Warnings


Mirapex Risks, Warnings, and Complications


Mirapex can cause new or worsening health problems in some people. Talk to your doctor or pharmacist about other treatments for your condition if you are at an increased risk of complications from this medication. Some of the risks of taking Mirapex include:

  • EXTREME SLEEPINESS: Patients treated with Mirapex have reported falling asleep suddenly during the daytime, including during routine activities such as eating, reading, watching TV, talking, or driving a motor vehicle. These effects can occur even one year after starting treatment. Risk factors include a history of sleep disorders, taking other medicines that can cause sleepiness, drinking alcohol, and drug interactions that can increase Mirapex (pramipexole) blood concentrations.

     Do not drive, operate machinery, or do other possibly dangerous activities until you know how Mirapex affects you. Tell your healthcare professional if you develop daytime sleepiness or fall asleep suddenly in the middle of routine activities. Give your doctor a list of all your medicines to prevent interactions with other drugs.

  • LOW BLOOD PRESSURE: Patients treated with Mirapex can develop symptomatic postural hypotension (low blood pressure when going from sitting or lying to standing). This is especially likely when the dose of the medicine is being increased. Get out of bed slowly to prevent loss of balance and falls. Tell your doctor if you have severe dizziness with changes in posture.

  • IMPULSIVE BEHAVIORS: Some patients taking Mirapex develop increased sexual urges or intense urges to gamble, spend money, binge eat, or other compulsive behaviors. It’s important your doctor knows of these behavior changes. Your family should know when and how to seek help if you are unaware of these urges and cannot seek care for yourself.

  • HALLUCINATIONS AND PSYCHOTIC BEHAVIORS: Auditory and visual hallucinations (hearing and seeing things that aren’t there) have been reported in people taking Mirapex. Age above 65 years is a risk factor. Also reported are new or worsening mental changes including psychotic behaviors, paranoia, delusions, mania, confusion, disorientation, aggression, agitation, and delirium. Tell your doctor without delay if you develop these symptoms.  

  • UNUSUAL POSTURE CHANGES: Posture changes such as the neck bending forward, the body bending forward, or the body tilting sideways have been reported after starting Mirapex treatment. A dose reduction or discontinuation of treatment may be necessary if unusual posture changes occur.

  • RENAL IMPAIRMENT: Mirapex is eliminated from the body by the kidneys. People with renal impairment (reduced kidney function) may need to take a lower dose of Mirapex. 

  • RHABDOMYOLYSIS: There are rare case reports of rhabdomyolysis (muscle damage) in patients who took Mirapex. Tell your doctor immediately if you develop muscle pain or weakness and dark urine after taking this medicine. 

  • SEVERE WITHDRAWAL SYMPTOMS: Stopping the medicine suddenly can lead to withdrawal symptoms such as fatigue, insomnia, reduced interest in activities, anxiety, depression, pain, and sweating. Do not stop taking Mirapex or make dose changes without your doctor’s approval.


Precautions Before Starting Mirapex

Tell your doctor if you have ever had allergic reactions to Mirapex, any of the active or inactive ingredients in Mirapex tablets, or any other medications. Your pharmacy can give you a list of ingredients.

Give your doctor and pharmacist a complete list of all your medicines, including prescription drugs, over-the-counter medicines, supplements, and herbal products. This can help avoid possible drug interactions.

Give your doctor a complete medical history. Mirapex may not be safe for people with certain medical conditions such as dizziness, fainting, low blood pressure, mental illness, muscle movement disorders other than restless legs, or kidney disease.

Tell your doctor if you are pregnant, could be pregnant, or are planning a pregnancy. We do not know if Mirapex can cause major birth defects. Also, tell your doctor if you are breast-feeding. Mirapex can affect milk production.

Precautions During Use of Mirapex

Keep all your medical and laboratory appointments. Your doctor may adjust your dose based on your response. They will also monitor you for side effects.

Mirapex can cause drowsiness or cause you to suddenly fall asleep during routine daily activities. Be cautious while driving and doing other possibly dangerous activities until you know how this medicine affects you. Tell your doctor if you find yourself suddenly falling asleep during activities such as driving, reading, eating, or watching TV.

Avoid alcohol while on Mirapex as it can make side effects like drowsiness and dizziness worse.

Mirapex can cause orthostatic hypotension (postural dizziness when arising quickly). Get up slowly from a sitting or lying position to prevent falls.

People who take Mirapex can develop increased sexual urges and other intense urges such as gambling, spending money, or binge eating. Tell your provider if you or family members notice any unusual urges or compulsive behaviors.

If you are taking Mirapex extended release tablets, tell your doctor if you notice pieces of swollen tablet in your stool, especially if this is accompanied by worsening symptoms of Parkinson’s disease. 

Tell all your healthcare providers and laboratory personnel you are on Mirapex, especially before any surgery or dental procedures.

Mirapex Drug Interactions

Certain other medicines can affect how Mirapex works. Possible interactions between Mirapex and other medicines can increase the risk of severe adverse reactions. Your healthcare provider may change the dose of your medicine, switch you to a different medication, or monitor you carefully for side effects if there are known interactions between Mirapex and your other medications. Mirapex can interact with the following medications:

  • Antihistamines
  • H2 blockers (acid reducers) such as cimetidine (Tagamet)
  • Medications used to treat nausea, allergies, and mental illnesses
  • Medications used to treat gastrointestinal conditions, such as metoclopramide (Reglan)
  • Sleeping pills, sedatives, tranquilizers, and muscle relaxants

Give your doctor or pharmacist a complete list of all the drugs prescribed to you as well as over-the-counter medications, dietary supplements, and herbal remedies. Also, tell your healthcare professional if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription medications.