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

Reese Marlowe in Health & Wellness August 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.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.2147/tcrm.s23889, Alternate LINK

Title: Pharmacovigilance Analysis Of Adverse Event Reports For Aliskiren Hemifumarate, A First-In-Class Direct Renin Inhibitor

Subject: Chemical Health and Safety

Journal: Therapeutics and Clinical Risk Management

Publisher: Informa UK Limited

Authors: Ayad Ali

Published: 2011-08-01

Everything You Need To Know

What is aliskiren and what is it used for?

Aliskiren hemifumarate, sold under brand names like Tekturna and Rasilez, is a direct renin inhibitor used to treat hypertension. It works by directly inhibiting renin, an enzyme that starts a process in the body that can raise blood pressure. It was approved in March 2007 but carries potential risks that both patients and healthcare providers should be aware of.

Why is postmarketing surveillance important for drugs like aliskiren?

Postmarketing surveillance is essential because clinical trials conducted before a drug is released have limitations. These limitations include restricted study populations and short follow-up periods, which may not capture all potential adverse events. Continuous monitoring and analysis of adverse event reports after the drug is on the market helps to ensure patient safety and allows for informed decisions about its use.

What adverse events were found to be associated with aliskiren in the pharmacovigilance analysis?

The data mining of the US Adverse Event Reporting System (AERS) database revealed significant associations between aliskiren and several adverse events. These include angioedema (EBGM of 3.9), renal dysfunction (EBGM of 3.4), hyperkalemia (EBGM of 7.4), dry cough (EBGM of 11.0), and diarrhea (EBGM of 4.3). Angioedema and renal dysfunction are particularly serious and require careful monitoring.

What precautions should patients and healthcare providers take when using aliskiren?

Patients taking aliskiren should be educated about the signs and symptoms of angioedema, such as swelling of the face, lips, tongue, or throat, and instructed to discontinue aliskiren and seek immediate medical attention if they occur. Healthcare providers should be cautious when prescribing aliskiren to individuals with pre-existing renal impairment or other risk factors for renal dysfunction. Regular monitoring of kidney function and potassium levels may be necessary.

What are the limitations of the pharmacovigilance analysis of aliskiren, and what additional research is needed?

The pharmacovigilance analysis focused solely on adverse event reports submitted to the US Adverse Event Reporting System (AERS) and may not capture the full scope of aliskiren's safety profile. The Multi-item Gamma Poisson Shrinker (MGPS) data mining algorithm used helps reveal associations. More comprehensive studies, including clinical trials and real-world data analyses, are needed to fully understand the long-term safety and effectiveness of Aliskiren across diverse populations and clinical settings. Factors such as concurrent medications, patient comorbidities, and genetic predispositions can also influence the risk of adverse events associated with Aliskiren, highlighting the need for personalized risk assessment and management strategies.