Simvastatin Side Effects (Zocor®)


Simvastatin Side Effects & History of Statins

Simvastatin, like almost any other beneficial medicine, may cause side effects for some patients. Before we go into simvastatin side effects, let’s bring in a little history about statins.
When statins first came on the market, manufacturers included a notice about muscle cramps, aches, pain, and weakness. In the late 1980s, it was clear that statins may trigger rhabdontyolysis, an excessive breakdown of muscle tissue creating a flood of waste cells that tumble through the bloodstream and into the kidneys where they may clog small passages and — theoretically — cause kidney failure.

In 2001, in clinical trials of more than 50,000 patients, researchers hadn’t linked a single death to statin-triggered kidney failure. However, cerivastatin (Baycol). a new statin introduced by Bayer A.G. in 1997. was different. The incidence of rhabdomyoly-sis among Baycol users was about ten times higher than among people taking other statin drugs, and the reaction was more likely to be really serious — read: fatal. By August 7, 2001 at least 31 deaths had been linked to Baycol in the United States, and the FDA had reports of more deaths out of the US. Shouldn’t come as a surprise to anyone that Bayer took Baycol off the market. The estimated number of cases of rhabdomyolysis caused by Baycol eventually rose into the thousands.

Today, the package inserts for all statin drugs include a warning about muscle pain & other possible side effects, which commonly include at least temporarily abnormal results on tests for liver enzymes, allergic rash, fatigue, headache and dizziness, low blood pressure, upset stomach (nausea, gas, diarrhea, or constipation).

The following list details the currently recognized simvastatin side effects:

SimvastatinContact your doctor if you experience

  • severe constipation
  • stomach pain
  • headache
  • nausea

or if you are experiencing any of these symptoms & they won’t go away.

Some side effects may be serious.

Call your doctor immediately if you experience:

  • muscle pain, tenderness, weakness
  • dark red urine
  • fever or chills
  • difficulty breathing or swallowing
  • swelling of the face, lips, tongue, throat, eyes, feet, hands, lower legs or ankles
  • tiredness, lack of energy or weakness
  • itching
  • joint pain
  • rash
  • flushing
  • hoarseness
  • blisters
  • sensitivity to light
  • hives

If you experience muscle pain, tenderness, weakness, dark red urine, lack of energy, tiredness, or weakness don’t take more simvastatin without consulting with your doctor:

Simvastatin can cause other not mentioned side effects. Contact your doctor if you encounter any uncommon or strange problems while you’re taking it.

If you’d like to report serious simvastatin side effects, you or your doctor can send a report to the FDA MedWatch Adverse Event Reporting program at http://www.fda.gov/Safety/MedWatch or call 1 (800) 332-1088