Drug adverse event reports (FAERS)

Depressed level of consciousness, Hypertension, Extra dose administered

Drugs: XYWAV

SeriousOther seriousReport 27325189
Safetyreportversion
1
Safetyreportid
27325189
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261008
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
US-JAZZ PHARMACEUTICALS-2026-US-020988
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
JAZZ
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
45
Patientonsetageunit
801
Patientweight
111.8
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Depressed level of consciousness
    Reactionoutcome
    1
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Hypertension
    Reactionoutcome
    1
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Extra dose administered
    Reactionoutcome
    1
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    XYWAV
    Drugauthorizationnumb
    212690
    Drugstructuredosagenumb
    9
    Drugstructuredosageunit
    002
    Drugseparatedosagenumb
    1
    Drugdosagetext
    9 GRAM SOLID (INGESTION)
    Drugdosageform
    Oral solution
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    CALCIUM OXYBATE\MAGNESIUM OXYBATE\POTASSIUM OXYBATE\SODIUM OXYBATE
    Harmonized identifiers (openFDA)
    Application number
    NDA212690
    Brand name
    XYWAV
    Generic name
    CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES
    Manufacturer name
    Jazz Pharmaceuticals, Inc.
    Product NDC
    68727-150
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    SODIUM OXYBATE, CALCIUM OXYBATE, POTASSIUM OXYBATE, MAGNESIUM OXYBATE
    RxCUI
    2393794, 2393795
    SPL ID
    6815ce2b-51e5-4d03-92a6-523718ab0d8c
    SPL set ID
    1e0ae43a-037f-42af-8e23-a0e51d75abe8
    Package NDC
    68727-150-01
    UNII
    7G33012534, 8W24SYD6ZI, S8NKF3H3KT, G983HLV265
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.