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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123914074 | 12391407 | 4 | F | 20160312 | 20160830 | 20160520 | 20160907 | EXP | US-JAZZ-2016-US-007314 | JAZZ | 56.36 | YR | F | Y | 86.00000 | KG | 20160907 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123914074 | 12391407 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 123914074 | 12391407 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G BID | U | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 123914074 | 12391407 | 3 | SS | MARCAINE | BUPIVACAINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 123914074 | 12391407 | 4 | SS | LIDOCAINE. | LIDOCAINE | 1 | U | 0 | |||||||||||
| 123914074 | 12391407 | 5 | SS | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | U | 0 | |||||||||||
| 123914074 | 12391407 | 6 | SS | STERILE WATER | WATER | 1 | U | 0 | |||||||||||
| 123914074 | 12391407 | 7 | SS | SUDAFED | PSEUDOEPHEDRINE HYDROCHLORIDE | 1 | UNK | N | 0 | TABLET | |||||||||
| 123914074 | 12391407 | 8 | C | PHENTERMINE. | PHENTERMINE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123914074 | 12391407 | 9 | C | CODEINE SULFATE. | CODEINE SULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123914074 | 12391407 | 10 | C | TESTOSTERONE. | TESTOSTERONE | 1 | UNK | U | 0 | ||||||||||
| 123914074 | 12391407 | 11 | C | ESTROGEN | ESTRONESUS SCROFA OVARY | 1 | UNK | U | 0 | ||||||||||
| 123914074 | 12391407 | 12 | C | PROGESTERONE. | PROGESTERONE | 1 | UNK | U | 0 | ||||||||||
| 123914074 | 12391407 | 13 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123914074 | 12391407 | 14 | C | Tizanidine Hcl | TIZANIDINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 123914074 | 12391407 | 15 | C | Msm | DIMETHYL SULFONE | 1 | U | 0 | CAPSULE | ||||||||||
| 123914074 | 12391407 | 16 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 123914074 | 12391407 | 17 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 123914074 | 12391407 | 18 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123914074 | 12391407 | 19 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 123914074 | 12391407 | 20 | C | Prelief | CALCIUM GLYCEROPHOSPHATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123914074 | 12391407 | 21 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123914074 | 12391407 | 22 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 123914074 | 12391407 | 23 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 123914074 | 12391407 | 24 | C | OXYTROL FOR WOMEN | OXYBUTYNIN | 1 | UNK | U | 0 | ||||||||||
| 123914074 | 12391407 | 25 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | CHEWABLE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123914074 | 12391407 | 1 | Narcolepsy |
| 123914074 | 12391407 | 3 | Cystitis interstitial |
| 123914074 | 12391407 | 4 | Cystitis interstitial |
| 123914074 | 12391407 | 5 | Cystitis interstitial |
| 123914074 | 12391407 | 6 | Cystitis interstitial |
| 123914074 | 12391407 | 7 | Product used for unknown indication |
| 123914074 | 12391407 | 8 | Product used for unknown indication |
| 123914074 | 12391407 | 9 | Cystitis interstitial |
| 123914074 | 12391407 | 10 | Hormone level abnormal |
| 123914074 | 12391407 | 11 | Hormone level abnormal |
| 123914074 | 12391407 | 12 | Hormone level abnormal |
| 123914074 | 12391407 | 13 | Myalgia |
| 123914074 | 12391407 | 14 | Back pain |
| 123914074 | 12391407 | 15 | Product used for unknown indication |
| 123914074 | 12391407 | 16 | Asthma |
| 123914074 | 12391407 | 17 | Hypersensitivity |
| 123914074 | 12391407 | 18 | Anxiety |
| 123914074 | 12391407 | 19 | Blood pressure measurement |
| 123914074 | 12391407 | 20 | Product used for unknown indication |
| 123914074 | 12391407 | 21 | Product used for unknown indication |
| 123914074 | 12391407 | 22 | Product used for unknown indication |
| 123914074 | 12391407 | 23 | Product used for unknown indication |
| 123914074 | 12391407 | 24 | Product used for unknown indication |
| 123914074 | 12391407 | 25 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123914074 | 12391407 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123914074 | 12391407 | Abdominal pain | |
| 123914074 | 12391407 | Condition aggravated | |
| 123914074 | 12391407 | Cystitis interstitial | |
| 123914074 | 12391407 | Dizziness | |
| 123914074 | 12391407 | Drug ineffective | |
| 123914074 | 12391407 | Hyperhidrosis | |
| 123914074 | 12391407 | Insomnia | |
| 123914074 | 12391407 | Narcolepsy | |
| 123914074 | 12391407 | Pain | |
| 123914074 | 12391407 | Pollakiuria | |
| 123914074 | 12391407 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 123914074 | 12391407 | 1 | 201601 | 2016 | 0 | |
| 123914074 | 12391407 | 2 | 20160312 | 0 | ||
| 123914074 | 12391407 | 7 | 20151103 | 0 | ||
| 123914074 | 12391407 | 8 | 201604 | 20160425 | 0 | |
| 123914074 | 12391407 | 9 | 20151125 | 0 | ||
| 123914074 | 12391407 | 10 | 20151103 | 0 | ||
| 123914074 | 12391407 | 11 | 20151103 | 0 | ||
| 123914074 | 12391407 | 12 | 20151103 | 0 | ||
| 123914074 | 12391407 | 13 | 20151103 | 0 | ||
| 123914074 | 12391407 | 18 | 20151103 | 0 | ||
| 123914074 | 12391407 | 20 | 20160513 | 0 | ||
| 123914074 | 12391407 | 21 | 201604 | 0 | ||
| 123914074 | 12391407 | 22 | 20151103 | 0 | ||
| 123914074 | 12391407 | 24 | 20160425 | 0 | ||
| 123914074 | 12391407 | 25 | 20160426 | 0 |