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Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.
Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.
Aliskiren and amlodipine is a combination medicine used to treat high blood pressure (hypertension).
Aliskiren and amlodipine may also be used for purposes not listed in this medication guide.
Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.
If you have diabetes, you should not use aliskiren and amlodipine together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).
You should not take aliskiren and amlodipine if you are also using cyclosporine or itraconazole.
You should not take this medicine if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine or itraconazole.
If you have diabetes, you should not use aliskiren and amlodipine together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or
• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with aliskiren and amlodipine if you have kidney disease.
To make sure aliskiren and amlodipine is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);
• liver disease;
• congestive heart failure;
• coronary artery disease (hardened arteries);
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• if you are on a low-salt diet; or
• if you have ever had an allergic reaction to an ACE inhibitor heart or blood pressure medicine (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, trandolapril).

FDA pregnancy category D. Do not use aliskiren and amlodipine if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.
It is not known whether aliskiren and amlodipine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; vomiting, severe stomach pain; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• chest pain or pressure, pain spreading to your jaw or shoulder;
• little or no urinating; or
• high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling.

Common side effects may include:

• swelling in your hands, ankles, or feet;
• dizziness, tired feeling;
• cough;
• diarrhea;
• stomach pain, upset stomach; or
• flu symptoms (fever, chills, body aches).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid taking this medicine with a high-fat meal, which can make it harder for your body to absorb aliskiren.
Do not use salt substitutes or potassium supplements while taking this medicine, unless your doctor has told you to.
Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of aliskiren and amlodipine.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with aliskiren and amlodipine, especially:

• antifungal medicine;
• any other heart or blood pressure medicines;
• atorvastatin (Lipitor) or simvastatin (Zocor);
• a diuretic or "water pill";
• HIV or AIDS medicine, such as indinavir or ritonavir;
• a potassium supplement such as K-Dur, Klor-Con;
• salt substitutes that contain potassium; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with aliskiren and amlodipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.