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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126157821 | 12615782 | 1 | I | 20160718 | 20160802 | 20160802 | EXP | US-EGALET US INC-US-2016EGA000271 | EGALET | CHANG CHIEN GC, MCCORMICK Z, ARAUJO M, CANDIDO KD. THE POTENTIAL CONTRIBUTING EFFECT OF KETOROLAC AND FLUOXETINE TO A SPINAL EPIDURAL HEMATOMA FOLLOWING A CERVICAL INTERLAMINAR EPIDURAL STEROID INJECTION: A CASE REPORT AND NARRATIVE REVIEW. PAIN PHYSICIAN. 2014;17(3):E385-E395 | 66.00 | YR | F | Y | 0.00000 | 20160802 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126157821 | 12615782 | 1 | PS | KETOROLAC | KETOROLACKETOROLAC TROMETHAMINE | 1 | Intramuscular | 30 MG, SINGLE | 22382 | 30 | MG | ||||||||
| 126157821 | 12615782 | 2 | SS | KETOROLAC | KETOROLACKETOROLAC TROMETHAMINE | 1 | 22382 | ||||||||||||
| 126157821 | 12615782 | 3 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | UNK | U | 0 | |||||||||
| 126157821 | 12615782 | 4 | C | FISH OIL | FISH OIL | 1 | 1 G, QD | U | 0 | 1 | G | ||||||||
| 126157821 | 12615782 | 5 | C | VITAMIN E /00110501/ | TOCOPHEROL | 1 | 50 IU, QD | U | 0 | 50 | IU | ||||||||
| 126157821 | 12615782 | 6 | C | LIDOCAINE. | LIDOCAINE | 1 | Subdermal | 1 DF, SINGLE | 0 | 1 | DF | ||||||||
| 126157821 | 12615782 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 8 | C | ATORVASTATIN | ATORVASTATIN | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 9 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 10 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 11 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 12 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 13 | C | DOCUSATE | DOCUSATE | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 14 | C | FENTANYL. | FENTANYL | 1 | UNK | U | 0 | PATCH | |||||||||
| 126157821 | 12615782 | 15 | C | CARISOPRODOL. | CARISOPRODOL | 1 | UNK | U | 0 | ||||||||||
| 126157821 | 12615782 | 16 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126157821 | 12615782 | 1 | Neck pain |
| 126157821 | 12615782 | 2 | Muscle spasms |
| 126157821 | 12615782 | 3 | Product used for unknown indication |
| 126157821 | 12615782 | 4 | Supplementation therapy |
| 126157821 | 12615782 | 5 | Vitamin supplementation |
| 126157821 | 12615782 | 6 | Product used for unknown indication |
| 126157821 | 12615782 | 7 | Product used for unknown indication |
| 126157821 | 12615782 | 8 | Product used for unknown indication |
| 126157821 | 12615782 | 9 | Product used for unknown indication |
| 126157821 | 12615782 | 10 | Product used for unknown indication |
| 126157821 | 12615782 | 11 | Product used for unknown indication |
| 126157821 | 12615782 | 12 | Product used for unknown indication |
| 126157821 | 12615782 | 13 | Product used for unknown indication |
| 126157821 | 12615782 | 14 | Product used for unknown indication |
| 126157821 | 12615782 | 15 | Product used for unknown indication |
| 126157821 | 12615782 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126157821 | 12615782 | HO |
| 126157821 | 12615782 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126157821 | 12615782 | Asthenia | |
| 126157821 | 12615782 | Drug interaction | |
| 126157821 | 12615782 | Hypoaesthesia | |
| 126157821 | 12615782 | Incontinence | |
| 126157821 | 12615782 | Quadriplegia | |
| 126157821 | 12615782 | Sensory loss | |
| 126157821 | 12615782 | Spinal epidural haematoma | |
| 126157821 | 12615782 | Unresponsive to stimuli |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |