The Safety Rates Drug Report

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Drug     Injury     Quarter    

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
125641871 12564187 1 I 20160711 20160718 20160718 EXP AU-DEPOMED, INC.-AU-2016DEP011462 DEPOMED CHIEW A. SUB-MAMMARY INJECTION OF ROPIVACAINE RESULTING IN SEVERE TOXICITY WITH SEIZURES. EMERG MED AUSTRALAS. 2016;28(2):246-247 37.00 YR F Y 54.00000 KG 20160715 OT AU AU

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
125641871 12564187 1 PS FENTANYL CITRATE. FENTANYL CITRATE 1 Intravenous (not otherwise specified) UNK 22569
125641871 12564187 2 SS ROPIVACAINE ROPIVACAINE 1 200 MG DILUTED IN 200 ML NORMAL SALINE, 3.7 MG/KG 0 200 MG
125641871 12564187 3 SS MIDAZOLAM MIDAZOLAMMIDAZOLAM HYDROCHLORIDE 1 3 MG, UNK 0 3 MG
125641871 12564187 4 SS MIDAZOLAM MIDAZOLAMMIDAZOLAM HYDROCHLORIDE 1 UNK 0
125641871 12564187 5 SS DEXMEDETOMIDINE. DEXMEDETOMIDINE 1 UNK 0
125641871 12564187 6 SS PROPOFOL. PROPOFOL 1 UNK 0
125641871 12564187 7 C ADRENALINE /00003901/ EPINEPHRINE 1 1 MG DILUTED IN 200 ML NORMAL SALINE 0 1 MG
125641871 12564187 8 C PARACETAMOL ACETAMINOPHEN 1 Intravenous (not otherwise specified) 1 G, UNK 0 1 G
125641871 12564187 9 C CEPHAZOLIN CEFAZOLIN 1 UNK 0
125641871 12564187 10 C DEXAMETHASONE. DEXAMETHASONE 1 Intravenous (not otherwise specified) 8 MG, UNK 0 8 MG
125641871 12564187 11 C ONDANSETRAN ONDANSETRON HYDROCHLORIDE 1 UNK 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125641871 12564187 1 Sedative therapy
125641871 12564187 2 Induction of anaesthesia
125641871 12564187 3 Sedation
125641871 12564187 5 Sedative therapy
125641871 12564187 6 Sedative therapy
125641871 12564187 7 Induction of anaesthesia
125641871 12564187 8 Product used for unknown indication
125641871 12564187 9 Product used for unknown indication
125641871 12564187 10 Product used for unknown indication
125641871 12564187 11 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
125641871 12564187 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125641871 12564187 Agitation
125641871 12564187 Anxiety
125641871 12564187 Generalised tonic-clonic seizure
125641871 12564187 Malaise
125641871 12564187 Paraesthesia oral
125641871 12564187 Toxicity to various agents

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found