pravastatin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antihyperlipidaemic substances, HMG CoA reductase inhibitors | 2239 | 81093-37-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 30 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1.57 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Hosey CM, Chan R, Benet LZ |
| S (Water solubility) | 300 mg/mL | Hosey CM, Chan R, Benet LZ |
| EoM (Fraction excreted unchanged in urine) | 47 % | Hosey CM, Chan R, Benet LZ |
| BA (Bioavailability) | 18 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.46 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 14 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.50 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 0.78 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 31, 1991 | FDA | BRISTOL MYERS SQUIBB |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myalgia | 162.71 | 10.66 | 350 | 44996 | 123969 | 50435809 |
| Contraindicated product administered | 100.38 | 10.66 | 9 | 45337 | 148949 | 50410829 |
| Acute kidney injury | 88.16 | 10.66 | 421 | 44925 | 227637 | 50332141 |
| Systemic lupus erythematosus | 83.62 | 10.66 | 13 | 45333 | 140609 | 50419169 |
| Drug ineffective | 80.15 | 10.66 | 421 | 44925 | 818912 | 49740866 |
| Synovitis | 79.50 | 10.66 | 9 | 45337 | 123856 | 50435922 |
| Hand deformity | 76.67 | 10.66 | 3 | 45343 | 100196 | 50459582 |
| Product dose omission issue | 76.62 | 10.66 | 347 | 44999 | 183491 | 50376287 |
| Hyperkalaemia | 65.81 | 10.66 | 138 | 45208 | 47951 | 50511827 |
| Atrioventricular block second degree | 63.73 | 10.66 | 40 | 45306 | 3581 | 50556197 |
| Glossodynia | 63.67 | 10.66 | 13 | 45333 | 115556 | 50444222 |
| Maternal exposure during pregnancy | 63.36 | 10.66 | 32 | 45314 | 159746 | 50400032 |
| Fall | 58.37 | 10.66 | 505 | 44841 | 334427 | 50225351 |
| Toxicity to various agents | 57.91 | 10.66 | 63 | 45283 | 212436 | 50347342 |
| Lactic acidosis | 55.63 | 10.66 | 104 | 45242 | 33251 | 50526527 |
| Treatment failure | 55.42 | 10.66 | 27 | 45319 | 137610 | 50422168 |
| Pericarditis | 55.08 | 10.66 | 4 | 45342 | 78685 | 50481093 |
| Lower respiratory tract infection | 53.93 | 10.66 | 10 | 45336 | 95191 | 50464587 |
| Muscle spasms | 51.51 | 10.66 | 236 | 45110 | 125317 | 50434461 |
| Myopathy | 50.49 | 10.66 | 51 | 45295 | 9088 | 50550690 |
| Wound | 50.40 | 10.66 | 16 | 45330 | 105778 | 50454000 |
| Exposure during pregnancy | 49.85 | 10.66 | 23 | 45323 | 120992 | 50438786 |
| Pulseless electrical activity | 48.87 | 10.66 | 44 | 45302 | 6797 | 50552981 |
| Bezoar | 45.99 | 10.66 | 23 | 45323 | 1325 | 50558453 |
| Infusion related reaction | 45.38 | 10.66 | 51 | 45295 | 169506 | 50390272 |
| Insulin autoimmune syndrome | 44.72 | 10.66 | 11 | 45335 | 67 | 50559711 |
| Arthropathy | 42.80 | 10.66 | 47 | 45299 | 157859 | 50401919 |
| Drug hypersensitivity | 42.38 | 10.66 | 376 | 44970 | 250634 | 50309144 |
| Drug abuse | 42.01 | 10.66 | 3 | 45343 | 59843 | 50499935 |
| Completed suicide | 39.46 | 10.66 | 36 | 45310 | 131853 | 50427925 |
| Full blood count decreased | 38.92 | 10.66 | 71 | 45275 | 22275 | 50537503 |
| Diarrhoea | 38.57 | 10.66 | 740 | 44606 | 587736 | 49972042 |
| Drug intolerance | 36.26 | 10.66 | 90 | 45256 | 219014 | 50340764 |
| Decreased bronchial secretion | 35.63 | 10.66 | 9 | 45337 | 62 | 50559716 |
| Discomfort | 35.61 | 10.66 | 27 | 45319 | 108353 | 50451425 |
| Chronic kidney disease | 33.82 | 10.66 | 95 | 45251 | 39676 | 50520102 |
| Swelling | 32.85 | 10.66 | 83 | 45263 | 200789 | 50358989 |
| Blood thyroid stimulating hormone normal | 30.73 | 10.66 | 9 | 45337 | 114 | 50559664 |
| Joint swelling | 29.78 | 10.66 | 116 | 45230 | 245170 | 50314608 |
| Psoriasis | 28.49 | 10.66 | 130 | 45216 | 68870 | 50490908 |
| Acute interstitial pneumonitis | 28.48 | 10.66 | 13 | 45333 | 610 | 50559168 |
| Colitis microscopic | 28.27 | 10.66 | 32 | 45314 | 6488 | 50553290 |
| Hyponatraemia | 27.80 | 10.66 | 164 | 45182 | 95975 | 50463803 |
| Duodenal ulcer perforation | 27.59 | 10.66 | 4 | 45342 | 45607 | 50514171 |
| Immune-mediated myositis | 27.55 | 10.66 | 15 | 45331 | 1030 | 50558748 |
| Therapeutic product effect decreased | 25.66 | 10.66 | 52 | 45294 | 135998 | 50423780 |
| Electrocardiogram PR prolongation | 24.66 | 10.66 | 12 | 45334 | 651 | 50559127 |
| Hepatic enzyme increased | 24.66 | 10.66 | 54 | 45292 | 137326 | 50422452 |
| Atrioventricular block first degree | 24.48 | 10.66 | 29 | 45317 | 6172 | 50553606 |
| Malaise | 23.99 | 10.66 | 428 | 44918 | 335104 | 50224674 |
| Interstitial lung disease | 23.31 | 10.66 | 102 | 45244 | 53074 | 50506704 |
| Memory impairment | 22.69 | 10.66 | 135 | 45211 | 79225 | 50480553 |
| Muscle rupture | 22.14 | 10.66 | 17 | 45329 | 2105 | 50557673 |
| Asthenia | 21.75 | 10.66 | 404 | 44942 | 318638 | 50241140 |
| Decreased appetite | 21.20 | 10.66 | 274 | 45072 | 200649 | 50359129 |
| Adenocarcinoma metastatic | 20.64 | 10.66 | 6 | 45340 | 74 | 50559704 |
| Laryngitis | 20.60 | 10.66 | 36 | 45310 | 10920 | 50548858 |
| Abdominal discomfort | 19.76 | 10.66 | 124 | 45222 | 231517 | 50328261 |
| Alopecia | 19.48 | 10.66 | 134 | 45212 | 244913 | 50314865 |
| Post viral fatigue syndrome | 19.36 | 10.66 | 8 | 45338 | 294 | 50559484 |
| Fixed eruption | 19.27 | 10.66 | 11 | 45335 | 828 | 50558950 |
| Congenital coronary artery malformation | 19.08 | 10.66 | 6 | 45340 | 98 | 50559680 |
| Anaemia | 19.08 | 10.66 | 325 | 45021 | 252131 | 50307647 |
| Impaired healing | 18.64 | 10.66 | 21 | 45325 | 69765 | 50490013 |
| Axonal neuropathy | 18.28 | 10.66 | 11 | 45335 | 913 | 50558865 |
| Alexithymia | 18.06 | 10.66 | 3 | 45343 | 0 | 50559778 |
| Rhabdomyolysis | 17.98 | 10.66 | 76 | 45270 | 38951 | 50520827 |
| Muscular weakness | 17.92 | 10.66 | 146 | 45200 | 94867 | 50464911 |
| Glycosylated haemoglobin increased | 17.59 | 10.66 | 33 | 45313 | 10573 | 50549205 |
| Diabetic ketoacidosis | 17.52 | 10.66 | 45 | 45301 | 17827 | 50541951 |
| Rheumatoid arthritis | 17.49 | 10.66 | 108 | 45238 | 202442 | 50357336 |
| Atrial fibrillation | 16.91 | 10.66 | 152 | 45194 | 101593 | 50458185 |
| Suicide attempt | 16.84 | 10.66 | 13 | 45333 | 51719 | 50508059 |
| Blood glucose increased | 16.50 | 10.66 | 115 | 45231 | 71209 | 50488569 |
| Product dispensing error | 16.44 | 10.66 | 29 | 45317 | 8862 | 50550916 |
| Infection | 16.11 | 10.66 | 90 | 45256 | 172864 | 50386914 |
| Renal tubular disorder | 16.09 | 10.66 | 15 | 45331 | 2422 | 50557356 |
| Blood loss anaemia | 15.64 | 10.66 | 27 | 45319 | 8112 | 50551666 |
| Bacteriuria | 15.59 | 10.66 | 9 | 45337 | 692 | 50559086 |
| Hypersensitivity | 15.49 | 10.66 | 121 | 45225 | 215040 | 50344738 |
| Ear haemorrhage | 15.35 | 10.66 | 11 | 45335 | 1226 | 50558552 |
| Cerebral haemorrhage | 15.14 | 10.66 | 56 | 45290 | 26996 | 50532782 |
| Cutaneous T-cell lymphoma | 15.14 | 10.66 | 11 | 45335 | 1253 | 50558525 |
| Scratch | 14.52 | 10.66 | 20 | 45326 | 4942 | 50554836 |
| Cardiac murmur functional | 14.52 | 10.66 | 4 | 45342 | 40 | 50559738 |
| Viral infection | 14.29 | 10.66 | 59 | 45287 | 29927 | 50529851 |
| Blood folate decreased | 14.23 | 10.66 | 8 | 45338 | 585 | 50559193 |
| Skin depigmentation | 14.16 | 10.66 | 9 | 45337 | 823 | 50558955 |
| Iron deficiency anaemia | 14.10 | 10.66 | 40 | 45306 | 16794 | 50542984 |
| Vertigo | 14.07 | 10.66 | 87 | 45259 | 51745 | 50508033 |
| Dysmetria | 14.02 | 10.66 | 7 | 45339 | 402 | 50559376 |
| Gastrointestinal haemorrhage | 14.00 | 10.66 | 113 | 45233 | 73208 | 50486570 |
| Gastrointestinal disorder | 13.94 | 10.66 | 41 | 45305 | 94415 | 50465363 |
| Angular cheilitis | 13.90 | 10.66 | 7 | 45339 | 409 | 50559369 |
| Fanconi syndrome | 13.87 | 10.66 | 10 | 45336 | 1126 | 50558652 |
| Potassium wasting nephropathy | 13.86 | 10.66 | 4 | 45342 | 48 | 50559730 |
| Urinary incontinence | 13.83 | 10.66 | 56 | 45290 | 28152 | 50531626 |
| Tachycardia | 13.53 | 10.66 | 45 | 45301 | 99718 | 50460060 |
| Essential hypertension | 13.14 | 10.66 | 18 | 45328 | 4426 | 50555352 |
| Red blood cell sedimentation rate increased | 13.05 | 10.66 | 5 | 45341 | 29411 | 50530367 |
| Influenza | 13.00 | 10.66 | 130 | 45216 | 89408 | 50470370 |
| Ill-defined disorder | 12.97 | 10.66 | 18 | 45328 | 54636 | 50505142 |
| Alanine aminotransferase | 12.92 | 10.66 | 4 | 45342 | 62 | 50559716 |
| Dry gangrene | 12.84 | 10.66 | 7 | 45339 | 482 | 50559296 |
| Febrile neutropenia | 12.60 | 10.66 | 45 | 45301 | 97622 | 50462156 |
| Hypochloraemia | 12.57 | 10.66 | 11 | 45335 | 1636 | 50558142 |
| Restless legs syndrome | 12.57 | 10.66 | 37 | 45309 | 15860 | 50543918 |
| Normocytic anaemia | 12.48 | 10.66 | 10 | 45336 | 1317 | 50558461 |
| Aspartate aminotransferase | 12.41 | 10.66 | 4 | 45342 | 71 | 50559707 |
| Hyperlipidaemia | 12.23 | 10.66 | 39 | 45307 | 17451 | 50542327 |
| Haematoma | 12.23 | 10.66 | 57 | 45289 | 30453 | 50529325 |
| Vitamin B6 deficiency | 12.16 | 10.66 | 4 | 45342 | 76 | 50559702 |
| Nasal congestion | 12.16 | 10.66 | 83 | 45263 | 51037 | 50508741 |
| Melaena | 12.13 | 10.66 | 52 | 45294 | 26812 | 50532966 |
| C-reactive protein increased | 12.03 | 10.66 | 26 | 45320 | 66448 | 50493330 |
| Cardiac failure congestive | 12.00 | 10.66 | 122 | 45224 | 84260 | 50475518 |
| Mucosal inflammation | 11.94 | 10.66 | 11 | 45335 | 40131 | 50519647 |
| Respiratory arrest | 11.90 | 10.66 | 6 | 45340 | 30003 | 50529775 |
| Constipation | 11.88 | 10.66 | 233 | 45113 | 185475 | 50374303 |
| Uterine dilation and evacuation | 11.84 | 10.66 | 3 | 45343 | 21 | 50559757 |
| Gastric infection | 11.82 | 10.66 | 14 | 45332 | 2978 | 50556800 |
| Cerebral mass effect | 11.82 | 10.66 | 8 | 45338 | 814 | 50558964 |
| Bronchitis | 11.81 | 10.66 | 144 | 45202 | 104015 | 50455763 |
| Road traffic accident | 11.67 | 10.66 | 48 | 45298 | 24304 | 50535474 |
| Pericardial haemorrhage | 11.66 | 10.66 | 10 | 45336 | 1448 | 50558330 |
| Tubulointerstitial nephritis | 11.64 | 10.66 | 35 | 45311 | 15176 | 50544602 |
| Papillitis | 11.60 | 10.66 | 3 | 45343 | 23 | 50559755 |
| Ligament rupture | 11.54 | 10.66 | 13 | 45333 | 2621 | 50557157 |
