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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122675056 | 12267505 | 6 | F | 20160311 | 20160728 | 20160414 | 20160804 | PER | PHEH2016US008491 | NOVARTIS | 52.47 | YR | F | Y | 90.00000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122675056 | 12267505 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 1644 | MG | 22527 | .5 | MG | CAPSULE | QD | ||||
| 122675056 | 12267505 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | UNK, QOD | 1644 | MG | 22527 | CAPSULE | |||||||
| 122675056 | 12267505 | 3 | C | CHANTIX | VARENICLINE TARTRATE | 1 | Unknown | U | 0 | ||||||||||
| 122675056 | 12267505 | 4 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | Unknown | 2 DF, BID | U | 0 | 2 | DF | BID | ||||||
| 122675056 | 12267505 | 5 | C | OXYCODONE | OXYCODONE | 1 | Unknown | UNK UNK, QW | U | 0 | /wk | ||||||||
| 122675056 | 12267505 | 6 | C | GRALISE | GABAPENTIN | 1 | Unknown | 3 DF, AT BEDTIME | U | 0 | 3 | DF | |||||||
| 122675056 | 12267505 | 7 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 2 DF, AT BEDTIME | U | 0 | 2 | DF | |||||||
| 122675056 | 12267505 | 8 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 122675056 | 12267505 | 9 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 122675056 | 12267505 | 10 | C | TIZANIDINE HCL | TIZANIDINE HYDROCHLORIDE | 1 | Unknown | 1 DF, TID | U | 0 | 1 | DF | TID | ||||||
| 122675056 | 12267505 | 11 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 1 IN MORNING AND 2 AT BEDTIME | U | 0 | 3 | DF | |||||||
| 122675056 | 12267505 | 12 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 1 DF, QID | U | 0 | 1 | DF | QID | ||||||
| 122675056 | 12267505 | 13 | C | AMBIEN CR | ZOLPIDEM TARTRATE | 1 | Unknown | 1 DF, AT BEDTIME | U | 0 | 1 | DF | |||||||
| 122675056 | 12267505 | 14 | C | AMFETAMINE | AMPHETAMINE | 1 | Unknown | (1 IN THE MORNING AND 1 AT NOON TIME) | U | 0 | 2 | DF | |||||||
| 122675056 | 12267505 | 15 | C | DONEPEZIL. | DONEPEZIL | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 122675056 | 12267505 | 16 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | 20 MG, (AT BEDTIME) | U | 0 | 20 | MG | |||||||
| 122675056 | 12267505 | 17 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 1 DF, PRN | U | 0 | 1 | DF | |||||||
| 122675056 | 12267505 | 18 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 122675056 | 12267505 | 19 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | Unknown | 1 DF, Q6H | U | 0 | 1 | DF | Q6H | ||||||
| 122675056 | 12267505 | 20 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 122675056 | 12267505 | 21 | C | LIDODERM | LIDOCAINE | 1 | Unknown | ( EVERY 2 TO 3 DAYS) | U | 0 | PATCH | ||||||||
| 122675056 | 12267505 | 22 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | U | 0 | ||||||||||
| 122675056 | 12267505 | 23 | C | FISH OIL | FISH OIL | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122675056 | 12267505 | 1 | Multiple sclerosis |
| 122675056 | 12267505 | 3 | Product used for unknown indication |
| 122675056 | 12267505 | 4 | Product used for unknown indication |
| 122675056 | 12267505 | 5 | Pain |
| 122675056 | 12267505 | 6 | Product used for unknown indication |
| 122675056 | 12267505 | 7 | Product used for unknown indication |
| 122675056 | 12267505 | 8 | Product used for unknown indication |
| 122675056 | 12267505 | 9 | Product used for unknown indication |
| 122675056 | 12267505 | 10 | Product used for unknown indication |
| 122675056 | 12267505 | 11 | Product used for unknown indication |
| 122675056 | 12267505 | 12 | Product used for unknown indication |
| 122675056 | 12267505 | 13 | Product used for unknown indication |
| 122675056 | 12267505 | 14 | Product used for unknown indication |
| 122675056 | 12267505 | 15 | Product used for unknown indication |
| 122675056 | 12267505 | 16 | Product used for unknown indication |
| 122675056 | 12267505 | 17 | Product used for unknown indication |
| 122675056 | 12267505 | 18 | Product used for unknown indication |
| 122675056 | 12267505 | 19 | Nausea |
| 122675056 | 12267505 | 20 | Product used for unknown indication |
| 122675056 | 12267505 | 21 | Product used for unknown indication |
| 122675056 | 12267505 | 22 | Product used for unknown indication |
| 122675056 | 12267505 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122675056 | 12267505 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122675056 | 12267505 | Balance disorder | |
| 122675056 | 12267505 | Blood glucose increased | |
| 122675056 | 12267505 | Carbon dioxide decreased | |
| 122675056 | 12267505 | Diplopia | |
| 122675056 | 12267505 | Erythema | |
| 122675056 | 12267505 | Lacrimation decreased | |
| 122675056 | 12267505 | Lepromatous leprosy | |
| 122675056 | 12267505 | Leprosy | |
| 122675056 | 12267505 | Lymphocyte count decreased | |
| 122675056 | 12267505 | Mean platelet volume increased | |
| 122675056 | 12267505 | Multiple sclerosis | |
| 122675056 | 12267505 | Muscular weakness | |
| 122675056 | 12267505 | Nodule | |
| 122675056 | 12267505 | Prescribed underdose | |
| 122675056 | 12267505 | Rash | |
| 122675056 | 12267505 | Type 2 lepra reaction | |
| 122675056 | 12267505 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 122675056 | 12267505 | 1 | 201112 | 20160406 | 0 |