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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300451 | 12530045 | 1 | I | 20160625 | 20160706 | 20160706 | EXP | US-NOVEL LABORATORIES, INC-2016-02921 | NOVEL LABS | KAISER J, ROYER P. PROFOUND HYPERTHERMIA AFTER POSTPARTUM RECTAL MISOPROSTOL ADMINISTRATION. OBSTETRICS AND GYNECOLOGY. 2016 JUN;127(6):1067-1069. | 21.00 | YR | F | Y | 0.00000 | 20160706 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300451 | 12530045 | 1 | PS | MISOPROSTOL. | MISOPROSTOL | 1 | Rectal | UNKNOWN | 91667 | 800 | UG | ||||||||
| 125300451 | 12530045 | 2 | C | PITOCIN | OXYTOCIN | 1 | Intramuscular | 0 | 20 | MG | |||||||||
| 125300451 | 12530045 | 3 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | 800 | MG | |||||||||
| 125300451 | 12530045 | 4 | C | LIDOCAINE. | LIDOCAINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125300451 | 12530045 | 1 | Postpartum haemorrhage |
| 125300451 | 12530045 | 2 | Product used for unknown indication |
| 125300451 | 12530045 | 3 | Product used for unknown indication |
| 125300451 | 12530045 | 4 | Anaesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125300451 | 12530045 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125300451 | 12530045 | Chills | |
| 125300451 | 12530045 | Encephalopathy | |
| 125300451 | 12530045 | Hyperthermia | |
| 125300451 | 12530045 | Mental status changes | |
| 125300451 | 12530045 | Sinus tachycardia | |
| 125300451 | 12530045 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |