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3D-Neuronavigation In Vivo Through a Patient's Brain During a Spontaneous Migraine Headache
Published on: June 2, 2014
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Drug-induced headache reports: a comprehensive disproportionality and time-to-onset pharmacovigilance study using the
Abdulaziz Ibrahim Alzarea1, Azfar Athar Ishaqui2, Muhammad Bilal Maqsood3
1Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka, Al-Jouf, Saudi Arabia.
Frontiers in Pain Research (Lausanne, Switzerland)
|November 24, 2025
Summary
This study found that certain medications, like glecaprevir/pibrentasvir and sofosbuvir/velpatasvir, are linked to headaches as an adverse drug reaction. Proactive monitoring for drug-associated headaches is recommended, especially early in treatment.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Real-World Evidence
Background:
- Headache is a frequent adverse drug reaction (ADR) across many drug classes.
- Systematic real-world evaluations of drug-associated headaches are limited.
- This study utilized the FDA Adverse Event Reporting System (FAERS) to investigate drug-headache associations.
Purpose of the Study:
- To explore the association between various medications and headache reporting as an ADR.
- To identify specific drugs and therapeutic classes associated with increased headache risk.
- To analyze the timing of headache onset in relation to medication use.
Main Methods:
- Retrospective disproportionality analysis of FAERS data (Q1-2018 to Q4-2024).
- Calculation of Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) to detect safety signals.
- Classification of drugs using the Anatomical Therapeutic Chemical (ATC) system and time-to-onset analysis.
Main Results:
- Over 313,000 headache-associated cases were identified, predominantly in females aged 51-65.
- Glecaprevir/pibrentasvir (ROR=10.445) and sofosbuvir/velpatasvir (ROR=9.729) showed high headache risk.
- Calcium homeostasis agents and systemic antivirals were ATC classes with significant headache signals; early-onset headaches linked to ofatumumab, late-onset to treprostinil.
Conclusions:
- Multiple drugs and therapeutic classes are significantly associated with headache as an ADR.
- Proactive headache monitoring is crucial, especially during early treatment phases.
- Further prospective studies are needed to elucidate mechanisms and develop preventive strategies.
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