Doxycycline and CNS Side Effects – Recommendations for Prescribing Information Leaflets

Introduction

Doxycycline, a widely used antibiotic for treating various bacterial infections, has recently been the subject of detailed evaluation by the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI). Based on the assessment of Adverse Drug Reaction (ADR) reports, new recommendations have been issued to ensure patient safety and enhance awareness regarding potential side effects associated with Doxycycline formulations.

Background

The NCC-PvPI, under the Indian Pharmacopoeia Commission (IPC), conducted a thorough review of ADR reports related to Doxycycline formulations. These reports were discussed during the 26th Signal Review Panel meeting held on March 24, 2025. The evaluation focused on the Patient Population Incidence of Adverse Drug Reactions (PPls-ADR) based on Individual Case Study Reports (ICSR). The findings highlighted the occurrence of Central Nervous System (CNS) side effects, including restlessness, anxiety, irritability, nervousness, and dizziness, in patients using Doxycycline.

Recommendations by NCC-PvPI and SEC

Following the NCC-PvPI’s assessment, the Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic convened on January 8, 2026, at the Central Drugs Standard Control Organization (COSCO) headquarters in New Delhi. After detailed deliberations, the SEC recommended that the Directorate General of Health Services (DGHS) take necessary measures to address these findings. Specifically, the committee advised COSCO to request State Drugs Controllers to direct manufacturers of Doxycycline formulations to include the identified CNS side effects as adverse drug reactions in the caution section of the Prescribing Information Leaflets (PILs) and promotional literature of the drug.

Action Plan

In response to these recommendations, the Office of the Drugs Controller General (India) has issued directives to all State and Union Territory Licensing Authorities. The authorities are tasked with ensuring that manufacturers under their jurisdiction update the PILs of Doxycycline formulations to include the following CNS side effects:

Restlessness
Anxiety
Irritability
Nervousness
Dizziness

This update aims to enhance patient awareness and ensure healthcare professionals are informed about these potential side effects when prescribing Doxycycline.

Importance of Pharmacovigilance

The recommendations underscore the critical role of pharmacovigilance in ensuring drug safety. By monitoring and assessing ADRs, regulatory bodies can take proactive measures to protect public health. The inclusion of CNS side effects in Doxycycline’s PILs is a significant step toward improving transparency and patient safety.

Next Steps

Manufacturers of Doxycycline formulations are required to comply with these directives and update their PILs and promotional materials accordingly. State Drugs Controllers are expected to oversee the implementation of these changes and report the actions taken to the Office of the Drugs Controller General (India).

Conclusion

The recent recommendations regarding Doxycycline and its CNS side effects highlight the importance of continuous monitoring and updating of drug safety information. Patients and healthcare providers are encouraged to stay informed about potential side effects and report any adverse reactions to the Pharmacovigilance Programme of India (PvPI). Together, we can ensure safer and more effective use of medications for all.

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Source: CDSCO

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