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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125413341 | 12541334 | 1 | I | 201601 | 20160201 | 20160708 | 20160708 | EXP | FR-UCBSA-2016004092 | UCB | 28.73 | YR | F | Y | 86.00000 | KG | 20160708 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125413341 | 12541334 | 1 | SS | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 525 MG, TOTAL (25 MG: 21 TABLETS ) | U | 0 | 525 | MG | FILM-COATED TABLET | 1X | |||||
| 125413341 | 12541334 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 150 MG, TOTAL (10 MG 15 TABLETS) | U | 0 | 150 | MG | ORAL DROPS, SOLUTION | 1X | |||||
| 125413341 | 12541334 | 3 | PS | KEPPRA | LEVETIRACETAM | 1 | 500 MG, 2X/DAY (BID) | U | U | 21035 | 500 | MG | BID | ||||||
| 125413341 | 12541334 | 4 | SS | BACLOFEN. | BACLOFEN | 1 | Oral | 960 MG, TOTAL (10 MG; 96 TABLETS) | U | 0 | 960 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 5 | SS | QUETIAPINE. | QUETIAPINE | 1 | Oral | 13200 MG, TOTAL (300 MG; 44 TABLETS) | U | 0 | 13200 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 6 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 5925 MG, TOTAL (75 MG; 79 TABLETS) | U | 0 | 5925 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 7 | SS | Theralene | TRIMEPRAZINE | 1 | Oral | 215 MG, TOTAL (5 MG; 43 TABLETS) | U | 0 | 215 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 8 | SS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 17 MG, TOTAL (0.25 MG: 68 TABLETS) | U | 0 | 17 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 9 | SS | Veratran | CLOTIAZEPAM | 1 | Oral | 90 MG, TOTAL (10 MG: 9 TABLETS ) | U | 0 | 90 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 10 | SS | IBUPROFEN. | IBUPROFEN | 1 | Oral | 4800 MG, TOTAL (400 MG; 12 TABLETS) | U | 0 | 4800 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 11 | SS | Ketum | KETOPROFEN | 1 | Oral | 900 MG, TOTAL (100 MG; 9 TABLETS) | U | 0 | 900 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 12 | SS | KETOPROFEN. | KETOPROFEN | 1 | Oral | 800 MG, TOTAL (100 MG; 8 TABLETS) | U | U | 0 | 800 | MG | TABLET | 1X | ||||
| 125413341 | 12541334 | 13 | SS | Naltrexone | NALTREXONE | 1 | Oral | 1400 MG, TOTAL (50 MG; 28 TABLETS) | U | 0 | 1400 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 14 | SS | Zopiclone | ZOPICLONE | 1 | Oral | 82.5 MG, TOTAL (7.5 MG: 11 TABLETS) | U | U | 0 | 82.5 | MG | TABLET | 1X | ||||
| 125413341 | 12541334 | 15 | SS | Pyostacine | PRISTINAMYCIN | 1 | Oral | 10000 MG, TOTAL (500 MG; 20 TABLETS) | U | 0 | 10000 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 16 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 100 MG, TOTAL (20 MG; 5 TABLETS) | U | 0 | 100 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 17 | SS | Daflon | DIOSMINHESPERIDIN | 1 | Oral | 59500 MG, TOTAL (700 MG; 85 TABLETS) | U | 0 | 59500 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 18 | SS | Sulfarlem | ANETHOLTRITHION | 1 | Oral | 3750 MG, TOTAL (25 MG; 150 TABLETS) | U | 0 | 3750 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 19 | SS | DOLIPRANE | ACETAMINOPHEN | 1 | Oral | 8 G, TOTAL (1 G; 8 TABLETS) | U | 0 | 8 | G | TABLET | 1X | |||||
| 125413341 | 12541334 | 20 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | 1400 MG, TOTAL (1000 MG; 14 TABLETS) | U | 0 | 1400 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 21 | SS | Spasfon | PHLOROGLUCINOL | 1 | Oral | 1600 MG, TOTAL (80 MG; 20 TABLETS) | U | 0 | 1600 | MG | TABLET | 1X | |||||
| 125413341 | 12541334 | 22 | C | RIVOTRIL | CLONAZEPAM | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | INJECTION | ||||||||
| 125413341 | 12541334 | 23 | C | CELOCURINE | SUCCINYLCHOLINE CHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125413341 | 12541334 | 24 | C | ETOMIDATE. | ETOMIDATE | 1 | UNK | U | 0 | ||||||||||
| 125413341 | 12541334 | 25 | C | Saline | SODIUM CHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 125413341 | 12541334 | 26 | C | FLUIMUCIL | ACETYLCYSTEINE | 1 | UNK | U | 0 | ||||||||||
| 125413341 | 12541334 | 27 | C | Gardenal | PHENOBARBITAL | 1 | LOADING DOSE | U | 0 | ||||||||||
| 125413341 | 12541334 | 28 | C | Gardenal | PHENOBARBITAL | 1 | MAINTENACE DOSE | U | 0 | ||||||||||
| 125413341 | 12541334 | 29 | C | Urbanyl | CLOBAZAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125413341 | 12541334 | 1 | Product used for unknown indication |
| 125413341 | 12541334 | 2 | Product used for unknown indication |
| 125413341 | 12541334 | 3 | Product used for unknown indication |
| 125413341 | 12541334 | 4 | Product used for unknown indication |
| 125413341 | 12541334 | 5 | Product used for unknown indication |
| 125413341 | 12541334 | 6 | Product used for unknown indication |
| 125413341 | 12541334 | 7 | Product used for unknown indication |
| 125413341 | 12541334 | 8 | Product used for unknown indication |
| 125413341 | 12541334 | 9 | Product used for unknown indication |
| 125413341 | 12541334 | 10 | Product used for unknown indication |
| 125413341 | 12541334 | 11 | Product used for unknown indication |
| 125413341 | 12541334 | 12 | Product used for unknown indication |
| 125413341 | 12541334 | 13 | Product used for unknown indication |
| 125413341 | 12541334 | 14 | Product used for unknown indication |
| 125413341 | 12541334 | 15 | Product used for unknown indication |
| 125413341 | 12541334 | 16 | Product used for unknown indication |
| 125413341 | 12541334 | 17 | Product used for unknown indication |
| 125413341 | 12541334 | 18 | Product used for unknown indication |
| 125413341 | 12541334 | 19 | Product used for unknown indication |
| 125413341 | 12541334 | 20 | Product used for unknown indication |
| 125413341 | 12541334 | 21 | Product used for unknown indication |
| 125413341 | 12541334 | 22 | Generalised tonic-clonic seizure |
| 125413341 | 12541334 | 23 | Altered state of consciousness |
| 125413341 | 12541334 | 24 | Altered state of consciousness |
| 125413341 | 12541334 | 25 | Haemodynamic instability |
| 125413341 | 12541334 | 26 | Product used for unknown indication |
| 125413341 | 12541334 | 27 | Status epilepticus |
| 125413341 | 12541334 | 29 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125413341 | 12541334 | OT |
| 125413341 | 12541334 | HO |
| 125413341 | 12541334 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125413341 | 12541334 | Alcohol withdrawal syndrome | |
| 125413341 | 12541334 | Coma | |
| 125413341 | 12541334 | Electrocardiogram QT prolonged | |
| 125413341 | 12541334 | Generalised tonic-clonic seizure | |
| 125413341 | 12541334 | Hepatocellular injury | |
| 125413341 | 12541334 | Intentional overdose | |
| 125413341 | 12541334 | Poisoning deliberate | |
| 125413341 | 12541334 | Seizure | |
| 125413341 | 12541334 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 125413341 | 12541334 | 1 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 2 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 3 | 201601 | 20160122 | 0 | |
| 125413341 | 12541334 | 4 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 5 | 20160117 | 20160117 | 0 | |
| 125413341 | 12541334 | 6 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 7 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 8 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 9 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 10 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 11 | 20160117 | 20160117 | 0 | |
| 125413341 | 12541334 | 12 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 13 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 14 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 15 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 16 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 17 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 18 | 20160115 | 20160117 | 0 | |
| 125413341 | 12541334 | 19 | 20160117 | 20160117 | 0 | |
| 125413341 | 12541334 | 20 | 20160114 | 20160117 | 0 | |
| 125413341 | 12541334 | 21 | 20160117 | 20160117 | 0 |