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This safety information outlines important considerations and potential risks associated with the use of Tizanidine (Zanaflex). Consult your healthcare provider if you have any concerns or questions.

• Low Blood Pressure: Tizanidine can lead to decreased blood pressure and dizziness, particularly when beginning treatment or adjusting the dose. To minimize these effects, doses should be increased gradually. To reduce the risk of falls, rise slowly from a lying position and use support if needed. Contact your healthcare provider if dizziness persists or your blood pressure drops significantly. Be cautious if you're over 65, taking blood pressure medications, fluvoxamine, or ciprofloxacin, or if you rise quickly from a lying position.

• Extreme Sleepiness: This medication may cause drowsiness and impact your concentration, especially if you are over 65 or using other sedative drugs. Avoid alcohol consumption and activities requiring full alertness, such as driving, until you know how Tizanidine affects you. Increased risk occurs when combined with alcohol, other sedative medications, or in individuals over 65.

• Medication Interactions: Certain drugs, such as clonidine or guanfacine, can interact with Tizanidine and exacerbate low blood pressure and dizziness. Avoid using Tizanidine with fluvoxamine or ciprofloxacin.

• Kidney Issues: For individuals with kidney problems, Tizanidine can accumulate, elevating the risk of side effects like drowsiness and dizziness. Lower doses may be necessary. Consult your healthcare provider if you have a history of kidney issues.

• Liver Damage: Tizanidine may cause liver damage. If you have liver issues, you may need regular liver function tests or may be advised against using this medication. Discuss with your provider if you have a history of liver problems.

• Hallucinations: A few individuals have reported hallucinations while taking Tizanidine, which typically resolve upon discontinuation. If you experience this, consult your healthcare provider for alternative treatments.

• Withdrawal Symptoms: Abrupt discontinuation can lead to withdrawal symptoms such as high blood pressure, rapid heartbeat, and muscle stiffness, especially if taken for over nine weeks or in high doses. Gradual dose reduction under medical supervision is recommended. Risks increase if taken with narcotic pain medications or if stopped suddenly.

• Allergic Reactions: Severe allergic reactions, including anaphylaxis, are possible. Seek emergency medical attention if you experience symptoms such as hives, rash, lip or tongue swelling, or difficulty breathing.

Contraindications: Do not use Tizanidine with medications that increase its levels in your body, such as strong CYP1A2 inhibitors like fluvoxamine or ciprofloxacin. Consult your healthcare provider if these apply to you.

Common side effects:

• dry mouth
• drowsiness
• weakness
• dizziness
• constipation

Less common but important to monitor:

• urinary tract infections
• blurry vision

Serious side effects:

• fainting
• mental or mood changes such as hallucinations
• irregular heartbeat
• symptoms of liver disease such as persistent nausea
• severe abdominal pain
• dark urine
• jaundice
• allergic reaction with trouble breathing
• rash
• swelling of the face, tongue, or throat

Interactions with high risk of serious adverse effects and should be avoided:

• Ciprofloxacin
• Fluvoxamine
• Viloxazine

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Alfentanil
• Alprazolam
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Capmatinib
• Cetirizine
• Cimetidine
• Clozapine
• Codeine
• Deferasirox
• Desogestrel
• Dienogest
• Dihydrocodeine
• Doxylamine
• Drospirenone
• Esketamine
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Famotidine
• Fentanyl
• Flibanserin
• Gabapentin
• Gabapentin Enacarbil
• Gestodene
• Givosiran
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Hydrocodone
• Hydromorphone
• Ketamine
• Lemborexant
• Levocetirizine
• Levonorgestrel
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Meperidine
• Mestranol
• Methacholine
• Methadone
• Metoclopramide
• Mexiletine
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Oxycodone
• Oxymorphone
• Peginterferon Alfa-2b
• Pentazocine
• Periciazine
• Pixantrone
• Ponesimod
• Potassium Oxybate
• Pregabalin
• Propafenone
• Quetiapine
• Remifentanil
• Remimazolam
• Revefenacin
• Rofecoxib
• Scopolamine
• Secretin Human
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Ticlopidine
• Tiotropium
• Tramadol
• Trazodone
• Vemurafenib
• Verapamil
• Voclosporin
• Zileuton
• Zolpidem

Interactions with low risk that usually do not require a change in therapy:

• Fosphenytoin
• Lisinopril
• Phenytoin