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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127098081 | 12709808 | 1 | I | 201603 | 20160415 | 20160902 | 20160902 | PER | US-UPSHER-SMITH LABORATORIES, INC.-16000699 | UPSHER-SMITH | 72.00 | YR | F | Y | 95.00000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127098081 | 12709808 | 1 | PS | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK, UNK | 77759 | TABLET | ||||||||||
| 127098081 | 12709808 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Oral | 2.5 MG, QD | 0 | 2.5 | MG | QD | |||||||
| 127098081 | 12709808 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 10 MG, UNK | U | 0 | 10 | MG | ||||||||
| 127098081 | 12709808 | 4 | C | METOPROLOL. | METOPROLOL | 1 | 25 MG, UNK | U | 0 | 25 | MG | ||||||||
| 127098081 | 12709808 | 5 | C | FLECAINIDE ACETATE. | FLECAINIDE ACETATE | 1 | 100 MG, UNK | U | 0 | 100 | MG | ||||||||
| 127098081 | 12709808 | 6 | C | LOSARTAN. | LOSARTAN | 1 | 100 MG, UNK | U | 0 | 100 | MG | ||||||||
| 127098081 | 12709808 | 7 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 20 MG, UNK | U | 0 | 20 | MG | ||||||||
| 127098081 | 12709808 | 8 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 4 MG, UNK | U | 0 | 4 | MG | ||||||||
| 127098081 | 12709808 | 9 | C | FENTANYL. | FENTANYL | 1 | 50 MCG, UNK | U | 0 | 50 | UG | ||||||||
| 127098081 | 12709808 | 10 | C | FIORINAL | ASPIRINBUTALBITALCAFFEINE | 1 | U | 0 | |||||||||||
| 127098081 | 12709808 | 11 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127098081 | 12709808 | 12 | C | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | |||||||||||
| 127098081 | 12709808 | 13 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127098081 | 12709808 | 1 | Product used for unknown indication |
| 127098081 | 12709808 | 2 | Hallucination |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127098081 | 12709808 | Asthenia | |
| 127098081 | 12709808 | Balance disorder | |
| 127098081 | 12709808 | Fatigue | |
| 127098081 | 12709808 | Oedema | |
| 127098081 | 12709808 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 127098081 | 12709808 | 1 | 201603 | 0 | ||
| 127098081 | 12709808 | 2 | 201603 | 0 |