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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127160451 | 12716045 | 1 | I | 20160809 | 20160906 | 20160906 | PER | US-JNJFOC-20160903739 | JOHNSON AND JOHNSON | 0.00 | F | Y | 0.00000 | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127160451 | 12716045 | 1 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | Y | U | UNKNOWN | 19835 | UNSPECIFIED | |||||||
| 127160451 | 12716045 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | Y | U | UNKNOWN | 19835 | UNSPECIFIED | |||||||
| 127160451 | 12716045 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||||
| 127160451 | 12716045 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||||
| 127160451 | 12716045 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 4 | G | ORAL SOLUTION | BID | |||||||
| 127160451 | 12716045 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 4.5 | G | ORAL SOLUTION | BID | |||||||
| 127160451 | 12716045 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 3.5 | G | ORAL SOLUTION | BID | |||||||
| 127160451 | 12716045 | 8 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 127160451 | 12716045 | 9 | C | METHYLPHENIDATE HYDROCHLORIDE. | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 127160451 | 12716045 | 10 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 127160451 | 12716045 | 11 | C | FOLIC ACID W/IRON | FERROUS SULFATEFOLIC ACID | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 127160451 | 12716045 | 12 | C | NUVIGIL | ARMODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 127160451 | 12716045 | 13 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127160451 | 12716045 | 2 | Product used for unknown indication |
| 127160451 | 12716045 | 3 | Narcolepsy |
| 127160451 | 12716045 | 4 | Narcolepsy |
| 127160451 | 12716045 | 5 | Narcolepsy |
| 127160451 | 12716045 | 6 | Narcolepsy |
| 127160451 | 12716045 | 7 | Narcolepsy |
| 127160451 | 12716045 | 8 | Product used for unknown indication |
| 127160451 | 12716045 | 9 | Product used for unknown indication |
| 127160451 | 12716045 | 10 | Product used for unknown indication |
| 127160451 | 12716045 | 11 | Product used for unknown indication |
| 127160451 | 12716045 | 12 | Product used for unknown indication |
| 127160451 | 12716045 | 13 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127160451 | 12716045 | Drug ineffective | |
| 127160451 | 12716045 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 127160451 | 12716045 | 3 | 201504 | 0 | ||
| 127160451 | 12716045 | 4 | 201205 | 2012 | 0 | |
| 127160451 | 12716045 | 5 | 201212 | 2013 | 0 | |
| 127160451 | 12716045 | 6 | 201303 | 2013 | 0 | |
| 127160451 | 12716045 | 7 | 201204 | 201205 | 0 |