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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125267572 | 12526757 | 2 | F | 200201 | 20160706 | 20160705 | 20160720 | EXP | GB-AUROBINDO-AUR-APL-2016-08545 | AUROBINDO | 62.55 | YR | F | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125267572 | 12526757 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 40 MG, UNK | U | 78406 | 40 | MG | |||||||
| 125267572 | 12526757 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 30 MG, UNK | U | 78406 | 30 | MG | |||||||
| 125267572 | 12526757 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, UNK | U | 78406 | 20 | MG | |||||||
| 125267572 | 12526757 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 10 MG, UNK | U | 78406 | 10 | MG | |||||||
| 125267572 | 12526757 | 5 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 5 MG, UNK | U | 78406 | 5 | MG | |||||||
| 125267572 | 12526757 | 6 | SS | SEROXAT | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125267572 | 12526757 | 7 | C | COCODAMOL | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 8 | C | COCODAMOL | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | U | 0 | ||||||||||
| 125267572 | 12526757 | 9 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 10 | C | DIHYDROCODEINE | DIHYDROCODEINE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 11 | C | DIHYDROCODEINE | DIHYDROCODEINE | 1 | UNK | U | 0 | ||||||||||
| 125267572 | 12526757 | 12 | C | DULOXETINE. | DULOXETINE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 13 | C | DULOXETINE. | DULOXETINE | 1 | UNK | U | 0 | ||||||||||
| 125267572 | 12526757 | 14 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 15 | C | MELATONIN | MELATONIN | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 16 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 17 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125267572 | 12526757 | 18 | C | QUETIAPINE. | QUETIAPINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125267572 | 12526757 | 19 | C | THYROXINE | LEVOTHYROXINE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 20 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 125267572 | 12526757 | 21 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 125267572 | 12526757 | 22 | C | XANAX | ALPRAZOLAM | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 23 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 24 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 125267572 | 12526757 | 25 | C | SENNA /00142201/ | SENNA LEAF | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 26 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 27 | C | SALBUTAMOL | ALBUTEROL | 1 | Unknown | U | 0 | INHALER | |||||||||
| 125267572 | 12526757 | 28 | C | TIOTROPIUM | TIOTROPIUM | 1 | U | 0 | |||||||||||
| 125267572 | 12526757 | 29 | C | ATORVASTIN | ATORVASTATIN | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 30 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 31 | C | SALMETEROL | SALMETEROL | 1 | Unknown | U | 0 | INHALER | |||||||||
| 125267572 | 12526757 | 32 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 33 | C | RISEDRONATE | RISEDRONATE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 125267572 | 12526757 | 34 | C | STEROIDS | UNSPECIFIED INGREDIENT | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125267572 | 12526757 | 1 | Tearfulness |
| 125267572 | 12526757 | 2 | Emotional distress |
| 125267572 | 12526757 | 6 | Product used for unknown indication |
| 125267572 | 12526757 | 7 | Product used for unknown indication |
| 125267572 | 12526757 | 9 | Product used for unknown indication |
| 125267572 | 12526757 | 10 | Product used for unknown indication |
| 125267572 | 12526757 | 12 | Product used for unknown indication |
| 125267572 | 12526757 | 14 | Product used for unknown indication |
| 125267572 | 12526757 | 15 | Product used for unknown indication |
| 125267572 | 12526757 | 16 | Product used for unknown indication |
| 125267572 | 12526757 | 17 | Product used for unknown indication |
| 125267572 | 12526757 | 18 | Product used for unknown indication |
| 125267572 | 12526757 | 19 | Product used for unknown indication |
| 125267572 | 12526757 | 20 | Product used for unknown indication |
| 125267572 | 12526757 | 21 | Product used for unknown indication |
| 125267572 | 12526757 | 22 | Product used for unknown indication |
| 125267572 | 12526757 | 23 | Product used for unknown indication |
| 125267572 | 12526757 | 24 | Product used for unknown indication |
| 125267572 | 12526757 | 25 | Product used for unknown indication |
| 125267572 | 12526757 | 26 | Product used for unknown indication |
| 125267572 | 12526757 | 27 | Product used for unknown indication |
| 125267572 | 12526757 | 28 | Product used for unknown indication |
| 125267572 | 12526757 | 29 | Product used for unknown indication |
| 125267572 | 12526757 | 30 | Product used for unknown indication |
| 125267572 | 12526757 | 31 | Product used for unknown indication |
| 125267572 | 12526757 | 32 | Product used for unknown indication |
| 125267572 | 12526757 | 33 | Product used for unknown indication |
| 125267572 | 12526757 | 34 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125267572 | 12526757 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125267572 | 12526757 | Agitation | |
| 125267572 | 12526757 | Alopecia | |
| 125267572 | 12526757 | Anorgasmia | |
| 125267572 | 12526757 | Anxiety | |
| 125267572 | 12526757 | Arthralgia | |
| 125267572 | 12526757 | Asthenia | |
| 125267572 | 12526757 | Confusional state | |
| 125267572 | 12526757 | Decreased appetite | |
| 125267572 | 12526757 | Depressed mood | |
| 125267572 | 12526757 | Disturbance in attention | |
| 125267572 | 12526757 | Drug withdrawal syndrome | |
| 125267572 | 12526757 | Gait disturbance | |
| 125267572 | 12526757 | Hallucination | |
| 125267572 | 12526757 | Headache | |
| 125267572 | 12526757 | Insomnia | |
| 125267572 | 12526757 | Irritability | |
| 125267572 | 12526757 | Lethargy | |
| 125267572 | 12526757 | Libido decreased | |
| 125267572 | 12526757 | Loss of libido | |
| 125267572 | 12526757 | Malaise | |
| 125267572 | 12526757 | Marital problem | |
| 125267572 | 12526757 | Morbid thoughts | |
| 125267572 | 12526757 | Nausea | |
| 125267572 | 12526757 | Nightmare | |
| 125267572 | 12526757 | Onychoclasis | |
| 125267572 | 12526757 | Psychiatric symptom | |
| 125267572 | 12526757 | Respiratory disorder | |
| 125267572 | 12526757 | Restlessness | |
| 125267572 | 12526757 | Sleep disorder | |
| 125267572 | 12526757 | Tearfulness | |
| 125267572 | 12526757 | 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 |
|---|---|---|---|---|---|---|
| 125267572 | 12526757 | 1 | 20010516 | 20050701 | 0 | |
| 125267572 | 12526757 | 6 | 20010516 | 0 | ||
| 125267572 | 12526757 | 9 | 198504 | 0 | ||
| 125267572 | 12526757 | 14 | 20020106 | 0 | ||
| 125267572 | 12526757 | 15 | 200708 | 0 | ||
| 125267572 | 12526757 | 16 | 200308 | 0 | ||
| 125267572 | 12526757 | 17 | 200107 | 0 | ||
| 125267572 | 12526757 | 18 | 200703 | 0 | ||
| 125267572 | 12526757 | 19 | 20080515 | 0 | ||
| 125267572 | 12526757 | 20 | 200712 | 0 | ||
| 125267572 | 12526757 | 21 | 20020808 | 0 | ||
| 125267572 | 12526757 | 22 | 20011206 | 0 | ||
| 125267572 | 12526757 | 23 | 200111 | 0 | ||
| 125267572 | 12526757 | 24 | 20080515 | 0 | ||
| 125267572 | 12526757 | 34 | 2007 | 0 |