Ontralfy Side Effects
Generic name: tizanidine
Note: This document provides detailed information about Ontralfy.
Applies to tizanidine: oral capsule, oral tablet Side Effects associated with tizanidine. Some dosage forms listed on this page may not apply specifically to the brand name Ontralfy.
Applies to tizanidine: oral capsule, oral tablet.
Precautions
It is important that your doctor check your progress at regular visits, especially during the first few weeks of treatment with this medicine. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with ciprofloxacin or fluvoxamine. Using these medicines together may cause serious unwanted effects.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates, medicine for seizures, other muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using tizanidine (the active ingredient contained in Ontralfy) /i>.
This medicine may cause dizziness, drowsiness, lightheadedness, clumsiness or unsteadiness, or vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.
Hallucinations (visual) may occur while you are using this medicine. Check with your doctor right away if you have hallucinations (seeing things that are not there).
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Do not suddenly Stop taking tizanidine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms.
Tizanidine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Serious side effects of Ontralfy
Along with its needed effects, tizanidine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking tizanidine:
More common side effects
- chest pain or discomfort
- fever or chills
- nausea or vomiting
- nervousness
- pain or burning while urinating
- unusual tiredness
Less common side effects
- blurred vision
- flu-like symptoms
- irregular heartbeat
- itching skin
- kidney stones
- right upper stomach tenderness
- seeing things that are not there
- shortness of breath
- weight gain
Incidence not known
- continuing vomiting
- general feeling of tiredness or weakness
- headache
- light-colored stools
Get emergency help immediately if any of the following symptoms of overdose occur while taking tizanidine:
Symptoms of overdose
- blurred vision
- change in consciousness
- chest pain or discomfort
- confusion
- decreased awareness or responsiveness
- difficult or troubled breathing
- dizziness, faintness or lightheadedness when getting up from a lying position
- irregular, fast or slow, or shallow breathing
- lightheadedness, dizziness, or fainting
- loss of consciousness
- pale or blue lips, fingernails, or skin
- severe sleepiness
- sleepiness or unusual drowsiness
- slow or irregular heartbeat
- sweating
- unusual tiredness or weakness
Other side effects of Ontralfy
Some side effects of tizanidine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- dizziness or lightheadedness, especially when getting up from a lying or sitting position
- drowsiness
- dry mouth
- fatigue
- sleepiness
- weakness
Less common side effects
- constipation
- nervousness
- sore throat
For healthcare professionals
Applies to tizanidine: oral capsule, oral tablet.
General adverse events
The most frequently reported adverse reactions include dry mouth, somnolence/sedation, asthenia, and dizziness.[Ref]
Nervous system
- Very common (10% or more): Somnolence (up to 48%), dizziness (up to 16%)
- Common (1% to 10%): Speech disorder, dyskinesia
- Frequency not reported: Headache, ataxia, dysarthria
- Postmarketing reports: Convulsion, paresthesia, tremor[Ref]
Gastrointestinal
- Very common (10% or more): Dry mouth (up to 49%)
- Common (1% to 10%): Vomiting, constipation
- Rare (0.01% to 0.1%): Nausea, gastrointestinal disorder
- Frequency not reported: Abdominal pain, loss of appetite[Ref]
Hepatic
- Common (1% to 10%): Liver test abnormality
- Very rare (less than 0.01%): Hepatic failure
- Frequency not reported: Hepatotoxicity
- Postmarketing reports: Hepatitis[Ref]
Cardiovascular
- Common (1% to 10%): Bradycardia, hypotension, tachycardia
- Postmarketing reports: Syncope, ventricular tachycardia, QT prolongation[Ref]
Ocular
- Common (1% to 10%): Amblyopia
- Frequency not reported: Accommodation disorder[Ref]
Dermatologic
- Frequency not reported: Pruritus
- Postmarketing reports: Stevens Johnson Syndrome, exfoliative dermatitis, rash[Ref]
Other
- Common (1% to 10%): Fatigue
- Frequency not reported: Drug withdrawal reactions including rebound hypertension, tachycardia, and hypertonia[Ref]
Genitourinary
- Common (1% to 10%): Urinary tract infection, urinary frequency[Ref]
Respiratory
- Common (1% to 10%): Pharyngitis, rhinitis[Ref]
Hypersensitivity
- Frequency not reported: Anaphylaxis, hypersensitivity reactions
- Postmarketing reports: Anaphylactic Reaction[Ref]
Immunologic
- Common (1% to 10%): Infection, flu syndrome[Ref]
Musculoskeletal
- Rare (0.01% to 0.1%): Muscular weakness
- Postmarketing reports: Arthralgia[Ref]
Psychiatric
- Common (1% to 10%): Nervousness
- Rare (0.01% to 0.1%): Hallucinations, insomnia, sleep disorders
- Frequency not reported: Confusional state
- Postmarketing reports: Depression[Ref]
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References
1. (2001) "Product Information. Zanaflex (tizanidine)." Acorda Therapeutics
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
Frequently asked questions
More about Ontralfy (tizanidine)
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: skeletal muscle relaxants
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Further information
Ontralfy side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.