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  • IPC Flags Hyperkalemia...

IPC Flags Hyperkalemia as Safety Alert Linked to Antihypertensive Drug Metoprolol

Written By : Susmita Roy Published On 2026-08-05T20:00:37+05:30  |  Updated On 5 Aug 2026 11:30 PM IST
IPC Flags Potential Hyponatraemia Risk with Blood Pressure Drug Clonidine
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New Delhi: The Indian Pharmacopoeia Commission (IPC), in its latest Drug Safety Alert, has flagged a safety signal indicating that the antihypertensive drug Metoprolol may be associated with hyperkalemia, a condition characterised by an abnormally high level of potassium in the blood.

In connection with the above, the Indian Pharmacopoeia Commission (IPC) has advised healthcare professionals and patients to closely monitor the possibility of the suspected adverse drug reaction (ADR) associated with the use of Metoprolol.

This follows an analysis of adverse drug reaction (ADR) reports available in the Pharmacovigilance Programme of India (PvPI) database, which identified hyperkalemia as a suspected adverse reaction associated with Metoprolol.
Metoprolol is an antihypertensive agent indicated for the treatment of essential hypertension and angina pectoris. According to the IPC safety alert, it is also used as an adjunct in the treatment of hyperthyroidism. Additional indications listed in the alert include functional heart disorders, migraine prophylaxis, cardiac arrhythmias, prevention of cardiac death and reinfarction following the acute phase of myocardial infarction, and stable symptomatic congestive heart failure (CHF). The alert also lists myocardial infarction as an additional indication.

Also Read:CDSCO Directs Inclusion of Fixed Drug Eruption Warning in Metronidazole Prescribing Information

The safety alert noted that, based on the analysis of ADR reports from the PvPI database, Metoprolol has been reported to be associated with hyperkalemia.

As per the issued Drug Safety Alert, the suspected drug and its associated ADR are as follows:

S. No.

Suspected Drug

Indication(s)

Adverse Drug Reaction

1

Metoprolol

Antihypertensive agent-

  • Indicated in the treatment of essential hypertension and angina pectoris.
  • Adjunct to the treatment of Hyperthyroidism.
  • Additional indication;
  • functional heart disorders,
  • Migraine prophylaxis,
  • Cardiac Arrhythmias,
  • Prevention of cardiac death and reinfarction after the acute phase of myocardial infarction
  • Stable symptomatic CHF.
  • Additional indication: For the treatment of myocardial infarction.

Hyperkalemia

In light of the above findings, the IPC has urged healthcare professionals and patients to closely monitor for the suspected adverse reaction associated with Metoprolol therapy.

Also Read:IPC Warns of Potential Hyponatraemia Risk with Blood Pressure Drug Clonidine

The safety alert further stated that if such an adverse reaction is encountered, it should be reported to the National Coordination Centre–Pharmacovigilance Programme of India (NCC-PvPI), IPC by filling of Suspected Adverse Drug Reactions Reporting Form by HCPs, Medicines Side Effect Reporting Form by Consumer (download from https://www.ipc.gov.in), PvPI Helpline Number 1800-180-3024, PvPI Mobile App 2.0 (available at Google Play Store) and Adverse Drug Reaction Monitoring System (https://adrmsipc.in/adrms/index.html)

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/2026/08/05/drug-safety-alert-june-30-2026-363389.pdf
drug safety alertIndian pharmacopeia commissionMetaprololadverse drug reactionPharmacovigilance Programme of IndiaNCC-PVPIhyperkalemiaantihypertensive drug
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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