| Polymyalgia rheumatica | 11.53 | 10.66 | 13 | 45333 | 2623 | 50557155 |
| Hepatotoxicity | 11.48 | 10.66 | 5 | 45341 | 27221 | 50532557 |
| Pancreatitis acute | 11.46 | 10.66 | 47 | 45299 | 23765 | 50536013 |
| Hepatitis cholestatic | 11.37 | 10.66 | 20 | 45326 | 6097 | 50553681 |
| Pulmonary renal syndrome | 11.27 | 10.66 | 6 | 45340 | 394 | 50559384 |
| Myxoedema | 11.25 | 10.66 | 4 | 45342 | 97 | 50559681 |
| Pain in extremity | 11.22 | 10.66 | 322 | 45024 | 272543 | 50287235 |
| Ocular retrobulbar haemorrhage | 10.88 | 10.66 | 4 | 45342 | 107 | 50559671 |
| Hip arthroplasty | 10.75 | 10.66 | 7 | 45339 | 30422 | 50529356 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myalgia | 156.85 | 11.08 | 306 | 36034 | 73713 | 29464474 |
| Acute kidney injury | 60.22 | 11.08 | 542 | 35798 | 264725 | 29273462 |
| Drug abuse | 56.99 | 11.08 | 14 | 36326 | 79869 | 29458318 |
| Shone complex | 49.82 | 11.08 | 13 | 36327 | 72 | 29538115 |
| Blood creatine phosphokinase increased | 49.29 | 11.08 | 135 | 36205 | 40509 | 29497678 |
| Myopathy | 45.00 | 11.08 | 60 | 36280 | 10473 | 29527714 |
| Interstitial lung disease | 38.79 | 11.08 | 157 | 36183 | 57561 | 29480626 |
| Fall | 37.05 | 11.08 | 356 | 35984 | 176822 | 29361365 |
| Lactic acidosis | 35.21 | 11.08 | 99 | 36241 | 30148 | 29508039 |
| Supravalvular aortic stenosis | 35.09 | 11.08 | 9 | 36331 | 46 | 29538141 |
| Aorta hypoplasia | 35.05 | 11.08 | 10 | 36330 | 81 | 29538106 |
| Puncture site haematoma | 33.74 | 11.08 | 11 | 36329 | 145 | 29538042 |
| Intraocular haematoma | 32.25 | 11.08 | 7 | 36333 | 14 | 29538173 |
| Drug interaction | 31.19 | 11.08 | 375 | 35965 | 197010 | 29341177 |
| Muscle rupture | 30.93 | 11.08 | 23 | 36317 | 1974 | 29536213 |
| Exercise lack of | 28.38 | 11.08 | 9 | 36331 | 108 | 29538079 |
| Phaeochromocytoma malignant | 27.29 | 11.08 | 8 | 36332 | 72 | 29538115 |
| Febrile neutropenia | 26.43 | 11.08 | 62 | 36278 | 112178 | 29426009 |
| Completed suicide | 26.28 | 11.08 | 44 | 36296 | 90202 | 29447985 |
| Hepatocellular injury | 25.18 | 11.08 | 70 | 36270 | 21173 | 29517014 |
| Congenital heart valve disorder | 24.72 | 11.08 | 7 | 36333 | 55 | 29538132 |
| Drug ineffective | 24.32 | 11.08 | 308 | 36032 | 362862 | 29175325 |
| Hyperkinetic heart syndrome | 24.23 | 11.08 | 8 | 36332 | 110 | 29538077 |
| Pseudolymphoma | 23.68 | 11.08 | 12 | 36328 | 515 | 29537672 |
| Treatment failure | 23.52 | 11.08 | 8 | 36332 | 36931 | 29501256 |
| Pemphigoid | 23.36 | 11.08 | 37 | 36303 | 7544 | 29530643 |
| Muscle spasms | 22.52 | 11.08 | 147 | 36193 | 64935 | 29473252 |
| Congenital aortic anomaly | 22.22 | 11.08 | 7 | 36333 | 82 | 29538105 |
| Mitral valve hypoplasia | 22.05 | 11.08 | 6 | 36334 | 40 | 29538147 |
| Gastritis fungal | 22.00 | 11.08 | 7 | 36333 | 85 | 29538102 |
| Coma uraemic | 21.92 | 11.08 | 6 | 36334 | 41 | 29538146 |
| Pericarditis fungal | 21.85 | 11.08 | 8 | 36332 | 152 | 29538035 |
| Cholestasis | 21.85 | 11.08 | 71 | 36269 | 23391 | 29514796 |
| Femoral artery aneurysm | 21.37 | 11.08 | 8 | 36332 | 162 | 29538025 |
| AST/ALT ratio abnormal | 21.36 | 11.08 | 5 | 36335 | 16 | 29538171 |
| Tendon rupture | 21.18 | 11.08 | 32 | 36308 | 6263 | 29531924 |
| Cerebral haematoma | 20.74 | 11.08 | 26 | 36314 | 4270 | 29533917 |
| Nephrogenic anaemia | 20.42 | 11.08 | 18 | 36322 | 1967 | 29536220 |
| Coarctation of the aorta | 19.12 | 11.08 | 10 | 36330 | 459 | 29537728 |
| Peripheral swelling | 19.11 | 11.08 | 139 | 36201 | 63600 | 29474587 |
| Toxicity to various agents | 19.06 | 11.08 | 130 | 36210 | 173531 | 29364656 |
| Aortic occlusion | 18.99 | 11.08 | 6 | 36334 | 71 | 29538116 |
| Myotonic dystrophy | 18.84 | 11.08 | 6 | 36334 | 73 | 29538114 |
| Xerosis | 18.70 | 11.08 | 10 | 36330 | 480 | 29537707 |
| Angina pectoris | 18.09 | 11.08 | 75 | 36265 | 27775 | 29510412 |
| Haemorrhagic transformation stroke | 17.93 | 11.08 | 14 | 36326 | 1292 | 29536895 |
| Arteriovenous fistula | 17.81 | 11.08 | 11 | 36329 | 695 | 29537492 |
| Subdural haematoma | 17.80 | 11.08 | 56 | 36284 | 18137 | 29520050 |
| Hyperlactacidaemia | 17.61 | 11.08 | 19 | 36321 | 2659 | 29535528 |
| Suicide attempt | 17.60 | 11.08 | 10 | 36330 | 34100 | 29504087 |
| Dependence on oxygen therapy | 17.56 | 11.08 | 7 | 36333 | 169 | 29538018 |
| Toxic optic neuropathy | 17.32 | 11.08 | 11 | 36329 | 730 | 29537457 |
| Intensive care unit acquired weakness | 17.21 | 11.08 | 12 | 36328 | 931 | 29537256 |
| Eosinophilic pneumonia | 16.66 | 11.08 | 19 | 36321 | 2827 | 29535360 |
| Lupus-like syndrome | 16.57 | 11.08 | 17 | 36323 | 2245 | 29535942 |
| Eosinophilic pleural effusion | 16.33 | 11.08 | 7 | 36333 | 204 | 29537983 |
| Hepatitis fulminant | 16.27 | 11.08 | 21 | 36319 | 3550 | 29534637 |
| Off label use | 16.26 | 11.08 | 266 | 36074 | 300534 | 29237653 |
| Hypoparathyroidism | 16.22 | 11.08 | 9 | 36331 | 465 | 29537722 |
| Cell death | 16.14 | 11.08 | 16 | 36324 | 2028 | 29536159 |
| Foetal exposure during pregnancy | 15.99 | 11.08 | 11 | 36329 | 33856 | 29504331 |
