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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283601 | 12528360 | 1 | I | 20160518 | 20160627 | 20160705 | 20160705 | EXP | GB-MHRA-ADR 23526827 | PHHY2016GB088580 | SANDOZ | 49.00 | YR | M | Y | 72.00000 | KG | 20160705 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283601 | 12528360 | 1 | PS | CLARITHROMYCIN. | CLARITHROMYCIN | 1 | Oral | 500 MG, BID | 1000 | MG | Y | U | D60173 | 65136 | 500 | MG | BID | ||
| 125283601 | 12528360 | 2 | C | LEMSIP /UNK/ | ACETAMINOPHENASCORBIC ACIDPHENYLEPHRINE HYDROCHLORIDESODIUM CITRATE | 1 | Unknown | U | 0 | ||||||||||
| 125283601 | 12528360 | 3 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | Y | 0 | ||||||||||
| 125283601 | 12528360 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125283601 | 12528360 | 1 | Lower respiratory tract infection |
| 125283601 | 12528360 | 2 | Product used for unknown indication |
| 125283601 | 12528360 | 3 | Lower respiratory tract infection |
| 125283601 | 12528360 | 4 | Lower respiratory tract infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125283601 | 12528360 | HO |
| 125283601 | 12528360 | OT |
| 125283601 | 12528360 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125283601 | 12528360 | Abnormal dreams | |
| 125283601 | 12528360 | Acute psychosis | |
| 125283601 | 12528360 | Confusional state | |
| 125283601 | 12528360 | Derealisation | |
| 125283601 | 12528360 | Hallucination | |
| 125283601 | 12528360 | Intentional self-injury | |
| 125283601 | 12528360 | Panic reaction | |
| 125283601 | 12528360 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 125283601 | 12528360 | 1 | 20160517 | 20160520 | 0 | |
| 125283601 | 12528360 | 3 | 20160515 | 20160520 | 0 | |
| 125283601 | 12528360 | 4 | 20160515 | 20160520 | 0 |