{
  "name": "Vyleesi 1.75 mg trial table adverse-reaction incidence",
  "description": "Adverse-reaction percentages from the Vyleesi 1.75 mg trial table, with the named treatment and comparison arms, both arm sizes, and the fetched label coordinates behind every row.",
  "author": "HealthspanLedger",
  "edition": "2026.09",
  "version": "8dc2dac8bf6c",
  "page": "https://healthspanledger.com/compounds/pt-141/side-effects",
  "citeAs": "HealthspanLedger. Vyleesi 1.75 mg trial table adverse-reaction incidence. Edition 2026.09 (version 8dc2dac8bf6c). Derived from VYLEESI (bremelanotide) injection — FDA-approved Prescribing Information (DailyMed SPL), retrieved 2026-09-19. Licensed CC BY 4.0. https://healthspanledger.com/compounds/pt-141/side-effects",
  "license": {
    "url": "https://creativecommons.org/licenses/by/4.0/",
    "name": "Creative Commons Attribution 4.0 International (CC BY 4.0)"
  },
  "source": {
    "name": "VYLEESI (bremelanotide) injection — FDA-approved Prescribing Information (DailyMed SPL)",
    "url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
    "retrieved": "2026-09-19",
    "publisherLastUpdated": null,
    "licenseName": "The label states no open-data license; its wording remains the publisher’s work."
  },
  "arrangement": "The source listings state no open data license. Their wording and images remain the publishers’ work. HealthspanLedger’s factual selection and arrangement is licensed CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/): reuse the table, including commercially, and credit HealthspanLedger with a link to the page it came from.",
  "temporalCoverage": "P24W",
  "measurementTechnique": "Transcription of one named adverse-reaction table from the fetched FDA label. Numeric percentage values and arm sizes are transcribed without calculation; display formatting may omit trailing zeros. Arms are not combined, rates are not inferred from bands, and no figure is carried from another molecule, product or trial.",
  "readThisFirst": [
    "These are trial-group frequencies, not a forecast of what will happen to one person.",
    "Rates from different products, doses, populations or trial designs cannot be compared as if the trials were one experiment.",
    "Each row preserves its own treatment and comparison arm sizes; no arms were pooled and no percentage was calculated from a frequency band."
  ],
  "rows": [
    {
      "reaction": "Nausea",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 40,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 1.3,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Flushing",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 20.3,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 0.3,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Injection site reactions",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 13.2,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 8.4,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Headache",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 11.3,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 1.9,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Vomiting",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 4.8,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 0.2,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Cough",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 3.3,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 1.3,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Fatigue",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 3.2,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 0.5,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Hot flush",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 2.7,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 0.2,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Paraesthesia",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 2.6,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 0,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Dizziness",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 2.2,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 0.5,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    },
    {
      "reaction": "Nasal congestion",
      "treatment_arm": "Vyleesi 1.75 mg",
      "treatment_arm_n": 627,
      "rate_percent": 2.1,
      "comparator_arm": "Placebo",
      "comparator_arm_n": 620,
      "comparator_rate_percent": 0.5,
      "source_url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.xml",
      "source_kind": "fda_label",
      "source_identifier": "SPL f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf",
      "source_section": "6.1, Table 1",
      "retrieved_at": "2026-09-19",
      "http_status": 200
    }
  ]
}