| Congenital aortic valve stenosis | 15.87 | 11.08 | 6 | 36334 | 125 | 29538062 |
| Sepsis | 15.55 | 11.08 | 107 | 36233 | 142575 | 29395612 |
| Heart transplant rejection | 15.08 | 11.08 | 12 | 36328 | 1139 | 29537048 |
| Diarrhoea | 15.07 | 11.08 | 524 | 35816 | 332174 | 29206013 |
| Transaminases abnormal | 15.01 | 11.08 | 7 | 36333 | 250 | 29537937 |
| Neutropenia | 14.74 | 11.08 | 98 | 36242 | 131613 | 29406574 |
| Thrombotic stroke | 14.70 | 11.08 | 7 | 36333 | 262 | 29537925 |
| Anti factor VIII antibody positive | 14.68 | 11.08 | 5 | 36335 | 76 | 29538111 |
| Left ventricular hypertrophy | 14.50 | 11.08 | 28 | 36312 | 6675 | 29531512 |
| Cerebrovascular accident | 14.31 | 11.08 | 151 | 36189 | 76760 | 29461427 |
| Thrombocytopenia | 14.25 | 11.08 | 102 | 36238 | 134721 | 29403466 |
| Glycosylated haemoglobin increased | 14.20 | 11.08 | 34 | 36306 | 9392 | 29528795 |
| Blood loss anaemia | 14.10 | 11.08 | 29 | 36311 | 7237 | 29530950 |
| Agitation | 14.03 | 11.08 | 26 | 36314 | 51278 | 29486909 |
| Hepatitis cholestatic | 13.95 | 11.08 | 28 | 36312 | 6865 | 29531322 |
| Constipation | 13.88 | 11.08 | 207 | 36133 | 113953 | 29424234 |
| Neutrophil count decreased | 13.86 | 11.08 | 20 | 36320 | 43547 | 29494640 |
| Congenital aortic stenosis | 13.85 | 11.08 | 5 | 36335 | 91 | 29538096 |
| Fatigue | 13.85 | 11.08 | 497 | 35843 | 316324 | 29221863 |
| Chronic kidney disease | 13.67 | 11.08 | 84 | 36256 | 36332 | 29501855 |
| Gait disturbance | 13.64 | 11.08 | 144 | 36196 | 73205 | 29464982 |
| Meningitis fungal | 13.56 | 11.08 | 5 | 36335 | 97 | 29538090 |
| Orthostatic tremor | 13.51 | 11.08 | 3 | 36337 | 7 | 29538180 |
| Echocardiogram abnormal | 13.42 | 11.08 | 10 | 36330 | 861 | 29537326 |
| Brain injury | 13.14 | 11.08 | 24 | 36316 | 5488 | 29532699 |
| Therapeutic response decreased | 13.10 | 11.08 | 7 | 36333 | 24704 | 29513483 |
| Bladder cyst | 12.81 | 11.08 | 5 | 36335 | 114 | 29538073 |
| Conjunctival haemorrhage | 12.74 | 11.08 | 16 | 36324 | 2632 | 29535555 |
| Hyperkalaemia | 12.60 | 11.08 | 123 | 36217 | 61269 | 29476918 |
| Diaphragmatic disorder | 12.36 | 11.08 | 10 | 36330 | 972 | 29537215 |
| Infusion related reaction | 12.22 | 11.08 | 22 | 36318 | 43864 | 29494323 |
| Eczema | 12.12 | 11.08 | 41 | 36299 | 13785 | 29524402 |
| Ketonuria | 12.06 | 11.08 | 8 | 36332 | 572 | 29537615 |
| Heart disease congenital | 11.97 | 11.08 | 11 | 36329 | 1269 | 29536918 |
| Hypoxic-ischaemic encephalopathy | 11.96 | 11.08 | 20 | 36320 | 4264 | 29533923 |
| Cardiogenic shock | 11.93 | 11.08 | 51 | 36289 | 19139 | 29519048 |
| Electrocardiogram ST segment depression | 11.81 | 11.08 | 14 | 36326 | 2171 | 29536016 |
| General physical health deterioration | 11.77 | 11.08 | 76 | 36264 | 102781 | 29435406 |
| Toxic epidermal necrolysis | 11.44 | 11.08 | 4 | 36336 | 18149 | 29520038 |
| Pruritus | 11.28 | 11.08 | 204 | 36136 | 116645 | 29421542 |
| Myoglobin urine | 11.16 | 11.08 | 3 | 36337 | 19 | 29538168 |
| Wrong dose | 11.15 | 11.08 | 7 | 36333 | 455 | 29537732 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myalgia | 249.27 | 10.07 | 533 | 68172 | 158084 | 64271943 |
| Acute kidney injury | 146.43 | 10.07 | 897 | 67808 | 448343 | 63981684 |
| Drug abuse | 92.51 | 10.07 | 15 | 68690 | 132359 | 64297668 |
| Lactic acidosis | 90.18 | 10.07 | 201 | 68504 | 61209 | 64368818 |
| Drug ineffective | 83.11 | 10.07 | 540 | 68165 | 839707 | 63590320 |
| Fall | 82.65 | 10.07 | 740 | 67965 | 416086 | 64013941 |
| Myopathy | 77.61 | 10.07 | 95 | 68610 | 17585 | 64412442 |
| Toxicity to various agents | 76.80 | 10.07 | 171 | 68534 | 363342 | 64066685 |
| Hyperkalaemia | 73.48 | 10.07 | 256 | 68449 | 100873 | 64329154 |
| Completed suicide | 70.57 | 10.07 | 81 | 68624 | 224333 | 64205694 |
| Synovitis | 69.74 | 10.07 | 11 | 68694 | 99079 | 64330948 |
| Contraindicated product administered | 61.74 | 10.07 | 19 | 68686 | 107810 | 64322217 |
| Interstitial lung disease | 61.38 | 10.07 | 236 | 68469 | 97496 | 64332531 |
| Maternal exposure during pregnancy | 54.71 | 10.07 | 17 | 68688 | 95867 | 64334160 |
| Hand deformity | 54.58 | 10.07 | 3 | 68702 | 62768 | 64367259 |
| Muscle spasms | 53.79 | 10.07 | 294 | 68411 | 140729 | 64289298 |
| Treatment failure | 51.82 | 10.07 | 30 | 68675 | 116786 | 64313241 |
| Blood creatine phosphokinase increased | 50.36 | 10.07 | 157 | 68548 | 58401 | 64371626 |
| Infusion related reaction | 47.85 | 10.07 | 63 | 68642 | 164404 | 64265623 |
| Exposure during pregnancy | 47.61 | 10.07 | 12 | 68693 | 77663 | 64352364 |
| Lower respiratory tract infection | 46.89 | 10.07 | 21 | 68684 | 94593 | 64335434 |
| Systemic lupus erythematosus | 45.66 | 10.07 | 13 | 68692 | 77599 | 64352428 |
| Pericarditis | 43.85 | 10.07 | 7 | 68698 | 62509 | 64367518 |
| Atrioventricular block second degree | 42.72 | 10.07 | 43 | 68662 | 6411 | 64423616 |
| Drug interaction | 39.77 | 10.07 | 573 | 68132 | 361510 | 64068517 |
| Arthropathy | 37.63 | 10.07 | 44 | 68661 | 120923 | 64309104 |
| Muscle rupture | 36.50 | 10.07 | 29 | 68676 | 3171 | 64426856 |
| Product dose omission issue | 35.06 | 10.07 | 339 | 68366 | 194408 | 64235619 |
| Puncture site haematoma | 34.29 | 10.07 | 11 | 68694 | 160 | 64429867 |
| Glossodynia | 34.26 | 10.07 | 13 | 68692 | 64683 | 64365344 |
| Decreased bronchial secretion | 33.84 | 10.07 | 9 | 68696 | 64 | 64429963 |
| Joint swelling | 33.73 | 10.07 | 117 | 68588 | 215265 | 64214762 |
| Febrile neutropenia | 33.56 | 10.07 | 96 | 68609 | 187561 | 64242466 |
| Hyponatraemia | 33.30 | 10.07 | 271 | 68434 | 148068 | 64281959 |
| Glycosylated haemoglobin increased | 32.52 | 10.07 | 60 | 68645 | 15959 | 64414068 |
| Drug hypersensitivity | 30.88 | 10.07 | 388 | 68317 | 237427 | 64192600 |
| Intraocular haematoma | 30.76 | 10.07 | 7 | 68698 | 23 | 64430004 |
| Chronic kidney disease | 30.13 | 10.07 | 132 | 68573 | 57787 | 64372240 |
| Bezoar | 29.59 | 10.07 | 22 | 68683 | 2181 | 64427846 |
| Suicide attempt | 29.06 | 10.07 | 20 | 68685 | 70987 | 64359040 |
| Blood thyroid stimulating hormone normal | 29.06 | 10.07 | 9 | 68696 | 116 | 64429911 |
| Phaeochromocytoma malignant | 28.42 | 10.07 | 8 | 68697 | 72 | 64429955 |
| Immune-mediated myositis | 27.86 | 10.07 | 23 | 68682 | 2655 | 64427372 |
| Full blood count decreased | 27.78 | 10.07 | 69 | 68636 | 22513 | 64407514 |
| Cholestasis | 27.05 | 10.07 | 107 | 68598 | 44765 | 64385262 |
| Blood loss anaemia | 26.91 | 10.07 | 51 | 68654 | 13841 | 64416186 |
| Pemphigoid | 26.82 | 10.07 | 49 | 68656 | 12937 | 64417090 |
| Cerebral haematoma | 25.87 | 10.07 | 35 | 68670 | 7150 | 64422877 |
| Wound | 25.79 | 10.07 | 26 | 68679 | 76451 | 64353576 |
| Subdural haematoma | 25.78 | 10.07 | 77 | 68628 | 27977 | 64402050 |
| Hepatocellular injury | 24.99 | 10.07 | 105 | 68600 | 45130 | 64384897 |
| Diarrhoea | 24.79 | 10.07 | 972 | 67733 | 721732 | 63708295 |
| Hyperkinetic heart syndrome | 24.71 | 10.07 | 8 | 68697 | 120 | 64429907 |
| Shone complex | 24.36 | 10.07 | 6 | 68699 | 30 | 64429997 |
| Mitral valve hypoplasia | 24.36 | 10.07 | 6 | 68699 | 30 | 64429997 |
| Congenital aortic valve stenosis | 24.19 | 10.07 | 6 | 68699 | 31 | 64429996 |
| Aorta hypoplasia | 24.03 | 10.07 | 6 | 68699 | 32 | 64429995 |
| Drug intolerance | 23.82 | 10.07 | 111 | 68594 | 187881 | 64242146 |
| Helicobacter infection | 23.36 | 10.07 | 6 | 68699 | 38356 | 64391671 |
| Insulin autoimmune syndrome | 23.02 | 10.07 | 10 | 68695 | 349 | 64429678 |
| Congenital heart valve disorder | 22.90 | 10.07 | 6 | 68699 | 40 | 64429987 |
| Coma uraemic | 22.64 | 10.07 | 6 | 68699 | 42 | 64429985 |
| Off label use | 22.30 | 10.07 | 509 | 68196 | 632297 | 63797730 |
| Heart transplant rejection | 22.26 | 10.07 | 15 | 68690 | 1272 | 64428755 |
| Pericarditis fungal | 22.17 | 10.07 | 8 | 68697 | 169 | 64429858 |
| Duodenal ulcer perforation | 21.90 | 10.07 | 5 | 68700 | 34620 | 64395407 |
| AST/ALT ratio abnormal | 21.84 | 10.07 | 5 | 68700 | 17 | 64430010 |
| Femoral artery aneurysm | 21.46 | 10.07 | 8 | 68697 | 186 | 64429841 |
| Eczema | 21.36 | 10.07 | 75 | 68630 | 29645 | 64400382 |
| Pulseless electrical activity | 21.34 | 10.07 | 44 | 68661 | 12695 | 64417332 |
| Atrial fibrillation | 20.86 | 10.07 | 276 | 68429 | 170813 | 64259214 |
| Coarctation of the aorta | 20.75 | 10.07 | 6 | 68699 | 60 | 64429967 |
| Gait disturbance | 20.69 | 10.07 | 277 | 68428 | 171878 | 64258149 |
| Therapeutic product effect decreased | 20.62 | 10.07 | 59 | 68646 | 115292 | 64314735 |
| Hepatitis cholestatic | 20.38 | 10.07 | 42 | 68663 | 12113 | 64417914 |
| Supravalvular aortic stenosis | 20.30 | 10.07 | 5 | 68700 | 25 | 64430002 |
| Congenital aortic stenosis | 20.30 | 10.07 | 5 | 68700 | 25 | 64430002 |
| Congenital aortic anomaly | 20.30 | 10.07 | 5 | 68700 | 25 | 64430002 |
| Rhabdomyolysis | 20.26 | 10.07 | 167 | 68538 | 91559 | 64338468 |
| Congenital coronary artery malformation | 20.24 | 10.07 | 6 | 68699 | 66 | 64429961 |
| Myositis | 20.10 | 10.07 | 50 | 68655 | 16327 | 64413700 |
| Acute interstitial pneumonitis | 20.04 | 10.07 | 13 | 68692 | 1034 | 64428993 |
| Myotonic dystrophy | 19.76 | 10.07 | 6 | 68699 | 72 | 64429955 |
| Infection | 19.59 | 10.07 | 116 | 68589 | 184764 | 64245263 |
| Laryngitis | 19.54 | 10.07 | 39 | 68666 | 10992 | 64419035 |
| Swelling | 19.47 | 10.07 | 96 | 68609 | 160122 | 64269905 |
| Hypersensitivity | 19.39 | 10.07 | 126 | 68579 | 196326 | 64233701 |
| Asthenia | 19.20 | 10.07 | 594 | 68111 | 427450 | 64002577 |
| Atrioventricular block first degree | 19.08 | 10.07 | 38 | 68667 | 10696 | 64419331 |
| Toxic optic neuropathy | 18.72 | 10.07 | 12 | 68693 | 935 | 64429092 |
| Tachycardia | 18.54 | 10.07 | 89 | 68616 | 149490 | 64280537 |
| Adenocarcinoma metastatic | 18.18 | 10.07 | 6 | 68699 | 96 | 64429931 |
| Exercise lack of | 18.05 | 10.07 | 9 | 68696 | 432 | 64429595 |
| Patent ductus arteriosus | 18.01 | 10.07 | 6 | 68699 | 99 | 64429928 |
| Gastritis fungal | 17.90 | 10.07 | 7 | 68698 | 186 | 64429841 |
| Colitis microscopic | 17.89 | 10.07 | 30 | 68675 | 7402 | 64422625 |
| Haemorrhagic transformation stroke | 17.83 | 10.07 | 17 | 68688 | 2372 | 64427655 |
| Pseudolymphoma | 17.82 | 10.07 | 12 | 68693 | 1017 | 64429010 |
| Folliculitis | 17.76 | 10.07 | 5 | 68700 | 30072 | 64399955 |
| Rheumatoid arthritis | 17.45 | 10.07 | 103 | 68602 | 164191 | 64265836 |
| Toxic epidermal necrolysis | 17.26 | 10.07 | 9 | 68696 | 37157 | 64392870 |
| Cerebrovascular accident | 16.79 | 10.07 | 222 | 68483 | 137361 | 64292666 |
| Arteriovenous fistula | 16.73 | 10.07 | 11 | 68694 | 895 | 64429132 |
| Tendon rupture | 16.65 | 10.07 | 36 | 68669 | 10731 | 64419296 |
| Hyperlactacidaemia | 16.54 | 10.07 | 23 | 68682 | 4821 | 64425206 |
| Heart disease congenital | 16.49 | 10.07 | 9 | 68696 | 521 | 64429506 |
| Haematoma | 16.01 | 10.07 | 94 | 68611 | 46156 | 64383871 |
| Corneal dystrophy | 15.99 | 10.07 | 7 | 68698 | 249 | 64429778 |
| Therapy non-responder | 15.57 | 10.07 | 29 | 68676 | 65870 | 64364157 |
| Eosinophilic pleural effusion | 15.56 | 10.07 | 7 | 68698 | 266 | 64429761 |
| Melaena | 15.52 | 10.07 | 104 | 68601 | 53444 | 64376583 |
| Discomfort | 15.48 | 10.07 | 40 | 68665 | 80838 | 64349189 |
| Fixed eruption | 15.43 | 10.07 | 15 | 68690 | 2144 | 64427883 |
| Red blood cell sedimentation rate increased | 15.37 | 10.07 | 7 | 68698 | 31228 | 64398799 |
| Mucosal inflammation | 15.27 | 10.07 | 27 | 68678 | 62557 | 64367470 |
| Anti factor VIII antibody positive | 15.26 | 10.07 | 5 | 68700 | 78 | 64429949 |
| Angina pectoris | 15.20 | 10.07 | 91 | 68614 | 44990 | 64385037 |
| Left ventricular failure | 15.20 | 10.07 | 30 | 68675 | 8387 | 64421640 |
| Intentional self-injury | 15.10 | 10.07 | 6 | 68699 | 29038 | 64400989 |
| Post viral fatigue syndrome | 14.84 | 10.07 | 7 | 68698 | 297 | 64429730 |
| Electrocardiogram PR prolongation | 14.61 | 10.07 | 12 | 68693 | 1375 | 64428652 |
| Eosinophilic pneumonia | 14.54 | 10.07 | 21 | 68684 | 4556 | 64425471 |
| Hypoparathyroidism | 14.54 | 10.07 | 10 | 68695 | 877 | 64429150 |
| Axonal neuropathy | 14.49 | 10.07 | 13 | 68692 | 1679 | 64428348 |
| Bladder cyst | 14.02 | 10.07 | 5 | 68700 | 102 | 64429925 |
| Blood glucose increased | 14.01 | 10.07 | 163 | 68542 | 97910 | 64332117 |
| Bacteriuria | 14.00 | 10.07 | 10 | 68695 | 932 | 64429095 |
| Cardiac murmur functional | 13.93 | 10.07 | 4 | 68701 | 39 | 64429988 |
| Xerosis | 13.67 | 10.07 | 10 | 68695 | 967 | 64429060 |
| Respiratory depression | 13.65 | 10.07 | 4 | 68701 | 23439 | 64406588 |
| Transient ischaemic attack | 13.53 | 10.07 | 87 | 68618 | 44095 | 64385932 |
| Behaviour disorder | 13.49 | 10.07 | 20 | 68685 | 4442 | 64425585 |
| Flushing | 13.49 | 10.07 | 41 | 68664 | 78607 | 64351420 |
| Coma | 13.43 | 10.07 | 48 | 68657 | 87567 | 64342460 |
| Atrial hypertrophy | 13.41 | 10.07 | 4 | 68701 | 45 | 64429982 |
| Diabetic ketoacidosis | 13.29 | 10.07 | 65 | 68640 | 29780 | 64400247 |
| Neuroleptic malignant syndrome | 13.27 | 10.07 | 5 | 68700 | 24991 | 64405036 |
| Therapeutic response decreased | 13.21 | 10.07 | 22 | 68683 | 52166 | 64377861 |
| Intraventricular haemorrhage | 13.12 | 10.07 | 19 | 68686 | 4134 | 64425893 |
| Impaired healing | 13.10 | 10.07 | 28 | 68677 | 60445 | 64369582 |
| Polymyalgia rheumatica | 13.07 | 10.07 | 17 | 68688 | 3342 | 64426685 |
| Decreased appetite | 13.03 | 10.07 | 392 | 68313 | 280897 | 64149130 |
| Restless legs syndrome | 13.00 | 10.07 | 44 | 68661 | 17072 | 64412955 |
| Sedation | 12.97 | 10.07 | 15 | 68690 | 41447 | 64388580 |
| Psoriasis | 12.97 | 10.07 | 125 | 68580 | 71578 | 64358449 |
| Cerebral haemorrhage | 12.92 | 10.07 | 96 | 68609 | 50994 | 64379033 |
| Blood glucose abnormal | 12.88 | 10.07 | 29 | 68676 | 8884 | 64421143 |
| Haemorrhage intracranial | 12.85 | 10.07 | 55 | 68650 | 23829 | 64406198 |
| Malaise | 12.61 | 10.07 | 529 | 68176 | 395718 | 64034309 |
| Emotional distress | 12.44 | 10.07 | 12 | 68693 | 36026 | 64394001 |
| Intensive care unit acquired weakness | 12.35 | 10.07 | 12 | 68693 | 1715 | 64428312 |
| Pancreatitis acute | 12.28 | 10.07 | 83 | 68622 | 42772 | 64387255 |
| Glycosuria | 12.25 | 10.07 | 13 | 68692 | 2061 | 64427966 |
| Iron deficiency anaemia | 12.24 | 10.07 | 51 | 68654 | 21838 | 64408189 |
| Muscular weakness | 12.19 | 10.07 | 197 | 68508 | 127141 | 64302886 |
| Acute respiratory failure | 12.16 | 10.07 | 93 | 68612 | 49841 | 64380186 |
| Hepatitis fulminant | 12.11 | 10.07 | 23 | 68682 | 6251 | 64423776 |
| Cerebral infarction | 12.07 | 10.07 | 80 | 68625 | 40964 | 64389063 |
| Echocardiogram abnormal | 11.99 | 10.07 | 12 | 68693 | 1777 | 64428250 |
| Full blood count abnormal | 11.98 | 10.07 | 63 | 68642 | 29694 | 64400333 |
| Cholestatic liver injury | 11.87 | 10.07 | 17 | 68688 | 3662 | 64426365 |
| Cardiac failure congestive | 11.75 | 10.07 | 200 | 68505 | 130380 | 64299647 |
| Prostate cancer metastatic | 11.75 | 10.07 | 16 | 68689 | 3288 | 64426739 |
| Thrombotic stroke | 11.72 | 10.07 | 8 | 68697 | 693 | 64429334 |
| Adenocarcinoma of appendix | 11.63 | 10.07 | 4 | 68701 | 73 | 64429954 |
| Angular cheilitis | 11.51 | 10.07 | 7 | 68698 | 497 | 64429530 |
| Hepatic enzyme increased | 11.51 | 10.07 | 86 | 68619 | 129857 | 64300170 |
| Anaemia | 11.47 | 10.07 | 503 | 68202 | 378177 | 64051850 |
| Pain | 11.39 | 10.07 | 478 | 68227 | 553033 | 63876994 |
| Meningitis fungal | 11.39 | 10.07 | 5 | 68700 | 179 | 64429848 |
| Dystonia | 11.39 | 10.07 | 3 | 68702 | 18862 | 64411165 |
| Uterine dilation and evacuation | 11.32 | 10.07 | 3 | 68702 | 21 | 64430006 |
| Sopor | 11.30 | 10.07 | 9 | 68696 | 29652 | 64400375 |
| Transaminases abnormal | 11.17 | 10.07 | 8 | 68697 | 748 | 64429279 |
| Hypoxic-ischaemic encephalopathy | 11.16 | 10.07 | 24 | 68681 | 7128 | 64422899 |
| Acute hepatic failure | 11.16 | 10.07 | 7 | 68698 | 26105 | 64403922 |
| Premature delivery | 11.14 | 10.07 | 3 | 68702 | 18586 | 64411441 |
| Dysgeusia | 11.11 | 10.07 | 87 | 68618 | 46960 | 64383067 |
| Cutaneous lupus erythematosus | 11.11 | 10.07 | 14 | 68691 | 2668 | 64427359 |
| Muscle haemorrhage | 10.99 | 10.07 | 21 | 68684 | 5732 | 64424295 |
| Low density lipoprotein increased | 10.98 | 10.07 | 25 | 68680 | 7715 | 64422312 |
| Mouth ulceration | 10.97 | 10.07 | 11 | 68694 | 32433 | 64397594 |
| Electrocardiogram ST segment depression | 10.94 | 10.07 | 18 | 68687 | 4371 | 64425656 |
| Hypersensitivity vasculitis | 10.91 | 10.07 | 23 | 68682 | 6738 | 64423289 |
| Hallucination | 10.85 | 10.07 | 122 | 68583 | 72666 | 64357361 |
| Neurotoxicity | 10.84 | 10.07 | 8 | 68697 | 27396 | 64402631 |
| Oedema peripheral | 10.81 | 10.07 | 297 | 68408 | 210020 | 64220007 |
| Blood folate decreased | 10.76 | 10.07 | 9 | 68696 | 1058 | 64428969 |
| Memory impairment | 10.76 | 10.07 | 139 | 68566 | 85543 | 64344484 |
| Tendon disorder | 10.76 | 10.07 | 22 | 68683 | 6310 | 64423717 |
| Pyuria | 10.71 | 10.07 | 12 | 68693 | 2021 | 64428006 |
| Cerebral mass effect | 10.62 | 10.07 | 11 | 68694 | 1695 | 64428332 |
| Cell death | 10.62 | 10.07 | 17 | 68688 | 4037 | 64425990 |
| Therapy cessation | 10.59 | 10.07 | 65 | 68640 | 32424 | 64397603 |
| Hypochloraemia | 10.58 | 10.07 | 12 | 68693 | 2049 | 64427978 |
| Dry gangrene | 10.52 | 10.07 | 8 | 68697 | 820 | 64429207 |
| Scratch | 10.39 | 10.07 | 22 | 68683 | 6467 | 64423560 |
| Pericardial haemorrhage | 10.36 | 10.07 | 17 | 68688 | 4119 | 64425908 |
| Pyrexia | 10.35 | 10.07 | 488 | 68217 | 558156 | 63871871 |
| Diaphragmatic disorder | 10.35 | 10.07 | 10 | 68695 | 1418 | 64428609 |
| Squamous cell carcinoma of skin | 10.35 | 10.07 | 32 | 68673 | 11844 | 64418183 |
| Respiratory arrest | 10.30 | 10.07 | 26 | 68679 | 52959 | 64377068 |
| Vertigo | 10.25 | 10.07 | 102 | 68603 | 58909 | 64371118 |
| Myopathy toxic | 10.25 | 10.07 | 8 | 68697 | 853 | 64429174 |
| Alopecia | 10.22 | 10.07 | 120 | 68585 | 165570 | 64264457 |
| Food interaction | 10.13 | 10.07 | 10 | 68695 | 1456 | 64428571 |
| Ligament rupture | 10.13 | 10.07 | 13 | 68692 | 2523 | 64427504 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C10AA03 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN HMG CoA reductase inhibitors |
| ATC | C10BA03 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents |
| ATC | C10BA11 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents |
| ATC | C10BA12 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Combinations of various lipid modifying agents |
| ATC | C10BX02 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs |
| FDA MoA | N0000000121 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| FDA EPC | N0000175589 | HMG-CoA Reductase Inhibitor |
| CHEBI has role | CHEBI:25212 | metabolites |
| CHEBI has role | CHEBI:35703 | Xenobiotic |
| CHEBI has role | CHEBI:35821 | anticholesteremic drugs |
| CHEBI has role | CHEBI:78298 | environmental contaminants |
| MeSH PA | D000924 | Anticholesteremic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| MeSH PA | D000960 | Hypolipidemic Agents |
| MeSH PA | D057847 | Lipid Regulating Agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypercholesterolemia | indication | 13644009 | |
| Arteriosclerotic vascular disease | indication | 72092001 | |
| Cerebrovascular accident | indication | 230690007 | |
| Familial hypercholesterolemia - heterozygous | indication | 238079002 | |
| Mixed hyperlipidemia | indication | 267434003 | |
| Hypertriglyceridemia | indication | 302870006 | |
| Familial type 3 hyperlipoproteinemia | indication | 398796005 | DOID:3145 |
| Primary Prevention of Coronary Heart Disease | indication | ||
| Prevention of Transient Ischemic Attacks | indication | ||
| Myocardial Infarction Prevention | indication | ||
| Slow Progression of Coronary Artery Disease | indication | ||
| Alcoholism | contraindication | 7200002 | |
| Peptic ulcer | contraindication | 13200003 | DOID:750 |
| Constipation | contraindication | 14760008 | DOID:2089 |
| Sarcoidosis | contraindication | 31541009 | DOID:11335 |
| Dehydration | contraindication | 34095006 | |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Low blood pressure | contraindication | 45007003 | |
| Vitamin K deficiency | contraindication | 52675005 | DOID:11249 |
| Nasal polyp | contraindication | 52756005 | |
| Acute nephropathy | contraindication | 58574008 | |
| Diarrhea | contraindication | 62315008 | |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Hyperparathyroidism | contraindication | 66999008 | DOID:13543 |
| Factor II deficiency | contraindication | 73975000 | |
| Reye's syndrome | contraindication | 74351001 | DOID:14525 |
| Gastrointestinal hemorrhage | contraindication | 74474003 | |
| Thrombotic thrombocytopenic purpura | contraindication | 78129009 | DOID:10772 |
| Gout | contraindication | 90560007 | DOID:13189 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Hemophilia | contraindication | 90935002 | |
| Kidney stone | contraindication | 95570007 | |
| Anemia due to enzyme deficiency | contraindication | 111577008 | |
| von Willebrand disorder | contraindication | 128105004 | DOID:12531 |
| Disorder of muscle | contraindication | 129565002 | DOID:423 |
| Liver function tests abnormal | contraindication | 166603001 | |
| Osteolysis | contraindication | 203522001 | |
| Hemorrhagic cerebral infarction | contraindication | 230706003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Rhabdomyolysis | contraindication | 240131006 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Surgical procedure | contraindication | 387713003 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Traumatic injury | contraindication | 417746004 | |
| Acute erosive gastritis | contraindication | 444926003 | |
| Uncontrolled Epilepsy | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.44 | acidic |
| pKa2 | 13.74 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| 3-hydroxy-3-methylglutaryl-coenzyme A reductase | Enzyme | INHIBITOR | IC50 | 7.52 | CHEMBL | CHEMBL | |||
| 3-hydroxy-3-methylglutaryl-coenzyme A reductase | Enzyme | IC50 | 8.38 | CHEMBL | |||||
| Solute carrier family 22 member 6 | Transporter | Ki | 4.28 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4020548 | VUID |
| N0000148255 | NUI |
| D00893 | KEGG_DRUG |
| 81131-70-6 | SECONDARY_CAS_RN |
| 4020369 | VANDF |
| 4020548 | VANDF |
| C0085542 | UMLSCUI |
| CHEBI:63618 | CHEBI |
| CHEMBL1144 | ChEMBL_ID |
| CHEMBL690 | ChEMBL_ID |
| D017035 | MESH_DESCRIPTOR_UI |
| DB00175 | DRUGBANK_ID |
| 54687 | PUBCHEM_CID |
| 2953 | IUPHAR_LIGAND_ID |
| 6070 | INN_ID |
| KXO2KT9N0G | UNII |
| 203144 | RXNORM |
| 1884 | MMSL |
| 5343 | MMSL |
| 81574 | MMSL |
| d00348 | MMSL |
| 003606 | NDDF |
| 003607 | NDDF |
| 373566006 | SNOMEDCT_US |
| 96305006 | SNOMEDCT_US |
| 96306007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-0771 | TABLET | 10 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-0771 | TABLET | 10 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7201 | TABLET | 20 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7201 | TABLET | 20 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7202 | TABLET | 40 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7202 | TABLET | 40 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7270 | TABLET | 80 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7270 | TABLET | 80 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8029 | TABLET | 20 mg | ORAL | ANDA | 28 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8030 | TABLET | 40 mg | ORAL | ANDA | 28 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8158 | TABLET | 10 mg | ORAL | ANDA | 28 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8159 | TABLET | 80 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8410 | TABLET | 80 mg | ORAL | ANDA | 28 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5235 | TABLET | 80 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-5891 | TABLET | 10 mg | ORAL | ANDA | 28 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-5892 | TABLET | 20 mg | ORAL | ANDA | 28 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-5893 | TABLET | 40 mg | ORAL | ANDA | 28 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-440 | TABLET | 10 mg | ORAL | ANDA | 27 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-505 | TABLET | 20 mg | ORAL | ANDA | 27 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-507 | TABLET | 40 mg | ORAL | ANDA | 27 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-008 | TABLET | 10 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-008 | TABLET | 10 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-009 | TABLET | 20 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-009 | TABLET | 20 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-010 | TABLET | 40 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-010 | TABLET | 40 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-011 | TABLET | 80 mg | ORAL | ANDA | 29 sections |
| PRAVASTATIN SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-011 | TABLET | 80 mg | ORAL | ANDA | 29 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-178 | TABLET | 10 mg | ORAL | ANDA | 24 sections |
| Pravastatin Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-179 | TABLET | 20 mg | ORAL | ANDA | 24 sections |