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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126305431 | 12630543 | 1 | I | 201607 | 20160725 | 20160808 | 20160808 | EXP | US-JNJFOC-20160801981 | JANSSEN | 64.47 | YR | A | M | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126305431 | 12630543 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | U | UNKNOWN | 21692 | 10 | MG | SUSTAINED RELEASE TABLETS | QID | ||||
| 126305431 | 12630543 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | N | UNKNOWN | 0 | 2.25 | G | ORAL SOLUTION | BID | |||||
| 126305431 | 12630543 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | N | UNKNOWN | 0 | ORAL SOLUTION | ||||||||
| 126305431 | 12630543 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | N | UNKNOWN | 0 | 3.75 | G | ORAL SOLUTION | BID | |||||
| 126305431 | 12630543 | 5 | C | HYDROCODONE BITARTRATE W/PARACETAMOL | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 7.5-325 | 0 | TABLET | |||||||||
| 126305431 | 12630543 | 6 | C | HYDROCODONE BITARTRATE W/PARACETAMOL | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 10-325 | 0 | TABLET | |||||||||
| 126305431 | 12630543 | 7 | C | KRILL OIL | DIETARY SUPPLEMENT | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126305431 | 12630543 | 8 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 0 | CHEWABLE TABLET | ||||||||||
| 126305431 | 12630543 | 9 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126305431 | 12630543 | 10 | C | CHANTIX | VARENICLINE TARTRATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126305431 | 12630543 | 11 | C | FOSAMAX | ALENDRONATE SODIUM | 1 | Unknown | 0 | TABLET | ||||||||||
| 126305431 | 12630543 | 12 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126305431 | 12630543 | 13 | C | OMEGA 3 6 9 | FISH OIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126305431 | 12630543 | 14 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | CAPSULE | ||||||||||
| 126305431 | 12630543 | 15 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | Unknown | 0 | TABLET | ||||||||||
| 126305431 | 12630543 | 16 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126305431 | 12630543 | 17 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 0 | TABLET | ||||||||||
| 126305431 | 12630543 | 18 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126305431 | 12630543 | 19 | C | MUCINEX | GUAIFENESIN | 1 | Unknown | 0 | TABLET | ||||||||||
| 126305431 | 12630543 | 20 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Unknown | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126305431 | 12630543 | 1 | Pain |
| 126305431 | 12630543 | 2 | Narcolepsy |
| 126305431 | 12630543 | 3 | Narcolepsy |
| 126305431 | 12630543 | 4 | Narcolepsy |
| 126305431 | 12630543 | 5 | Product used for unknown indication |
| 126305431 | 12630543 | 6 | Product used for unknown indication |
| 126305431 | 12630543 | 7 | Product used for unknown indication |
| 126305431 | 12630543 | 8 | Product used for unknown indication |
| 126305431 | 12630543 | 9 | Product used for unknown indication |
| 126305431 | 12630543 | 10 | Product used for unknown indication |
| 126305431 | 12630543 | 11 | Product used for unknown indication |
| 126305431 | 12630543 | 12 | Product used for unknown indication |
| 126305431 | 12630543 | 13 | Product used for unknown indication |
| 126305431 | 12630543 | 14 | Product used for unknown indication |
| 126305431 | 12630543 | 15 | Product used for unknown indication |
| 126305431 | 12630543 | 16 | Product used for unknown indication |
| 126305431 | 12630543 | 17 | Product used for unknown indication |
| 126305431 | 12630543 | 18 | Product used for unknown indication |
| 126305431 | 12630543 | 19 | Product used for unknown indication |
| 126305431 | 12630543 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126305431 | 12630543 | HO |
| 126305431 | 12630543 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126305431 | 12630543 | Drug ineffective | |
| 126305431 | 12630543 | Hangover | |
| 126305431 | 12630543 | Hip fracture | |
| 126305431 | 12630543 | Insomnia | |
| 126305431 | 12630543 | Sleep talking | |
| 126305431 | 12630543 | Somnambulism |
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 |
|---|---|---|---|---|---|---|
| 126305431 | 12630543 | 1 | 201607 | 0 | ||
| 126305431 | 12630543 | 2 | 200509 | 200510 | 0 | |
| 126305431 | 12630543 | 3 | 200510 | 201607 | 0 | |
| 126305431 | 12630543 | 4 | 201607 | 0 | ||
| 126305431 | 12630543 | 5 | 20151103 | 20160608 | 0 | |
| 126305431 | 12630543 | 6 | 20160609 | 0 | ||
| 126305431 | 12630543 | 7 | 201605 | 0 | ||
| 126305431 | 12630543 | 8 | 20151103 | 0 | ||
| 126305431 | 12630543 | 9 | 20151103 | 0 | ||
| 126305431 | 12630543 | 10 | 20151103 | 20151103 | 0 | |
| 126305431 | 12630543 | 11 | 20151103 | 0 | ||
| 126305431 | 12630543 | 12 | 20151103 | 0 | ||
| 126305431 | 12630543 | 13 | 20151103 | 201605 | 0 | |
| 126305431 | 12630543 | 14 | 20151103 | 0 | ||
| 126305431 | 12630543 | 15 | 20151103 | 0 | ||
| 126305431 | 12630543 | 16 | 20151103 | 20151103 | 0 | |
| 126305431 | 12630543 | 17 | 20151103 | 0 | ||
| 126305431 | 12630543 | 18 | 20150701 | 0 | ||
| 126305431 | 12630543 | 19 | 20110125 | 0 |