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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124104564 | 12410456 | 4 | F | 2016 | 20160823 | 20160527 | 20160829 | EXP | US-SHIRE-US201606142 | SHIRE | 59.79 | YR | F | Y | 105.67000 | KG | 20160829 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124104564 | 12410456 | 1 | PS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 40 MG, 1X/DAY:QD (ONE CAPSULE IN THE MORNING) | Y | U | 21977 | 40 | MG | CAPSULE | QD | ||||
| 124104564 | 12410456 | 2 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, UNKNOWN | Y | U | 21977 | 30 | MG | CAPSULE | QD | ||||
| 124104564 | 12410456 | 3 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 30 MG, OTHER (TAKING EVERY OTHER DAY) | Y | U | 21977 | 30 | MG | CAPSULE | |||||
| 124104564 | 12410456 | 4 | SS | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Oral | UNK, UNKNOWN | Y | U | 0 | 60 | MG | QD | |||||
| 124104564 | 12410456 | 5 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 50 MG, 1X/DAY:QD | U | 0 | 50 | MG | QD | ||||||
| 124104564 | 12410456 | 6 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 60 MG, 1X/DAY:QD | U | 0 | 60 | MG | QD | ||||||
| 124104564 | 12410456 | 7 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 10 UNK, UNK | U | 0 | 10 | MG | QD | ||||||
| 124104564 | 12410456 | 8 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Oral | 10 MG, 1X/DAY:QD | 0 | 10 | MG | TABLET | QD | ||||||
| 124104564 | 12410456 | 9 | C | MYRBETRIQ | MIRABEGRON | 1 | Oral | 50 MG, 1X/DAY:QD | 0 | 50 | MG | TABLET | QD | ||||||
| 124104564 | 12410456 | 10 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 10 MG, OTHER(EVERY 8 HOURS) | 0 | 10 | MG | ||||||||
| 124104564 | 12410456 | 11 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 15 MG, 1X/DAY:QD | 0 | 15 | MG | QD | |||||||
| 124104564 | 12410456 | 12 | C | DITROPAN | OXYBUTYNIN CHLORIDE | 1 | Oral | 10 MG, 1X/DAY:QD | 0 | 10 | MG | QD | |||||||
| 124104564 | 12410456 | 13 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | UNK , 2X/DAY:BID (1.5 TABLET 2 TIMES EVERY DAY) | 0 | TABLET | BID | ||||||||
| 124104564 | 12410456 | 14 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 15 MG, 1X/DAY:QD | 0 | 15 | MG | TABLET | QD | ||||||
| 124104564 | 12410456 | 15 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 45 MG, 1X/DAY:QD | 0 | 45 | MG | TABLET | QD | ||||||
| 124104564 | 12410456 | 16 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 15 MG, 2X/DAY:BID | 0 | 15 | MG | TABLET | BID | ||||||
| 124104564 | 12410456 | 17 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | Oral | 90 MG, 1X/DAY:QD | 0 | 90 | MG | TABLET | QD | ||||||
| 124104564 | 12410456 | 18 | C | FINACEA | AZELAIC ACID | 1 | Unknown | 15 %, 2X/DAY:BID(2 TIMES EVERY DAY A THIN LAYER TO THE AFFECTED AREA) | 0 | 15 | PCT | GEL | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124104564 | 12410456 | 1 | Attention deficit/hyperactivity disorder |
| 124104564 | 12410456 | 4 | Product used for unknown indication |
| 124104564 | 12410456 | 5 | Attention deficit/hyperactivity disorder |
| 124104564 | 12410456 | 8 | Urinary incontinence |
| 124104564 | 12410456 | 9 | Urinary incontinence |
| 124104564 | 12410456 | 10 | Osteoarthritis |
| 124104564 | 12410456 | 11 | Product used for unknown indication |
| 124104564 | 12410456 | 12 | Product used for unknown indication |
| 124104564 | 12410456 | 13 | Anxiety disorder |
| 124104564 | 12410456 | 17 | Hypothyroidism |
| 124104564 | 12410456 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124104564 | 12410456 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124104564 | 12410456 | Abasia | |
| 124104564 | 12410456 | Adverse drug reaction | |
| 124104564 | 12410456 | Asthenia | |
| 124104564 | 12410456 | Dizziness | |
| 124104564 | 12410456 | Drug interaction | |
| 124104564 | 12410456 | Drug intolerance | |
| 124104564 | 12410456 | Fatigue | |
| 124104564 | 12410456 | Feeling abnormal | |
| 124104564 | 12410456 | Headache | |
| 124104564 | 12410456 | Hot flush | |
| 124104564 | 12410456 | Inappropriate schedule of drug administration | |
| 124104564 | 12410456 | Restlessness | |
| 124104564 | 12410456 | Rosacea | |
| 124104564 | 12410456 | Serum serotonin increased | |
| 124104564 | 12410456 | Thyroid disorder |
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 |
|---|---|---|---|---|---|---|
| 124104564 | 12410456 | 1 | 20160413 | 201605 | 0 | |
| 124104564 | 12410456 | 2 | 20160511 | 0 | ||
| 124104564 | 12410456 | 4 | 201607 | 0 | ||
| 124104564 | 12410456 | 5 | 20150330 | 2015 | 0 | |
| 124104564 | 12410456 | 6 | 20150812 | 0 | ||
| 124104564 | 12410456 | 8 | 20150330 | 0 | ||
| 124104564 | 12410456 | 10 | 20160316 | 0 | ||
| 124104564 | 12410456 | 12 | 20160405 | 0 | ||
| 124104564 | 12410456 | 13 | 201503 | 0 | ||
| 124104564 | 12410456 | 16 | 201503 | 0 | ||
| 124104564 | 12410456 | 18 | 20160606 | 0 |