Drug adverse event reports (FAERS)

Off label use, Hypoaesthesia

Drugs: STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCT, ZINC, VITAMIN C +1

Not seriousReport 26485908
Safetyreportversion
1
Safetyreportid
26485908
Primarysourcecountry
US
Transmissiondateformat
102
Transmissiondate
20260415
Reporttype
1
Serious
2
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260311
Receiptdateformat
102
Receiptdate
20260311
Fulfillexpeditecriteria
3
Authoritynumb
807019
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
FDA-CTU
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
41
Patientonsetageunit
801
Patientweight
47.25
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Off label use
  2. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Hypoaesthesia
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCT
    Drugdosagetext
    OTHER ROUTE : INJECTION TO UNDER EYES;
    Drugadministrationroute
    050
    Drugindication
    Skin cosmetic procedure
    Drugstartdateformat
    102
    Drugstartdate
    20260209
    Drugadditional
    2
    Activesubstance
    Activesubstancename
    STEM CELL, EXOSOME, GROWTH FACTOR OR TISSUE DERIVED UNAPPROVED PRODUCTS
  2. Drugcharacterization
    2
    Medicinalproduct
    ZINC
    Activesubstance
    Activesubstancename
    ZINC
    Harmonized identifiers (openFDA)
    Brand name
    ZINCUM METALLICUM, ZINC
    Generic name
    ZINC, ZINC GLUCONATE, ZINC CHLORIDE
    Manufacturer name
    Boiron, Wal-Mart Stores,Inc.,, Hospira, Inc.
    Product NDC
    0220-5434, 49035-881, 0409-4090, 0220-5437, 0220-5465, 0220-5436, 0220-5433, 0220-5440, 0220-5438, 0220-5435, 0220-5439
    Product type
    HUMAN OTC DRUG, HUMAN PRESCRIPTION DRUG
    Route
    ORAL, INTRAVENOUS
    Substance name
    ZINC, ZINC GLUCONATE, ZINC CHLORIDE
    SPL ID
    0a367b49-add2-4974-e063-6394a90a66c3, 4221f075-943c-26a6-e063-6294a90a4990, f23dc08f-8388-4379-811e-4043346c18bd, f2f5a316-245c-cd5b-e053-2995a90a7362, 00edbed0-998e-a9fb-e063-6394a90ada4a, 0a36cd60-0ab6-432f-e063-6294a90a6034, f7e59aea-64cd-a69b-e053-6294a90af7b5, 0a36aba0-d57a-46ba-e063-6294a90a238f, 00f1b06e-2bea-566c-e063-6294a90a1734, 0a36c18a-5f88-8cd2-e063-6394a90a561e, 0a36aba0-d579-46ba-e063-6294a90a238f
    SPL set ID
    857e20b3-10c5-5551-e053-2a91aa0a4509, ef4d82f6-2b77-41cd-9f4a-86ca9906a00d, 9a1914a0-e195-4233-c1be-bc2075580eb8, 852f97b5-8da5-2e09-e053-2a91aa0a8bb4, 0eba1030-7c33-11e6-8959-424c58303031, 853c03ff-e1e6-08d0-e053-2a91aa0a9dba, 857e92e8-3986-34b7-e053-2991aa0a72ba, 85276a06-7e35-2546-e053-2a91aa0a25ec, 8529a2da-fc9f-014c-e053-2991aa0a0203, 853cb3dd-772d-208c-e053-2a91aa0a6189, 8529427a-d5c9-e373-e053-2991aa0ab66d
    Package NDC
    0220-5434-41, 49035-881-25, 0409-4090-11, 0409-4090-01, 0220-5437-41, 0220-5465-41, 0220-5436-41, 0220-5433-41, 0220-5440-41, 0220-5438-41, 0220-5435-41, 0220-5439-41
    UNII
    J41CSQ7QDS, U6WSN5SQ1Z, 86Q357L16B
    Application number
    NDA018959
    RxCUI
    237508
  3. Drugcharacterization
    2
    Medicinalproduct
    VITAMIN C
    Activesubstance
    Activesubstancename
    ASCORBIC ACID
    Harmonized identifiers (openFDA)
    Application number
    M001
    Brand name
    VITAMIN C SERUM
    Generic name
    VITAMIN C
    Manufacturer name
    FlexiGo Inc
    Product NDC
    85524-2627
    Product type
    HUMAN OTC DRUG
    Route
    TOPICAL
    Substance name
    HYALURONIC ACID, NIACINAMIDE, ASCORBIC ACID
    SPL ID
    496e7d41-2177-7b0c-e063-6394a90a98f1
    SPL set ID
    496e7d41-2176-7b0c-e063-6394a90a98f1
    Package NDC
    85524-2627-1, 85524-2627-2, 85524-2627-3, 85524-2627-4, 85524-2627-5, 85524-2627-6
    Nui
    N0000193618, M0001797
    Pharm class epc
    Vitamin C [EPC]
    Pharm class cs
    Ascorbic Acid [CS]
    UNII
    S270N0TRQY, 25X51I8RD4, PQ6CK8PD0R
  4. Drugcharacterization
    2
    Medicinalproduct
    VITAMIN D
    Activesubstance
    Activesubstancename
    VITAMIN D NOS
    Harmonized identifiers (openFDA)
    Application number
    ANDA090455
    Brand name
    VITAMIN D
    Generic name
    ERGOCALCIFEROL
    Manufacturer name
    Strides Pharma Science Limited
    Product NDC
    64380-737
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    ERGOCALCIFEROL
    RxCUI
    1367410
    SPL ID
    1cc589f7-cd6d-40a6-8fce-c965e8945eae
    SPL set ID
    2c4c0a36-12cf-444d-9d57-de983eef4d36
    Package NDC
    64380-737-06, 64380-737-25
    Nui
    M0007651, N0000175909
    Pharm class cs
    Ergocalciferols [CS]
    Pharm class epc
    Provitamin D2 Compound [EPC]
    UNII
    VS041H42XC
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20260209
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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.