Applies to aliskiren: oral tablet.
Warning
Oral route (Tablet; Pellet)
When pregnancy is detected, discontinue aliskiren as soon as possible, since drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Serious side effects of Aliskiren
Along with its needed effects, aliskiren may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while 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, 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
- pain in the groin or genitals
- sharp back pain just below the ribs
- swelling of the feet or lower legs
- vomiting
Incidence not known
- Blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- itching
- 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
Other side effects of Aliskiren
Some side effects of aliskiren may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Back pain
- belching
- dizziness
- heartburn
- indigestion
- muscle aches
- rash
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to aliskiren: oral tablet.
Hypersensitivity
Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: Angioedema[Ref]
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.[Ref]
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.[Ref]
Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)
Postmarketing reports: Nausea, vomiting[Ref]
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)[Ref]
Metabolic
Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: Peripheral edema, hyponatremia[Ref]
Nervous system
Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness.[Ref]
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.[Ref]
Respiratory
Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough[Ref]
Cardiovascular
Rare (less than 0.1%): Hypotension[Ref]
Hematologic
Uncommon (0.1% to 1%): Small decreases in hemoglobin and hematocrit
Postmarketing reports: Increased blood creatinine[Ref]
Musculoskeletal
Common (1% to 10%): Back pain
Other
Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus[Ref]
