Drug adverse event reports (FAERS)

Hypersensitivity

Drugs: HUMALOG, INSULIN LISPRO

SeriousHospitalizationReport 26940071
Safetyreportversion
1
Safetyreportid
26940071
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20260709
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20260630
Receiptdateformat
102
Receiptdate
20260630
Fulfillexpeditecriteria
2
Companynumb
US-ELI_LILLY_AND_COMPANY-US202606025993
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ELI LILLY AND CO
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Hypersensitivity
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    HUMALOG
    Drugauthorizationnumb
    020563
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK UNK, UNKNOWN
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    INSULIN LISPRO
    Harmonized identifiers (openFDA)
    Application number
    BLA021017, BLA205747, BLA020563, BLA021018
    Brand name
    HUMALOG MIX75/25 KWIKPEN, HUMALOG MIX75/25, HUMALOG KWIKPEN, HUMALOG JUNIOR KWIKPEN, HUMALOG, HUMALOG TEMPO PEN, HUMALOG MIX50/50 KWIKPEN
    Generic name
    INSULIN LISPRO
    Manufacturer name
    Eli Lilly and Company
    Product NDC
    0002-8797, 0002-7511, 0002-7712, 0002-7510, 0002-7533, 0002-8799, 0002-7516, 0002-7714, 0002-8213, 0002-0800, 0002-8798
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    SUBCUTANEOUS, INTRAVENOUS
    Substance name
    INSULIN LISPRO
    RxCUI
    259111, 752388, 847252, 847254, 242120, 865098, 1652239, 1652242, 1652639, 1652640, 1652644, 1652646, 1926331, 1926332, 2621571, 2621572, 847211, 847213
    SPL ID
    272b1d09-c7ee-4ee3-abe1-ad200cb61df8, 03be5386-187a-420f-9021-55778a73eba0, bb223066-95c4-45b5-9ef4-3a6bf5a1cffd
    SPL set ID
    c73da51a-1899-45ad-b6cf-9c52c36a25dd, c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f, b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae
    Package NDC
    0002-7511-01, 0002-8797-01, 0002-8797-59, 0002-8797-61, 0002-7510-01, 0002-7510-17, 0002-7533-01, 0002-8799-01, 0002-8799-59, 0002-7516-01, 0002-7516-59, 0002-7516-99, 0002-7714-01, 0002-7714-59, 0002-7714-61, 0002-8213-01, 0002-8213-05, 0002-0800-01, 0002-7712-01, 0002-7712-27, 0002-7712-61, 0002-8798-01, 0002-8798-59, 0002-8798-99
    Nui
    N0000004931, N0000175453
    Pharm class cs
    Insulin [Chemical/Ingredient]
    Pharm class epc
    Insulin Analog [EPC]
    UNII
    GFX7QIS1II, 059QF0KO0R
  2. Drugcharacterization
    1
    Medicinalproduct
    INSULIN LISPRO
    Drugauthorizationnumb
    020563
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK UNK, UNKNOWN
    Drugindication
    Product used for unknown indication
    Actiondrug
    5
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    INSULIN LISPRO
    Harmonized identifiers (openFDA)
    Application number
    BLA209196, BLA020563, BLA021017, BLA205747, BLA021018
    Brand name
    ADMELOG, INSULIN LISPRO, INSULIN LISPRO JUNIOR KWIKPEN, INSULIN LISPRO KWIKPEN, HUMALOG MIX75/25 KWIKPEN, HUMALOG MIX75/25, HUMALOG KWIKPEN, HUMALOG JUNIOR KWIKPEN, HUMALOG, HUMALOG TEMPO PEN, HUMALOG MIX50/50 KWIKPEN, INSULIN LISPRO PROTAMINE AND INSULIN LISPRO INJECTABLE SUSPENSION MIX75/25 KWIKPEN
    Generic name
    INSULIN LISPRO
    Manufacturer name
    Sanofi-Aventis U.S. LLC, Eli Lilly and Company
    Product NDC
    0024-5924, 0024-5925, 0024-5926, 0002-7737, 0002-8222, 0002-7752, 0002-8797, 0002-7511, 0002-7712, 0002-7510, 0002-7533, 0002-8799, 0002-7516, 0002-7714, 0002-8213, 0002-0800, 0002-8798, 0002-8233
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS, SUBCUTANEOUS
    Substance name
    INSULIN LISPRO
    RxCUI
    242120, 1652639, 1992169, 1992171, 1926331, 259111, 752388, 847252, 847254, 865098, 1652239, 1652242, 1652640, 1652644, 1652646, 1926332, 2621571, 2621572, 847211, 847213
    SPL ID
    9631cc90-ea8d-42bb-ba01-ed8f09b8a6c5, 6329aa6b-3571-4196-83b0-fc99de56f3ab, 272b1d09-c7ee-4ee3-abe1-ad200cb61df8, 03be5386-187a-420f-9021-55778a73eba0, bb223066-95c4-45b5-9ef4-3a6bf5a1cffd, 03dce3f6-da85-4635-9c62-478226005b60
    SPL set ID
    0691def8-4a7b-4de3-866f-a280989f47f1, 97d5e596-aae1-42c9-ae89-c3780959c467, c73da51a-1899-45ad-b6cf-9c52c36a25dd, c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f, b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae, e49f701d-c19f-4cb2-b63f-01a917b33abc
    Package NDC
    0024-5924-10, 0024-5925-01, 0024-5925-05, 0024-5925-00, 0024-5926-05, 0002-7737-01, 0002-8222-01, 0002-8222-59, 0002-7752-01, 0002-7752-05, 0002-7511-01, 0002-8797-01, 0002-8797-59, 0002-8797-61, 0002-7510-01, 0002-7510-17, 0002-7533-01, 0002-8799-01, 0002-8799-59, 0002-7516-01, 0002-7516-59, 0002-7516-99, 0002-7714-01, 0002-7714-59, 0002-7714-61, 0002-8213-01, 0002-8213-05, 0002-0800-01, 0002-7712-01, 0002-7712-27, 0002-7712-61, 0002-8798-01, 0002-8798-59, 0002-8798-99, 0002-8233-01, 0002-8233-05
    Nui
    N0000004931, N0000175453
    Pharm class cs
    Insulin [Chemical/Ingredient]
    Pharm class epc
    Insulin Analog [EPC]
    UNII
    GFX7QIS1II, 059QF0KO0R
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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.