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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125530151 | 12553015 | 1 | I | 201312 | 20160614 | 20160713 | 20160713 | EXP | US-MALLINCKRODT-T201602597 | MALLINCKRODT | 62.70 | YR | F | Y | 59.00000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125530151 | 12553015 | 1 | PS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | Transdermal | 25MCG/HR, ONE PATCH EVERY 48 HRS | UNKNOWN | 77154 | TRANSDERMAL PATCH | ||||||||
| 125530151 | 12553015 | 2 | SS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | 77154 | TRANSDERMAL PATCH | |||||||||||
| 125530151 | 12553015 | 3 | SS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | 77154 | TRANSDERMAL PATCH | |||||||||||
| 125530151 | 12553015 | 4 | SS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | 77154 | TRANSDERMAL PATCH | |||||||||||
| 125530151 | 12553015 | 5 | SS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | 77154 | TRANSDERMAL PATCH | |||||||||||
| 125530151 | 12553015 | 6 | SS | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 6 TO 8 TABLETS DAILY WITH FOOD | U | UNKNOWN | 0 | ||||||||
| 125530151 | 12553015 | 7 | SS | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | WEANED DOWN TO 1/2 TABLET AT NIGHT | U | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125530151 | 12553015 | 1 | Post-traumatic pain |
| 125530151 | 12553015 | 2 | Migraine |
| 125530151 | 12553015 | 3 | Neck pain |
| 125530151 | 12553015 | 4 | Back pain |
| 125530151 | 12553015 | 5 | Systemic lupus erythematosus |
| 125530151 | 12553015 | 6 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125530151 | 12553015 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125530151 | 12553015 | Drug effect incomplete | |
| 125530151 | 12553015 | Gastrointestinal haemorrhage | |
| 125530151 | 12553015 | Insomnia | |
| 125530151 | 12553015 | Muscle spasms | |
| 125530151 | 12553015 | Myalgia | |
| 125530151 | 12553015 | Restless legs syndrome | |
| 125530151 | 12553015 | Therapy cessation | |
| 125530151 | 12553015 | Wrong technique in product usage process |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |