Pharmacologic class (EPC) · 2 drug pages

Renin inhibitor: adverse event reports filed with FDA

4,115 reports list a drug in this class as a suspect or interacting product, 2007–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,115
reports across the class: 0% of all reports; 71
reports, 12 months to June 2026: 100 in the 12 months before; 74.7%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Renin inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 4,115 adverse event reports received by FDA, 0% of the database, from February 2007 to June 2026.

71 reports arrived in the 12 months to June 2026, down 29% from 100 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 74.7% of the class's reports are marked serious, 14.1% record death among the outcomes and 30.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are blood pressure increased (11%), asthenia (10.2%) and dizziness (10%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
TekturnaAliskiren hemifumarate	brand	2,257	18	56.1%	Dizziness
Aliskiren	generic	1,858	53	97.4%	Asthenia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Blood pressure increaseda raised blood pressure reading11%454
Astheniaweakness or lack of energy10.2%421
Dizzinesslight-headedness or unsteadiness10%410
Nauseafeeling sick9.9%408
Headachehead pain9.7%401
Dyspnoeashortness of breath9.3%382
Falla fall9.2%379
Malaisegeneral feeling of being unwell8.7%360
Fatiguetiredness8.7%359
Coughcough8.7%357
Diarrhoealoose or frequent stools8.2%337
Vomitingbeing sick7.4%306
Pyrexiafever6.7%274
Hypertensionhigh blood pressure6.5%266
Cerebrovascular accidentstroke6.3%258
Syncopefainting6.1%250
Drug ineffectivethe medicine did not work as expected5.9%243
Pruritusitching5.7%235
Arthralgiajoint pain5.5%228
Abdominal painstomach or belly pain5.4%221
Myalgiamuscle pain5.4%221
Somnolencedrowsiness5.4%221
Decreased appetitereduced appetite5.3%219
Tachycardiafast heart rate5.3%219
Haemorrhagic stroke5.1%210

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death14.1%582

Life-threatening8%330

Hospitalisation (initial or prolonged)30.8%1,267

Disability4.1%170

Congenital anomaly2.6%108

Other serious52.5%2,161

Not serious25.3%1,040

Patient age

Under 20%1

2 to 110.1%6

12 to 170.1%3

18 to 442.4%97

45 to 6414.4%591

65 to 7413%534

75 and over11.8%484

Age not given58.3%2,399

Who reported

Physician43.9%1,807

Pharmacist1.5%62

Other health professional21.4%881

Lawyer0.6%24

Consumer or non-health professional28.9%1,190

Not given3.7%151

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Renin inhibitor reports

Which drugs are in the Renin inhibitor class on this site?

Tekturna and Aliskiren. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

4,115 reports through June 2026, 71 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

blood pressure increased (11%), asthenia (10.2%), dizziness (10%), nausea (9.9%) and headache (9.7%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.