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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127700041 | 12770004 | 1 | I | 20160907 | 20160922 | 20160922 | EXP | ES-ALKEM LABORATORIES LIMITED-ES-ALKEM-2016-00190 | ALKEM | 84.00 | YR | M | Y | 0.00000 | 20160922 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127700041 | 12770004 | 1 | PS | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | 12.5 MG, BID | 201504 | 12.5 | MG | Q12H | ||||||||
| 127700041 | 12770004 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | 2.5 MG, BID | 0 | 2.5 | MG | Q12H | ||||||||
| 127700041 | 12770004 | 3 | SS | DONEPEZIL. | DONEPEZIL | 1 | 10 MG, QD | 0 | 10 | MG | QD | ||||||||
| 127700041 | 12770004 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0.125 MG, UNK | 0 | .125 | MG | |||||||||
| 127700041 | 12770004 | 5 | C | TIOTROPIUM BROMIDE | TIOTROPIUM BROMIDE | 1 | Respiratory (inhalation) | 18 MCG, QD | 0 | QD | |||||||||
| 127700041 | 12770004 | 6 | C | TAMSULOSIN | TAMSULOSIN | 1 | 0.4 MG, UNK | 0 | .4 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127700041 | 12770004 | 1 | Restlessness |
| 127700041 | 12770004 | 2 | Product used for unknown indication |
| 127700041 | 12770004 | 3 | Product used for unknown indication |
| 127700041 | 12770004 | 4 | Product used for unknown indication |
| 127700041 | 12770004 | 5 | Product used for unknown indication |
| 127700041 | 12770004 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127700041 | 12770004 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127700041 | 12770004 | Acute kidney injury | |
| 127700041 | 12770004 | Atelectasis | |
| 127700041 | 12770004 | Neuroleptic malignant syndrome | |
| 127700041 | 12770004 | Respiratory failure | |
| 127700041 | 12770004 | Respiratory tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |