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Tizanidine Side Effects

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Common Tizanidine Side Effects


The most commonly reported Tizanidine side effects (click to view or check a box to report):

Completed Suicide (32)
Hypotension (29)
Dizziness (29)
Blood Pressure Decreased (21)
Nausea (19)
Headache (19)
Cardiac Arrest (16)
Loss Of Consciousness (15)
Respiratory Arrest (13)
Somnolence (13)
Bradycardia (13)
Asthenia (13)
Pain (12)
Aspartate Aminotransferase Increased (12)
Alanine Aminotransferase Increased (11)
Muscle Spasms (10)
Insomnia (10)
Fatigue (9)
Pyrexia (9)
Rash (9)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Tizanidine Side Effects Reported to FDA



Tizanidine Side Effect Report#9928279
Drowning, Hallucination
This is a report of a 61-year-old male patient (weight: NA) from SA, suffering from the following health symptoms/conditions: NA, who was treated with Tizanidine (dosage: Unk Ukn, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Drowning, Hallucination after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tizanidine treatment in male patients, resulting in Drowning side effect.
Tizanidine Side Effect Report#9858588
Cardio-respiratory Arrest
This report suggests a potential Tizanidine Hydrochloride Cardio-respiratory Arrest side effect(s) that can have serious consequences. A 33-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tizanidine Hydrochloride (dosage: ; Po) starting NS. After starting Tizanidine Hydrochloride the patient began experiencing various side effects, including: Cardio-respiratory ArrestAdditional drugs used concurrently:
  • Acetaminophen (; Po)
  • Benzodiazepine (; Po)
Although Tizanidine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardio-respiratory Arrest, may still occur.
Tizanidine Side Effect Report#9835034
Fatigue
This Fatigue problem was reported by a pharmacist from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain,fibromyalgia. On
May 22, 2013 this consumer started treatment with Tizanidine (dosage: 2 Mg, 1 Tab Qd). The following drugs were being taken at the same time: NA. When using Tizanidine, the patient experienced the following unwanted symptoms/side effects: FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fatigue, may become evident only after a product is in use by the general population.
Tizanidine Side Effect Report#9825302
Vomiting, Depressed Level Of Consciousness, Hyperkalaemia, Syncope, Bradycardia, Hypotension
This Vomiting side effect was reported by a pharmacist from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: musculoskeletal stiffness.The patient was prescribed Tizanidine (drug dosage: 4 Mg Prn/as Needed Oral?1 Dose), which was initiated on NS. Concurrently used drugs:
  • Aspirin
  • Calcium
  • Diltiazem La
  • Ezetimibe
  • Metformin
  • Niacin/lovastatin
  • Olmesartan/hctz
  • Meloxicam
.After starting to take Tizanidine the consumer reported adverse symptoms, such as: Vomiting, Depressed Level Of Consciousness, Hyperkalaemia, Syncope, Bradycardia, HypotensionThese side effects may potentially be related to Tizanidine. The patient was hospitalized.
Tizanidine Side Effect Report#9802324
Dysstasia, Syncope, Hypotension, Orthostatic Hypotension, Convulsion
This is a report of a 18-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Tizanidine (dosage: NA, start time: NS), combined with:
  • Fluvoxamine Maleate
  • Midodrine Hcl
  • Fludrocortisone
  • Desvenlafaxine
  • Clonazepam
  • Topiramate
  • Drospirenone W/ethinylestradiol
  • Zolpidem
and developed a serious reaction and side effect(s): Dysstasia, Syncope, Hypotension, Orthostatic Hypotension, Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tizanidine treatment in female patients, resulting in Dysstasia side effect.
Tizanidine Side Effect Report#9783515
Orthostatic Hypotension, Syncope, Dizziness
This report suggests a potential Tizanidine Orthostatic Hypotension side effect(s) that can have serious consequences. A 18-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tizanidine (dosage: NA) starting NS. After starting Tizanidine the patient began experiencing various side effects, including: Orthostatic Hypotension, Syncope, DizzinessAdditional drugs used concurrently:
  • Fluvoxamine
  • Fludrocortisone (fludrocortisone) (fludrocortisone)
  • Desvenlafaxine (desvenafaxine) (desvenlafaxine)
  • Clonazepam (clonazepam) (clonazepam)
  • Zolpidem (zolpidem) (zolpidem)
  • Oxycodone (oxycodone) (oxycodone)
  • Topiramate (topiramate) (topiramate)
  • Midodrine (midodrine) (midodrine)
Although Tizanidine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Orthostatic Hypotension, may still occur.
Tizanidine Side Effect Report#9773658
Dizziness Postural, Convulsion, Orthostatic Hypotension, Syncope
This Dizziness Postural problem was reported by a health professional from US. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Tizanidine (dosage: Unk,unk). The following drugs were being taken at the same time:
  • Fluvoxamine Maleate (Unk,unk)
  • Midodrine Hcl (Unk,unk)
  • Fludrocortisone (Unk,unk)
  • Desvenlafaxine (Unk,unk)
  • Clonazepam (Unk,unk)
  • Topiramate (Unk,unk)
  • Drospirenone W/ethinylestradiol (Unk,unk)
  • Zolpidem (Unk,unk)
When using Tizanidine, the patient experienced the following unwanted symptoms/side effects: Dizziness Postural, Convulsion, Orthostatic Hypotension, SyncopeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness Postural, may become evident only after a product is in use by the general population.
Tizanidine Side Effect Report#9746413
Suicidal Ideation
This Suicidal Ideation side effect was reported by a health professional from US. A 30-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tizanidine (drug dosage: 4 Mg, Unk), which was initiated on NS. Concurrently used drugs:
  • Butrans (Unk)
  • Keppra (500 Mg, Unk)
  • Zoloft (100 Mg, Unk)
  • Percocet (10/325, Unk)
  • Valium (5 Mg, Unk)
.After starting to take Tizanidine the consumer reported adverse symptoms, such as: Suicidal IdeationThese side effects may potentially be related to Tizanidine.
Tizanidine Side Effect Report#9728055
Influenza, Blood Pressure Decreased, Myalgia, Blood Pressure Increased, Spinal Pain, Eye Pain, Toothache, Headache, Sinus Headache
This is a report of a 65-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: headache,muscle spasms, who was treated with Tizanidine Hcl (dosage: NA, start time:
Oct 16, 2013), combined with: NA. and developed a serious reaction and side effect(s): Influenza, Blood Pressure Decreased, Myalgia, Blood Pressure Increased, Spinal Pain, Eye Pain, Toothache, Headache, Sinus Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tizanidine Hcl treatment in female patients, resulting in Influenza side effect.
Tizanidine Side Effect Report#9718769
Haemochromatosis, Skin Hyperpigmentation, Nocturia, Contusion, Dysuria, Hypoaesthesia, Headache, Decreased Appetite, Nausea
This report suggests a potential Tizanidine Haemochromatosis side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tizanidine (dosage: Unk,unk) starting NS. After starting Tizanidine the patient began experiencing various side effects, including: Haemochromatosis, Skin Hyperpigmentation, Nocturia, Contusion, Dysuria, Hypoaesthesia, Headache, Decreased Appetite, NauseaAdditional drugs used concurrently:
  • Red Blood Cells (Unk,unk)
  • Ferrous Sulfate (65 Mg, Bid)
  • Hydroxychloroquine (200 Mg, Bid)
  • Aspirin (Unk,unk)
  • Multivitamins (Unk,unk)
  • Folic Acid (Unk,unk)
  • Vitamin A (Unk,unk)
  • Biotin (Unk,unk)
Although Tizanidine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemochromatosis, may still occur.
Tizanidine Side Effect Report#9663765
Product Substitution Issue
This Product Substitution Issue problem was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: nerve injury. On
Sep 06, 2013 this consumer started treatment with Tizanidine Hydrochloride (dosage: 2x A Day, 3 At Bedtime). The following drugs were being taken at the same time: NA. When using Tizanidine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Product Substitution Issue, may become evident only after a product is in use by the general population.
Tizanidine Side Effect Report#9633219
Rash, Blister
This Rash side effect was reported by a health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Tizanidine (drug dosage: 1 Po), which was initiated on NS. Concurrently used drugs: NA..After starting to take Tizanidine the consumer reported adverse symptoms, such as: Rash, BlisterThese side effects may potentially be related to Tizanidine.
Tizanidine Side Effect Report#9631461
Asthenia, Movement Disorder, Speech Disorder, Paralysis
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: fibromyalgia, who was treated with Tizanidine (dosage: 1-4 Tablets, At Bedtime, Po, start time:
Jan 26, 2013), combined with: NA. and developed a serious reaction and side effect(s): Asthenia, Movement Disorder, Speech Disorder, Paralysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tizanidine treatment in female patients, resulting in Asthenia side effect.
Tizanidine Side Effect Report#9621740
Completed Suicide
This report suggests a potential Tizanidine Hydrochloride Tablets Completed Suicide side effect(s) that can have serious consequences. A 29-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tizanidine Hydrochloride Tablets (dosage: NA) starting NS. After starting Tizanidine Hydrochloride Tablets the patient began experiencing various side effects, including: Completed SuicideAdditional drugs used concurrently:
  • Promethazine
Although Tizanidine Hydrochloride Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Completed Suicide, may still occur.
Tizanidine Side Effect Report#9604591
Hallucinations, Mixed
This Hallucinations, Mixed problem was reported by a health professional from ES. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: muscle spasticity,urinary tract infection,factor v deficiency,deep vein thrombosis,pulmonary embolism,hypothyroidism,hypertension,osteoporosis. On 2009 this consumer started treatment with Tizanidine (dosage: 4 Mg, Tid). The following drugs were being taken at the same time:
  • Ciprofloxacin (500 Mg, Bid)
  • Acenocumarol (Unk)
  • Acenocumarol
  • Acenocumarol
  • Levothyroxine (50-75 Ug/day)
  • Enalapril (20 Mg/day)
  • Alendronate (70 Mg, 1/week)
  • Calcium Carbonate (2.5 G/day)
When using Tizanidine, the patient experienced the following unwanted symptoms/side effects: Hallucinations, MixedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hallucinations, Mixed, may become evident only after a product is in use by the general population.
Tizanidine Side Effect Report#9531871
Balance Disorder, Vertigo, Nausea, Muscular Weakness
This Balance Disorder side effect was reported by a health professional from US. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tizanidine (drug dosage: 1 Pill), which was initiated on
Sep 10, 2013. Concurrently used drugs:
  • Skelaxin
  • Prochlorperazine
  • Cenestin
  • Xanaax
.After starting to take Tizanidine the consumer reported adverse symptoms, such as: Balance Disorder, Vertigo, Nausea, Muscular WeaknessThese side effects may potentially be related to Tizanidine.
Tizanidine Side Effect Report#9531452
Hallucination
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Tizanidine (dosage: NA, start time:
Sep 08, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hallucination after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tizanidine treatment in female patients, resulting in Hallucination side effect.
Tizanidine Side Effect Report#9507544
Suicidal Ideation
This report suggests a potential Tizanidine (tizanidine) Suicidal Ideation side effect(s) that can have serious consequences. A 30-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tizanidine (tizanidine) (dosage: NA) starting NS. After starting Tizanidine (tizanidine) the patient began experiencing various side effects, including: Suicidal IdeationAdditional drugs used concurrently:
  • Butrans
  • Keppra (levetiracetam)
  • Zoloft (sertraline Hydrochloride)
  • Percocet (10/325, Unk)
  • Valium (diazepam)
Although Tizanidine (tizanidine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicidal Ideation, may still occur.
Tizanidine Side Effect Report#9486715
Thrombosis, Nephrolithiasis, Pulmonary Embolism
This Thrombosis problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: myalgia,fibromyalgia. On
Feb 16, 2013 this consumer started treatment with Tizanidine (dosage: 4 Mg 1/2 Tab(2 Mg) At Bedtime By Mouth). The following drugs were being taken at the same time: NA. When using Tizanidine, the patient experienced the following unwanted symptoms/side effects: Thrombosis, Nephrolithiasis, Pulmonary EmbolismThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombosis, may become evident only after a product is in use by the general population.
Tizanidine Side Effect Report#9467761
Pulmonary Embolism, Deep Vein Thrombosis, Arrhythmia, Nephrolithiasis, Urinary Retention, Vomiting, Activities Of Daily Living Impaired, Pain, Asthenia
This Pulmonary Embolism side effect was reported by a physician from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: fibromyalgia,off label use.The patient was prescribed Tizanidine Hydrochloride Tablets (drug dosage: NA), which was initiated on
Feb 14, 2013. Concurrently used drugs: NA..After starting to take Tizanidine Hydrochloride Tablets the consumer reported adverse symptoms, such as: Pulmonary Embolism, Deep Vein Thrombosis, Arrhythmia, Nephrolithiasis, Urinary Retention, Vomiting, Activities Of Daily Living Impaired, Pain, AstheniaThese side effects may potentially be related to Tizanidine Hydrochloride Tablets. The patient was hospitalized.
Tizanidine Side Effect Report#9444511
Allergic Hepatitis, Hepatic Necrosis, Hepatic Fibrosis, Hepatotoxicity
This is a report of a 64-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Tizanidine (dosage: NA, start time: NS), combined with:
  • Oxaprozin
  • Interferon Beta
  • Hydrochlorothiazide
  • Lisinopril (lisinopril)
  • Simvastatin (simvastatin)
  • Clonazepam (clonazepam)
  • Polyethylene Glycol (macrogol)
and developed a serious reaction and side effect(s): Allergic Hepatitis, Hepatic Necrosis, Hepatic Fibrosis, Hepatotoxicity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tizanidine treatment in female patients, resulting in Allergic Hepatitis side effect. The patient was hospitalized.
Tizanidine Side Effect Report#9409655
Dysstasia, Activities Of Daily Living Impaired, Somnolence
This report suggests a potential Tizanidine Dysstasia side effect(s) that can have serious consequences. A 45-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Tizanidine (dosage: 4 Mg, Unk) starting NS. After starting Tizanidine the patient began experiencing various side effects, including: Dysstasia, Activities Of Daily Living Impaired, SomnolenceAdditional drugs used concurrently:
  • Ambien (Unk)
  • Lortab (Unk, 3x/day)
  • Lyrica (50 Mg, 3x/day)
  • Lyrica
  • Celebrex (200 Mg, 2x/day)
Although Tizanidine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dysstasia, may still occur.
Tizanidine Side Effect Report#9388815
Hypokalaemia, Electrocardiogram Qt Prolonged, Sinus Tachycardia, Metabolic Acidosis, Unresponsive To Stimuli
This Hypokalaemia problem was reported by a health professional from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Tizanidine (dosage: NA). The following drugs were being taken at the same time: NA. When using Tizanidine, the patient experienced the following unwanted symptoms/side effects: Hypokalaemia, Electrocardiogram Qt Prolonged, Sinus Tachycardia, Metabolic Acidosis, Unresponsive To StimuliThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypokalaemia, may become evident only after a product is in use by the general population.
Tizanidine Side Effect Report#9380410
Renal Tubular Disorder, Metabolic Acidosis, Unresponsive To Stimuli, Mental Impairment, Sinus Tachycardia, Electrocardiogram Qt Prolonged, Hypokalaemia, Blood Sodium Increased
This Renal Tubular Disorder side effect was reported by a health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tizanidine (tizanidine) (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Tizanidine (tizanidine) the consumer reported adverse symptoms, such as: Renal Tubular Disorder, Metabolic Acidosis, Unresponsive To Stimuli, Mental Impairment, Sinus Tachycardia, Electrocardiogram Qt Prolonged, Hypokalaemia, Blood Sodium IncreasedThese side effects may potentially be related to Tizanidine (tizanidine). The patient was hospitalized.
Tizanidine Side Effect Report#9372099
Unresponsive To Stimuli, Hypokalaemia, Mental Impairment, Urine Potassium Increased
This is a report of a 47-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Tizanidine Hydrochlroide (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Unresponsive To Stimuli, Hypokalaemia, Mental Impairment, Urine Potassium Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tizanidine Hydrochlroide treatment in female patients, resulting in Unresponsive To Stimuli side effect. The patient was hospitalized.


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The appearance of Tizanidine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Tizanidine Side Effects for Women?

Women Side EffectsReports
Dizziness 24
Completed Suicide 18
Nausea 18
Hypotension 15
Blood Pressure Decreased 14
Headache 12
Loss Of Consciousness 11
Insomnia 10
Somnolence 10
Asthenia 9

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Tizanidine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Tizanidine Side Effects

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    How Effective is Tizanidine for You?

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    Tizanidine Safety Alerts, Active Ingredients, Usage Information

    NDC0185-0034
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary Nametizanidine hydrochloride
    Nametizanidine hydrochloride
    Dosage FormTABLET
    RouteORAL
    On market since20021126
    LabelerEon Labs, Inc.
    Active Ingredient(s)TIZANIDINE HYDROCHLORIDE
    Strength(s)2
    Unit(s)mg/1
    Pharma ClassAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]

    More About Tizanidine

    Side Effects reported to FDA: 353

    Tizanidine safety alerts: 2007

    Reported deaths: 23

    Reported hospitalizations: 83

    Zanaflex (tizanidine hydrochloride) Tablets and Capsules

    Audience: Healthcare professionals

    [Posted 04/11/2007] Acorda Therapeutics and FDA informed healthcare professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the product labeling for Zanaflex, a drug used to treat spasticity. In pharmacokinetic studies where tizanidine was coadministered with either fluvoxamine or ciprofloxacin (CYP1A2 inhibitors), the serum concentration of tizanidine was significantly increased and potentiated its hypotensive and sedative effects. Although there are no clinical studies evaluating the effects of other CYP1A2 inhibitors on tizanidine, coadministration of tizanidine with other CYP1A2 inhibitors (zileuton, other fluroquinolones, antiarrythmics, cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine) should be avoided.

    [March 27, 2007 - Letter - Acorda Therapeutics]
    [July 2006 - Label - Acorda Therapeutics]

    Latest Tizanidine clinical trials