540 110320766
Clostridium difficile infection 24.56 10.36 92 84901 52037 110452269
Influenza like illness 24.30 10.36 133 84860 88279 110416027
Hypotension 24.00 10.36 549 84444 523300 109981006
Constipation 23.50 10.36 396 84597 357390 110146916
Sciatica 23.25 10.36 22 84971 92377 110411929
Dermatillomania 23.14 10.36 9 84984 330 110503976
Cough 23.11 10.36 490 84503 461151 110043155
Nasopharyngitis 23.05 10.36 193 84800 394168 110110138
C-reactive protein increased 22.89 10.36 88 84905 217831 110286475
Nail disorder 22.80 10.36 8 84985 57927 110446379
Drug ineffective 22.78 10.36 947 84046 1519593 108984713
Blood potassium decreased 22.65 10.36 92 84901 54022 110450284
Exposure during pregnancy 22.17 10.36 61 84932 167363 110336943
Hemianopia 22.01 10.36 18 84975 2850 110501456
Purpura 21.89 10.36 54 84939 24334 110479972
Fatigue 21.75 10.36 1142 83851 1214816 109289490
Device related sepsis 21.59 10.36 28 84965 7619 110496687
Congenital central hypoventilation syndrome 21.01 10.36 5 84988 31 110504275
Oedema peripheral 20.94 10.36 362 84631 328298 110176008
Pulmonary hypertension 20.87 10.36 91 84902 55129 110449177
Tongue exfoliation 20.80 10.36 7 84986 168 110504138
Diarrhoea 20.74 10.36 1072 83921 1138433 109365873
Hepatic encephalopathy 20.70 10.36 58 84935 28198 110476108
Epilepsy 20.70 10.36 28 84965 100181 110404125
Metabolic acidosis 20.40 10.36 139 84854 99605 110404701
Mental status changes 19.91 10.36 113 84880 76009 110428297
Obesity 19.32 10.36 36 84957 113315 110390991
Hyperlipidaemia 19.22 10.36 66 84927 35782 110468524
Hepatitis fulminant 19.14 10.36 28 84965 8532 110495774
Impaired work ability 19.13 10.36 54 84939 26365 110477941
Model for end stage liver disease score increased 19.09 10.36 5 84988 48 110504258
Illness 19.04 10.36 21 84972 82150 110422156
Foot deformity 18.56 10.36 7 84986 48473 110455833
Tongue oedema 18.45 10.36 27 84966 8229 110496077
Bronchitis 18.33 10.36 193 84800 156839 110347467
Tachycardia 17.97 10.36 259 84734 226386 110277920
Myelosuppression 17.88 10.36 28 84965 94312 110409994
Gastrointestinal haemorrhage 17.74 10.36 200 84793 165318 110338988
Infection 17.42 10.36 186 84807 362014 110142292
Bronchospasm 17.39 10.36 57 84936 30182 110474124
Hospice care 17.38 10.36 33 84960 12440 110491866
Cytokine release syndrome 17.38 10.36 17 84976 70289 110434017
Breast conserving surgery 17.33 10.36 10 84983 897 110503409
Pulmonary embolism 16.97 10.36 245 84748 214229 110290077
Impaired quality of life 16.74 10.36 56 84937 29961 110474345
Lower limb fracture 16.65 10.36 20 84973 75328 110428978
Hip fracture 16.53 10.36 62 84931 35089 110469217
Prothrombin time shortened 16.45 10.36 17 84976 3629 110500677
Prothrombin level abnormal 16.44 10.36 6 84987 184 110504122
Gait inability 16.38 10.36 52 84941 136324 110367982
Accidental exposure to product 16.37 10.36 9 84984 49999 110454307
Blood pressure systolic increased 16.33 10.36 24 84969 82967 110421339
Bilirubin conjugated abnormal 16.14 10.36 6 84987 194 110504112
Enterococcal infection 16.11 10.36 43 84950 20323 110483983
Blood urea increased 16.00 10.36 84 84909 54873 110449433
Respiratory distress 15.93 10.36 99 84894 68775 110435531
Product complaint 15.93 10.36 34 84959 13938 110490368
Road traffic accident 15.87 10.36 37 84956 107361 110396945
Hepatotoxicity 15.85 10.36 93 84900 63307 110440999
Lip pain 15.76 10.36 14 84979 2480 110501826
Onychomycosis 15.72 10.36 5 84988 38526 110465780
Lupus-like syndrome 15.43 10.36 6 84987 40786 110463520
Respiratory tract oedema 15.36 10.36 10 84983 1113 110503193
