Tekturnaaliskiren
According to the FDA label: Aliskiren tablets are a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
3,805 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Tekturna in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Nausea 368 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 367 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Blood Pressure Increased 359 reports
A reading showing higher than normal blood pressure. Similar to hypertension, which describes the ongoing condition.
Full definition in the glossary →Headache 342 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Cough 288 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Dizziness 283 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Fall 281 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Malaise 272 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Cerebrovascular Accident 271 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Asthenia 265 reports
Physical weakness or lack of strength.
Full definition in the glossary →Pain 244 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Diarrhoea 234 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Anxiety 231 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Vomiting 227 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Hypertension 218 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 2,232 |
| Male | 1,205 |
| Unknown | 40 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3 |
| 18-34 | 11 |
| 35-49 | 95 |
| 50-64 | 508 |
| 65-74 | 559 |
| 75+ | 458 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Tekturna. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 1,661 |
| Non-Serious | 1,617 |
| Hospitalization | 835 |
| Life-Threatening | 261 |
| Death | 183 |
| Disability | 125 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Tekturna. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 622 |
| 2008 | 687 |
| 2009 | 221 |
| 2010 | 200 |
| 2011 | 257 |
| 2012 | 473 |
| 2013 | 181 |
| 2014 | 171 |
| 2015 | 202 |
| 2016 | 156 |
| 2017 | 87 |
| 2018 | 90 |
| 2019 | 102 |
| 2020 | 53 |
| 2021 | 51 |
| 2022 | 43 |
| 2023 | 19 |
| 2024 | 102 |
| 2025 | 73 |
| 2026 (partial) | 15 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Tekturna
In FDA adverse event reports that mention Tekturna, these medications appeared most often in the same report.
- Aspirin (743 reports)
- Levothyroxine (454 reports)
- Furosemide (443 reports)
- Amlodipine (435 reports)
- Ergocalciferol (432 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026