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.
How to Take It
Take Tekturna once a day, at the same time each day. You can take it with or without food, but try to take it the same way each time. High-fat meals can affect how well the medicine works. Your doctor may start you on 150 mg and increase it to 300 mg if needed.
This is a plain-language summary of aliskiren's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tekturna can cause serious harm or death to an unborn baby. If you are pregnant or plan to become pregnant, talk to your doctor about other blood pressure medicines. Breastfeeding is not recommended while taking Tekturna.
This is a plain-language summary of aliskiren's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of aliskiren's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Tekturna at room temperature, away from moisture.
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
- Weakness
Weakness
367 reports
- Fall
Fall
356 reports
- Feeling sick to your stomach
Feeling sick to your stomach
336 reports
- Shortness of breath
Shortness of breath
314 reports
- Headache
Headache
301 reports
- Feeling unwell
Feeling unwell
290 reports
- Increased blood pressure
Increased blood pressure
286 reports
- Throwing up
Throwing up
280 reports
- Tiredness
Tiredness
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) 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.
What to do: Avoid taking these drugs together, especially if you have diabetes or kidney disease. Your doctor will likely choose a different treatment to protect your kidneys.
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.
What to do: Do not use this combination if you have diabetes or existing kidney problems. Your provider will monitor your blood pressure and kidney health very closely if these drugs are used.
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.
What to do: Do not take these together if you have diabetes or kidney problems. Your doctor will likely prescribe only one of these to protect your health.
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.
What to do: This combination should not be used in patients with diabetes or kidney disease. Talk to your doctor about using only one of these medications to protect your kidneys.
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.
What to do: Avoid this combination, especially if you have diabetes or kidney issues. Your doctor should monitor your kidney function and blood pressure closely.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is aliskiren safe during pregnancy?
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 →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: March 7, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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