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<p>Idiopathic intracranial hypertension (IIH) is a rare but potentially vision-threatening disorder most commonly reported in young women and associated with certain medications, including tetracycline-class antibiotics and isotretinoin. Both are widely prescribed for acne and rosacea, leading to overlapping exposure in at-risk populations. We performed a retrospective pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) from January 2015 to March 2025 to compare IIH reporting frequencies across drug classes. Reports with acne or rosacea indications were identified and grouped into four mutually exclusive categories: isotretinoin alone, tetracyclines alone, combination therapy, or unexposed controls.A total of 72,510 reports were analyzed. IIH reporting was highest with isotretinoin–tetracycline combination therapy (0.81%), followed by tetracyclines alone (0.46%) and isotretinoin alone (0.097%), while controls demonstrated a much lower rate (0.0044%).These findings are consistent with prior case reports and support existing clinical guidelines that advise against co-prescribing isotretinoin and tetracyclines. The low rate of IIH in unexposed acne and rosacea patients further reinforces a likely drug-related rather than disease-related effect. Limitations include underreporting, duplicate submissions, and the inability to establish causality or calculate absolute risk. In conclusion, tetracyclines and isotretinoin are associated with increased IIH reporting in FAERS, with the greatest frequency seen in combination therapy.</p>

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Evaluating the association between tetracycline-class antibiotics, isotretinoin, and idiopathic intracranial hypertension: a pharmacovigilance study using FAERS data (2015–2025)

  • 期刊论文

  • 发表日期：

    2026年7月20日

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  • Olga Gomeniouk,
  • Sophia Mense,
  • Paige Adams,
  • Kevin Truong-Balderas,
  • Ethan Ritz,
  • David C. Reid

摘要

Idiopathic intracranial hypertension (IIH) is a rare but potentially vision-threatening disorder most commonly reported in young women and associated with certain medications, including tetracycline-class antibiotics and isotretinoin. Both are widely prescribed for acne and rosacea, leading to overlapping exposure in at-risk populations. We performed a retrospective pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) from January 2015 to March 2025 to compare IIH reporting frequencies across drug classes. Reports with acne or rosacea indications were identified and grouped into four mutually exclusive categories: isotretinoin alone, tetracyclines alone, combination therapy, or unexposed controls.A total of 72,510 reports were analyzed. IIH reporting was highest with isotretinoin–tetracycline combination therapy (0.81%), followed by tetracyclines alone (0.46%) and isotretinoin alone (0.097%), while controls demonstrated a much lower rate (0.0044%).These findings are consistent with prior case reports and support existing clinical guidelines that advise against co-prescribing isotretinoin and tetracyclines. The low rate of IIH in unexposed acne and rosacea patients further reinforces a likely drug-related rather than disease-related effect. Limitations include underreporting, duplicate submissions, and the inability to establish causality or calculate absolute risk. In conclusion, tetracyclines and isotretinoin are associated with increased IIH reporting in FAERS, with the greatest frequency seen in combination therapy.