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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126433191 | 12643319 | 1 | I | 201607 | 20160727 | 20160811 | 20160811 | EXP | US-SUN PHARMACEUTICAL INDUSTRIES LTD-2016US-121225 | RANBAXY | 77.61 | YR | F | Y | 0.00000 | 20160811 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126433191 | 12643319 | 1 | PS | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Oral | 3 DF, DAILY | N | 65061 | 3 | DF | CAPSULE | ||||||
| 126433191 | 12643319 | 2 | C | Adavir Diskus | 2 | Respiratory (inhalation) | 1 PUFF, BID ( IN MORNING + EVENING) | U | 0 | Q12H | |||||||||
| 126433191 | 12643319 | 3 | C | Carvediol | CARVEDILOL | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | Q12H | |||||
| 126433191 | 12643319 | 4 | C | CLARITIN | LORATADINE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | ||||||
| 126433191 | 12643319 | 5 | C | Cymbalata | 2 | Oral | 1 DF, QD | U | 0 | 1 | DF | ||||||||
| 126433191 | 12643319 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | ||||||
| 126433191 | 12643319 | 7 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | Q12H | |||||
| 126433191 | 12643319 | 8 | C | ISOSORBIDE MONONITRATE. | ISOSORBIDE MONONITRATE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | PROLONGED-RELEASE TABLET | ||||||
| 126433191 | 12643319 | 9 | C | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Oral | 2 DF, DAILY | U | 0 | 2 | DF | TABLET | ||||||
| 126433191 | 12643319 | 10 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | ||||||
| 126433191 | 12643319 | 11 | C | LIDOCAINE. | LIDOCAINE | 1 | Topical | UNK UNK, TID | U | 0 | OINTMENT | Q8H | |||||||
| 126433191 | 12643319 | 12 | C | LINZESS | LINACLOTIDE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | ||||||
| 126433191 | 12643319 | 13 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | Q12H | |||||
| 126433191 | 12643319 | 14 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | Sublingual | UNK, PRN | U | 0 | SUBLINGUAL TABLET | ||||||||
| 126433191 | 12643319 | 15 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | ||||||
| 126433191 | 12643319 | 16 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | ||||||
| 126433191 | 12643319 | 17 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Nasal | 1 DF, QD ( INHALE 1CAPSULE BY INHALATION ROUTE) | U | 0 | 1 | DF | CAPSULE | ||||||
| 126433191 | 12643319 | 18 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 2 DF, PRN( 2 DF EVERY 8 HOURS AS NEEDED) | U | 0 | 2 | DF | PROLONGED-RELEASE TABLET | ||||||
| 126433191 | 12643319 | 19 | C | VALSARTAN. | VALSARTAN | 1 | Oral | 1 DF, QD | U | U | 0 | 1 | DF | TABLET | |||||
| 126433191 | 12643319 | 20 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | ||||||
| 126433191 | 12643319 | 21 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | Oral | 1 DF, 1/WEEK | U | 0 | 1 | DF | CAPSULE | /wk | |||||
| 126433191 | 12643319 | 22 | C | VYTORIN | EZETIMIBESIMVASTATIN | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126433191 | 12643319 | 1 | Product used for unknown indication |
| 126433191 | 12643319 | 2 | Product used for unknown indication |
| 126433191 | 12643319 | 3 | Product used for unknown indication |
| 126433191 | 12643319 | 4 | Product used for unknown indication |
| 126433191 | 12643319 | 5 | Product used for unknown indication |
| 126433191 | 12643319 | 6 | Product used for unknown indication |
| 126433191 | 12643319 | 7 | Product used for unknown indication |
| 126433191 | 12643319 | 8 | Product used for unknown indication |
| 126433191 | 12643319 | 9 | Product used for unknown indication |
| 126433191 | 12643319 | 10 | Product used for unknown indication |
| 126433191 | 12643319 | 11 | Product used for unknown indication |
| 126433191 | 12643319 | 12 | Product used for unknown indication |
| 126433191 | 12643319 | 13 | Product used for unknown indication |
| 126433191 | 12643319 | 14 | Myocardial infarction |
| 126433191 | 12643319 | 15 | Product used for unknown indication |
| 126433191 | 12643319 | 16 | Product used for unknown indication |
| 126433191 | 12643319 | 17 | Product used for unknown indication |
| 126433191 | 12643319 | 18 | Product used for unknown indication |
| 126433191 | 12643319 | 19 | Product used for unknown indication |
| 126433191 | 12643319 | 20 | Product used for unknown indication |
| 126433191 | 12643319 | 21 | Product used for unknown indication |
| 126433191 | 12643319 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126433191 | 12643319 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126433191 | 12643319 | Dysarthria | |
| 126433191 | 12643319 | Dysphonia | |
| 126433191 | 12643319 | Dyspnoea | |
| 126433191 | 12643319 | Fatigue | |
| 126433191 | 12643319 | Foreign body | |
| 126433191 | 12643319 | Haemorrhage | |
| 126433191 | 12643319 | Product physical issue | |
| 126433191 | 12643319 | Productive cough | |
| 126433191 | 12643319 | Pyrexia | |
| 126433191 | 12643319 | Throat irritation |
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 |
|---|---|---|---|---|---|---|
| 126433191 | 12643319 | 1 | 2016 | 201607 | 0 | |
| 126433191 | 12643319 | 2 | 20160502 | 0 | ||
| 126433191 | 12643319 | 3 | 20130807 | 0 | ||
| 126433191 | 12643319 | 4 | 20151030 | 0 | ||
| 126433191 | 12643319 | 5 | 20130807 | 0 | ||
| 126433191 | 12643319 | 6 | 20130807 | 0 | ||
| 126433191 | 12643319 | 7 | 20130807 | 0 | ||
| 126433191 | 12643319 | 8 | 20160331 | 0 | ||
| 126433191 | 12643319 | 9 | 20160309 | 0 | ||
| 126433191 | 12643319 | 10 | 20160607 | 0 | ||
| 126433191 | 12643319 | 11 | 20150717 | 0 | ||
| 126433191 | 12643319 | 12 | 20160304 | 0 | ||
| 126433191 | 12643319 | 13 | 20160309 | 0 | ||
| 126433191 | 12643319 | 14 | 20160126 | 0 | ||
| 126433191 | 12643319 | 15 | 20160407 | 0 | ||
| 126433191 | 12643319 | 16 | 20160302 | 0 | ||
| 126433191 | 12643319 | 17 | 20160309 | 0 | ||
| 126433191 | 12643319 | 18 | 20160106 | 0 | ||
| 126433191 | 12643319 | 19 | 20151111 | 0 | ||
| 126433191 | 12643319 | 20 | 20160309 | 0 | ||
| 126433191 | 12643319 | 21 | 20160418 | 0 | ||
| 126433191 | 12643319 | 22 | 20130807 | 0 |