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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978722 | 12497872 | 2 | F | 200201 | 20160704 | 20160625 | 20160726 | EXP | GB-APOTEX-2016AP009330 | APOTEX | 62.00 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978722 | 12497872 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 40 MG, UNK | U | U | 0 | 40 | MG | TABLET | |||||
| 124978722 | 12497872 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | 30 MG, UNK | U | U | 0 | 30 | MG | TABLET | ||||||
| 124978722 | 12497872 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | 20 MG, UNK | U | U | 0 | 20 | MG | TABLET | ||||||
| 124978722 | 12497872 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 10 MG, UNK | U | U | 0 | 10 | MG | TABLET | |||||
| 124978722 | 12497872 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 5 MG, UNK | U | U | 0 | 5 | MG | TABLET | |||||
| 124978722 | 12497872 | 6 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978722 | 12497872 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 8 | C | XANAX | ALPRAZOLAM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978722 | 12497872 | 9 | C | XANAX | ALPRAZOLAM | 1 | Unknown | 0.5 MG, TID | U | U | 0 | .5 | MG | TID | |||||
| 124978722 | 12497872 | 10 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 11 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 12 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | 150 MG, UNK | U | U | 0 | 150 | MG | |||||||
| 124978722 | 12497872 | 13 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 14 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 15 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | 15 MG, UNK | U | U | 0 | 15 | MG | ||||||
| 124978722 | 12497872 | 16 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 17 | C | DULOXETINE. | DULOXETINE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 18 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 19 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | INCREASED TO 300 MG | U | U | 0 | ||||||||
| 124978722 | 12497872 | 20 | C | MELATONIN | MELATONIN | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 21 | C | DIHYDROCODEINE | DIHYDROCODEINE | 1 | Unknown | U | U | 0 | |||||||||
| 124978722 | 12497872 | 22 | C | CO CODAMOL | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978722 | 12497872 | 23 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978722 | 12497872 | 24 | C | THYROXINE | LEVOTHYROXINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978722 | 12497872 | 25 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978722 | 12497872 | 26 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978722 | 12497872 | 27 | C | SALBUTAMOL | ALBUTEROL | 1 | Unknown | UNK | U | U | 0 | INHALER | |||||||
| 124978722 | 12497872 | 28 | C | TIOTROPIUM | TIOTROPIUM | 1 | Respiratory (inhalation) | UNK | U | U | 0 | ||||||||
| 124978722 | 12497872 | 29 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978722 | 12497872 | 1 | Tearfulness |
| 124978722 | 12497872 | 2 | Emotional distress |
| 124978722 | 12497872 | 6 | Product used for unknown indication |
| 124978722 | 12497872 | 7 | Product used for unknown indication |
| 124978722 | 12497872 | 8 | Product used for unknown indication |
| 124978722 | 12497872 | 10 | Product used for unknown indication |
| 124978722 | 12497872 | 11 | Product used for unknown indication |
| 124978722 | 12497872 | 13 | Product used for unknown indication |
| 124978722 | 12497872 | 14 | Product used for unknown indication |
| 124978722 | 12497872 | 16 | Product used for unknown indication |
| 124978722 | 12497872 | 17 | Product used for unknown indication |
| 124978722 | 12497872 | 18 | Product used for unknown indication |
| 124978722 | 12497872 | 20 | Product used for unknown indication |
| 124978722 | 12497872 | 21 | Product used for unknown indication |
| 124978722 | 12497872 | 22 | Product used for unknown indication |
| 124978722 | 12497872 | 23 | Product used for unknown indication |
| 124978722 | 12497872 | 24 | Product used for unknown indication |
| 124978722 | 12497872 | 25 | Product used for unknown indication |
| 124978722 | 12497872 | 26 | Rash |
| 124978722 | 12497872 | 27 | Product used for unknown indication |
| 124978722 | 12497872 | 28 | Product used for unknown indication |
| 124978722 | 12497872 | 29 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978722 | 12497872 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978722 | 12497872 | Agitation | |
| 124978722 | 12497872 | Alopecia | |
| 124978722 | 12497872 | Anorgasmia | |
| 124978722 | 12497872 | Anxiety | |
| 124978722 | 12497872 | Arthralgia | |
| 124978722 | 12497872 | Asthenia | |
| 124978722 | 12497872 | Confusional state | |
| 124978722 | 12497872 | Decreased appetite | |
| 124978722 | 12497872 | Depressed mood | |
| 124978722 | 12497872 | Disturbance in attention | |
| 124978722 | 12497872 | Drug withdrawal syndrome | |
| 124978722 | 12497872 | Gait disturbance | |
| 124978722 | 12497872 | Hallucination | |
| 124978722 | 12497872 | Headache | |
| 124978722 | 12497872 | Insomnia | |
| 124978722 | 12497872 | Irritability | |
| 124978722 | 12497872 | Lethargy | |
| 124978722 | 12497872 | Libido decreased | |
| 124978722 | 12497872 | Loss of libido | |
| 124978722 | 12497872 | Malaise | |
| 124978722 | 12497872 | Marital problem | |
| 124978722 | 12497872 | Morbid thoughts | |
| 124978722 | 12497872 | Nausea | |
| 124978722 | 12497872 | Nightmare | |
| 124978722 | 12497872 | Onychoclasis | |
| 124978722 | 12497872 | Psychiatric symptom | |
| 124978722 | 12497872 | Respiratory disorder | |
| 124978722 | 12497872 | Restlessness | |
| 124978722 | 12497872 | Sleep disorder | |
| 124978722 | 12497872 | Tearfulness | |
| 124978722 | 12497872 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 124978722 | 12497872 | 1 | 20010516 | 20050701 | 0 | |
| 124978722 | 12497872 | 6 | 20010516 | 0 | ||
| 124978722 | 12497872 | 7 | 198504 | 0 | ||
| 124978722 | 12497872 | 8 | 20011206 | 0 | ||
| 124978722 | 12497872 | 10 | 20020808 | 0 | ||
| 124978722 | 12497872 | 11 | 20020106 | 0 | ||
| 124978722 | 12497872 | 13 | 200107 | 0 | ||
| 124978722 | 12497872 | 14 | 200111 | 0 | ||
| 124978722 | 12497872 | 16 | 200308 | 0 | ||
| 124978722 | 12497872 | 18 | 200703 | 0 | ||
| 124978722 | 12497872 | 20 | 200708 | 0 | ||
| 124978722 | 12497872 | 23 | 200712 | 0 | ||
| 124978722 | 12497872 | 24 | 20080515 | 0 | ||
| 124978722 | 12497872 | 25 | 20080515 | 0 |