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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125934441 | 12593444 | 1 | I | 20160608 | 20160715 | 20160726 | 20160726 | EXP | GB-MHRA-TPP12014555C3601864YC1467817259692 | PHHY2016GB098050 | SANDOZ | 64.00 | YR | F | Y | 79.00000 | KG | 20160726 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125934441 | 12593444 | 1 | PS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | Unknown | Y | U | 200889 | |||||||||
| 125934441 | 12593444 | 2 | C | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | 28 | DF | U | 0 | 1 | DF | QD | ||||
| 125934441 | 12593444 | 3 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 1 DF, QD | 369 | DF | U | 0 | 1 | DF | QD | ||||
| 125934441 | 12593444 | 4 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 1 DF, QD | 2 | DF | Y | 0 | 1 | DF | QD | ||||
| 125934441 | 12593444 | 5 | C | NAPROXEN. | NAPROXEN | 1 | Oral | 1 DF, BID (WITH FOOD) | 738 | DF | U | 0 | 1 | DF | BID | ||||
| 125934441 | 12593444 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 2 DF, QD | 738 | DF | U | 0 | 2 | DF | QD | ||||
| 125934441 | 12593444 | 7 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 6 DF, QD | 6 | DF | Y | 0 | 6 | DF | QD | ||||
| 125934441 | 12593444 | 8 | C | SALBUTAMOL | ALBUTEROL | 1 | Respiratory (inhalation) | 2 DF, UNK | U | 0 | 2 | DF | |||||||
| 125934441 | 12593444 | 9 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | 369 | DF | U | 0 | 1 | DF | QD | ||||
| 125934441 | 12593444 | 10 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 1 DF, BID (MORNING AND EVENING. CAN USE TWICE) | 738 | DF | U | 0 | 1 | DF | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125934441 | 12593444 | 1 | Product used for unknown indication |
| 125934441 | 12593444 | 2 | Product used for unknown indication |
| 125934441 | 12593444 | 3 | Product used for unknown indication |
| 125934441 | 12593444 | 4 | Product used for unknown indication |
| 125934441 | 12593444 | 5 | Product used for unknown indication |
| 125934441 | 12593444 | 6 | Product used for unknown indication |
| 125934441 | 12593444 | 7 | Product used for unknown indication |
| 125934441 | 12593444 | 8 | Product used for unknown indication |
| 125934441 | 12593444 | 9 | Product used for unknown indication |
| 125934441 | 12593444 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125934441 | 12593444 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125934441 | 12593444 | Agitation | |
| 125934441 | 12593444 | Depressed mood | |
| 125934441 | 12593444 | Hallucination | |
| 125934441 | 12593444 | Mood swings | |
| 125934441 | 12593444 | Self-injurious ideation |
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 |
|---|---|---|---|---|---|---|
| 125934441 | 12593444 | 1 | 20160608 | 20160706 | 0 | |
| 125934441 | 12593444 | 2 | 20160706 | 0 | ||
| 125934441 | 12593444 | 3 | 20150605 | 0 | ||
| 125934441 | 12593444 | 4 | 20160606 | 20160623 | 0 | |
| 125934441 | 12593444 | 5 | 20150605 | 0 | ||
| 125934441 | 12593444 | 6 | 20150605 | 0 | ||
| 125934441 | 12593444 | 7 | 20160608 | 20160613 | 0 | |
| 125934441 | 12593444 | 8 | 20150605 | 0 | ||
| 125934441 | 12593444 | 9 | 20150605 | 0 | ||
| 125934441 | 12593444 | 10 | 20150605 | 0 |