May 22 2022

Adverse reactions to Aliskiren

  • 1. Abdominal pain
  • Unknow frequency or casuality not established.

  • 2. Anemia
  • Was observed in clinical trials a discrete decrease in hemoglobin (-0.8 g / L) and hematocrit (16%) in patients only treated with Aliskiren..

  • 3. Angioedema
  • There have been observations of edema of larynx and glottis causing airway obstruction or lips, tongue and face in patients treated with aliskiren, but has not been possible to establish a relationship causal. Is a medical emergency that must be addressed properly and promptly, as the result can be fatal..

  • 4. Arterial hypotension
  • Infrequently, you may see hypotension, especially in patients with water or sodium depletion, as in those treated with high doses of diuretics..

  • 5. Arthralgia
  • Unknow frequency or casuality not established.

  • 6. Asthenia
  • Frequent.

  • 7. Backache
  • Frequent.

  • 8. Blood creatinine increased
  • When administered alone, the rise in creatinine occurs in 1% of patients, being of small value (~ 1μmol / L).

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  • 9. Bronchitis
  • Frequent.

  • 10. Constipation
  • Frequent.

  • 11. Cough
  • Frequent.

  • 12. Decreased renal function
  • Infrequent.

  • 13. Diarrhea
  • Frequent.

  • 14. Dizziness
  • Frequent.

  • 15. Dyspepsia
  • Unknow frequency or casuality not established.

  • 16. Epistaxis
  • Unknow frequency or casuality not established.

  • 17. Feeling flu
  • Frequent.

  • 18. Headache
  • Frequent.

  • 19. Hyperkalemia
  • When administered alone, the rise of K is modest and infrequent. When given together with an ACEI in diabetics, the frequency is increased considerably..

  • 20. Hypersensitivity reactions
  • It is rare adverse effects, although usually-serious..

  • 21. Hyperuricemia
  • The aliskiren monotherapy produces a modest increase of uric acid, approximately about 6 micromol / L, five times less than hydrochlorothiazide. This increase in uric acid increases the risk of some adverse events such as gout and kidney stones, whose incidence would rise in both cases to 0.2% compared to the value in untreated patients (0-0.1%)..

  • 22. Increased CK
  • In controlled clinical trials in the short term, CK elevations were more than 300% in 1% of patients, twice that of those treated with placebo. It is considered that this effect is dose dependent and more common in males.

  • 23. Insomnia
  • Unknow frequency or casuality not established.

  • 24. Limb pain
  • Unknow frequency or casuality not established.

  • 25. Muscle spasms
  • Unknow frequency or casuality not established.

  • 26. Myositis
  • Unknow frequency or casuality not established.

  • 27. Nasopharyngitis
  • Frequent.

  • 28. Neck pain
  • Unknow frequency or casuality not established.

  • 29. Peripheral edema
  • Frequency estimate: 0.31/1000 patients/year.

  • 30. QT prolongation
  • It was published a case of possible adverse effects of aliskiren, although causality has not been established firmly... Peitz GJ et al; South Med J 102 (4): 411-2 (2009)

  • 31. Renal failure
  • Both acute renal failure, and combined with underlying chronic failure rarely or very rarely happen.

    He has published a case of acute renal failure with hyperkalemia in a 76-year-old received irbesartan and spironolactone.
    . Venzin RM et al; Clin Nephrol 71 (3): 326-8 (2009).

  • 32. Rhabdomyolysis
  • Unknow frequency or casuality not established.

  • 33. Rhinitis
  • Frequent.

  • 34. Severe skin reactions
  • There have been rare cases of Stevens Johnson syndrome and toxic epidermal necrolysis..

  • 35. Shoulder pain
  • Unknow frequency or casuality not established.

  • 36. Sickness
  • Unknow frequency or casuality not established.

  • 37. Skin rash
  • Frequent.

  • 38. Sore throat
  • Unknow frequency or casuality not established.

  • 39. Urinary infection
  • Unknow frequency or casuality not established.

  • 40. Vertigo
  • Unknow frequency or casuality not established.