Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 565685810 | 5656858 | 10 | F | 19991013 | 20160715 | 20041102 | 20160729 | EXP | US-ROCHE-384635 | ROCHE | 17.01 | YR | M | Y | 46.30000 | KG | 20160729 | MD | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 565685810 | 5656858 | 1 | PS | ACCUTANE | ISOTRETINOIN | 1 | Oral | U | 18662 | ||||||||||
| 565685810 | 5656858 | 2 | SS | ACCUTANE | ISOTRETINOIN | 1 | Oral | ALTERNATING DOSE OF 40MG WITH AN UNKNOWN DOSE. | U | 18662 | CAPSULE | ||||||||
| 565685810 | 5656858 | 3 | SS | ACCUTANE | ISOTRETINOIN | 1 | Oral | 11 CAPSULES PER WEEK. | U | 18662 | 40 | MG | CAPSULE | ||||||
| 565685810 | 5656858 | 4 | SS | ACCUTANE | ISOTRETINOIN | 1 | Oral | U | 18662 | 40 | MG | CAPSULE | |||||||
| 565685810 | 5656858 | 5 | SS | ACCUTANE | ISOTRETINOIN | 1 | Oral | U | 18662 | 40 | MG | CAPSULE | TIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 565685810 | 5656858 | 1 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 565685810 | 5656858 | DS |
| 565685810 | 5656858 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 565685810 | 5656858 | Abdominal pain | |
| 565685810 | 5656858 | Abdominal pain upper | |
| 565685810 | 5656858 | Acne | |
| 565685810 | 5656858 | Anaemia | |
| 565685810 | 5656858 | Anal fistula | |
| 565685810 | 5656858 | Anal inflammation | |
| 565685810 | 5656858 | Anorectal discomfort | |
| 565685810 | 5656858 | Aphthous ulcer | |
| 565685810 | 5656858 | Colitis | |
| 565685810 | 5656858 | Colitis ulcerative | |
| 565685810 | 5656858 | Crohn's disease | |
| 565685810 | 5656858 | Diarrhoea | |
| 565685810 | 5656858 | Diarrhoea haemorrhagic | |
| 565685810 | 5656858 | Dry skin | |
| 565685810 | 5656858 | Gastritis | |
| 565685810 | 5656858 | Gastroenteritis adenovirus | |
| 565685810 | 5656858 | Gastrointestinal disorder | |
| 565685810 | 5656858 | Haemorrhoids | |
| 565685810 | 5656858 | Herpes oesophagitis | |
| 565685810 | 5656858 | Inflammatory bowel disease | |
| 565685810 | 5656858 | Internal injury | |
| 565685810 | 5656858 | Intestinal haemorrhage | |
| 565685810 | 5656858 | Lip exfoliation | |
| 565685810 | 5656858 | Odynophagia | |
| 565685810 | 5656858 | Oesophageal ulcer | |
| 565685810 | 5656858 | Pain | |
| 565685810 | 5656858 | Perirectal abscess | |
| 565685810 | 5656858 | Pouchitis | |
| 565685810 | 5656858 | Proctitis | |
| 565685810 | 5656858 | Proctitis ulcerative | |
| 565685810 | 5656858 | Pyrexia | |
| 565685810 | 5656858 | Rectal haemorrhage | |
| 565685810 | 5656858 | Rhinitis allergic | |
| 565685810 | 5656858 | Vomiting | |
| 565685810 | 5656858 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 565685810 | 5656858 | 1 | 19990929 | 19991013 | 0 | |
| 565685810 | 5656858 | 2 | 19991013 | 19991110 | 0 | |
| 565685810 | 5656858 | 3 | 19991110 | 20000119 | 0 | |
| 565685810 | 5656858 | 4 | 20000119 | 20000223 | 0 | |
| 565685810 | 5656858 | 5 | 20000223 | 20000926 | 0 |