isotretinoin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| retinol derivatives | 1508 | 4759-48-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 30 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.50 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 6.66 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 40 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 7, 1982 | FDA |
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 |
|---|---|---|---|---|---|---|
| Unintended pregnancy | 7323.88 | 21.20 | 1349 | 21639 | 3597 | 50578539 |
| Abortion induced | 2991.70 | 21.20 | 720 | 22268 | 8624 | 50573512 |
| Exposure during pregnancy | 2779.94 | 21.20 | 1262 | 21726 | 119753 | 50462383 |
| Pregnancy | 1893.72 | 21.20 | 650 | 22338 | 28927 | 50553209 |
| Depression | 1307.72 | 21.20 | 853 | 22135 | 164570 | 50417566 |
| Blood triglycerides increased | 1097.13 | 21.20 | 341 | 22647 | 10971 | 50571165 |
| Lip dry | 826.75 | 21.20 | 226 | 22762 | 4561 | 50577575 |
| Mood altered | 816.77 | 21.20 | 281 | 22707 | 12492 | 50569644 |
| Dry skin | 759.71 | 21.20 | 377 | 22611 | 42814 | 50539322 |
| Treatment noncompliance | 678.92 | 21.20 | 312 | 22676 | 29838 | 50552298 |
| Suicidal ideation | 676.86 | 21.20 | 379 | 22609 | 55006 | 50527130 |
| No adverse event | 601.76 | 21.20 | 297 | 22691 | 33281 | 50548855 |
| Pregnancy test false positive | 583.37 | 21.20 | 96 | 22892 | 83 | 50582053 |
| Abortion spontaneous | 551.67 | 21.20 | 301 | 22687 | 41471 | 50540665 |
| Mood swings | 380.54 | 21.20 | 172 | 22816 | 15782 | 50566354 |
| Selective abortion | 302.78 | 21.20 | 54 | 22934 | 107 | 50582029 |
| Pregnancy on oral contraceptive | 301.49 | 21.20 | 73 | 22915 | 885 | 50581251 |
| Drug exposure before pregnancy | 299.84 | 21.20 | 69 | 22919 | 660 | 50581476 |
| Maternal exposure during pregnancy | 216.83 | 21.20 | 312 | 22676 | 159466 | 50422670 |
| Chapped lips | 215.46 | 21.20 | 65 | 22923 | 1877 | 50580259 |
| Maternal exposure before pregnancy | 191.70 | 21.20 | 78 | 22910 | 5519 | 50576617 |
| Depressed mood | 184.31 | 21.20 | 140 | 22848 | 33883 | 50548253 |
| Dry eye | 180.36 | 21.20 | 135 | 22853 | 31960 | 50550176 |
| Headache | 176.04 | 21.20 | 566 | 22422 | 505969 | 50076167 |
| Anxiety | 174.40 | 21.20 | 299 | 22689 | 177307 | 50404829 |
| Sacroiliitis | 161.41 | 21.20 | 56 | 22932 | 2541 | 50579595 |
| Idiopathic intracranial hypertension | 155.11 | 21.20 | 53 | 22935 | 2296 | 50579840 |
| Crying | 154.44 | 21.20 | 103 | 22885 | 20313 | 50561823 |
| Blood cholesterol increased | 152.75 | 21.20 | 155 | 22833 | 55060 | 50527076 |
| Cheilitis | 146.97 | 21.20 | 57 | 22931 | 3553 | 50578583 |
| Product administration interrupted | 134.04 | 21.20 | 39 | 22949 | 990 | 50581146 |
| Pregnancy test positive | 127.26 | 21.20 | 25 | 22963 | 100 | 50582036 |
| Inflammatory bowel disease | 124.76 | 21.20 | 50 | 22938 | 3400 | 50578736 |
| Xerosis | 118.90 | 21.20 | 32 | 22956 | 605 | 50581531 |
| Adverse drug reaction | 117.55 | 21.20 | 135 | 22853 | 55087 | 50527049 |
| Pneumonia | 113.79 | 21.20 | 18 | 22970 | 378383 | 50203753 |
| Ectopic pregnancy | 113.75 | 21.20 | 42 | 22946 | 2285 | 50579851 |
| Pregnancy with contraceptive device | 113.38 | 21.20 | 49 | 22939 | 4030 | 50578106 |
| Pregnancy on contraceptive | 111.50 | 21.20 | 34 | 22954 | 1018 | 50581118 |
| Adverse event | 110.46 | 21.20 | 117 | 22871 | 43646 | 50538490 |
| Vaginal haemorrhage | 109.22 | 21.20 | 90 | 22898 | 24461 | 50557675 |
| Therapy cessation | 108.77 | 21.20 | 92 | 22896 | 25919 | 50556217 |
| Product dispensing error | 108.72 | 21.20 | 61 | 22927 | 8830 | 50573306 |
| Myalgia | 106.04 | 21.20 | 197 | 22791 | 124122 | 50458014 |
| Fall | 102.81 | 21.20 | 15 | 22973 | 334917 | 50247219 |
| Epistaxis | 100.15 | 21.20 | 134 | 22854 | 63820 | 50518316 |
| Dyspnoea | 94.59 | 21.20 | 67 | 22921 | 547541 | 50034595 |
| Vision blurred | 92.71 | 21.20 | 144 | 22844 | 78503 | 50503633 |
| Infectious mononucleosis | 92.36 | 21.20 | 33 | 22955 | 1633 | 50580503 |
| Diarrhoea | 87.99 | 21.20 | 83 | 22905 | 588393 | 49993743 |
| Normal newborn | 87.54 | 21.20 | 48 | 22940 | 6643 | 50575493 |
| Arthralgia | 87.51 | 21.20 | 412 | 22576 | 438290 | 50143846 |
| Self-injurious ideation | 86.51 | 21.20 | 34 | 22954 | 2195 | 50579941 |
| Haematochezia | 84.01 | 21.20 | 97 | 22891 | 39785 | 50542351 |
| Suicide attempt | 81.90 | 21.20 | 109 | 22879 | 51623 | 50530513 |
| Acne | 75.20 | 21.20 | 66 | 22922 | 19529 | 50562607 |
| Acute kidney injury | 72.80 | 21.20 | 9 | 22979 | 228049 | 50354087 |
| Epiphyses premature fusion | 70.38 | 21.20 | 13 | 22975 | 34 | 50582102 |
| Product quality issue | 69.99 | 21.20 | 78 | 22910 | 30780 | 50551356 |
| Rheumatoid arthritis | 69.79 | 21.20 | 6 | 22982 | 202544 | 50379592 |
| Night blindness | 69.73 | 21.20 | 19 | 22969 | 377 | 50581759 |
| Emotional disorder | 66.92 | 21.20 | 50 | 22938 | 11786 | 50570350 |
| Panic attack | 64.11 | 21.20 | 60 | 22928 | 19282 | 50562854 |
| Nasal dryness | 62.03 | 21.20 | 31 | 22957 | 3548 | 50578588 |
| Peripheral swelling | 61.34 | 21.20 | 10 | 22978 | 205926 | 50376210 |
| Abortion | 60.62 | 21.20 | 26 | 22962 | 2098 | 50580038 |
| Asthenia | 60.46 | 21.20 | 35 | 22953 | 319007 | 50263129 |
| Nasal vestibulitis | 59.10 | 21.20 | 10 | 22978 | 12 | 50582124 |
| Toxicity to various agents | 57.62 | 21.20 | 13 | 22975 | 212486 | 50369650 |
| Colitis ulcerative | 57.24 | 21.20 | 53 | 22935 | 16801 | 50565335 |
| Hypotension | 57.06 | 21.20 | 18 | 22970 | 235451 | 50346685 |
| Irritability | 56.29 | 21.20 | 67 | 22921 | 28359 | 50553777 |
| Contraindicated product administered | 55.41 | 21.20 | 3 | 22985 | 148955 | 50433181 |
| Infusion related reaction | 53.34 | 21.20 | 7 | 22981 | 169550 | 50412586 |
| Hidradenitis | 52.52 | 21.20 | 23 | 22965 | 1952 | 50580184 |
| Cough | 50.85 | 21.20 | 23 | 22965 | 241241 | 50340895 |
| Joint swelling | 50.74 | 21.20 | 24 | 22964 | 245262 | 50336874 |
| Infection | 48.06 | 21.20 | 10 | 22978 | 172944 | 50409192 |
| Arthropathy | 46.27 | 21.20 | 8 | 22980 | 157898 | 50424238 |
| Rectal haemorrhage | 45.95 | 21.20 | 71 | 22917 | 38487 | 50543649 |
| Synovitis | 44.54 | 21.20 | 3 | 22985 | 123862 | 50458274 |
| Swelling | 44.15 | 21.20 | 18 | 22970 | 200854 | 50381282 |
| Lipids increased | 43.59 | 21.20 | 17 | 22971 | 1075 | 50581061 |
| Pruritus | 43.39 | 21.20 | 39 | 22949 | 283529 | 50298607 |
| Hypertension | 43.16 | 21.20 | 21 | 22967 | 211182 | 50370954 |
| Scar | 41.76 | 21.20 | 38 | 22950 | 11780 | 50570356 |
| Drug ineffective | 41.44 | 21.20 | 212 | 22776 | 819121 | 49763015 |
| Crohn's disease | 40.97 | 21.20 | 26 | 22962 | 4707 | 50577429 |
| Confusional state | 40.31 | 21.20 | 17 | 22971 | 185911 | 50396225 |
| Pain | 38.32 | 21.20 | 135 | 22853 | 578768 | 50003368 |
| Affective disorder | 36.44 | 21.20 | 25 | 22963 | 5156 | 50576980 |
| Sepsis | 36.27 | 21.20 | 8 | 22980 | 132917 | 50449219 |
| Drug hypersensitivity | 35.51 | 21.20 | 37 | 22951 | 250973 | 50331163 |
| Anger | 35.35 | 21.20 | 34 | 22954 | 11299 | 50570837 |
| Stomatitis | 34.89 | 21.20 | 3 | 22985 | 101341 | 50480795 |
| Fatigue | 34.09 | 21.20 | 186 | 22802 | 707415 | 49874721 |
| Depressive symptom | 33.89 | 21.20 | 20 | 22968 | 3180 | 50578956 |
| Therapeutic product effect decreased | 33.65 | 21.20 | 10 | 22978 | 136040 | 50446096 |
| Back pain | 33.48 | 21.20 | 192 | 22796 | 219838 | 50362298 |
| Product prescribing error | 32.89 | 21.20 | 44 | 22944 | 20917 | 50561219 |
| Menstruation irregular | 32.55 | 21.20 | 25 | 22963 | 6137 | 50575999 |
| Lip exfoliation | 31.64 | 21.20 | 11 | 22977 | 502 | 50581634 |
| Neutropenia | 31.31 | 21.20 | 14 | 22974 | 147951 | 50434185 |
| Bronchitis | 31.12 | 21.20 | 5 | 22983 | 104154 | 50477982 |
| Drug interaction | 31.06 | 21.20 | 27 | 22961 | 199594 | 50382542 |
| Social avoidant behaviour | 30.99 | 21.20 | 18 | 22970 | 2779 | 50579357 |
| General physical health deterioration | 30.90 | 21.20 | 13 | 22975 | 142421 | 50439715 |
| Febrile neutropenia | 30.78 | 21.20 | 4 | 22984 | 97663 | 50484473 |
| Discomfort | 30.65 | 21.20 | 6 | 22982 | 108374 | 50473762 |
| Respiratory failure | 30.58 | 21.20 | 3 | 22985 | 91178 | 50490958 |
| Neuropathy peripheral | 30.40 | 21.20 | 4 | 22984 | 96753 | 50485383 |
| Product use issue | 30.31 | 21.20 | 15 | 22973 | 149460 | 50432676 |
| Atrial fibrillation | 30.14 | 21.20 | 5 | 22983 | 101740 | 50480396 |
| Renal failure | 29.95 | 21.20 | 6 | 22982 | 106627 | 50475509 |
| Visual impairment | 29.78 | 21.20 | 83 | 22905 | 68192 | 50513944 |
| Device related bacteraemia | 29.12 | 21.20 | 7 | 22981 | 82 | 50582054 |
| Musculoskeletal stiffness | 29.06 | 21.20 | 11 | 22977 | 128470 | 50453666 |
| Systemic lupus erythematosus | 28.68 | 21.20 | 14 | 22974 | 140608 | 50441528 |
| Pyrexia | 28.34 | 21.20 | 84 | 22904 | 380119 | 50202017 |
| Intentional self-injury | 28.15 | 21.20 | 43 | 22945 | 23069 | 50559067 |
| Major depression | 28.05 | 21.20 | 24 | 22964 | 6860 | 50575276 |
| Laboratory test abnormal | 28.01 | 21.20 | 43 | 22945 | 23165 | 50558971 |
| Hyponatraemia | 27.87 | 21.20 | 5 | 22983 | 96134 | 50486002 |
| Cardiac failure congestive | 27.72 | 21.20 | 3 | 22985 | 84379 | 50497757 |
| Anaemia | 27.69 | 21.20 | 45 | 22943 | 252411 | 50329725 |
| Unevaluable event | 27.40 | 21.20 | 63 | 22925 | 46003 | 50536133 |
| Off label use | 27.27 | 21.20 | 332 | 22656 | 474094 | 50108042 |
| Pain in extremity | 26.90 | 21.20 | 52 | 22936 | 272813 | 50309323 |
| Aggression | 26.73 | 21.20 | 40 | 22948 | 21076 | 50561060 |
| Nasopharyngitis | 26.64 | 21.20 | 29 | 22959 | 192898 | 50389238 |
| Somnolence | 26.58 | 21.20 | 19 | 22969 | 154966 | 50427170 |
| Tearfulness | 26.42 | 21.20 | 18 | 22970 | 3669 | 50578467 |
| Oedema peripheral | 26.26 | 21.20 | 20 | 22968 | 157941 | 50424195 |
| Skin odour abnormal | 26.25 | 21.20 | 13 | 22975 | 1459 | 50580677 |
| Hypertriglyceridaemia | 26.24 | 21.20 | 21 | 22967 | 5470 | 50576666 |
| Mononucleosis syndrome | 25.97 | 21.20 | 7 | 22981 | 133 | 50582003 |
| Vomiting | 25.63 | 21.20 | 115 | 22873 | 460643 | 50121493 |
| Mental disorder | 25.50 | 21.20 | 40 | 22948 | 21951 | 50560185 |
| Urinary tract infection | 25.45 | 21.20 | 39 | 22949 | 223981 | 50358155 |
| Pericarditis | 25.34 | 21.20 | 3 | 22985 | 78686 | 50503450 |
| Aspartate aminotransferase increased | 24.86 | 21.20 | 85 | 22903 | 77913 | 50504223 |
| Abortion induced complete | 24.55 | 21.20 | 4 | 22984 | 3 | 50582133 |
| Injection site pain | 24.29 | 21.20 | 10 | 22978 | 111014 | 50471122 |
| Anal fissure | 24.27 | 21.20 | 16 | 22972 | 3089 | 50579047 |
| Pleural effusion | 24.13 | 21.20 | 4 | 22984 | 81450 | 50500686 |
| Renal impairment | 24.08 | 21.20 | 3 | 22985 | 75658 | 50506478 |
| Haemoglobin decreased | 23.98 | 21.20 | 14 | 22974 | 127202 | 50454934 |
| Vulvovaginal dryness | 23.86 | 21.20 | 14 | 22974 | 2203 | 50579933 |
| Platelet count decreased | 23.84 | 21.20 | 8 | 22980 | 100718 | 50481418 |
| Gait disturbance | 23.68 | 21.20 | 20 | 22968 | 149985 | 50432151 |
| Liver function test abnormal | 23.52 | 21.20 | 58 | 22930 | 44281 | 50537855 |
| Congenital anomaly | 22.95 | 21.20 | 12 | 22976 | 1509 | 50580627 |
| Anotia | 22.75 | 21.20 | 4 | 22984 | 7 | 50582129 |
| Death | 22.73 | 21.20 | 74 | 22914 | 325305 | 50256831 |
| Hypokalaemia | 22.62 | 21.20 | 6 | 22982 | 87986 | 50494150 |
| Hypoaesthesia | 22.61 | 21.20 | 15 | 22973 | 127242 | 50454894 |
| Loss of libido | 22.40 | 21.20 | 11 | 22977 | 1212 | 50580924 |
| Acne cystic | 22.12 | 21.20 | 8 | 22980 | 410 | 50581726 |
| Weight increased | 22.12 | 21.20 | 36 | 22952 | 201855 | 50380281 |
| Hypersensitivity | 22.08 | 21.20 | 40 | 22948 | 215121 | 50367015 |
| Blood creatinine increased | 21.99 | 21.20 | 4 | 22984 | 76156 | 50505980 |
| Loss of personal independence in daily activities | 21.76 | 21.20 | 3 | 22985 | 70047 | 50512089 |
| Meibomian gland dysfunction | 21.74 | 21.20 | 6 | 22982 | 125 | 50582011 |
| Photosensitivity reaction | 21.65 | 21.20 | 28 | 22960 | 12883 | 50569253 |
| Proctitis ulcerative | 21.64 | 21.20 | 7 | 22981 | 255 | 50581881 |
| Hysterectomy | 21.51 | 21.20 | 22 | 22966 | 7868 | 50574268 |
| Migraine | 21.39 | 21.20 | 79 | 22909 | 75201 | 50506935 |
| Keratoconus | 21.25 | 21.20 | 4 | 22984 | 12 | 50582124 |
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 |
|---|---|---|---|---|---|---|
| Depression | 1505.16 | 22.63 | 767 | 14142 | 84380 | 29475238 |
| Suicidal ideation | 1130.95 | 22.63 | 479 | 14430 | 34237 | 29525381 |
| Mood altered | 1069.55 | 22.63 | 317 | 14592 | 7794 | 29551824 |
| Lip dry | 984.30 | 22.63 | 201 | 14708 | 905 | 29558713 |
| Blood triglycerides increased | 716.39 | 22.63 | 262 | 14647 | 12572 | 29547046 |
| Dry skin | 667.05 | 22.63 | 294 | 14615 | 23013 | 29536605 |
| Mood swings | 419.01 | 22.63 | 152 | 14757 | 7099 | 29552519 |
| Cheilitis | 348.23 | 22.63 | 98 | 14811 | 1978 | 29557640 |
| Acne fulminans | 286.53 | 22.63 | 52 | 14857 | 102 | 29559516 |
| Chapped lips | 279.40 | 22.63 | 61 | 14848 | 398 | 29559220 |
| Arthralgia | 257.27 | 22.63 | 333 | 14576 | 139284 | 29420334 |
| Sacroiliitis | 248.55 | 22.63 | 66 | 14843 | 1061 | 29558557 |
| Anger | 246.84 | 22.63 | 117 | 14792 | 10773 | 29548845 |
| Depressed mood | 239.35 | 22.63 | 131 | 14778 | 16317 | 29543301 |
| Epistaxis | 200.54 | 22.63 | 183 | 14726 | 51521 | 29508097 |
| Dry eye | 192.14 | 22.63 | 87 | 14822 | 7209 | 29552409 |
| Inflammatory bowel disease | 189.69 | 22.63 | 63 | 14846 | 2248 | 29557370 |
| Anxiety | 157.36 | 22.63 | 204 | 14705 | 85161 | 29474457 |
| Suicide attempt | 150.60 | 22.63 | 130 | 14779 | 33980 | 29525638 |
| Xerosis | 148.63 | 22.63 | 37 | 14872 | 453 | 29559165 |
| Exposure via body fluid | 143.24 | 22.63 | 28 | 14881 | 95 | 29559523 |
| Colitis ulcerative | 140.99 | 22.63 | 85 | 14824 | 12684 | 29546934 |
| Acne | 138.39 | 22.63 | 75 | 14834 | 9145 | 29550473 |
| Normal newborn | 133.56 | 22.63 | 28 | 14881 | 146 | 29559472 |
| Self-injurious ideation | 130.15 | 22.63 | 43 | 14866 | 1508 | 29558110 |
| Aggression | 128.39 | 22.63 | 121 | 14788 | 35420 | 29524198 |
| Myalgia | 125.70 | 22.63 | 170 | 14739 | 73849 | 29485769 |
| Headache | 124.68 | 22.63 | 272 | 14637 | 173735 | 29385883 |
| Irritability | 124.10 | 22.63 | 97 | 14812 | 22055 | 29537563 |
| Nasal vestibulitis | 118.61 | 22.63 | 19 | 14890 | 8 | 29559610 |
| Educational problem | 116.84 | 22.63 | 31 | 14878 | 496 | 29559122 |
| SAPHO syndrome | 115.42 | 22.63 | 21 | 14888 | 42 | 29559576 |
| Acute kidney injury | 112.85 | 22.63 | 5 | 14904 | 265262 | 29294356 |
| Blood cholesterol increased | 109.01 | 22.63 | 78 | 14831 | 15517 | 29544101 |
| Aspartate aminotransferase increased | 104.13 | 22.63 | 139 | 14770 | 59586 | 29500032 |
| Erectile dysfunction | 101.16 | 22.63 | 79 | 14830 | 17930 | 29541688 |
| Crohn's disease | 95.74 | 22.63 | 41 | 14868 | 2968 | 29556650 |
| Pneumonia | 94.24 | 22.63 | 23 | 14886 | 320149 | 29239469 |
| Epiphyses premature fusion | 92.54 | 22.63 | 16 | 14893 | 20 | 29559598 |
| Adverse event | 92.27 | 22.63 | 70 | 14839 | 15221 | 29544397 |
| Depressive symptom | 91.71 | 22.63 | 34 | 14875 | 1683 | 29557935 |
| Infectious mononucleosis | 88.20 | 22.63 | 25 | 14884 | 517 | 29559101 |
| Adverse drug reaction | 87.12 | 22.63 | 82 | 14827 | 23938 | 29535680 |
| Alanine aminotransferase increased | 81.76 | 22.63 | 136 | 14773 | 70808 | 29488810 |
| Treatment noncompliance | 80.85 | 22.63 | 79 | 14830 | 24148 | 29535470 |
| Hepatic enzyme increased | 73.69 | 22.63 | 88 | 14821 | 33711 | 29525907 |
| Neutrophilic dermatosis | 73.17 | 22.63 | 18 | 14891 | 209 | 29559409 |
| Toxicity to various agents | 68.46 | 22.63 | 5 | 14904 | 173656 | 29385962 |
| Pyogenic granuloma | 68.14 | 22.63 | 17 | 14892 | 210 | 29559408 |
| Crying | 67.92 | 22.63 | 39 | 14870 | 5312 | 29554306 |
| Fall | 67.35 | 22.63 | 6 | 14903 | 177172 | 29382446 |
| Dyspnoea | 67.21 | 22.63 | 41 | 14868 | 326691 | 29232927 |
| Irritable bowel syndrome | 65.16 | 22.63 | 31 | 14878 | 2870 | 29556748 |
| Hidradenitis | 64.14 | 22.63 | 21 | 14888 | 715 | 29558903 |
| No adverse event | 64 | 22.63 | 60 | 14849 | 17418 | 29542200 |
| Hypotension | 63.18 | 22.63 | 11 | 14898 | 194343 | 29365275 |
| Disturbance in attention | 62.56 | 22.63 | 65 | 14844 | 21359 | 29538259 |
| Product quality issue | 60.97 | 22.63 | 56 | 14853 | 15839 | 29543779 |
| Personality change | 59.39 | 22.63 | 34 | 14875 | 4604 | 29555014 |
| Therapy cessation | 57.52 | 22.63 | 52 | 14857 | 14410 | 29545208 |
| Dermoid cyst | 56.95 | 22.63 | 14 | 14895 | 162 | 29559456 |
| Intentional self-injury | 53.93 | 22.63 | 47 | 14862 | 12414 | 29547204 |
| Sepsis | 53.75 | 22.63 | 5 | 14904 | 142677 | 29416941 |
| Ingrowing nail | 53.71 | 22.63 | 19 | 14890 | 821 | 29558797 |
| Pregnancy of partner | 53.16 | 22.63 | 15 | 14894 | 305 | 29559313 |
| Liver function test abnormal | 52.94 | 22.63 | 69 | 14840 | 28849 | 29530769 |
| Death | 52.80 | 22.63 | 57 | 14852 | 342027 | 29217591 |
| Nasal dryness | 51.94 | 22.63 | 19 | 14890 | 905 | 29558713 |
| Abnormal behaviour | 50.04 | 22.63 | 60 | 14849 | 23067 | 29536551 |
| Back pain | 49.67 | 22.63 | 138 | 14771 | 102146 | 29457472 |
| Night blindness | 48.99 | 22.63 | 13 | 14896 | 208 | 29559410 |
| Alopecia | 48.84 | 22.63 | 54 | 14855 | 19030 | 29540588 |
| Lipids increased | 46.67 | 22.63 | 17 | 14892 | 800 | 29558818 |
| Anotia | 46.15 | 22.63 | 7 | 14902 | 0 | 29559618 |
| Intestinal haemorrhage | 46.05 | 22.63 | 25 | 14884 | 3054 | 29556564 |
| Proctitis ulcerative | 45.82 | 22.63 | 10 | 14899 | 65 | 29559553 |
| Emotional disorder | 44.75 | 22.63 | 29 | 14880 | 4902 | 29554716 |
| Anaemia | 44.41 | 22.63 | 23 | 14886 | 200928 | 29358690 |
| Atrial fibrillation | 41.71 | 22.63 | 3 | 14906 | 105643 | 29453975 |
| Paronychia | 41.47 | 22.63 | 23 | 14886 | 2930 | 29556688 |
| Keloid scar | 40.95 | 22.63 | 8 | 14901 | 27 | 29559591 |
| Photosensitivity reaction | 40.22 | 22.63 | 35 | 14874 | 9223 | 29550395 |
| Diarrhoea | 38.67 | 22.63 | 68 | 14841 | 332630 | 29226988 |
| Exposure during pregnancy | 38.50 | 22.63 | 33 | 14876 | 8521 | 29551097 |
| Device related bacteraemia | 37.63 | 22.63 | 10 | 14899 | 161 | 29559457 |
| Affective disorder | 37.59 | 22.63 | 22 | 14887 | 3104 | 29556514 |
| Paternal drugs affecting foetus | 37.06 | 22.63 | 8 | 14901 | 49 | 29559569 |
| Idiopathic intracranial hypertension | 36.30 | 22.63 | 13 | 14896 | 582 | 29559036 |
| Haemoglobin decreased | 35.46 | 22.63 | 6 | 14903 | 108369 | 29451249 |
| Choroid melanoma | 35.41 | 22.63 | 6 | 14903 | 6 | 29559612 |
| Febrile neutropenia | 35.04 | 22.63 | 7 | 14902 | 112233 | 29447385 |
| Vision blurred | 34.69 | 22.63 | 68 | 14841 | 40108 | 29519510 |
| Platelet count decreased | 33.80 | 22.63 | 6 | 14903 | 104666 | 29454952 |
| Decreased interest | 33.77 | 22.63 | 18 | 14891 | 2120 | 29557498 |
| Pregnancy | 33.44 | 22.63 | 10 | 14899 | 251 | 29559367 |
| Panic attack | 33.22 | 22.63 | 30 | 14879 | 8296 | 29551322 |
| Epiphyseal injury | 32.97 | 22.63 | 5 | 14904 | 0 | 29559618 |
| Pyoderma gangrenosum | 31.90 | 22.63 | 14 | 14895 | 1075 | 29558543 |
| Live birth | 31.18 | 22.63 | 9 | 14900 | 199 | 29559419 |
| Product administration interrupted | 30.98 | 22.63 | 10 | 14899 | 325 | 29559293 |
| Asthenia | 30.81 | 22.63 | 38 | 14871 | 215212 | 29344406 |
| Rectal haemorrhage | 30.46 | 22.63 | 59 | 14850 | 34490 | 29525128 |
| Thrombocytopenia | 30.40 | 22.63 | 15 | 14894 | 134808 | 29424810 |
| Short stature | 30.37 | 22.63 | 7 | 14902 | 60 | 29559558 |
| Apathy | 30.23 | 22.63 | 25 | 14884 | 6146 | 29553472 |
| Melanocytic naevus | 29.97 | 22.63 | 16 | 14893 | 1890 | 29557728 |
| Rosacea | 29.67 | 22.63 | 13 | 14896 | 994 | 29558624 |
| Colitis | 29.57 | 22.63 | 55 | 14854 | 31193 | 29528425 |
| Drug interaction | 29.14 | 22.63 | 34 | 14875 | 197351 | 29362267 |
| Urethritis noninfective | 29.03 | 22.63 | 5 | 14904 | 6 | 29559612 |
| Nervous system neoplasm | 29.01 | 22.63 | 8 | 14901 | 149 | 29559469 |
| Mental disorder | 28.76 | 22.63 | 34 | 14875 | 12871 | 29546747 |
| Social avoidant behaviour | 28.42 | 22.63 | 18 | 14891 | 2924 | 29556694 |
| Cardiac failure congestive | 27.98 | 22.63 | 3 | 14906 | 76578 | 29483040 |
| Cerebellar hypoplasia | 27.82 | 22.63 | 5 | 14904 | 9 | 29559609 |
| Neutropenia | 27.71 | 22.63 | 16 | 14893 | 131695 | 29427923 |
| Loss of libido | 27.19 | 22.63 | 16 | 14893 | 2280 | 29557338 |
| General physical health deterioration | 27.15 | 22.63 | 9 | 14900 | 102848 | 29456770 |
| Bone marrow oedema | 27.12 | 22.63 | 10 | 14899 | 487 | 29559131 |
| Drug abuse | 27.08 | 22.63 | 4 | 14905 | 79879 | 29479739 |
| Renal failure | 27.03 | 22.63 | 13 | 14896 | 118586 | 29441032 |
| Myocardial infarction | 26.85 | 22.63 | 11 | 14898 | 110285 | 29449333 |
| Anomaly of external ear congenital | 26.80 | 22.63 | 7 | 14902 | 105 | 29559513 |
| Lip haemorrhage | 26.53 | 22.63 | 11 | 14898 | 734 | 29558884 |
| Vascular skin disorder | 26.37 | 22.63 | 4 | 14905 | 0 | 29559618 |
| Henoch-Schonlein purpura | 26.35 | 22.63 | 13 | 14896 | 1303 | 29558315 |
| Pustule | 24.97 | 22.63 | 8 | 14901 | 254 | 29559364 |
| Ligament rupture | 24.77 | 22.63 | 11 | 14898 | 869 | 29558749 |
| Low density lipoprotein increased | 23.82 | 22.63 | 18 | 14891 | 3886 | 29555732 |
| Urethritis | 23.67 | 22.63 | 8 | 14901 | 301 | 29559317 |
| Ear malformation | 23.67 | 22.63 | 8 | 14901 | 301 | 29559317 |
| Colour vision tests normal | 23.60 | 22.63 | 4 | 14905 | 4 | 29559614 |
| Cardiac arrest | 23.46 | 22.63 | 7 | 14902 | 85584 | 29474034 |
| Psychotic disorder | 23.36 | 22.63 | 39 | 14870 | 20315 | 29539303 |
| Proctitis | 23.10 | 22.63 | 14 | 14895 | 2105 | 29557513 |
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 |
|---|---|---|---|---|---|---|
| Unintended pregnancy | 3941.76 | 19.52 | 736 | 25987 | 2398 | 64469611 |
| Exposure during pregnancy | 2420.48 | 19.52 | 981 | 25742 | 76694 | 64395315 |
| Depression | 1817.89 | 19.52 | 1056 | 25667 | 182235 | 64289774 |
| Abortion induced | 1759.89 | 19.52 | 429 | 26294 | 5959 | 64466050 |
| Blood triglycerides increased | 1430.25 | 19.52 | 461 | 26262 | 18405 | 64453604 |
| Mood altered | 1192.68 | 19.52 | 386 | 26337 | 15593 | 64456416 |
| Suicidal ideation | 1122.96 | 19.52 | 548 | 26175 | 65994 | 64406015 |
| Lip dry | 1106.87 | 19.52 | 281 | 26442 | 4637 | 64467372 |
| Dry skin | 977.32 | 19.52 | 459 | 26264 | 50702 | 64421307 |
| Pregnancy | 915.50 | 19.52 | 339 | 26384 | 20526 | 64451483 |
| Treatment noncompliance | 690.61 | 19.52 | 344 | 26379 | 43138 | 64428871 |
| Mood swings | 542.68 | 19.52 | 221 | 26502 | 17247 | 64454762 |
| Abortion spontaneous | 410.97 | 19.52 | 203 | 26520 | 24940 | 64447069 |
| Sacroiliitis | 397.65 | 19.52 | 113 | 26610 | 2899 | 64469110 |
| Depressed mood | 333.19 | 19.52 | 209 | 26514 | 40803 | 64431206 |
| Chapped lips | 331.20 | 19.52 | 90 | 26633 | 1948 | 64470061 |
| Cheilitis | 300.88 | 19.52 | 101 | 26622 | 4555 | 64467454 |
| Acne fulminans | 288.04 | 19.52 | 51 | 26672 | 109 | 64471900 |
| Dry eye | 287.52 | 19.52 | 168 | 26555 | 28851 | 64443158 |
| Pregnancy test false positive | 287.03 | 19.52 | 48 | 26675 | 60 | 64471949 |
| Drug exposure before pregnancy | 280.99 | 19.52 | 60 | 26663 | 435 | 64471574 |
| Pregnancy on oral contraceptive | 275.60 | 19.52 | 64 | 26659 | 707 | 64471302 |
| Headache | 242.37 | 19.52 | 616 | 26107 | 528851 | 63943158 |
| Blood cholesterol increased | 219.39 | 19.52 | 175 | 26548 | 49891 | 64422118 |
| Selective abortion | 217.08 | 19.52 | 34 | 26689 | 17 | 64471992 |
| Arthralgia | 214.14 | 19.52 | 526 | 26197 | 441734 | 64030275 |
| Xerosis | 210.70 | 19.52 | 54 | 26669 | 923 | 64471086 |
| Anxiety | 208.16 | 19.52 | 331 | 26392 | 202318 | 64269691 |
| Adverse drug reaction | 197.23 | 19.52 | 158 | 26565 | 45306 | 64426703 |
| Epistaxis | 196.12 | 19.52 | 222 | 26501 | 97909 | 64374100 |
| Maternal exposure during pregnancy | 193.46 | 19.52 | 218 | 26505 | 95666 | 64376343 |
| Anger | 179.69 | 19.52 | 100 | 26623 | 15641 | 64456368 |
| Crying | 174.76 | 19.52 | 107 | 26616 | 19983 | 64452026 |
| Myalgia | 172.37 | 19.52 | 266 | 26457 | 158351 | 64313658 |
| Product administration interrupted | 169.81 | 19.52 | 47 | 26676 | 1091 | 64470918 |
| Therapy cessation | 167.26 | 19.52 | 125 | 26598 | 32364 | 64439645 |
| Suicide attempt | 157.99 | 19.52 | 170 | 26553 | 70837 | 64401172 |
| Maternal exposure before pregnancy | 157.74 | 19.52 | 58 | 26665 | 3425 | 64468584 |
| Irritability | 147.33 | 19.52 | 122 | 26601 | 36624 | 64435385 |
| Idiopathic intracranial hypertension | 146.99 | 19.52 | 51 | 26672 | 2542 | 64469467 |
| Acute kidney injury | 141.80 | 19.52 | 12 | 26711 | 449228 | 64022781 |
| Pneumonia | 137.22 | 19.52 | 32 | 26691 | 559544 | 63912465 |
| Epiphyses premature fusion | 135.00 | 19.52 | 24 | 26699 | 53 | 64471956 |
| Infectious mononucleosis | 129.65 | 19.52 | 42 | 26681 | 1691 | 64470318 |
| Self-injurious ideation | 129.29 | 19.52 | 49 | 26674 | 3148 | 64468861 |
| Educational problem | 125.84 | 19.52 | 30 | 26693 | 374 | 64471635 |
| Fall | 124.00 | 19.52 | 14 | 26709 | 416812 | 64055197 |
| Aggression | 121.38 | 19.52 | 121 | 26602 | 46111 | 64425898 |
| Vision blurred | 117.54 | 19.52 | 165 | 26558 | 90151 | 64381858 |
| Aspartate aminotransferase increased | 116.41 | 19.52 | 191 | 26532 | 119597 | 64352412 |
| Inflammatory bowel disease | 112.68 | 19.52 | 49 | 26674 | 4489 | 64467520 |
| Pregnancy test positive | 112.05 | 19.52 | 21 | 26702 | 69 | 64471940 |
| Pregnancy with contraceptive device | 108.30 | 19.52 | 43 | 26680 | 3131 | 64468878 |
| Vaginal haemorrhage | 107.59 | 19.52 | 78 | 26645 | 19266 | 64452743 |
| Night blindness | 107.24 | 19.52 | 27 | 26696 | 428 | 64471581 |
| SAPHO syndrome | 106.62 | 19.52 | 22 | 26701 | 132 | 64471877 |
| Dyspnoea | 105.80 | 19.52 | 86 | 26637 | 718588 | 63753421 |
| Ectopic pregnancy | 105.29 | 19.52 | 35 | 26688 | 1529 | 64470480 |
| Toxicity to various agents | 101.36 | 19.52 | 15 | 26708 | 363498 | 64108511 |
| Pregnancy on contraceptive | 96.88 | 19.52 | 28 | 26695 | 763 | 64471246 |
| No adverse event | 94.53 | 19.52 | 85 | 26638 | 28476 | 64443533 |
| Off label use | 94.04 | 19.52 | 512 | 26211 | 632294 | 63839715 |
| Adverse event | 93.91 | 19.52 | 98 | 26625 | 39391 | 64432618 |
| Colitis ulcerative | 93.42 | 19.52 | 77 | 26646 | 22951 | 64449058 |
| Alanine aminotransferase increased | 91.12 | 19.52 | 187 | 26536 | 138844 | 64333165 |
| Acne | 85.02 | 19.52 | 73 | 26650 | 23008 | 64449001 |
| Hypotension | 83.49 | 19.52 | 27 | 26696 | 380947 | 64091062 |
| Depressive symptom | 81.51 | 19.52 | 39 | 26684 | 4457 | 64467552 |
| Hidradenitis | 81.03 | 19.52 | 32 | 26691 | 2297 | 64469712 |
| Haematochezia | 80.07 | 19.52 | 117 | 26606 | 66256 | 64405753 |
| Erectile dysfunction | 79.67 | 19.52 | 55 | 26668 | 12572 | 64459437 |
| Panic attack | 78.66 | 19.52 | 67 | 26656 | 20886 | 64451123 |
| Nasal dryness | 77.65 | 19.52 | 35 | 26688 | 3491 | 64468518 |
| Diarrhoea | 75.02 | 19.52 | 115 | 26608 | 722589 | 63749420 |
| Pyogenic granuloma | 73.31 | 19.52 | 20 | 26703 | 439 | 64471570 |
| Personality change | 72.75 | 19.52 | 45 | 26678 | 8548 | 64463461 |
| Emotional disorder | 68.21 | 19.52 | 50 | 26673 | 12557 | 64459452 |
| Anaemia | 68.18 | 19.52 | 36 | 26687 | 378644 | 64093365 |
| Sepsis | 67.75 | 19.52 | 8 | 26715 | 230333 | 64241676 |
| Device related bacteraemia | 64.88 | 19.52 | 17 | 26706 | 318 | 64471691 |
| Neutrophilic dermatosis | 60.72 | 19.52 | 18 | 26705 | 537 | 64471472 |
| Asthenia | 60.62 | 19.52 | 53 | 26670 | 427991 | 64044018 |
| Product quality issue | 58.72 | 19.52 | 67 | 26656 | 29732 | 64442277 |
| Crohn's disease | 57.75 | 19.52 | 24 | 26699 | 1965 | 64470044 |
| Back pain | 57.27 | 19.52 | 230 | 26493 | 249941 | 64222068 |
| Peripheral swelling | 55.17 | 19.52 | 10 | 26713 | 209143 | 64262866 |
| Loss of libido | 53.38 | 19.52 | 24 | 26699 | 2380 | 64469629 |
| Scar | 52.67 | 19.52 | 44 | 26679 | 13354 | 64458655 |
| Respiratory failure | 51.59 | 19.52 | 4 | 26719 | 161179 | 64310830 |
| Liver function test abnormal | 51.39 | 19.52 | 90 | 26633 | 59311 | 64412698 |
| Disturbance in attention | 50.38 | 19.52 | 73 | 26650 | 41001 | 64431008 |
| Low density lipoprotein increased | 49.50 | 19.52 | 34 | 26689 | 7706 | 64464303 |
| Haemoglobin decreased | 47.97 | 19.52 | 11 | 26712 | 195052 | 64276957 |
| Dermoid cyst | 47.84 | 19.52 | 13 | 26710 | 281 | 64471728 |
| Atrial fibrillation | 47.76 | 19.52 | 7 | 26716 | 171082 | 64300927 |
| Lipids increased | 47.66 | 19.52 | 19 | 26704 | 1398 | 64470611 |
| Rheumatoid arthritis | 47.57 | 19.52 | 6 | 26717 | 164288 | 64307721 |
| Febrile neutropenia | 45.32 | 19.52 | 11 | 26712 | 187646 | 64284363 |
| Intentional self-injury | 45.29 | 19.52 | 58 | 26665 | 28986 | 64443023 |
| Drug interaction | 45.27 | 19.52 | 50 | 26673 | 362033 | 64109976 |
| Death | 45.15 | 19.52 | 82 | 26641 | 482623 | 63989386 |
| Infection | 44.33 | 19.52 | 11 | 26712 | 184869 | 64287140 |
| Social avoidant behaviour | 44.09 | 19.52 | 26 | 26697 | 4531 | 64467478 |
| Infusion related reaction | 43.07 | 19.52 | 8 | 26715 | 164459 | 64307550 |
| Abortion | 43.06 | 19.52 | 17 | 26706 | 1219 | 64470790 |
| Renal impairment | 41.44 | 19.52 | 4 | 26719 | 135013 | 64336996 |
| Renal failure | 41.32 | 19.52 | 12 | 26711 | 181676 | 64290333 |
| Neutropenia | 41.31 | 19.52 | 24 | 26699 | 239600 | 64232409 |
| Tearfulness | 40.90 | 19.52 | 25 | 26698 | 4648 | 64467361 |
| Drug abuse | 40.42 | 19.52 | 4 | 26719 | 132370 | 64339639 |
| Affective disorder | 39.96 | 19.52 | 28 | 26695 | 6552 | 64465457 |
| Cardiac failure congestive | 39.73 | 19.52 | 4 | 26719 | 130576 | 64341433 |
| Myocardial infarction | 39.50 | 19.52 | 10 | 26713 | 165811 | 64306198 |
| General physical health deterioration | 38.90 | 19.52 | 18 | 26705 | 204407 | 64267602 |
| Pyoderma gangrenosum | 38.86 | 19.52 | 21 | 26702 | 3097 | 64468912 |
| Cough | 38.55 | 19.52 | 41 | 26682 | 302107 | 64169902 |
| Libido decreased | 37.85 | 19.52 | 24 | 26699 | 4760 | 64467249 |
| Major depression | 37.83 | 19.52 | 29 | 26694 | 7787 | 64464222 |
| Bradycardia | 37.64 | 19.52 | 3 | 26720 | 118216 | 64353793 |
| Confusional state | 37.32 | 19.52 | 32 | 26691 | 261112 | 64210897 |
| Thrombocytopenia | 36.38 | 19.52 | 24 | 26699 | 223777 | 64248232 |
| Photosensitivity reaction | 36.04 | 19.52 | 41 | 26682 | 18132 | 64453877 |
| Hypertension | 35.57 | 19.52 | 33 | 26690 | 259228 | 64212781 |
| Cardiac arrest | 35.35 | 19.52 | 10 | 26713 | 154054 | 64317955 |
| Joint swelling | 35.14 | 19.52 | 23 | 26700 | 215359 | 64256650 |
| Hepatic enzyme increased | 35.07 | 19.52 | 126 | 26597 | 129817 | 64342192 |
| Platelet count decreased | 34.76 | 19.52 | 13 | 26710 | 167698 | 64304311 |
| Rectal haemorrhage | 34.53 | 19.52 | 78 | 26645 | 61739 | 64410270 |
| Epiphyseal injury | 33.95 | 19.52 | 5 | 26718 | 0 | 64472009 |
| Ingrowing nail | 33.72 | 19.52 | 17 | 26706 | 2174 | 64469835 |
| Hyponatraemia | 33.35 | 19.52 | 10 | 26713 | 148329 | 64323680 |
| Abnormal behaviour | 33.13 | 19.52 | 54 | 26669 | 33568 | 64438441 |
| Bipolar disorder | 32.53 | 19.52 | 25 | 26698 | 6736 | 64465273 |
| Decreased interest | 32.06 | 19.52 | 19 | 26704 | 3341 | 64468668 |
| Drug hypersensitivity | 31.77 | 19.52 | 31 | 26692 | 237784 | 64234225 |
| Hypokalaemia | 31.76 | 19.52 | 6 | 26717 | 121897 | 64350112 |
| Lip exfoliation | 31.66 | 19.52 | 11 | 26712 | 550 | 64471459 |
| Gun shot wound | 31.44 | 19.52 | 13 | 26710 | 1051 | 64470958 |
| Pregnancy of partner | 31.29 | 19.52 | 9 | 26714 | 241 | 64471768 |
| Tinnitus | 31.19 | 19.52 | 53 | 26670 | 34080 | 64437929 |
| Exposure via body fluid | 31.04 | 19.52 | 9 | 26714 | 248 | 64471761 |
| Mental disorder | 30.98 | 19.52 | 46 | 26677 | 26399 | 64445610 |
| Blood creatinine increased | 30.80 | 19.52 | 9 | 26714 | 135773 | 64336236 |
| Hypertriglyceridaemia | 30.63 | 19.52 | 30 | 26693 | 11175 | 64460834 |
| Visual impairment | 30.32 | 19.52 | 83 | 26640 | 73994 | 64398015 |
| Affect lability | 30.22 | 19.52 | 27 | 26696 | 8963 | 64463046 |
| Neuropathy peripheral | 30.16 | 19.52 | 6 | 26717 | 117519 | 64354490 |
| Septic shock | 30.15 | 19.52 | 4 | 26719 | 105433 | 64366576 |
| Oedema peripheral | 29.76 | 19.52 | 26 | 26697 | 210291 | 64261718 |
| Bronchitis | 29.09 | 19.52 | 5 | 26718 | 108738 | 64363271 |
| Contraindicated product administered | 28.76 | 19.52 | 5 | 26718 | 107824 | 64364185 |
| Pruritus | 28.33 | 19.52 | 54 | 26669 | 312346 | 64159663 |
| Growth failure | 27.54 | 19.52 | 8 | 26715 | 222 | 64471787 |
| Oedema | 27.49 | 19.52 | 3 | 26720 | 91932 | 64380077 |
| Migraine | 27.43 | 19.52 | 72 | 26651 | 62605 | 64409404 |
| Abortion induced complete | 27.16 | 19.52 | 4 | 26719 | 0 | 64472009 |
| Alopecia | 27.10 | 19.52 | 138 | 26585 | 165552 | 64306457 |
| Paronychia | 26.93 | 19.52 | 22 | 26701 | 6470 | 64465539 |
| Meibomian gland dysfunction | 26.71 | 19.52 | 7 | 26716 | 131 | 64471878 |
| Product use issue | 26.41 | 19.52 | 15 | 26708 | 151700 | 64320309 |
| Proctitis ulcerative | 26.16 | 19.52 | 8 | 26715 | 266 | 64471743 |
| Melanocytic naevus | 26.11 | 19.52 | 18 | 26705 | 4102 | 64467907 |
| Hypoxia | 26.05 | 19.52 | 3 | 26720 | 88146 | 64383863 |
| Coma | 25.84 | 19.52 | 3 | 26720 | 87612 | 64384397 |
| Urinary tract infection | 25.73 | 19.52 | 35 | 26688 | 231561 | 64240448 |
| Synovitis | 25.55 | 19.52 | 5 | 26718 | 99085 | 64372924 |
| Stomatitis | 25.35 | 19.52 | 7 | 26716 | 109598 | 64362411 |
| Urethritis noninfective | 25.34 | 19.52 | 5 | 26718 | 23 | 64471986 |
| Keratoconus | 25.15 | 19.52 | 6 | 26717 | 75 | 64471934 |
| Apathy | 25.13 | 19.52 | 27 | 26696 | 11205 | 64460804 |
| Interstitial lung disease | 25.06 | 19.52 | 5 | 26718 | 97727 | 64374282 |
| Menstruation irregular | 24.92 | 19.52 | 18 | 26705 | 4417 | 64467592 |
| Malaise | 24.68 | 19.52 | 83 | 26640 | 396164 | 64075845 |
| Colour vision tests normal | 24.39 | 19.52 | 4 | 26719 | 4 | 64472005 |
| Psychotic disorder | 24.39 | 19.52 | 48 | 26675 | 34530 | 64437479 |
| Multiple organ dysfunction syndrome | 24.36 | 19.52 | 6 | 26717 | 101407 | 64370602 |
| Hypoglycaemia | 24.34 | 19.52 | 4 | 26719 | 89888 | 64382121 |
| Tremor | 23.93 | 19.52 | 16 | 26707 | 148214 | 64323795 |
| Pyrexia | 23.85 | 19.52 | 135 | 26588 | 558509 | 63913500 |
| Nasopharyngitis | 23.47 | 19.52 | 28 | 26695 | 196045 | 64275964 |
| Blood pressure decreased | 22.98 | 19.52 | 4 | 26719 | 86195 | 64385814 |
| Laboratory test abnormal | 22.83 | 19.52 | 38 | 26685 | 24025 | 64447984 |
| Keloid scar | 22.76 | 19.52 | 6 | 26717 | 115 | 64471894 |
| Myopia | 22.35 | 19.52 | 12 | 26711 | 1746 | 64470263 |
| Choroid melanoma | 22.07 | 19.52 | 5 | 26718 | 49 | 64471960 |
| Vomiting | 22.03 | 19.52 | 136 | 26587 | 550981 | 63921028 |
| Cardiac failure | 21.76 | 19.52 | 14 | 26709 | 132359 | 64339650 |
| Skin odour abnormal | 21.68 | 19.52 | 12 | 26711 | 1855 | 64470154 |
| Wound | 21.63 | 19.52 | 3 | 26720 | 76474 | 64395535 |
| Somnolence | 21.40 | 19.52 | 32 | 26691 | 203613 | 64268396 |
| Urethritis | 21.31 | 19.52 | 8 | 26715 | 500 | 64471509 |
| Swelling | 21.25 | 19.52 | 21 | 26702 | 160197 | 64311812 |
| Paternal drugs affecting foetus | 21.15 | 19.52 | 4 | 26719 | 14 | 64471995 |
| Aspartate aminotransferase abnormal | 21.14 | 19.52 | 11 | 26712 | 1503 | 64470506 |
| Weight increased | 21.02 | 19.52 | 35 | 26688 | 213313 | 64258696 |
| Lip haemorrhage | 21.01 | 19.52 | 10 | 26713 | 1129 | 64470880 |
| Bone marrow oedema | 20.92 | 19.52 | 10 | 26713 | 1140 | 64470869 |
| Type 1 diabetes mellitus | 20.91 | 19.52 | 18 | 26705 | 5687 | 64466322 |
| Injection site pain | 20.89 | 19.52 | 10 | 26713 | 111398 | 64360611 |
| Vascular skin disorder | 20.73 | 19.52 | 4 | 26719 | 16 | 64471993 |
| Cerebrovascular accident | 20.71 | 19.52 | 16 | 26707 | 137567 | 64334442 |
| Therapeutic product effect decreased | 20.66 | 19.52 | 11 | 26712 | 115340 | 64356669 |
| Vulvovaginal dryness | 20.51 | 19.52 | 11 | 26712 | 1597 | 64470412 |
| Gastrointestinal haemorrhage | 20.41 | 19.52 | 15 | 26708 | 132297 | 64339712 |
| Vitamin A increased | 20.37 | 19.52 | 3 | 26720 | 0 | 64472009 |
| Blood pressure increased | 20.26 | 19.52 | 25 | 26698 | 172527 | 64299482 |
| Central vision loss | 20.17 | 19.52 | 4 | 26719 | 19 | 64471990 |
| Dehydration | 20.05 | 19.52 | 37 | 26686 | 216726 | 64255283 |
| Henoch-Schonlein purpura | 19.81 | 19.52 | 12 | 26711 | 2194 | 64469815 |
| Arthropathy | 19.60 | 19.52 | 13 | 26710 | 120954 | 64351055 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D10AD04 | DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Retinoids for topical use in acne |
| ATC | D10AD54 | DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Retinoids for topical use in acne |
| ATC | D10BA01 | DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR SYSTEMIC USE Retinoids for treatment of acne |
| FDA CS | M0018962 | Retinoids |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| CHEBI has role | CHEBI:50176 | keratolytic drugs |
| CHEBI has role | CHEBI:50905 | teratogeno |
| FDA EPC | N0000175607 | Retinoid |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D009676 | Noxae |
| MeSH PA | D013723 | Teratogens |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypertensive disorder | indication | 38341003 | DOID:10763 |
| Severe Recalcitrant Nodular Acne | indication | ||
| Primary cutaneous T-cell lymphoma | off-label use | 400122007 | |
| Severe Recalcitrant Nodular Rosacea | off-label use | ||
| Anuria | contraindication | 2472002 | DOID:2983 |
| Osteomalacia | contraindication | 4598005 | DOID:10573 |
| Suicidal thoughts | contraindication | 6471006 | |
| Alcoholism | contraindication | 7200002 | |
| Rectal hemorrhage | contraindication | 12063002 | |
| Hypercholesterolemia | contraindication | 13644009 | |
| Hyperkalemia | contraindication | 14140009 | |
| Hearing loss | contraindication | 15188001 | |
| Agranulocytosis | contraindication | 17182001 | DOID:12987 |
| Secondary angle-closure glaucoma | contraindication | 21571006 | |
| Inflammatory bowel disease | contraindication | 24526004 | DOID:0050589 |
| Hypovolemia | contraindication | 28560003 | |
| Acute cerebrovascular insufficiency | contraindication | 29322000 | |
| Dehydration | contraindication | 34095006 | |
| Depressive disorder | contraindication | 35489007 | |
| Hyperuricemia | contraindication | 35885006 | DOID:1920 |
| Immunosuppression | contraindication | 38013005 | |
| Angioedema | contraindication | 41291007 | DOID:1558 |
| Hypokalemia | contraindication | 43339004 | |
| Low blood pressure | contraindication | 45007003 | |
| Disorder of cardiovascular system | contraindication | 49601007 | DOID:1287 |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Anorexia nervosa | contraindication | 56882008 | DOID:8689 |
| Sympathectomy | contraindication | 57071006 | |
| Tinnitus | contraindication | 60862001 | |
| Corneal opacity | contraindication | 64634000 | |
| Osteoporosis | contraindication | 64859006 | DOID:11476 |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Hyperparathyroidism | contraindication | 66999008 | DOID:13543 |
| Benign intracranial hypertension | contraindication | 68267002 | DOID:11459 |
| Psychotic disorder | contraindication | 69322001 | |
| Hypochloremic alkalosis | contraindication | 70134007 | |
| Hepatic coma | contraindication | 72836002 | DOID:12550 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Disorder of bone | contraindication | 76069003 | DOID:0080001 |
| Hereditary angioneurotic edema | contraindication | 82966003 | DOID:14735 |
| Hyponatremia | contraindication | 89627008 | |
| Congenital neutropenia | contraindication | 89655007 | |
| Gout | contraindication | 90560007 | DOID:13189 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Disorder of connective tissue | contraindication | 105969002 | DOID:65 |
