IPC Warns of Potential Hyponatraemia Risk with Blood Pressure Drug Clonidine
New Delhi: The Indian Pharmacopoeia Commission (IPC), in its latest Drug Safety Alert, has flagged a potential safety signal indicating that the antihypertensive drug Clonidine may be associated with hyponatraemia, a condition characterised by abnormally low sodium levels in the blood.
In connection with the above, the Indian Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, has advised healthcare professionals and patients to remain vigilant and closely monitor the occurrence of this suspected adverse drug reaction (ADR) during treatment with the drug.
This follows an analysis of adverse drug reaction (ADR) reports available in the Pharmacovigilance Programme of India (PvPI) database, which identified the safety concern.
Clonidine is a centrally acting alpha-2 adrenergic agonist primarily indicated for the treatment of hypertension. By stimulating alpha-2 receptors in the brain, the drug reduces sympathetic outflow from the central nervous system, thereby lowering blood pressure. In addition to hypertension, clonidine is also used in certain cases for attention-deficit hyperactivity disorder (ADHD), management of withdrawal symptoms, and other off-label indications.
The safety alert noted that Clonidine is indicated for the treatment of hypertension. Based on a preliminary analysis of ADR reports from the PvPI database, the drug has been linked to hyponatremia. Hyponatremia occurs when the concentration of sodium in the blood falls below normal levels, potentially leading to symptoms such as nausea, headache, confusion, fatigue, muscle weakness, seizures, and, in severe cases, coma.
As per the issued Drug Safety Alert (File No. P.17019/03/2026-DSA dated May 27, 2026), the suspected drug and its associated ADR are as follows:
| S. No. | Suspected Drug | Indication | Adverse Drug Reaction |
|---|
| 1 | Clonidine | Treatment of hypertension | Hyponatremia |
In light of the above findings, the IPC has urged healthcare professionals and consumers to carefully monitor for this suspected adverse reaction.
The safety alert further stated that any such adverse reactions should be reported to the National Coordination Centre (NCC)-PvPI, IPC, by submitting the Suspected Adverse Drug Reactions Reporting Form for healthcare professionals or the Medicines Side Effect Reporting Form for consumers, available on the official IPC website. Reports may also be submitted through the PvPI Helpline (1800-180-3024), the PvPI Mobile App 2.0 available on Google Play Store, or the ADR Monitoring System (ADRMS) portal.
To view the official alert, click the link below:
