Prescription medication · Direct Renin Inhibitor
aliskiren
Also sold as Tekturna. Tekturna is used to treat high blood pressure in adults and children who weigh at least 110 pounds and are 6 years or older.
Data updated 2026-05-15
- 2,229
- FDA reportsRarely reported
- 28
- InteractionsSeveral interactions
- 66% less
- Generic vs brandBig savings
- $12.70
- Brand price (NADAC)
What the data shows
aliskiren (Tekturna) is a prescription Direct Renin Inhibitor, among the least-reported drugs the FDA tracks (2,229 FDA reports), whose generic runs roughly half the brand price or less (66% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
aliskiren (Tekturna) is a prescription Direct Renin Inhibitor. Tekturna is used to treat high blood pressure in adults and children who weigh at least 110 pounds and are 6 years or older.
Tekturna is a medicine used to treat high blood pressure. It helps lower blood pressure, which can reduce the risk of strokes and heart attacks.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$12.70/unit
Generic Price
$4.36/unit
Generic Savings
66%
Generic Available
Yes (1 manufacturer)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Tekturna is used to treat high blood pressure in adults and children who weigh at least 110 pounds and are 6 years or older.
Common side effects
Diarrhea
Key warnings
Tekturna can harm your unborn baby, even causing death.
The sections below are summarized in plain English from aliskiren's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Tekturna works by blocking a substance in your body called renin. Renin helps to control your blood pressure. By blocking renin, Tekturna helps to lower your blood pressure.
Side Effects (from patient reports)
Based on 2,229 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for aliskiren, by number of reports
- Asthenia
Asthenia
367 reports
- Fall
Fall
356 reports
- Nausea
Nausea
336 reports
- Dyspnoea
Dyspnoea
315 reports
- Headache
Headache
301 reports
- Malaise
Malaise
290 reports
- Blood Pressure Increased
Blood Pressure Increased
287 reports
- Vomiting
Vomiting
280 reports
- Fatigue
Fatigue
277 reports
- Cough
Cough
276 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for aliskiren each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where aliskiren sits
aliskiren has more FDA adverse-event reports than 14% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is aliskiren; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 2,229 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
2,229
Reports Mentioning Death
558
25.0% of reports — not proof of cause
Hospitalization Reports
1,137
Top Indication
Hypertension
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ASTHENIA | 367 |
| 2 | FALL | 356 |
| 3 | NAUSEA | 336 |
| 4 | DYSPNOEA | 315 |
| 5 | HEADACHE | 301 |
| 6 | MALAISE | 290 |
| 7 | BLOOD PRESSURE INCREASED | 287 |
| 8 | VOMITING | 280 |
| 9 | FATIGUE | 277 |
| 10 | COUGH | 276 |
| 11 | PYREXIA | 269 |
| 12 | DIZZINESS | 252 |
| 13 | DIARRHOEA | 232 |
| 14 | SYNCOPE | 225 |
| 15 | DECREASED APPETITE | 218 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Tekturna can harm your unborn baby, even causing death. If you become pregnant, stop taking Tekturna right away and tell your doctor.
Known Drug Interactions
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with Lotrel in patients with diabetes. Avoid use of aliskiren with Lotrel in patients with renal impairment [glomerular filtration rate (GFR) < 60 mL/min].
Mechanism: Both of these drugs target the same system that controls blood pressure, which can cause your blood pressure to drop too low. This combination also increases the risk of kidney damage and high potassium levels.
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR < 60 mL/min).
Mechanism: Using these two medicines together can over-block the system that regulates blood pressure and kidney health. This can lead to dangerously low blood pressure, high potassium, or sudden kidney failure.
7.2 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with Edarbyclor in patients with diabetes. Avoid use of aliskiren with Edarbyclor in patients with renal impairment (GFR <60 mL/min).
Mechanism: Both drugs block the same system that controls blood pressure, which can cause your blood pressure to drop too low and strain your kidneys. This can also lead to dangerously high potassium levels in your blood.
7.4 Dual Blockade of the Renin-Angiotensin System (RAS) Dual Blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with benazepril hydrochloride in patients with diabetes. Avoid use of aliskiren with benazepril hydrochloride in patients with renal impairment (GFR < 60 ml/min).
Mechanism: These medicines both target the same pathway for blood pressure control, which increases the risk of kidney failure and high potassium. Using them together can cause your blood pressure to fall to unsafe levels.
7.4 Combination Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes. Avoid use of aliskiren with candesartan cilexetil in patients with renal impairment (GFR <60 ml/min) [see Contraindications (4)].
Mechanism: Both drugs work on the same system to lower blood pressure, which can lead to severe kidney problems and high potassium levels. This double-blocking effect makes side effects much more likely than taking just one drug.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take Tekturna if I have diabetes?
What should I do if I have swelling while taking Tekturna?
Can I take Tekturna with other blood pressure medicines?
Does Tekturna interact with pain relievers?
What if I have kidney problems?
Can Tekturna cause allergic reactions?
Will Tekturna cause diarrhea?
How long does it take for Tekturna to work?
What dose of Tekturna will I take?
Are there any foods I should avoid?
What are the common side effects of aliskiren?
Does aliskiren interact with other medications?
What drug class is aliskiren?
Is there a generic version of aliskiren?
What pregnancy or breastfeeding source fields are listed for aliskiren?
Related Medications in Direct Renin Inhibitor
Other drugs grouped near aliskiren - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with aliskiren →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with aliskiren →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with aliskiren →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with aliskiren →
amlodipine/valsartan
Exforge
Exforge HCT is a combination medicine used to treat high blood pressure.
Compare with aliskiren →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for aliskiren: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 2,229.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 25.03%.
- desoximetasone Δ 0.07 pts · 18,159 reports · Topical Corticosteroid 24.97%death share
- rivastigmine Δ 0.24 pts · 17,976 reports · Acetylcholinesterase Inhibitor 25.28%death share
- remdesivir Δ 0.25 pts · 13,113 reports · Nucleotide Analog (Antiviral) 24.78%death share
- codeine Δ 0.44 pts · 3,245 reports · Opioid Analgesic 24.59%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for aliskiren
The FDA label for aliskiren (sold under brand names such as Tekturna) classifies it as a prescription-only medication in the Direct Renin Inhibitor class. Tekturna is used to treat high blood pressure in adults and children who weigh at least 110 pounds and are 6 years or older. Official labeling lists 1 commonly reported side effect, including Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,229 voluntary reports. The database also lists 28 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $4.36 versus $12.70 for the brand - a 66% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: March 7, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages