Adverse effects of valsartan
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Common Adverse Effects of Valsartan and Sacubitril/Valsartan
Valsartan, an angiotensin II receptor blocker (ARB), and its combination with sacubitril (sacubitril/valsartan) are widely used for hypertension and heart failure. The most frequently reported adverse effects of valsartan alone include malaise or lassitude, dizziness, and headache or migraine. These effects are generally mild, with malaise/lassitude and dizziness being the most common reasons for discontinuation. Other possible side effects are impotence, cough, facial edema, hyperkalemia, and rare cases of angioedema. Importantly, no unexpected serious adverse events have been identified in large patient cohorts, and valsartan is associated with a lower risk of dry cough compared to ACE inhibitors 14.
For sacubitril/valsartan, hypotension is the most commonly reported adverse event, followed by dizziness, cough, peripheral swelling, increased blood potassium, and renal impairment. These side effects are consistent across randomized controlled trials and real-world data. Compared to ACE inhibitors or ARBs alone, sacubitril/valsartan tends to have a similar or lower risk of most adverse events, except for a higher risk of hypotension 2358+1 MORE.
Serious and Less Common Adverse Effects
Angioedema and Hyperkalemia
Angioedema is a known but rare risk with both valsartan and sacubitril/valsartan. The rate of angioedema with sacubitril/valsartan is low and similar to that seen with other heart failure medications. Hyperkalemia and worsening renal function are also possible but occur at rates comparable to other ARBs and are generally manageable 1589+1 MORE.
Ototoxicity and Neurological Effects
Recent pharmacovigilance studies have identified ototoxicity (hearing-related side effects such as dizziness, hypoacusis, balance disorder, and deafness) as a potential but underreported risk with sacubitril/valsartan. Most ototoxic events occur within the first three months of treatment, and while hospitalization is sometimes required, life-threatening outcomes are rare 36.
Sudden Cardiac Death and Other Rare Events
There is some evidence of increased reporting of sudden cardiac death, particularly early after starting sacubitril/valsartan, especially in patients taking other medications with pro-arrhythmic potential. This highlights the need for careful monitoring, especially when combining sacubitril/valsartan with other drugs that affect heart rhythm .
Risk Factors and Patient Populations
Patients with lower baseline blood pressure, worse heart failure symptoms, or impaired kidney function are at higher risk for adverse events such as hypotension, renal dysfunction, and hyperkalemia. These patients may require closer monitoring and may be more likely to discontinue treatment due to side effects .
Comparison with Other Medications
Compared to ACE inhibitors and other ARBs, valsartan and sacubitril/valsartan generally have a favorable safety profile. Sacubitril/valsartan is associated with fewer side effects overall, except for a higher risk of hypotension. The risk of cough is lower with valsartan than with ACE inhibitors, making it a good alternative for patients who experience persistent cough with ACE inhibitors 24510.
Conclusion
Valsartan and sacubitril/valsartan are generally well-tolerated, with the most common adverse effects being mild and manageable. Hypotension, dizziness, and renal effects are the most notable risks, especially in vulnerable patient groups. Rare but serious events such as angioedema, ototoxicity, and sudden cardiac death require awareness and monitoring. Overall, these medications offer a favorable balance of benefits and risks for most patients with hypertension or heart failure 1234+6 MORE.
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