Does amiodarone cause hypotension?

From the Guidelines

Yes, amiodarone can cause hypotension.

Amiodarone-Induced Hypotension

• The medication is known to cause hypotension, particularly when administered intravenously, due to its vasodilatory effects and the presence of vasoactive solvents like polysorbate 80 in some formulations 1.
• The risk of hypotension is dose-dependent, with higher doses increasing the likelihood of this adverse effect 1.
• Hypotension is listed as a potential adverse effect of amiodarone in various guidelines and studies, including the American Family Physician guidelines for amiodarone use and monitoring 1 and the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation 1.
• The incidence of hypotension with amiodarone is relatively common, especially in the acute setting, and may require close monitoring and adjustment of the dose or administration rate 1.
• It is essential to be aware of the potential for hypotension when using amiodarone, especially in patients with pre-existing hypotension or those who are hemodynamically unstable 1.

From the FDA Drug Label

WARNINGS Hypotension Hypotension is the most common adverse effect seen with Amiodarone HCl injection. In clinical trials, treatment-emergent, drug-related hypotension was reported as an adverse effect in 288 (16%) of 1836 patients treated with amiodarone HCl injection Effects of an inadvertent overdose of amiodarone HCl injection include hypotension, cardiogenic shock, bradycardia, AV block, and hepatotoxicity. Hypotension and cardiogenic shock should be treated by slowing the infusion rate or with standard therapy: vasopressor drugs, positive inotropic agents, and volume expansion.

Yes, amiodarone can cause hypotension, as evidenced by the high incidence of treatment-emergent, drug-related hypotension in clinical trials 2 and the presence of hypotension as an effect of overdose 2.

From the Research

Amiodarone and Hypotension

• Amiodarone can cause hypotension, which is the most frequent adverse event reported with intravenous amiodarone 3, 4, 5.
• The hypotension has been attributed to the vasoactive solvents of the standard formulation, polysorbate 80 and benzyl alcohol, both known to exhibit negative inotropy and hypotensive effect 4.
• A new aqueous formulation of intravenous amiodarone (Amio-Aqueous) does not contain vasoactive excipients and may be less toxic and cause less hypotension than the standard formulation 3, 4, 6.
• Studies have shown that Amio-Aqueous is at least as safe as lidocaine in terms of causing hypotension when administered rapidly 3.
• In some studies, no patient developed hypotension after administration of Amio-Aqueous 6.
• However, other studies have shown that intravenous amiodarone can cause a significant, but transient decrease in arterial pressure in the first 15 minutes after administration 5.
• A cyclodextrin-based formulation of intravenous amiodarone (PM101) has also been shown to be devoid of hypotension in healthy human subjects 7.

Factors Influencing Hypotension

• The rate of infusion is a significant factor in the development of hypotension, with rapid administration increasing the risk of hypotension 3, 5.
• The dose of amiodarone may also play a role in the development of hypotension, although the relationship is not entirely clear 4, 5.
• The presence of underlying cardiac disease may also influence the risk of hypotension with amiodarone administration 7.

Comparison with Other Formulations

• Amio-Aqueous has been compared to the standard formulation of intravenous amiodarone (Cordarone IV) and has been shown to be safer in terms of causing hypotension 3, 4, 6.
• PM101 has been compared to the standard loading dose of intravenous amiodarone and has been shown to be noninferior in terms of causing hypotension 7.