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tizanidine

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Brand names: Zanaflex

Central Alpha-2 Agonist (Muscle Relaxant) Rx

Tizanidine is a muscle relaxant. It is used to treat spasticity, which is when your muscles are tight or stiff.

Drug Pricing (NADAC)

Generic Price

$0.08/unit

Generic Available

Yes (14 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Tizanidine is used to treat spasticity in adults.

Common side effects

Dry mouth, Sleepiness, Weakness

Key warnings

Tizanidine can cause low blood pressure, liver problems, and hallucinations.

How It Works

Tizanidine works by affecting certain chemicals in your brain. It is an alpha-2 adrenergic agonist. This action helps to reduce muscle spasms and tightness.

How to Take It

Take tizanidine every 6 to 8 hours as needed. Do not take more than 3 doses in 24 hours. You can take it with or without food, but be consistent. Your doctor may increase your dose every 1 to 4 days by 2 to 4 mg.

Pregnancy & Breastfeeding

Tizanidine may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if tizanidine passes into breast milk, so talk to your doctor if you are breastfeeding.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store tizanidine at room temperature, away from light and moisture.

Side Effects (from patient reports)

Based on 13,125 FDA adverse event reports.

Tiredness
1,693
Aches
1,615
Medicine not working
1,572
Feeling sick to your stomach
1,530
Falling down
1,318
Head pain
1,289
Long-term kidney problems
1,110
Loose stool
1,067
Feeling unsteady
986
Using medicine for unapproved purpose
945

FDA Adverse Event Report Analysis

Detailed analysis of 22,750 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

22,750

Death-Related Reports

1,739

Hospitalization Reports

6,474

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 15,795 (75%)
Male 5,288 (25%)

Age Distribution

0–17 215
18–44 3,121
45–64 7,737
65–74 2,732
75+ 1,135

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 1,693
2 PAIN 1,614
3 DRUG INEFFECTIVE 1,572
4 NAUSEA 1,529
5 FALL 1,318
6 HEADACHE 1,289
7 CHRONIC KIDNEY DISEASE 1,110
8 DIARRHOEA 1,066
9 DIZZINESS 986
10 OFF LABEL USE 945
11 ARTHRALGIA 814
12 ACUTE KIDNEY INJURY 808
13 VOMITING 792
14 ASTHENIA 778
15 ANXIETY 773

Reactions in Death Reports

DEATH 499
COMPLETED SUICIDE 485
TOXICITY TO VARIOUS AGENTS 274
CARDIO-RESPIRATORY ARREST 129
CARDIAC ARREST 108
SUSPECTED SUICIDE 106
ACUTE KIDNEY INJURY 100
CHRONIC KIDNEY DISEASE 98
RENAL FAILURE 76
RESPIRATORY ARREST 72

Reactions in Hospitalization Reports

FALL 598
PAIN 484
NAUSEA 480
PNEUMONIA 452
URINARY TRACT INFECTION 428
FATIGUE 424
DYSPNOEA 348
ACUTE KIDNEY INJURY 338
HEADACHE 337
VOMITING 337

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Tizanidine can cause low blood pressure, liver problems, and hallucinations. It can also make you very sleepy, especially if you drink alcohol or take other medicines that cause sleepiness. Your doctor should check your liver function before you start taking tizanidine and one month after you reach your highest dose. Do not stop taking tizanidine suddenly, as this can cause withdrawal symptoms.

Known Drug Interactions

( 7.2 , 12.3 ) 7.1 Strong CYP1A2 Inhibitors Concomitant use of tizanidine with strong cytochrome P450 1A2 (CYP1A2) inhibitors (e.g., fluvoxamine, ciprofloxacin) is contraindicated.

Mechanism: Ciprofloxacin stops the body from breaking down tizanidine. This can cause tizanidine to build up to dangerous levels in your system.

What to do: Do not take these two medicines together. Ask your doctor for a different antibiotic or muscle relaxer.

( 7.2 , 12.3 ) 7.1 Strong CYP1A2 Inhibitors Concomitant use of tizanidine with strong cytochrome P450 1A2 (CYP1A2) inhibitors (e.g., fluvoxamine, ciprofloxacin) is contraindicated.

Mechanism: Fluvoxamine blocks the enzyme that normally clears tizanidine from your body. This leads to much higher amounts of tizanidine in your blood than intended.

What to do: This combination should not be used. Your doctor will need to change one of your medications to a safer option.

moderate famotidine

( 7.1 ) • Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. 7.2 Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate. Refer to the full prescribing information for tizanidine.

Mechanism: Famotidine can slow down the body's ability to clear tizanidine, which may lead to dangerously high levels of the drug in your blood.

What to do: Avoid taking these two drugs together if possible to prevent side effects like very low blood pressure or extreme drowsiness.

7.2 Moderate or Weak CYP1A2 Inhibitors Concomitant use of tizanidine with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided.

Mechanism: Acyclovir blocks a specific liver enzyme that breaks down tizanidine. This causes the muscle relaxant to stay in your body at much higher levels, which can be dangerous.

What to do: You should avoid taking these two medications together to prevent serious side effects.

7.2 Moderate or Weak CYP1A2 Inhibitors Concomitant use of tizanidine with moderate or weak CYP1A2 inhibitors (e.g., zileuton, antiarrhythmics [amiodarone, mexiletine, propafenone, and verapamil], cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine) should be avoided.

Mechanism: Verapamil slows down the liver process that clears tizanidine from your body, which can lead to higher drug levels.

What to do: You should avoid taking these two medications at the same time.

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Common Questions

Can I drink alcohol while taking tizanidine?
No, alcohol can increase the sleepiness caused by tizanidine.
What should I do if I feel dizzy after taking tizanidine?
Lie down until the dizziness passes. Be careful when standing up.
Can I drive while taking tizanidine?
Tizanidine can cause sleepiness, so be careful driving or operating machinery until you know how it affects you.
Will tizanidine cure my spasticity?
Tizanidine helps to manage spasticity symptoms, but it is not a cure.
How long does it take for tizanidine to start working?
Tizanidine starts working quickly, but the effects last only a short time.
Can I take tizanidine with other medicines?
Talk to your doctor about all the medicines you take, especially those that lower blood pressure or cause sleepiness.
What happens if I take too much tizanidine?
Seek medical attention immediately. Overdoses can cause serious side effects.
How will I know if tizanidine is working?
You should notice a decrease in muscle stiffness and spasms.
Can I switch between the tablet and capsule forms of tizanidine?
The tablet and capsule forms are absorbed differently. Talk to your doctor before switching.
What tests will my doctor do while I'm taking tizanidine?
Your doctor will check your liver function with blood tests.
What are the common side effects of tizanidine?
The most commonly reported side effects of tizanidine include Dry mouth, Sleepiness, Weakness, Dizziness. Based on 13,125 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does tizanidine interact with other medications?
Yes, tizanidine has 17 known drug interactions. Notable interactions include ciprofloxacin, fluvoxamine, famotidine. Always inform your doctor about all medications you are taking.
What drug class is tizanidine?
tizanidine belongs to the Central Alpha-2 Agonist (Muscle Relaxant) drug class. It requires a prescription (Rx). Tizanidine is used to treat spasticity in adults.
Is tizanidine safe during pregnancy?
Tizanidine may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has tizanidine been recalled?
There is 1 recall associated with tizanidine products. Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. Check the recalls section below for full details and affected products.

Active Recalls

Class II June 21, 2023

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Dr Reddy's Laboratories Limited

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What the FDA Data Shows for tizanidine

The FDA label for tizanidine (sold under brand names such as Zanaflex) classifies it as a prescription-only medication in the Central Alpha-2 Agonist (Muscle Relaxant) class. Tizanidine is used to treat spasticity in adults. Official labeling lists 4 commonly reported side effects, including Dry mouth, Sleepiness, Weakness.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 13,125 voluntary reports. The database also lists 17 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.08.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: March 11, 2025

All federal data sources used on this page