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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126268671 | 12626867 | 1 | I | 20160725 | 20160805 | 20160805 | EXP | CA-ARBOR PHARMACEUTICALS, LLC-CA-2016ARB000504 | ARBOR | TREMBLAY F, CHAPDELAINE H, LAVOIE A, BERTHIAUME Y, SABBAH L, BERNSTEIN SC, ET AL. TOXIC EPIDERMAL NECROLYSIS IN A PATIENT WITH CYSTIC FIBROSIS. J ALLERGY CLIN IMMUNOL PRACT. 2016;4(3):526-528 | 42.00 | YR | M | Y | 0.00000 | 20160805 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126268671 | 12626867 | 1 | PS | CIPROFLOXACINFLUOCINOLONE ACETONIDE | CIPROFLOXACINFLUOCINOLONE ACETONIDE | 1 | Oral | UNK | Y | 208251 | |||||||||
| 126268671 | 12626867 | 2 | SS | CIPROFLOXACINFLUOCINOLONE ACETONIDE | CIPROFLOXACINFLUOCINOLONE ACETONIDE | 1 | Y | 208251 | |||||||||||
| 126268671 | 12626867 | 3 | SS | MEROPENEM. | MEROPENEM | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 126268671 | 12626867 | 4 | SS | OSELTAMIVIR | OSELTAMIVIR | 1 | UNK | 0 | |||||||||||
| 126268671 | 12626867 | 5 | SS | TOBRAMYCIN. | TOBRAMYCIN | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 126268671 | 12626867 | 6 | SS | TOBRAMYCIN. | TOBRAMYCIN | 1 | NEBULIZED, ALTERING EVERY OTHER MONTH WITH AZTREONAM | Y | 0 | ||||||||||
| 126268671 | 12626867 | 7 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 126268671 | 12626867 | 8 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | UNK | U | 0 | ||||||||||
| 126268671 | 12626867 | 9 | C | AZTREONAM. | AZTREONAM | 1 | NEBULIZED, ALTERING EVERY OTHER MONTH WITH TOBRAMYCIN | U | 0 | ||||||||||
| 126268671 | 12626867 | 10 | C | DORNASE ALFA | DORNASE ALFA | 1 | UNK, NEBULIZED | U | 0 | ||||||||||
| 126268671 | 12626867 | 11 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | UNK | U | 0 | ||||||||||
| 126268671 | 12626867 | 12 | C | OMALIZUMAB | OMALIZUMAB | 1 | UNK | U | 0 | ||||||||||
| 126268671 | 12626867 | 13 | C | CICLESONIDE | CICLESONIDE | 1 | UNK | U | 0 | ||||||||||
| 126268671 | 12626867 | 14 | C | BUDESONIDE W/FORMOTEROL | BUDESONIDEFORMOTEROL | 1 | UNK | U | 0 | ||||||||||
| 126268671 | 12626867 | 15 | C | SALINE /00075401/ | SODIUM CHLORIDE | 1 | Nasal | UNK | U | 0 | |||||||||
| 126268671 | 12626867 | 16 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | UNK | U | 0 | ||||||||||
| 126268671 | 12626867 | 17 | C | PANCREATIC ENZYMES | UNSPECIFIED INGREDIENT | 1 | UNK | U | 0 | ||||||||||
| 126268671 | 12626867 | 18 | C | INSULIN | INSULIN NOS | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126268671 | 12626867 | 1 | Infective pulmonary exacerbation of cystic fibrosis |
| 126268671 | 12626867 | 2 | Influenza like illness |
| 126268671 | 12626867 | 3 | Infective pulmonary exacerbation of cystic fibrosis |
| 126268671 | 12626867 | 4 | Influenza like illness |
| 126268671 | 12626867 | 5 | Infective pulmonary exacerbation of cystic fibrosis |
| 126268671 | 12626867 | 7 | Infective pulmonary exacerbation of cystic fibrosis |
| 126268671 | 12626867 | 8 | Product used for unknown indication |
| 126268671 | 12626867 | 9 | Product used for unknown indication |
| 126268671 | 12626867 | 10 | Product used for unknown indication |
| 126268671 | 12626867 | 11 | Product used for unknown indication |
| 126268671 | 12626867 | 12 | Product used for unknown indication |
| 126268671 | 12626867 | 13 | Product used for unknown indication |
| 126268671 | 12626867 | 14 | Product used for unknown indication |
| 126268671 | 12626867 | 15 | Product used for unknown indication |
| 126268671 | 12626867 | 16 | Product used for unknown indication |
| 126268671 | 12626867 | 17 | Product used for unknown indication |
| 126268671 | 12626867 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126268671 | 12626867 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126268671 | 12626867 | Blister | |
| 126268671 | 12626867 | C-reactive protein increased | |
| 126268671 | 12626867 | Conjunctival hyperaemia | |
| 126268671 | 12626867 | Oral mucosal blistering | |
| 126268671 | 12626867 | Rash erythematous | |
| 126268671 | 12626867 | Rash generalised | |
| 126268671 | 12626867 | Rash maculo-papular | |
| 126268671 | 12626867 | Red blood cell sedimentation rate increased | |
| 126268671 | 12626867 | Sepsis | |
| 126268671 | 12626867 | Skin lesion | |
| 126268671 | 12626867 | Skin necrosis | |
| 126268671 | 12626867 | Stevens-Johnson syndrome | |
| 126268671 | 12626867 | Toxic epidermal necrolysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |