Aliskiren / amlodipine Side Effects
For the Consumer
Applies to aliskiren / amlodipine: oral tablet
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
- Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
- Very bad dizziness or passing out.
- Chest pain that is new or worse.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Stiff muscles, shakiness, or muscle movements that are not normal.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Flu-like signs.
- Feeling tired or weak.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Rare (less than 0.1%): Hypotension
Common (1% to 10%): palpitations
Common (1% to 10%): Rash
Rare (less than 0.1%): Angioedema (involving the face, hands, or whole body)
Postmarketing reports: Severe cutaneous adverse reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis)
Common (1% to 10%): Rash, erythematous rash
Postmarketing reports: Gynecomastia[Ref]
Common (1% to 10%): Nausea, dysphagia, abdominal pain
Uncommon (0.1% to 1%): Micturition disorder, micturition frequency, nocturia
Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: Angioedema
Uncommon (0.1% to 1%): Allergic reaction[Ref]
Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Uncommon (0.1% to 1%): Hyperglycemia, thirst, weight loss, weight gain
Very rare (less than 0.01%): Acute porphyria exacerbation
Frequency not reported: New-onset diabetes[Ref]
Uncommon (0.1% to 1%): Asthenia, rigors
Common (1% to 10%): Myalgia
Uncommon (0.1% to 1%): Arthralgia, arthrosis, muscle cramps
Rare (less than 0.1%): Hypertonia, muscle weakness, twitching, ataxia[Ref]
Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness
Common (1% to 10%): Headache, dizziness, somnolence
Rare (less than 0.1%): Abnormal visual accommodation, xerophthalmia[Ref]
Rare (less than 0.1%): Interstitial nephritis[Ref]
Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough
Common (1% to 10%): Epistaxis
Uncommon (0.1% to 1%): Dyspnea
Rare (less than 0.1%): Coughing, rhinitis
Postmarketing reports: Pulmonary edema was reported during a study of patients with NYHA Class III or IV heart failure without clinical symptoms or objective evidence of underlying ischemic disease.[Ref]
Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus[Ref]
1. "Product Information. Tekamlo (aliskiren-amlodipine)." Novartis Pharmaceuticals, East Hanover, NJ.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about aliskiren/amlodipine
- During Pregnancy
- Dosage Information
- Drug Interactions
- Drug class: miscellaneous antihypertensive combinations
- FDA Alerts (1)
Other brands: Tekamlo