| Inflammatory disease of liver | contraindication | 128241005 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Acute pancreatitis | contraindication | 197456007 | DOID:2913 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Neonatal hyperbilirubinemia | contraindication | 281610001 | |
| Pregnancy, function | contraindication | 289908002 | |
| Renal artery stenosis | contraindication | 302233006 | |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Keratoconjunctivitis sicca | contraindication | 302896008 | DOID:12895 |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Bone marrow depression | contraindication | 307762000 | |
| Severe diarrhea | contraindication | 409587002 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Myocardial ischemia | contraindication | 414795007 | DOID:3393 |
| Obesity | contraindication | 414916001 | DOID:9970 |
| Azotemia | contraindication | 445009001 | |
| Predisposition To Hypertriglyceridemia | contraindication | ||
| Hemodialysis with High-Flux Membrane | 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 | 4.17 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Retinoic acid receptor beta | Nuclear hormone receptor | INHIBITOR | CHEMBL | CHEMBL | |||||
| Alpha-2B adrenergic receptor | GPCR | Ki | 5.52 | DRUG MATRIX | |||||
| Adenosine receptor A3 | GPCR | Ki | 5.63 | DRUG MATRIX | |||||
| Retinoic acid receptor alpha | Nuclear hormone receptor | ED50 | 8.23 | WOMBAT-PK | |||||
| Alcohol dehydrogenase 4 | Enzyme | Ki | 5.52 | WOMBAT-PK | |||||
| Dehydrogenase/reductase SDR family member 9 | Enzyme | Ki | 4.52 | WOMBAT-PK | |||||
| 11-cis retinol dehydrogenase | Enzyme | Ki | 7 | WOMBAT-PK | |||||
| 17-beta-hydroxysteroid dehydrogenase type 6 | Enzyme | Ki | 5.40 | WOMBAT-PK | |||||
| Mitogen-activated protein kinase 14 | Kinase | IC50 | 5.60 | DRUG MATRIX | |||||
| Mitogen-activated protein kinase 1 | Kinase | IC50 | 6.34 | DRUG MATRIX | |||||
| 5-hydroxytryptamine receptor 2B | GPCR | Ki | 6.27 | DRUG MATRIX | |||||
| Olfactory receptor 51E2 | GPCR | IC50 | 6.80 | CHEMBL | |||||
| Cellular retinoic acid-binding protein 1 | Cytosolic other | IC50 | 6.05 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4017801 | VUID |
| N0000146162 | NUI |
| D00348 | KEGG_DRUG |
| 4017801 | VANDF |
| C0022265 | UMLSCUI |
| CHEBI:6067 | CHEBI |
| 3KV | PDB_CHEM_ID |
| REA | PDB_CHEM_ID |
| CHEMBL547 | ChEMBL_ID |
| DB00982 | DRUGBANK_ID |
| D015474 | MESH_DESCRIPTOR_UI |
| 5282379 | PUBCHEM_CID |
| 7600 | IUPHAR_LIGAND_ID |
| 4617 | INN_ID |
| EH28UP18IF | UNII |
| 202795 | RXNORM |
| 4937 | MMSL |
| 58 | MMSL |
| 71962 | MMSL |
| d01245 | MMSL |
| 001961 | NDDF |
| 38314008 | SNOMEDCT_US |
| 387208003 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0245-0570 | CAPSULE, LIQUID FILLED | 10 mg | ORAL | ANDA | 31 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0245-0571 | CAPSULE, LIQUID FILLED | 20 mg | ORAL | ANDA | 31 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0245-0573 | CAPSULE, LIQUID FILLED | 30 mg | ORAL | ANDA | 31 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0245-0575 | CAPSULE, LIQUID FILLED | 40 mg | ORAL | ANDA | 31 sections |
| Amnesteem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6611 | CAPSULE | 10 mg | ORAL | ANDA | 25 sections |
| Amnesteem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6612 | CAPSULE | 20 mg | ORAL | ANDA | 25 sections |
| Amnesteem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6614 | CAPSULE | 40 mg | ORAL | ANDA | 25 sections |
| Claravis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0555-1054 | CAPSULE, LIQUID FILLED | 10 mg | ORAL | ANDA | 23 sections |
| Claravis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0555-1055 | CAPSULE, LIQUID FILLED | 20 mg | ORAL | ANDA | 23 sections |
| Claravis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0555-1056 | CAPSULE, LIQUID FILLED | 30 mg | ORAL | ANDA | 23 sections |
| Claravis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0555-1057 | CAPSULE, LIQUID FILLED | 40 mg | ORAL | ANDA | 23 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2433 | CAPSULE | 10 mg | ORAL | ANDA | 30 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2434 | CAPSULE | 20 mg | ORAL | ANDA | 30 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2435 | CAPSULE | 30 mg | ORAL | ANDA | 30 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2436 | CAPSULE | 40 mg | ORAL | ANDA | 30 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2451 | CAPSULE | 25 mg | ORAL | ANDA | 30 sections |
| Isotretinoin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2501 | CAPSULE | 35 mg | ORAL | ANDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-002 | CAPSULE | 8 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-002 | CAPSULE | 8 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-003 | CAPSULE | 16 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-003 | CAPSULE | 16 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-004 | CAPSULE | 20 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-004 | CAPSULE | 20 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-005 | CAPSULE | 24 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-005 | CAPSULE | 24 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-006 | CAPSULE | 28 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-006 | CAPSULE | 28 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-007 | CAPSULE | 32 mg | ORAL | NDA | 30 sections |
| Absorica LD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-007 | CAPSULE | 32 mg | ORAL | NDA | 30 sections |
| Absorica | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10631-115 | CAPSULE | 10 mg | ORAL | NDA | 30 sections |