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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118853143 | 11885314 | 3 | F | 2015 | 20151204 | 20160104 | 20160729 | EXP | US-JNJFOC-20151217724 | JANSSEN | 0.00 | A | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118853143 | 11885314 | 1 | PS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 19835 | UNSPECIFIED | ||||||||
| 118853143 | 11885314 | 2 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 19835 | UNSPECIFIED | ||||||||
| 118853143 | 11885314 | 3 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | N | 21121 | 36 | MG | SUSTAINED RELEASE TABLETS | |||||||
| 118853143 | 11885314 | 4 | SS | LYRICA | PREGABALIN | 1 | Unknown | Y | 0 | CAPSULE | |||||||||
| 118853143 | 11885314 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | U | 0 | 2.25 | G | ORAL SOLUTION | BID | ||||||
| 118853143 | 11885314 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 0 | ORAL SOLUTION | ||||||||
| 118853143 | 11885314 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | U | 0 | 4.5 | G | ORAL SOLUTION | BID | ||||||
| 118853143 | 11885314 | 8 | C | LIDOCAINE HYDROCHLORIDE. | LIDOCAINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 118853143 | 11885314 | 9 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | 0 | 600 | MG | TABLET | ||||||||
| 118853143 | 11885314 | 10 | C | CELEBREX | CELECOXIB | 1 | Unknown | 0 | CAPSULE | ||||||||||
| 118853143 | 11885314 | 11 | C | XANAX | ALPRAZOLAM | 1 | Unknown | 0 | TABLET | ||||||||||
| 118853143 | 11885314 | 12 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 118853143 | 11885314 | 13 | C | NASONEX | MOMETASONE FUROATE | 1 | Unknown | 0 | NASAL SPRAY | ||||||||||
| 118853143 | 11885314 | 14 | C | CLARITIN | LORATADINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 118853143 | 11885314 | 15 | C | COLACE | DOCUSATE SODIUM | 1 | Unknown | 0 | CAPSULE | ||||||||||
| 118853143 | 11885314 | 16 | C | DESOGESTREL W/ETHINYLESTRADIOL | DESOGESTRELETHINYL ESTRADIOL | 1 | Unknown | 0 | TABLET | ||||||||||
| 118853143 | 11885314 | 17 | C | VITAMINE C | ASCORBIC ACID | 1 | Unknown | 0 | TABLET | ||||||||||
| 118853143 | 11885314 | 18 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 118853143 | 11885314 | 19 | C | FLURBIPROFEN. | FLURBIPROFEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 118853143 | 11885314 | 20 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118853143 | 11885314 | 2 | Product used for unknown indication |
| 118853143 | 11885314 | 3 | Product used for unknown indication |
| 118853143 | 11885314 | 4 | Product used for unknown indication |
| 118853143 | 11885314 | 5 | Narcolepsy |
| 118853143 | 11885314 | 6 | Narcolepsy |
| 118853143 | 11885314 | 7 | Narcolepsy |
| 118853143 | 11885314 | 8 | Product used for unknown indication |
| 118853143 | 11885314 | 9 | Product used for unknown indication |
| 118853143 | 11885314 | 10 | Product used for unknown indication |
| 118853143 | 11885314 | 11 | Product used for unknown indication |
| 118853143 | 11885314 | 12 | Product used for unknown indication |
| 118853143 | 11885314 | 13 | Product used for unknown indication |
| 118853143 | 11885314 | 14 | Product used for unknown indication |
| 118853143 | 11885314 | 15 | Product used for unknown indication |
| 118853143 | 11885314 | 16 | Product used for unknown indication |
| 118853143 | 11885314 | 17 | Product used for unknown indication |
| 118853143 | 11885314 | 18 | Product used for unknown indication |
| 118853143 | 11885314 | 19 | Product used for unknown indication |
| 118853143 | 11885314 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118853143 | 11885314 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118853143 | 11885314 | Abdominal discomfort | |
| 118853143 | 11885314 | Abdominal pain upper | |
| 118853143 | 11885314 | Activities of daily living impaired | |
| 118853143 | 11885314 | Anxiety | |
| 118853143 | 11885314 | Asthenia | |
| 118853143 | 11885314 | Cognitive disorder | |
| 118853143 | 11885314 | Depression | |
| 118853143 | 11885314 | Dizziness postural | |
| 118853143 | 11885314 | Dyslexia | |
| 118853143 | 11885314 | Fibromyalgia | |
| 118853143 | 11885314 | Hypertension | |
| 118853143 | 11885314 | Influenza like illness | |
| 118853143 | 11885314 | Loss of consciousness | |
| 118853143 | 11885314 | Pain | |
| 118853143 | 11885314 | Palpitations | |
| 118853143 | 11885314 | Respiratory distress | |
| 118853143 | 11885314 | Temporomandibular joint syndrome | |
| 118853143 | 11885314 | Weight decreased | |
| 118853143 | 11885314 | Wheezing | |
| 118853143 | 11885314 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 118853143 | 11885314 | 3 | 20130910 | 0 | ||
| 118853143 | 11885314 | 4 | 20130213 | 0 | ||
| 118853143 | 11885314 | 5 | 201301 | 2013 | 0 | |
| 118853143 | 11885314 | 6 | 2013 | 2013 | 0 | |
| 118853143 | 11885314 | 7 | 2013 | 0 | ||
| 118853143 | 11885314 | 9 | 20091201 | 0 | ||
| 118853143 | 11885314 | 10 | 20130202 | 0 | ||
| 118853143 | 11885314 | 11 | 20121206 | 0 | ||
| 118853143 | 11885314 | 12 | 20121101 | 0 | ||
| 118853143 | 11885314 | 13 | 20120601 | 0 | ||
| 118853143 | 11885314 | 14 | 20101201 | 0 | ||
| 118853143 | 11885314 | 15 | 20091201 | 0 | ||
| 118853143 | 11885314 | 20 | 20121101 | 0 |