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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122098944 | 12209894 | 4 | F | 20160816 | 20160325 | 20160826 | EXP | GB-TEVA-645295ACC | TEVA | 23.00 | YR | F | Y | 44.20000 | KG | 20160826 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122098944 | 12209894 | 1 | PS | NITROFURANTOIN. | NITROFURANTOIN | 1 | Unknown | 50 MILLIGRAM DAILY; NOCTE? | U | U | UNKNOWN | 73652 | 50 | MG | QD | ||||
| 122098944 | 12209894 | 2 | SS | FRISIUM | CLOBAZAM | 1 | Oral | 30 MILLIGRAM DAILY; | U | U | 5HN4D | 0 | 10 | MG | TABLET | TID | |||
| 122098944 | 12209894 | 3 | SS | FRISIUM | CLOBAZAM | 1 | Oral | 90 MILLIGRAM DAILY; | U | U | 5HN4D | 0 | 30 | MG | TABLET | TID | |||
| 122098944 | 12209894 | 4 | SS | NORMACOL | KARAYA GUM | 1 | Unknown | U | U | UNKNOWN | 0 | ||||||||
| 122098944 | 12209894 | 5 | SS | BUCCOLAM | MIDAZOLAM HYDROCHLORIDE | 1 | Unknown | WHEN NEEDED IF SEIZURE LASTS FOR 5 OR MORE MINUTES | U | U | UNKNOWN? | 0 | 10 | MG | |||||
| 122098944 | 12209894 | 6 | SS | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | 2-3 SACHETS WHEN NEEDED? | U | U | UNKNOWN? | 0 | |||||||
| 122098944 | 12209894 | 7 | C | CHLORAL HYDRATE | CHLORAL HYDRATE | 1 | Oral | 1.2 MILLIGRAM DAILY; | U | UNKNOWN | 0 | 1.2 | MG | QD | |||||
| 122098944 | 12209894 | 8 | C | GLYCOPYRROLATE. | GLYCOPYRROLATE | 1 | Oral | 5 MILLIGRAM DAILY; | U | UNKNOWN | 0 | 2.5 | MG | BID | |||||
| 122098944 | 12209894 | 9 | C | LAMICTAL | LAMOTRIGINE | 1 | Oral | 150 MG 125 MG AM, 150 MG PM? | U | UNKNOWN | 0 | BID | |||||||
| 122098944 | 12209894 | 10 | C | Noctonin | 2 | Oral | 4 MILLIGRAM DAILY; | U | UNKNOWN | 0 | 4 | MG | QD | ||||||
| 122098944 | 12209894 | 11 | C | Noctonin | 2 | U | UNKNOWN | 0 | |||||||||||
| 122098944 | 12209894 | 12 | C | NEURONTIN | GABAPENTIN | 1 | Oral | 1500 MILLIGRAM DAILY; AT AGE 5? | U | UNKNOWN | 0 | 500 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122098944 | 12209894 | 1 | Product used for unknown indication |
| 122098944 | 12209894 | 2 | Epilepsy |
| 122098944 | 12209894 | 4 | Product used for unknown indication |
| 122098944 | 12209894 | 7 | Product used for unknown indication |
| 122098944 | 12209894 | 8 | Product used for unknown indication |
| 122098944 | 12209894 | 9 | Seizure |
| 122098944 | 12209894 | 10 | Sleep disorder |
| 122098944 | 12209894 | 11 | Epilepsy |
| 122098944 | 12209894 | 12 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122098944 | 12209894 | LT |
| 122098944 | 12209894 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122098944 | 12209894 | Constipation | |
| 122098944 | 12209894 | Drooling | |
| 122098944 | 12209894 | Drug ineffective | |
| 122098944 | 12209894 | Seizure | |
| 122098944 | 12209894 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 122098944 | 12209894 | 2 | 20150212 | 0 |