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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126570511 | 12657051 | 1 | I | 20160529 | 20160601 | 20160816 | 20160816 | PER | US-PERRIGO-16US016765 | PERRIGO | 78.21 | YR | F | Y | 58.96000 | KG | 20160816 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126570511 | 12657051 | 1 | PS | LORATADINE. | LORATADINE | 1 | Oral | 10 MG, EVERY 4 HOURS | Y | 6CE1857 | 76301 | TABLET | |||||||
| 126570511 | 12657051 | 2 | SS | LORATADINE. | LORATADINE | 1 | Y | 76301 | TABLET | ||||||||||
| 126570511 | 12657051 | 3 | SS | LORATADINE. | LORATADINE | 1 | Y | 76301 | TABLET | ||||||||||
| 126570511 | 12657051 | 4 | SS | LORATADINE. | LORATADINE | 1 | Y | 76301 | TABLET | ||||||||||
| 126570511 | 12657051 | 5 | SS | LORATADINE. | LORATADINE | 1 | Y | 76301 | TABLET | ||||||||||
| 126570511 | 12657051 | 6 | SS | IBUPROFEN. | IBUPROFEN | 1 | Oral | 200 MG, EVERY 4 HOURS, PRN | Y | P96855 | 0 | ||||||||
| 126570511 | 12657051 | 7 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 500 MG, SINGLE AT BEDTIME | Y | 5KE1258 | 0 | 500 | MG | ||||||
| 126570511 | 12657051 | 8 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Y | 0 | |||||||||||
| 126570511 | 12657051 | 9 | C | FISH OIL | FISH OIL | 1 | Oral | UNK | U | UNKNOWN | 0 | ||||||||
| 126570511 | 12657051 | 10 | C | VITAMINS NOS | VITAMINS | 1 | Oral | UNK | U | UNKNOWN | 0 | ||||||||
| 126570511 | 12657051 | 11 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | UNK | U | UNKNOWN | 0 | ||||||||
| 126570511 | 12657051 | 12 | C | ANTIBIOTICS | UNSPECIFIED INGREDIENT | 1 | Unknown | UNK | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126570511 | 12657051 | 1 | Sinus headache |
| 126570511 | 12657051 | 2 | Rhinorrhoea |
| 126570511 | 12657051 | 3 | Eye pruritus |
| 126570511 | 12657051 | 4 | Nasal pruritus |
| 126570511 | 12657051 | 5 | Throat irritation |
| 126570511 | 12657051 | 6 | Sinus headache |
| 126570511 | 12657051 | 7 | Sinus headache |
| 126570511 | 12657051 | 8 | Insomnia |
| 126570511 | 12657051 | 9 | Supplementation therapy |
| 126570511 | 12657051 | 10 | Supplementation therapy |
| 126570511 | 12657051 | 11 | Hypertension |
| 126570511 | 12657051 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126570511 | 12657051 | Inappropriate schedule of drug administration | |
| 126570511 | 12657051 | Insomnia | |
| 126570511 | 12657051 | Off label use | |
| 126570511 | 12657051 | Overdose |
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 |
|---|---|---|---|---|---|---|
| 126570511 | 12657051 | 1 | 20160529 | 20160531 | 0 | |
| 126570511 | 12657051 | 6 | 20160529 | 20160531 | 0 | |
| 126570511 | 12657051 | 7 | 20160531 | 20160531 | 0 | |
| 126570511 | 12657051 | 11 | 20160425 | 0 |