Drug adverse event reports (FAERS)

Seizure, Convulsive threshold lowered, Product use in unapproved indication +4

Drugs: UNAPPROVED PRODUCT OTC, OTHER CLAIMS, BPC-157, BACTERIOSTATIC WATER

SeriousHospitalizationReport 26725788
Safetyreportversion
1
Safetyreportid
26725788
Primarysourcecountry
US
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260506
Receiptdateformat
102
Receiptdate
20260506
Fulfillexpeditecriteria
3
Authoritynumb
818586
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
FDA-CTU
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientsex
1
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Seizure
  2. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Convulsive threshold lowered
  3. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product use in unapproved indication
  4. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product information content complaint
  5. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product contamination
  6. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product sterility issue
  7. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Product advertising issue
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    UNAPPROVED PRODUCT OTC, OTHER CLAIMS
    Drugauthorizationnumb
    99
    Drugdosagetext
    IBUTAMOREN
    Drugindication
    Supplementation therapy
    Drugtreatmentduration
    1
    Drugtreatmentdurationunit
    802
    Drugrecurreadministration
    1
    Drugadditional
    2
    Activesubstance
    Activesubstancename
    UNAPPROVED PRODUCT OTC, OTHER CLAIMS
  2. Drugcharacterization
    1
    Medicinalproduct
    BPC-157
    Drugauthorizationnumb
    99
    Activesubstance
    Activesubstancename
    BPC-157
  3. Drugcharacterization
    1
    Medicinalproduct
    UNAPPROVED PRODUCT OTC, OTHER CLAIMS
    Activesubstance
    Activesubstancename
    UNAPPROVED PRODUCT OTC, OTHER CLAIMS
  4. Drugcharacterization
    1
    Medicinalproduct
    BACTERIOSTATIC WATER
    Activesubstance
    Activesubstancename
    WATER
    Harmonized identifiers (openFDA)
    Application number
    NDA018802
    Brand name
    BACTERIOSTATIC WATER
    Generic name
    BACTERIOSTATIC WATER
    Manufacturer name
    Hospira, Inc., Fujian Genohope Biotech Ltd.
    Product NDC
    0409-3977, 0409-1093, 84502-115
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Substance name
    WATER
    SPL ID
    dfac2c43-36b4-4fc0-a22d-f70c4aad5f97, 54f66ba5-5bb2-3927-e063-6294a90ab7fb
    SPL set ID
    87d6e9dc-fe3b-4593-ac9a-d7493d1959c7, 54f66b82-c9e5-a2bc-e063-6394a90adbbc
    Package NDC
    0409-3977-01, 0409-3977-03, 0409-1093-14, 0409-1093-04, 84502-115-01, 84502-115-02
    UNII
    059QF0KO0R
  5. Drugcharacterization
    1
    Medicinalproduct
    UNAPPROVED PRODUCT OTC, OTHER CLAIMS
    Activesubstance
    Activesubstancename
    UNAPPROVED PRODUCT OTC, OTHER CLAIMS
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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.