Vascular device infection 15.29 10.36 37 84956 16475 110487831
Intentional product misuse 15.05 10.36 52 84941 132852 110371454
Wrong dose 15.03 10.36 14 84979 2635 110501671
Staphylococcal bacteraemia 15.03 10.36 37 84956 16651 110487655
Staphylococcal sepsis 14.99 10.36 38 84955 17416 110486890
Pneumonitis 14.68 10.36 105 84888 76426 110427880
Hypokalaemia 14.66 10.36 209 84784 182239 110322067
Viral infection 14.64 10.36 80 84913 53059 110451247
Toxicity to various agents 14.49 10.36 271 84722 480284 110024022
Postresuscitation encephalopathy 14.46 10.36 4 84989 48 110504258
Mucosal erosion 14.27 10.36 14 84979 2810 110501496
Atelectasis 14.25 10.36 61 84932 36651 110467655
Eyelid myoclonus 14.16 10.36 5 84988 139 110504167
Pulmonary arterial hypertension 14.13 10.36 56 84937 32512 110471794
Blood creatinine increased 14.10 10.36 208 84785 182681 110321625
Face oedema 14.08 10.36 57 84936 33412 110470894
Lymphocytosis 14.03 10.36 19 84974 5392 110498914
Fluid retention 14.02 10.36 122 84871 94185 110410121
Chills 14.02 10.36 215 84778 190365 110313941
Brain death 13.97 10.36 21 84972 6552 110497754
Immune-mediated pancreatitis 13.88 10.36 8 84985 716 110503590
Graft loss 13.84 10.36 10 84983 1318 110502988
Pyrexia 13.75 10.36 832 84161 897433 109606873
Feeling abnormal 13.73 10.36 205 84788 180506 110323800
Small intestinal obstruction 13.67 10.36 55 84938 32158 110472148
Herpes simplex sepsis 13.64 10.36 4 84989 60 110504246
Autoimmune hepatitis 13.52 10.36 33 84960 14771 110489535
Cataract 13.52 10.36 106 84887 79379 110424927
Liver function test increased 13.49 10.36 30 84963 88518 110415788
Haematocrit decreased 13.44 10.36 92 84901 66025 110438281
Blood alkaline phosphatase increased 13.42 10.36 97 84896 70838 110433468
Blood bilirubin increased 13.30 10.36 102 84891 75870 110428436
Herpes simplex hepatitis 13.24 10.36 8 84985 781 110503525
Hip arthroplasty 13.22 10.36 14 84979 55799 110448507
Therapy partial responder 13.14 10.36 6 84987 37055 110467251
Sputum increased 13.13 10.36 19 84974 5732 110498574
Cardiac disorder 13.13 10.36 102 84891 76178 110428128
Prader-Willi syndrome 12.99 10.36 3 84990 16 110504290
Pelvic pain 12.96 10.36 34 84959 15908 110488398
Hepatitis viral 12.91 10.36 10 84983 1465 110502841
Therapeutic product effect incomplete 12.85 10.36 110 84883 223695 110280611
Chest discomfort 12.74 10.36 196 84797 173652 110330654
Adverse event 12.71 10.36 42 84951 108767 110395539
Haemoptysis 12.60 10.36 96 84897 71258 110433048
Neoplasm progression 12.40 10.36 19 84974 64576 110439730
Abscess rupture 12.32 10.36 6 84987 381 110503925
Disability 12.19 10.36 4 84989 30219 110474087
Haemolytic uraemic syndrome 12.16 10.36 17 84976 4968 110499338
Nasal congestion 12.04 10.36 122 84871 98160 110406146
Confusional state 11.85 10.36 272 84721 468408 110035898
Adverse reaction 11.79 10.36 4 84989 29590 110474716
Tracheal injury 11.74 10.36 5 84988 232 110504074
Dysgeusia 11.72 10.36 93 84900 69892 110434414
Blood pressure fluctuation 11.69 10.36 25 84968 74799 110429507
Haemodialysis 11.66 10.36 35 84958 17684 110486622
Alcohol withdrawal syndrome 11.59 10.36 11 84982 2119 110502187
Left atrial dilatation 11.59 10.36 14 84979 3546 110500760
Tremor 11.55 10.36 219 84774 202013 110302293
Dose calculation error 11.53 10.36 6 84987 439 110503867
Lung disorder 11.49 10.36 86 84907 179961 110324345
Skin irritation 11.47 10.36 33 84960 16286 110488020
Post procedural haematoma 11.36 10.36 12 84981 2627 110501679
Cystic fibrosis 11.34 10.36 16 84977 4715 110499591
Necrotising colitis 11.33 10.36 10 84983 1755 110502551
