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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104905532 | 10490553 | 2 | F | 199501 | 20151217 | 20141002 | 20151231 | EXP | US-JNJFOC-20140918658 | JOHNSON AND JOHNSON | ALECK KA, BARTLEY DL. MULTIPLE MALFORMATION SYNDROME FOLLOWING FLUCONAZOLE USE IN PREGNANCY: REPORT OF AN ADDITIONAL PATIENT. AMERICAN JOURNAL OF MEDICAL GENETICS 31-OCT-1997?72 (3):253-256. | 27.00 | YR | A | F | Y | 0.00000 | 20151231 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104905532 | 10490553 | 1 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | N | 0 | 1200 | MG | UNSPECIFIED | |||||||
| 104905532 | 10490553 | 2 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | N | 0 | 800 | MG | UNSPECIFIED | |||||||
| 104905532 | 10490553 | 3 | PS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | N | 999999 | 400 | MG | UNSPECIFIED | |||||||
| 104905532 | 10490553 | 4 | SS | IBUPROFEN. | IBUPROFEN | 1 | Oral | U | 17463 | 600 | MG | UNSPECIFIED | |||||||
| 104905532 | 10490553 | 5 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | U | 0 | 1 | G | UNSPECIFIED | |||||||
| 104905532 | 10490553 | 6 | SS | COMPAZINE | PROCHLORPERAZINE MALEATE | 1 | Unknown | 5 TO 10 MG | 0 | UNSPECIFIED | |||||||||
| 104905532 | 10490553 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 104905532 | 10490553 | 8 | SS | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | UNSPECIFIED | ||||||||
| 104905532 | 10490553 | 9 | SS | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 104905532 | 10490553 | 10 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 104905532 | 10490553 | 11 | SS | ROXANOL | MORPHINE SULFATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 104905532 | 10490553 | 12 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 104905532 | 10490553 | 13 | SS | AMPHOTERICIN B. | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | UNSPECIFIED | TIW | |||||||
| 104905532 | 10490553 | 14 | SS | AMPHOTERICIN B. | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | 0 | 50 | MG | UNSPECIFIED | TIW | |||||||
| 104905532 | 10490553 | 15 | SS | AMPHOTERICIN B. | AMPHOTERICIN B | 1 | Intrathecal | 0 | .5 | MG | UNSPECIFIED | TIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104905532 | 10490553 | 1 | Meningitis coccidioides |
| 104905532 | 10490553 | 2 | Meningitis coccidioides |
| 104905532 | 10490553 | 3 | Meningitis coccidioides |
| 104905532 | 10490553 | 4 | Product used for unknown indication |
| 104905532 | 10490553 | 5 | Product used for unknown indication |
| 104905532 | 10490553 | 6 | Nausea |
| 104905532 | 10490553 | 7 | Product used for unknown indication |
| 104905532 | 10490553 | 8 | Product used for unknown indication |
| 104905532 | 10490553 | 9 | Vomiting |
| 104905532 | 10490553 | 10 | Nausea |
| 104905532 | 10490553 | 11 | Pain |
| 104905532 | 10490553 | 12 | Staphylococcal infection |
| 104905532 | 10490553 | 13 | Meningitis coccidioides |
| 104905532 | 10490553 | 14 | Meningitis coccidioides |
| 104905532 | 10490553 | 15 | Meningitis coccidioides |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104905532 | 10490553 | HO |
| 104905532 | 10490553 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104905532 | 10490553 | Amniotic cavity infection | |
| 104905532 | 10490553 | Breech delivery | |
| 104905532 | 10490553 | Caesarean section | |
| 104905532 | 10490553 | Device related infection | |
| 104905532 | 10490553 | Drug administration error | |
| 104905532 | 10490553 | Drug ineffective | |
| 104905532 | 10490553 | Exposure during pregnancy | |
| 104905532 | 10490553 | Intentional overdose | |
| 104905532 | 10490553 | Maternal exposure during pregnancy | |
| 104905532 | 10490553 | Meningitis | |
| 104905532 | 10490553 | Nausea | |
| 104905532 | 10490553 | Pain | |
| 104905532 | 10490553 | Pregnancy | |
| 104905532 | 10490553 | Premature baby | |
| 104905532 | 10490553 | Premature delivery | |
| 104905532 | 10490553 | Premature rupture of membranes | |
| 104905532 | 10490553 | Staphylococcal infection | |
| 104905532 | 10490553 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 104905532 | 10490553 | 1 | 199505 | 0 | ||
| 104905532 | 10490553 | 2 | 199501 | 199502 | 0 | |
| 104905532 | 10490553 | 3 | 199312 | 199501 | 0 | |
| 104905532 | 10490553 | 11 | 19950301 | 19950412 | 0 | |
| 104905532 | 10490553 | 13 | 199309 | 199312 | 0 | |
| 104905532 | 10490553 | 14 | 199502 | 199505 | 0 | |
| 104905532 | 10490553 | 15 | 199309 | 0 |