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Safety Information

Acorda Therapeutics®, Inc. is committed to the safe and effective use of Zanaflex Capsules® (tizanidine hydrochloride).

This section will provide important safety information for the product, information regarding your Zanaflex Capsules® prescription and explain some of the differences between the capsule and tablet formulations.

What Are Zanaflex Capsules®?

Zanaflex Capsules® are approved for the management of spasticity. Zanaflex Capsules® have a short-term effect in the body. Your doctor may tell you to take your medication just before you perform activities that are made more difficult by spasticity.

Important Safety Information

You should not take Zanaflex Capsules® if you are currently taking fluvoxamine (Luvox®), or ciprofloxacin (Cipro®). If you are taking clonidine (Catapres® and Catapres TTS®) or other blood pressure medications, tell your doctor before taking Zanaflex Capsules®. Please be aware that there is limited information about the long-term use of Zanaflex® (more than one year) or use by people who are taking more than 8 mg in a single dose or more than 24 mg per day.


Zanaflex Capsules® may cause side effects in some people, including the following:

  • Use with fluvoxamine or ciprofloxacin is contraindicated and results in significant increases in tizanidine plasma levels.
  • Sudden drop in blood pressure: Some people in clinical studies experienced this effect, known as hypotension.
  • Possible liver damage: Changes in liver function tests have been found in some patients which could be the result of liver damage. In most cases, these changes resolved when the drug was stopped. In very rare cases, liver damage was permanent.
  • Sleepiness: You should not drive or operate heavy machinery while taking this drug. Sleepiness could be made worse if you take this medication with alcohol or certain other drugs.
  • Hallucinations: In two studies, a small percentage of people had hallucinations (saw things that did not really exist).
  • The most common side effects reported in clinical studies were dry mouth, sleepiness, weakness, tiredness and dizziness.
  • Talk to your doctor if you have kidney or liver damage and if you are pregnant or plan to become pregnant. Also talk to your doctor about any medicines you are currently taking, including birth control pills.
  • Since this medication can decrease your spasticity, please be careful when using Zanaflex Capsules® if your spasticity helps you with posture or balance.
  • Your experience with Zanaflex Capsules® may change depending on whether you take this medication with food or without food, including potential changes in efficacy and side effects. Follow your doctor’s instructions on how to take your medication.
  • Suddenly stopping treatment can cause certain medical problems; therefore, you should always talk to your doctor before deciding to stop Zanaflex Capsules® treatment.

For more information, ask your doctor or pharmacist or contact Acorda Medical, Inc. Information at 1-800-367-5109.


Please see below for Important Safety Information.
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Be sure you received what your doctor ordered.


Zanaflex Capsules® (tizanidine hydrochloride) is a short-acting drug indicated for the management of spasticity. Because of the short duration of effect, treatment with Zanaflex Capsules® (tizanidine hydrochloride) should be reserved for those daily activities and times when relief of spasticity is most important.

Important Safety Information:

  • Use with fluvoxamine or ciprofloxacin is contraindicated and results in significant increases in tizanidine plasma levels.
  • There is a limited data base for chronic use of single doses above 8 mg and multiple doses above 24 mg per day.
  • Tizanidine is an alpha2-adrenergic agonist and can produce hypotension. In a single-dose study where patients were not titrated, two-thirds of patients given 8 mg of Zanaflex experienced hypotension, which may be minimized by titration of dose. The hypotensive effect is dose related and has been measured following single doses of 2 mg or more.
  • Tizanidine occasionally causes liver injury, most often of the hepatocellular type.
  • Patients should be advised that sedation may interfere with daily activities. These effects appear to be dose related.
  • Visual hallucinations or delusions occurred in 3% (5/170) of study patients in two North American clinical trials.
  • Use with caution in hepatic or renally impaired patients.
  • Use with oral contraceptives results in 50% decrease in tizanidine clearance.
  • To discontinue therapy, taper the dose in patients receiving high doses over long time periods to reduce the risk of hypertension, tachycardia and hypertonia.
  • In vitro studies indicate that neither tizanidine nor the major metabolites are likely to affect the metabolism of other drugs metabolized by cytochrome P450 isoenzymes.
  • Most common adverse events with tizanidine include dry mouth (49%), somnolence (48%), asthenia [weakness, fatigue and/or tiredness] (41%), dizziness (16%) and increased ALT (5%). Other adverse events include UTI, infection and constipation.
  • Food has complex effects on tizanidine pharmacokinetics, which differ for the different formulations. These pharmacokinetic differences may result in clinically significant differences when switching formulations, or changing administration during a fed or fasted state. These changes may result in increased adverse events or a delayed/more rapid onset of activity, depending on the nature of the switch.
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