White blood cell count decreased 11.30 10.36 243 84750 229147 110275159
Pneumonia necrotising 11.29 10.36 10 84983 1765 110502541
Biopsy liver abnormal 11.23 10.36 6 84987 463 110503843
Laryngeal pain 11.18 10.36 18 84975 5957 110498349
Injury 11.15 10.36 85 84908 177180 110327126
Blood pressure diastolic decreased 10.98 10.36 7 84986 35878 110468428
Cardiac failure congestive 10.97 10.36 170 84823 150830 110353476
Anion gap increased 10.88 10.36 15 84978 4329 110499977
Chromaturia 10.80 10.36 48 84945 29312 110474994
Complication associated with device 10.80 10.36 37 84956 20036 110484270
Injection site haemorrhage 10.68 10.36 52 84941 32976 110471330
Tachypnoea 10.64 10.36 59 84934 39336 110464970
Bone pain 10.61 10.36 86 84907 65047 110439259
Brain herniation 10.61 10.36 22 84971 8841 110495465
Squamous cell carcinoma of the tongue 10.52 10.36 7 84986 808 110503498
Cardiac pacemaker insertion 10.48 10.36 18 84975 6283 110498023
No adverse event 10.46 10.36 26 84967 73813 110430493
Drug ineffective for unapproved indication 10.45 10.36 123 84870 102715 110401591
Nausea 10.43 10.36 1093 83900 1234597 109269709
Weight 10.42 10.36 3 84990 42 110504264
Dialysis 10.41 10.36 36 84957 19583 110484723

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R05CB01 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
Mucolytics
ATC S01XA08 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
ATC V03AB23 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Antidotes
FDA PE N0000008867 Decreased Respiratory Secretion Viscosity
FDA EPC N0000175429 Antidote
FDA MoA N0000175547 Reduction Activity
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000975 Antioxidants
MeSH PA D000998 Antiviral Agents
MeSH PA D005100 Expectorants
MeSH PA D016166 Free Radical Scavengers
MeSH PA D019141 Respiratory System Agents
FDA EPC N0000175776 Mucolytic
FDA PE N0000175960 Increased Glutathione Concentration
FDA EPC N0000175961 Antidote for Acetaminophen Overdose
CHEBI has role CHEBI:22586 antioxidants
CHEBI has role CHEBI:35441 antiinfective agents
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:48578 free radical scavengers
CHEBI has role CHEBI:73336 wound-healing drug
CHEBI has role CHEBI:74529 antidotes to acetaminophen poisoning
CHEBI has role CHEBI:77034 mucolytics
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:173084 ferroptosis inhibitors
CHEBI has role CHEBI:176497 geroprotectors

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

DiseaseRelationSNOMED_IDDOID
Bronchiectasis indication 12295008 DOID:9563
Amyloidosis indication 17602002 DOID:9120
Bronchitis indication 32398004 DOID:6132
General anesthesia indication 50697003
Poisoning by acetaminophen indication 70273001
Cystic fibrosis of the lung indication 86555001
Support of pincer nail correction indication 247486000
Atelectasis due to Mucous Obstruction indication
Thick Bronchial Secretions indication
Contrast Media-Induced Nephrotoxicity Prevention indication
Meconium ileus off-label use 206523001
Bronchial Studies off-label use
Bronchospasm contraindication 4386001
Peptic ulcer contraindication 13200003 DOID:750
Esophageal varices contraindication 28670008
Low blood pressure contraindication 45007003
Decreased respiratory function contraindication 80954004
Acute exacerbation of asthma contraindication 708038006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.22 acidic
pKa2 9.96 acidic
