A patient surrounded by medical symbols, representing the balance between medication benefits and potential side effects.

Aliskiren Safety: What You Need to Know About This Hypertension Drug

Author's portrait.
Reese Marlowe in Health & Wellness May 2025 • 4 min read.

"A closer look at the adverse effects and postmarketing analysis of aliskiren hemifumarate."


In the realm of cardiovascular health, managing hypertension often involves a variety of medications, each with its own mechanism and potential side effects. One such medication, aliskiren hemifumarate, marketed under brand names like Tekturna and Rasilez, belongs to a class of drugs known as direct renin inhibitors. Aliskiren was developed by Novartis Pharmaceuticals and approved in March 2007, but what should patients and healthcare providers know about its safety profile?

A research article titled "Pharmacovigilance analysis of adverse event reports for aliskiren hemifumarate, a first-in-class direct renin inhibitor," published in Therapeutics and Clinical Risk Management in 2011, sheds light on the postmarketing safety surveillance of aliskiren. The study, led by Ayad K Ali, aimed to evaluate the adverse event reports associated with aliskiren to better understand its safety profile following its release to the market.

Postmarketing surveillance is vital because premarketing clinical trials have inherent limitations, such as restricted study populations and short follow-up durations. These limitations make it challenging to identify all potential adverse events before a drug is widely used. Therefore, continuous monitoring and analysis of adverse event reports are crucial for ensuring patient safety and making informed decisions about medication use.

What Adverse Events Are Linked to Aliskiren?

A patient surrounded by medical symbols, representing the balance between medication benefits and potential side effects.

The research study utilized data from the US Adverse Event Reporting System (AERS) to conduct a retrospective pharmacovigilance analysis. The AERS database contains reports submitted by manufacturers, patients, physicians, and other healthcare professionals. By applying the Multi-item Gamma Poisson Shrinker (MGPS) data mining algorithm, the researchers calculated empiric Bayes geometric mean (EBGM) values to identify associations between aliskiren and specific adverse events.

From January 2007 through December 2008, the AERS database contained 1,592 reports related to aliskiren. The analysis revealed several adverse events with significant associations:

  • Angioedema: EBGM of 3.9 (95% CI: 3.2-4.7)
  • Renal Dysfunction: EBGM of 3.4 (95% CI: 2.6-4.5)
  • Hyperkalemia: EBGM of 7.4 (95% CI: 3.4-13.0)
  • Dry Cough: EBGM of 11.0 (95% CI: 7.8–14.2)
  • Diarrhea: EBGM of 4.3 (95% CI: 3.2-5.8)
These findings suggest that aliskiren is associated with an increased risk of angioedema, renal dysfunction, hyperkalemia, dry cough, and diarrhea. Among these, angioedema and renal dysfunction are particularly noteworthy, as they represent potential serious adverse events that warrant careful consideration.

What This Means for Aliskiren Users

The pharmacovigilance analysis underscores the importance of monitoring for adverse events associated with aliskiren treatment. Patients should be educated about the signs and symptoms of angioedema and instructed to discontinue aliskiren and seek immediate medical attention if they experience any of these symptoms. Healthcare providers should exercise caution when prescribing aliskiren to patients with pre-existing renal impairment or other risk factors for renal dysfunction. By staying informed and vigilant, patients and healthcare providers can work together to minimize the risks associated with aliskiren and ensure optimal outcomes in hypertension management.

Everything You Need To Know

1

What is Aliskiren, and how does it work?

Aliskiren hemifumarate, often sold under brand names like Tekturna and Rasilez, is a medication classified as a direct renin inhibitor. It works by blocking the action of renin, an enzyme that plays a crucial role in the renin-angiotensin-aldosterone system (RAAS). This system regulates blood pressure. By inhibiting renin, Aliskiren helps to lower blood pressure.

2

What are the most significant adverse events associated with Aliskiren?

The study highlighted angioedema and renal dysfunction as particularly noteworthy adverse events associated with Aliskiren. Angioedema is characterized by swelling, often of the face, lips, tongue, or throat, which can be life-threatening if it obstructs the airway. Renal dysfunction refers to a decline in kidney function. The identification of these adverse events underscores the importance of monitoring patients closely during Aliskiren treatment. This helps to ensure patient safety and facilitate timely intervention if these events occur.

3

How was the data analyzed to determine the adverse effects of Aliskiren?

The study relied on data from the US Adverse Event Reporting System (AERS), a database that collects reports of adverse events from manufacturers, patients, physicians, and other healthcare professionals. Using the Multi-item Gamma Poisson Shrinker (MGPS) data mining algorithm, researchers analyzed the reports to identify associations between Aliskiren and specific adverse events. This method allowed them to calculate empiric Bayes geometric mean (EBGM) values, which helped to determine the strength of these associations.

4

Why is postmarketing surveillance important for a drug like Aliskiren?

Postmarketing surveillance is essential because it provides a way to monitor the safety of a drug after it has been approved and released to the market. Premarketing clinical trials, while important, have limitations, such as involving a specific patient population and a limited time frame. These may not uncover all potential adverse events. Postmarketing surveillance, which continuously collects and analyzes data from real-world use, helps identify rare or delayed adverse events that might not have been detected during the premarketing phase. This process informs ongoing risk-benefit assessments.

5

What should patients and healthcare providers be aware of when using Aliskiren?

Patients taking Aliskiren should be aware of the potential for adverse events, including angioedema, renal dysfunction, hyperkalemia, dry cough, and diarrhea. If a patient experiences signs of angioedema, such as swelling of the face, lips, tongue, or throat, they should immediately stop taking Aliskiren and seek medical attention. Regular monitoring of kidney function is crucial, especially in patients with pre-existing renal impairment or other risk factors. Healthcare providers and patients working together to stay informed and vigilant are essential to minimize the risks associated with Aliskiren and ensure safe and effective hypertension management.

Newsletter Subscribe

Subscribe to get the latest articles and insights directly in your inbox.