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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125212151 | 12521215 | 1 | I | 20150518 | 20160701 | 20160701 | EXP | PHHY2015US062824 | SANDOZ | 0.00 | F | Y | 63.56000 | KG | 20160701 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125212151 | 12521215 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, Q 4 WEEKS | U | 0 | 150 | MG | |||||||
| 125212151 | 12521215 | 2 | PS | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, TID (TAKES 3, 20MG PILLS ONCE A DAY) | U | 80336 | 20 | MG | TABLET | TID | |||||
| 125212151 | 12521215 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 60 MG, QD (WITH FOOD OR MILK) | U | 80336 | 60 | MG | TABLET | QD | |||||
| 125212151 | 12521215 | 4 | SS | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 1 DF, Q6H | U | 0 | 1 | DF | Q6H | ||||||
| 125212151 | 12521215 | 5 | SS | LEVAQUIN | LEVOFLOXACIN | 1 | Unknown | U | 0 | ||||||||||
| 125212151 | 12521215 | 6 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 2 DF, BID (50/150, 2 PUFFS TWICE A DAY) | U | 0 | 2 | DF | BID | ||||||
| 125212151 | 12521215 | 7 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 2 DF, QD (230-21 MCG, 2 PUFFS) (SUSPENSION AND SOLUTION FOR SPRAY) | U | 0 | 2 | DF | QD | ||||||
| 125212151 | 12521215 | 8 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Nasal | 50 UG, QD (EACH NASEL) | U | 0 | 50 | UG | NASAL DROP (NASAL SPRAY TOO) | QD | |||||
| 125212151 | 12521215 | 9 | C | DUONEB | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Unknown | 4 DF, QD (0.5-2.5 MG/3ML) | U | 0 | 4 | DF | QD | ||||||
| 125212151 | 12521215 | 10 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Unknown | 1 DF, Q4H (2 PUFFS AS NEEDED ) | U | 0 | 1 | DF | Q4H | ||||||
| 125212151 | 12521215 | 11 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 18 UG, QD | U | 0 | 18 | UG | CAPSULE | QD | |||||
| 125212151 | 12521215 | 12 | C | CLINDAMYCIN PHOSPHATE. | CLINDAMYCIN PHOSPHATE | 1 | Topical | 1 %, BID (APPLICATION TO FACE AND CHEST) | U | 0 | 1 | PCT | GEL | BID | |||||
| 125212151 | 12521215 | 13 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | 0.5 MG, QD | U | 0 | .5 | MG | TABLET | QD | |||||
| 125212151 | 12521215 | 14 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 100 MG, UNK | U | 0 | 100 | MG | TABLET | QD | |||||
| 125212151 | 12521215 | 15 | C | TEMOVATE | CLOBETASOL PROPIONATE | 1 | Topical | 0.05 %, BID (APPLICATION TO AFFECTED AREA) | U | 0 | .05 | PCT | CREAM | BID | |||||
| 125212151 | 12521215 | 16 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | Oral | 100 UG/ML, AS DIRECTED | U | 0 | |||||||||
| 125212151 | 12521215 | 17 | C | EPIPEN | EPINEPHRINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125212151 | 12521215 | 1 | Asthma |
| 125212151 | 12521215 | 2 | Asthma |
| 125212151 | 12521215 | 4 | Asthma |
| 125212151 | 12521215 | 5 | Infection |
| 125212151 | 12521215 | 6 | Asthma |
| 125212151 | 12521215 | 8 | Asthma |
| 125212151 | 12521215 | 9 | Product used for unknown indication |
| 125212151 | 12521215 | 10 | Product used for unknown indication |
| 125212151 | 12521215 | 11 | Product used for unknown indication |
| 125212151 | 12521215 | 12 | Product used for unknown indication |
| 125212151 | 12521215 | 13 | Product used for unknown indication |
| 125212151 | 12521215 | 14 | Product used for unknown indication |
| 125212151 | 12521215 | 15 | Product used for unknown indication |
| 125212151 | 12521215 | 16 | Product used for unknown indication |
| 125212151 | 12521215 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125212151 | 12521215 | OT |
| 125212151 | 12521215 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125212151 | 12521215 | Abdominal pain upper | |
| 125212151 | 12521215 | Alopecia | |
| 125212151 | 12521215 | Drug ineffective | |
| 125212151 | 12521215 | Dyspnoea | |
| 125212151 | 12521215 | Hyperhidrosis | |
| 125212151 | 12521215 | Injection site erythema | |
| 125212151 | 12521215 | Injection site pain | |
| 125212151 | 12521215 | Injection site swelling | |
| 125212151 | 12521215 | Limb mass | |
| 125212151 | 12521215 | Loss of consciousness | |
| 125212151 | 12521215 | Malaise | |
| 125212151 | 12521215 | Pulmonary function test decreased | |
| 125212151 | 12521215 | Vomiting | |
| 125212151 | 12521215 | Weight decreased | |
| 125212151 | 12521215 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 125212151 | 12521215 | 1 | 2007 | 0 |