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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123278912 | 12327891 | 2 | F | 20160425 | 20160503 | 20160720 | EXP | US-MYLANLABS-2016M1018172 | MYLAN | BRAHMBHATT K, WHITGOB E. DIAGNOSIS AND MANAGEMENT OF DELIRIUM IN CRITICALLY ILL INFANTS: CASE REPORT AND REVIEW. PEDIATRICS 2016;137:NO. 3. | 0.00 | Y | 0.00000 | 20160719 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123278912 | 12327891 | 1 | PS | MORPHINE | MORPHINE | 1 | Unknown | 40 MG EVERY 4 HOURS, RECEIVING 3-6 DOSES/24 HOURS | Y | U | 200824 | ||||||||
| 123278912 | 12327891 | 2 | SS | MORPHINE | MORPHINE | 1 | Y | U | 200824 | ||||||||||
| 123278912 | 12327891 | 3 | SS | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 4 MG EVERY 6 HOURS, RECEIVING 4-6 DOSES/24 HOURS | Y | 0 | |||||||||
| 123278912 | 12327891 | 4 | SS | LORAZEPAM. | LORAZEPAM | 1 | Y | 0 | |||||||||||
| 123278912 | 12327891 | 5 | SS | METHADONE | METHADONE HYDROCHLORIDE | 1 | Unknown | INITIAL DOSE NOT STATED, INCREASED TO 5 MG EVERY 6 HOURS | U | U | 0 | ||||||||
| 123278912 | 12327891 | 6 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | 400 MCG/KG/HOUR | U | U | 0 | ||||||||
| 123278912 | 12327891 | 7 | SS | LIDOCAINE. | LIDOCAINE | 1 | Intravenous (not otherwise specified) | 20 MCG/KG/MINUTE | U | U | 0 | ||||||||
| 123278912 | 12327891 | 8 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | U | U | 0 | 2.5 | MG | |||||||
| 123278912 | 12327891 | 9 | C | SILDENAFIL. | SILDENAFIL | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 10 | C | HEPARIN | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 123278912 | 12327891 | 11 | C | MILRINONE | MILRINONE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 123278912 | 12327891 | 12 | C | SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 123278912 | 12327891 | 13 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 123278912 | 12327891 | 14 | C | SALBUTAMOL | ALBUTEROL | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 123278912 | 12327891 | 15 | C | SALBUTAMOL | ALBUTEROL | 1 | Nasal | 0 | |||||||||||
| 123278912 | 12327891 | 16 | C | VECURONIUM BROMIDE. | VECURONIUM BROMIDE | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 123278912 | 12327891 | 17 | C | GENTAMICIN. | GENTAMICIN | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 18 | C | CHLOROTHIAZIDE. | CHLOROTHIAZIDE | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 19 | C | CALCIUM CHLORIDE. | CALCIUM CHLORIDE | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 20 | C | CALCIUM | CALCIUM | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 123278912 | 12327891 | 21 | C | ALBUMIN HUMAN | ALBUMIN HUMAN | 1 | Unknown | AS NEEDED | 0 | ||||||||||
| 123278912 | 12327891 | 22 | C | MEROPENEM. | MEROPENEM | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 23 | C | NYSTATIN. | NYSTATIN | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 24 | C | TOBRAMYCIN. | TOBRAMYCIN | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 25 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 26 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 27 | C | LACTOBACILLUS | LACTOBACILLUS ACIDOPHILUS | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 28 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Unknown | 0 | |||||||||||
| 123278912 | 12327891 | 29 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123278912 | 12327891 | 1 | Agitation |
| 123278912 | 12327891 | 2 | Akathisia |
| 123278912 | 12327891 | 3 | Agitation |
| 123278912 | 12327891 | 4 | Akathisia |
| 123278912 | 12327891 | 5 | Delirium |
| 123278912 | 12327891 | 6 | Product used for unknown indication |
| 123278912 | 12327891 | 7 | Product used for unknown indication |
| 123278912 | 12327891 | 8 | Product used for unknown indication |
| 123278912 | 12327891 | 9 | Product used for unknown indication |
| 123278912 | 12327891 | 10 | Product used for unknown indication |
| 123278912 | 12327891 | 11 | Product used for unknown indication |
| 123278912 | 12327891 | 12 | Product used for unknown indication |
| 123278912 | 12327891 | 13 | Product used for unknown indication |
| 123278912 | 12327891 | 14 | Product used for unknown indication |
| 123278912 | 12327891 | 16 | Product used for unknown indication |
| 123278912 | 12327891 | 17 | Product used for unknown indication |
| 123278912 | 12327891 | 18 | Product used for unknown indication |
| 123278912 | 12327891 | 19 | Product used for unknown indication |
| 123278912 | 12327891 | 20 | Product used for unknown indication |
| 123278912 | 12327891 | 21 | Product used for unknown indication |
| 123278912 | 12327891 | 22 | Product used for unknown indication |
| 123278912 | 12327891 | 23 | Product used for unknown indication |
| 123278912 | 12327891 | 24 | Product used for unknown indication |
| 123278912 | 12327891 | 25 | Product used for unknown indication |
| 123278912 | 12327891 | 26 | Product used for unknown indication |
| 123278912 | 12327891 | 27 | Product used for unknown indication |
| 123278912 | 12327891 | 28 | Product used for unknown indication |
| 123278912 | 12327891 | 29 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123278912 | 12327891 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123278912 | 12327891 | Delirium | |
| 123278912 | 12327891 | Electrocardiogram QT prolonged | |
| 123278912 | 12327891 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |