India drug safety
CDSCO medicine-safety and regulatory updates for doctors in India Check the original source and local guidance before use.
Oxcarbazepine: CDSCO adverse drug reaction update
September 14, 2026
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This AI summary is based on Central Drugs Standard Control Organisation (CDSCO). The original source link and last refresh date are saved here for you to check.
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CDSCO has issued an adverse drug reaction notification noting Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome reported with oxcarbazepine. The alert highlights a potential association but lacks information on frequency, severity distribution, latency, patient factors, or outcomes, and does not establish causality. No recommendations or management details are included. This remains a pharmacovigilance signal with uncertainty pending further evaluation. Clinicians should remain alert to updates from CDSCO that may clarify risk and provide more detailed guidance.
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Create free account Already registered? Sign inFludrocortisone: CDSCO adverse drug reaction update
September 21, 2026
CDSCO has reported hypokalaemia as an adverse drug reaction associated with fludrocortisone. The notice is a pharmacovigilance signal and does not include data on incidence, severity, timing, dose relationship, or outcomes. No guidance on monitoring or management is provided, and causality is not established. The status reflects uncertainty pending further assessment. Healthcare professionals may consider this signal in clinical vigilance and look for additional CDSCO updates or supportive data that could refine understanding of risk and inform practice.
About this update
Based on Central Drugs Standard Control Organisation (CDSCO) and saved with the original source record.
View official sourceTeneligliptin: CDSCO adverse drug reaction update
September 21, 2026
CDSCO has issued an adverse drug reaction notification identifying bullous pemphigoid reported with teneligliptin. The update signals a potential association but does not provide incidence, severity spectrum, causality assessment, or clinical management details. No additional patient characteristics, time to onset, or outcomes are described. This notification serves as a pharmacovigilance alert and indicates uncertainty about frequency and risk factors. Clinicians should be aware of the signal and monitor emerging CDSCO communications or further evaluations that may clarify the relationship and clinical implications.
About this update
Based on Central Drugs Standard Control Organisation (CDSCO) and saved with the original source record.
View official sourceOxcarbazepine: CDSCO adverse drug reaction update
September 14, 2026
CDSCO has issued an adverse drug reaction notification noting Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome reported with oxcarbazepine. The alert highlights a potential association but lacks information on frequency, severity distribution, latency, patient factors, or outcomes, and does not establish causality. No recommendations or management details are included. This remains a pharmacovigilance signal with uncertainty pending further evaluation. Clinicians should remain alert to updates from CDSCO that may clarify risk and provide more detailed guidance.
About this update
Based on Central Drugs Standard Control Organisation (CDSCO) and saved with the original source record.
View official sourceTranexamic Acid: CDSCO adverse drug reaction update
July 21, 2026
CDSCO pharmacovigilance update identifies back pain as a reported adverse reaction with tranexamic acid. The notification signals a potential association but provides no data on frequency, severity, patient characteristics, or causality assessment. It serves as an alert within the national ADR reporting system rather than a full risk evaluation. Clinicians should be aware of the report and consult current product information and local guidance for context.
About this update
Based on Central Drugs Standard Control Organisation (CDSCO) and saved with the original source record.
View official sourceTranexamic Acid: CDSCO adverse drug reaction update
July 21, 2026
CDSCO pharmacovigilance update identifies back pain as a reported adverse reaction with tranexamic acid. The notification signals a potential association but provides no data on frequency, severity, patient characteristics, or causality assessment. It serves as an alert within the national ADR reporting system rather than a full risk evaluation. Clinicians should be aware of the report and consult current product information and local guidance for context.
About this update
Based on Central Drugs Standard Control Organisation (CDSCO) and saved with the original source record.
View official sourceThese AI summaries are a quick starting point. Check the original source, local guidance and your own clinical judgement before using them.