pKa3 12.92 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 9327028 July 21, 2031 COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 8722738 April 6, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 8747894 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 9561204 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 8747894 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 9561204 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS Nov. 26, 2027 ADDITION OF A TWO-BAG DOSING REGIMEN

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Cytochrome c Enzyme WOMBAT-PK
Vascular endothelial growth factor A Secreted WOMBAT-PK
Superoxide dismutase [Mn], mitochondrial Enzyme WOMBAT-PK
Glutathione synthetase Enzyme MODULATOR DRUGBANK
Cystine/glutamate transporter Transporter MODULATOR SCIENTIFIC LITERATURE

External reference:

IDSource
4018810 VUID
N0000147113 NUI
D00221 KEGG_DRUG
197 RXNORM
C0001047 UMLSCUI
CHEBI:28939 CHEBI
CHEMBL600 ChEMBL_ID
DB06151 DRUGBANK_ID
D000111 MESH_DESCRIPTOR_UI
12035 PUBCHEM_CID
1535 INN_ID
10945 IUPHAR_LIGAND_ID
WYQ7N0BPYC UNII
4127 MMSL
48605 MMSL
893 MMSL
d00762 MMSL
1ZT PDB_CHEM_ID
SC2 PDB_CHEM_ID
4018810 VANDF
000720 NDDF
003524 NDDF
387440002 SNOMEDCT_US
77731008 SNOMEDCT_US
WYQ7N0BPYC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9433 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 27 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3307 SOLUTION 100 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3308 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7504 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7510 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7604 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7610 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7630 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0574-0805 INJECTION 200 mg INTRAVENOUS NDA authorized generic 23 sections
ACETYLCYSTEINE Human Prescription Drug Label 1 14445-412 INJECTION 200 mg INTRAVENOUS ANDA 21 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 17478-660 INJECTION 200 mg INTRAVENOUS ANDA 22 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 25021-812 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 23 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 25021-812 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 23 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 42494-435 SOLUTION 100 mg RESPIRATORY (INHALATION) ANDA 19 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 42494-436 SOLUTION 200 mg RESPIRATORY (INHALATION) ANDA 19 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 54868-5670 SOLUTION 200 mg ORAL ANDA 18 sections
Acetylcysteine Human Prescription Drug Label 1 55150-259 INJECTION, SOLUTION 6 g INTRAVENOUS ANDA 22 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5730 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5730 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5731 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5731 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
Folcyteine HUMAN PRESCRIPTION DRUG LABEL 5 59088-795 TABLET 200 mg ORAL unapproved drug other 11 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-690 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-690 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-691 SOLUTION 100 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-692 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-693 SOLUTION 100 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-694 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-694 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-695 SOLUTION 100 mg ORAL ANDA 17 sections