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What the label lists and what reports show

Aliskiren side effects

Aliskiren's FDA label: “Most common adverse reaction: diarrhea (incidence 2.3%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US Inc.” FAERS holds 5,999 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (661 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the aliskiren FDA label on DailyMed (effective March 7, 2024, LXO US Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are possible side effects of Tekturna?

Tekturna may cause serious side effects, including: See “ What is the most important information I should know about Tekturna? ” Serious allergic reactions that can be life threatening. Stop taking Tekturna and get emergency medical help right away and if you get any of these symptoms of a serious reactions during treatment with Tekturna: trouble breathing or swallowing chest tightness aised bumps (hives) rash swelling of the face, lips, tongue, throat, arms, legs or the whole body itching dizziness vomiting stomach (abdomen) pain Low blood pressure (hypotension). Your blood pressure may get too low if you also take water pills, are on a low-salt diet, sweat more than normal, receive dialysis treatments, have heart problems, or have vomiting or diarrhea. Lie down if you feel faint or dizzy and call your doctor right away. Kidney problems, including kidney failure. […]

Source: FDA drug label, NDA021985 (Lxo Ireland), as published by LXO US Inc., effective March 7, 2024 (SPL set 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reaction: diarrhea (incidence 2.3%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US Inc.

From the label: adverse reactions, continued

Most common adverse reaction: diarrhea (incidence 2.3%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US Inc. at 1-844-800-8007 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Most common adverse reaction: diarrhea (incidence 2.3%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LXO US Inc. at 1-844-800-8007 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The following serious adverse reactions are discussed in greater detail in other sections of the label: Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Anaphylactic Reactions and Head and Neck Angioedema [see Warnings and Precautions ( 5.3 )] Hypotension [see Warnings and Precautions ( 5.4 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Adult Hypertension Data described below reflect the evaluation of the safety of Tekturna in more than 6,460 patients, including over 1,740 treated for longer than 6 months, and more than 1,250 patients for longer than 1 year. …

Source: FDA drug label, NDA021985 (Lxo Ireland), as published by LXO US Inc., effective March 7, 2024 (SPL set 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2), via openFDA; the full label on DailyMed

What do FAERS reports show?

5,999 reports list aliskiren among the medicines taken, each a report of something that happened, not proof the medicine caused it; 744 are coded as a death and 1,918 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Aliskiren: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions