Aliskiren Side Effects

Not all side effects for aliskiren may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to aliskiren: oral tablet

In addition to its needed effects, some unwanted effects may be caused by aliskiren. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking aliskiren:

Less common
  • Body aches or pain
  • chills
  • cough
  • diarrhea
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Rare
  • Ankle, knee, or great toe joint pain
  • blood in the urine
  • joint pain
  • joint stiffness or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of bladder control
  • loss of consciousness
  • lower back or side pain
  • nausea and vomiting
  • pain in the groin or genitals
  • sharp back pain just below the ribs
  • swelling of the feet or lower legs
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • itching
  • joint or muscle pain
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sores, ulcers, or white spots in the mouth or on the lips
  • tingling of the hands or feet
  • unusual weight gain or loss

Some of the side effects that can occur with aliskiren may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • back pain
  • belching
  • dizziness
  • heartburn
  • indigestion
  • muscle aches
  • rash
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to aliskiren: oral tablet

Hypersensitivity

Two cases of angioedema with respiratory symptoms were reported with aliskiren use in clinical studies, and two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of angioedema cases in completed studies was 0.06%. Twenty-six other cases of edema involving the face, hands, or whole body were reported with aliskiren use, including four which led to discontinuation. In the placebo controlled studies, the incidence of edema involving the face, hands or whole body was 0.4% with aliskiren compared with 0.5% with placebo.

Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: Angioedema

Gastrointestinal

In women and the elderly (65 years of age or older), increases in diarrhea rates were evident starting at a dose of 150 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation.

Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)

Dermatologic

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)

Metabolic

Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: Peripheral edema

Nervous system

Episodes of tonic-clonic seizures were reported in two patients treated with aliskiren in the clinical trials. One patient had predisposing causes for seizures and a negative electroencephalogram (EEG) and cerebral imaging following the seizures (the other patient's EEG and imaging results were not reported). Aliskiren was discontinued and there was no rechallenge.

Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness.

Respiratory

Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough

Cardiovascular

Rare (less than 0.1%): Hypotension

Hematologic

Uncommon (0.1% to 1%): Small decreases in hemoglobin and hematocrit
Postmarketing reports: Increased blood creatinine

Musculoskeletal

Common (1% to 10%): Back pain

Other

Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus

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