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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125111042 | 12511104 | 2 | F | 20160718 | 20160629 | 20160728 | EXP | US-MYLANLABS-2016M1026433 | MYLAN | 0.00 | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125111042 | 12511104 | 1 | PS | Clozapine Tablets, USP | CLOZAPINE | 1 | Oral | 100 MG, HS | U | 75417 | 100 | MG | TABLET | QD | |||||
| 125111042 | 12511104 | 2 | SS | Clozapine Tablets, USP | CLOZAPINE | 1 | Oral | 25 MG, AM | U | 75417 | 25 | MG | TABLET | QD | |||||
| 125111042 | 12511104 | 3 | SS | LITHIUM. | LITHIUM | 1 | Oral | 300 MG, BID | Y | U | 0 | 300 | MG | BID | |||||
| 125111042 | 12511104 | 4 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 325 MG, Q6H, PRN | 0 | 325 | MG | Q6H | |||||||
| 125111042 | 12511104 | 5 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 125111042 | 12511104 | 6 | C | MYLANTA | ALUMINUM HYDROXIDEDIMETHICONEMAGNESIUM HYDROXIDE | 1 | Oral | 30 ML, QD, PRN | 0 | 30 | ML | QD | |||||||
| 125111042 | 12511104 | 7 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | 875/125 MG, BID | 0 | 875 | MG | BID | |||||||
| 125111042 | 12511104 | 8 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Oral | 250 MG, QD | 0 | 250 | MG | QD | |||||||
| 125111042 | 12511104 | 9 | C | BENZTROPINE | BENZTROPINE | 1 | Oral | 2 MG, TID | 0 | 2 | MG | TID | |||||||
| 125111042 | 12511104 | 10 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125111042 | 12511104 | 11 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125111042 | 12511104 | 12 | C | FLUPHENAZINE | FLUPHENAZINE | 1 | Oral | 25 MG, HS | 0 | 25 | MG | QD | |||||||
| 125111042 | 12511104 | 13 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Oral | 25 MG, TID | 0 | 25 | MG | TID | |||||||
| 125111042 | 12511104 | 14 | C | NOVOLOG | INSULIN ASPART | 1 | SLIDING SCALE | 0 | |||||||||||
| 125111042 | 12511104 | 15 | C | LACTINEX /00079701/ | 2 | 1 DF, QD | 0 | 1 | DF | QD | |||||||||
| 125111042 | 12511104 | 16 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 50 ?G, QD | 0 | 50 | UG | QD | |||||||
| 125111042 | 12511104 | 17 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | 240 MG, QD | 0 | 240 | MG | QD | ||||||||
| 125111042 | 12511104 | 18 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 125111042 | 12511104 | 19 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID | |||||||
| 125111042 | 12511104 | 20 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 8 MG, Q8H, PRN | 0 | 8 | MG | Q8H | ||||||||
| 125111042 | 12511104 | 21 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 17 G, QD, PRN | 0 | 17 | G | QD | |||||||
| 125111042 | 12511104 | 22 | C | SENNA S | DOCUSATE SODIUMSENNA LEAF | 1 | Oral | 2 DF, BID | 0 | 2 | DF | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125111042 | 12511104 | 3 | Affective disorder |
| 125111042 | 12511104 | 4 | Pain |
| 125111042 | 12511104 | 5 | Pyrexia |
| 125111042 | 12511104 | 6 | Dyspepsia |
| 125111042 | 12511104 | 20 | Vomiting |
| 125111042 | 12511104 | 21 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125111042 | 12511104 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125111042 | 12511104 | Dehydration | |
| 125111042 | 12511104 | Pneumonia | |
| 125111042 | 12511104 | Toxicity to various agents | |
| 125111042 | 12511104 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 125111042 | 12511104 | 3 | 2016 | 0 |