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aliskiren

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Brand names: Tekturna

Direct Renin Inhibitor Rx

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.

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.

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.

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.

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.

Storage

Store Tekturna at room temperature, away from moisture.

Side Effects (from patient reports)

Based on 3,083 FDA adverse event reports.

Weakness
367
Fall
356
Feeling sick to your stomach
336
Shortness of breath
314
Headache
301
Feeling unwell
290
Increased blood pressure
286
Throwing up
280
Tiredness
277
Cough
276

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

Death-Related Reports

558

Hospitalization Reports

1,137

Top Indication

Hypertension

Gender Distribution

Female 885 (51%)
Male 848 (48%)

Age Distribution

0–17 10
18–44 75
45–64 434
65–74 389
75+ 336

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

DYSPNOEA 201
HAEMORRHAGIC STROKE 200
TACHYCARDIA 200
CARDIO-RESPIRATORY ARREST 194
FALL 193
SEPSIS 193
ALTERED STATE OF CONSCIOUSNESS 186
DIARRHOEA 186
OCULAR DISCOMFORT 185
PRURITUS 184

Reactions in Hospitalization Reports

ASTHENIA 177
CEREBROVASCULAR ACCIDENT 171
NAUSEA 167
FALL 163
CONFUSIONAL STATE 150
DYSARTHRIA 149
ANXIETY 144
APHASIA 143
HEMIPARESIS 143
SENSORY LOSS 143

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.

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Common Questions

Can I take Tekturna if I have diabetes?
You should not take Tekturna with certain other medicines (ARBs or ACEIs) if you have diabetes.
What should I do if I have swelling while taking Tekturna?
Tell your doctor right away if you have swelling of your face, tongue, or throat.
Can I take Tekturna with other blood pressure medicines?
Talk to your doctor before taking Tekturna with other blood pressure medicines. Combining Tekturna with certain medicines can cause problems.
Does Tekturna interact with pain relievers?
Yes, some pain relievers (NSAIDs) can affect how well Tekturna works and may cause kidney problems.
What if I have kidney problems?
Talk to your doctor. Tekturna may not be right for you, especially if you are also taking an ARB or ACE inhibitor.
Can Tekturna cause allergic reactions?
Yes, some people have had serious allergic reactions, including swelling of the face, tongue, or throat. Stop taking Tekturna and get medical help right away if this happens.
Will Tekturna cause diarrhea?
Diarrhea is a common side effect of Tekturna.
How long does it take for Tekturna to work?
It may take up to 2 weeks to see the full effect of Tekturna on your blood pressure.
What dose of Tekturna will I take?
The usual starting dose is 150 mg once daily. Your doctor may increase the dose to 300 mg if needed.
Are there any foods I should avoid?
Try to take Tekturna the same way each time with regard to meals. High-fat meals can affect how much medicine your body absorbs.
What are the common side effects of aliskiren?
The most commonly reported side effects of aliskiren include Diarrhea. Based on 3,083 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does aliskiren interact with other medications?
Yes, aliskiren has 28 known drug interactions. Notable interactions include amlodipine/benazepril, amlodipine/valsartan, azilsartan. Always inform your doctor about all medications you are taking.
What drug class is aliskiren?
aliskiren belongs to the Direct Renin Inhibitor drug class. It requires a prescription (Rx). Tekturna is used to treat high blood pressure in adults and children who weigh at least 110 pounds and are 6 years or older.
Is there a generic version of aliskiren?
Yes, generic aliskiren is available from 1 manufacturer. The generic costs $4.36 per unit compared to $12.70 for the brand version, saving approximately 66%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is aliskiren safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 3,083 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

All federal data sources used on this page