Aliskiren / amlodipine Side Effects

For the Consumer

Applies to aliskiren / amlodipine: oral tablet

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

Major Side Effects

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

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

• Abdominal or stomach pain
• blistering, peeling, or loosening of the skin
• chills
• clay-colored stools
• cough
• dark urine
• diarrhea
• dizziness
• fever
• headache
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with aliskiren / amlodipine 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:

• Acid or sour stomach
• itching skin
• lack or loss of strength
• muscle cramps
• rash
• stomach discomfort or upset

• Swelling of the breasts or breast soreness in both females and males

For Healthcare Professionals

Applies to aliskiren / amlodipine: oral tablet

Cardiovascular

Aliskiren:
Rare (less than 0.1%): Hypotension

Amlodipine:
Common (1% to 10%): palpitations
Uncommon (0.1% to 1%): Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, tachycardia, vasculitis
Rare (less than 0.1%): Myocardial infarction, angina^[Ref]

Dermatologic

Aliskiren:
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)

Amlodipine:
Common (1% to 10%): Rash, erythematous rash
Uncommon (0.1% to 1%): Angioedema, erythema multiforme, increased sweating, maculopapular rash, pruritus
Rare (less than 0.1%): Alopecia, dermatitis, skin discoloration, skin dryness, urticaria, lichen planus, telangiectasia^[Ref]

Endocrine

Amlodipine:
Postmarketing reports: Gynecomastia^[Ref]

Gastrointestinal

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

Amlodipine:
Common (1% to 10%): Nausea, dysphagia, abdominal pain
Uncommon (0.1% to 1%): Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, vomiting
Rare (less than 0.1%): Gastritis, increased appetite, loose stools, taste perversion, dysgeusia^[Ref]

Genitourinary

Amlodipine:
Uncommon (0.1% to 1%): Micturition disorder, micturition frequency, nocturia
Rare (less than 0.1%): Dysuria, polyuria^[Ref]

Hematologic

Amlodipine:
Uncommon (0.1% to 1%): Leukopenia, purpura, thrombocytopenia^[Ref]

Hypersensitivity

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

Amlodipine:
Uncommon (0.1% to 1%): Allergic reaction^[Ref]

Hepatic

Amlodipine:
Postmarketing reports: Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)-Some cases were severe enough to require hospitalization^[Ref]

Metabolic

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

Amlodipine:
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]

Musculoskeletal

Uncommon (0.1% to 1%): Asthenia, rigors

Amlodipine:
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]

Nervous system

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

Amlodipine:
Common (1% to 10%): Headache, dizziness, somnolence
Uncommon (0.1% to 1%): Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, tremor
Rare (less than 0.1%): Migraine^[Ref]

Ocular

Amlodipine:
Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain
Rare (less than 0.1%): Abnormal visual accommodation, xerophthalmia^[Ref]

Psychiatric

Amlodipine:
Rare (less than 0.1%): Abnormal dreams, anxiety, depersonalization, depression, insomnia, nervousness, agitation, amnesia, apathy^[Ref]

Renal

Amlodipine:
Rare (less than 0.1%): Interstitial nephritis^[Ref]

Respiratory

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

Amlodipine:
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]

Other

Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus^[Ref]

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

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