Pacerone is associated with life-threatening lung damage (pulmonary toxicity), blindness, and death. The risk of side effects increases when it is combined with the anti-cholesterol drug Zocor.



Pacerone is a brand-name of the generic drug amiodarone that is manufactured by Upsher-Smith Laboratories. It has been prescribed to millions of people to help treat irregular heart rhythm in the lower chambers of the heart (ventricles), also known as ventricular arrhythmias.

What is the problem?

Amiodarone may cause potentially deadly pulmonary toxicity, liver damage, blindness, and worsened irregular heart rhythm. Due to these risks, it should only be used by adults with life-threatening heart problems when other treatments have failed.

According to an FDA Safety Communication from 2005, the most serious risk is pulmonary toxicity, which may affect 17% of patients on 400-mg/day doses. Pulmonary toxicity is fatal in 10% of cases.

Worsening Heart Problems

  • Light-headedness
  • Fainting
  • Irregular heartbeat
  • Heart palpitations

Symptoms of Lung Damage

  • Fever
  • Shortness of breath
  • Wheezing
  • Irritating cough
  • Coughing up blood

Other Health Problems

  • Fatigue
  • Vision problems
  • Blindness
  • Numbness
  • Loss of muscle coordination in arms and legs

Toxic Epidermal Necrolysis (TEN)

Toxic Epidermal Necrolysis (TEN) is a rare but severe skin reaction that causes large portions of the epidermis (the uppermost layer of skin) to detach from the layers of skin below. It is most severe in the eyes, mouth, and vagina. The patient may require feeding with a gastric tube directly into the stomach. The eyes can be severely damaged, and the condition may cause blindness.

FDA Warning: Pacerone + Simvastatin

In December 2011, the FDA published a Safety Communication regarding the risk of muscle injury when Pacerone is combined with simvastatin. People taking both medications should limit the dose of simvastatin to 20-mg per day.

Pacerone + Simvastatin and Muscle Injuries

According to the FDA, combining Pacerone and simvastatin increases the risk of muscle injury. Symptoms include muscle pain, tenderness, and cramping. Left untreated, it can worsen and lead to rhabdomyolysis, a life-threatening disease that can cause kidney failure or even death.

Pacerone Side Effects

  • Lung damage
  • Chronic pulmonary fibrosis
  • Pulmonary toxicity
  • Vision loss
  • Blindness
  • Rhabdomyolysis
  • Liver damage
  • Worsening irregular heart rhythm
  • Skin reactions
  • Death


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