Pramipexole is used to treat Parkinson's disease (PD) and restless legs syndrome (RLS). The dosage depends on what form you’re taking: the immediate-release tablet is taken 3 times per day and the extended-release tablet is taken once per day. The immediate-release is only available as a lower-cost generic (the brand name Mirapex has been discontinued in the US). The extended-release version of this medication is available as brand (Mirapex ER) and generic. Side effects include nausea, drowsiness, dizziness, and tiredness.
Parkinson's disease
Moderate-to-severe restless legs syndrome - immediate-release tablets only
Pramipexole is a dopamine agonist. It's not completely known how pramipexole works. But it's thought to raise dopamine levels in the brain to help improve movement problems for people with Parkinson's disease or restless legs syndrome.
Source: DailyMed
Along with its needed effects, a medicine 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:
More common
Dizziness, lightheadedness, or fainting, especially when standing up suddenly from a sitting/lying position
drowsiness
hallucinations (seeing, hearing, or feeling things that are not there)
trouble sleeping
twitching, twisting, or other unusual body movements
unusual tiredness or weakness
Less common
Confusion
difficulty with swallowing
double vision or other changes in vision
falling asleep without warning
fearfulness, suspiciousness, or other mental changes
memory loss
muscle or joint pain
muscle weakness
restlessness or need to keep moving
swelling of the body
tightness in the chest
troubled breathing
writhing, twisting, or other unusual body movements
Rare
Abnormal thinking
bloody or cloudy urine
difficult, burning, or painful urination
dizziness
frequent urge to urinate
loss of bladder control
swelling of the arms or legs
Some side effects 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Works well to control movement problems
Available in a lower-cost generic version
Extended-release tablet can be taken once daily
Only available as a tablet
Can cause extreme sleepiness
Immediate-release tablets need to be taken 3 times per day.
You can take pramipexole with or without food. But if it upsets your stomach, try taking it with food to help.
Pramipexole can make you sleepy and can even make you fall asleep suddenly without warning. Don't drive or and do other things that require concentration until you know how this medication affects you and if you feel sleepy. If you already have a problem with staying awake during the day or take other medications that make you sleepy, let your provider know.
Don't drink alcohol while taking pramipexole because it can make you even sleepier.
Pramipexole can suddenly lower your blood pressure when you stand up from a sitting or lying position. Make sure to hold onto something when you're getting up so you don't lose your balance from any dizziness you might feel. If you fall and hit your head, get medical help right away.
Don't change your dose or stop taking pramipexole without talking to your provider first. Doing so can cause withdrawal symptoms, such as anxiety, panic attacks, depression, fatigue, and pain. Follow your provider's instructions to lower your dose slowly over a period of time to stop the medication completely.
For the extended-release tablet: Swallow the tablet whole. Don't crush, chew, or split the tablets in half. It's possible to see a swollen original tablet or swollen pieces of the tablet in your stool. If this happens, contact your provider.
Pramipexole can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Already feeling sleepy | History of sleep problems | Taking other sedatives or medications that make you sleepy | Drinking alcohol
Pramipexole can make you sleepy, and you can even fall asleep suddenly. Your risk is higher if you're also taking other medications that can cause sleepiness, such as benzodiazepines, muscle relaxants, and sleep medications. Make sure you know how pramipexole affects you before driving a car or doing activities that require your concentration. Talk to your healthcare provider if you feel too sleepy from pramipexole or have fallen asleep without warning while taking the medication.
Risk factors: Low blood pressure | Taking medications that lowers blood pressure | History of medical conditions that can lower blood pressure | High pramipexole doses
Pramipexole can cause a drop in blood pressure when you stand from a sitting or lying position. This can lead to dizziness, loss of balance, or falls. Make sure to get up slowly and hold onto something after sitting or lying down. If you experience a fall while taking pramipexole, contact your provider.
Pramipexole can cause compulsive behavior, which are intense urges and behaviors that are hard to control. Let your provider know if you or your loved ones notice new urges or habits when taking pramipexole. These can include gambling, sexual urges, shopping, or binge eating. Your provider might need to adjust or stop your medication.
Risk factors: Age 65 years or older | History of mental health problems (e.g., psychosis) | Advanced Parkinson's disease
Some people taking pramipexole had hallucinations (seeing or hearing things that are not there). Some also experienced agitation, confusion, and violent behavior. People with a history of mental health problems are generally not recommended to take pramipexole because the medication might worsen the condition. If you or your loved ones notice any hallucinations or other changes in behavior while taking pramipexole, contact your provider.
Pramipexole can cause or worsen uncontrolled body movements, such as eye-twitching or lip-smacking. If you experience any uncontrolled movements and aren't able to stop them, talk to your provider right away.
Some people taking pramipexole have had changes to their posture. This typically occurred after starting the medication or after the dose is raised, but it can also occur after several months of treatment. Let your provider know if you experience any changes to your posture.
Though rare, some people with advanced Parkinson's disease who took pramipexole developed a serious and life-threatening muscle problem called rhabdomyolysis. If you notice any of symptoms of rhabdomyolysis, such as severe muscle pain, dark-colored urine, weakness, and tiredness, stop pramipexole and get medical attention right away.
Pramipexole can potentially worsen your RLS symptoms. It can also make your symptoms spread to other parts of your body, make the restlessness feeling in your legs more intense, or cause your symptoms to start earlier in the day. Stopping pramipexole can also cause rebound RLS, which means your RLS symptoms can come back and be worse than before you started taking pramipexole.
Parkinson's disease:
Immediate-release tablets: The typical starting dose is 0.125 mg by mouth three times per day. If needed, your provider might raise your dose every 5 to 7 days to up to 1.5 mg three times per day.
Extended-release tablets: The typical starting dose is 0.375 mg by mouth once daily. If needed, your provider might raise your dose every 5 to 7 days to up to 4.5 mg once daily.
Restless legs syndrome:
Immediate-release tablets: The typical starting dose is 0.125 mg by mouth once daily, 2 to 3 hours before bedtime. If needed, your provider might raise your dose every 4 to 7 days to up to 0.5 mg once daily.
Your dose might differ if you have kidney problems.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Parkinson's disease
Moderate-to-severe restless legs syndrome - immediate-release tablets only
Parkinson's disease (PD)
Parkinsonism (conditions that cause people to have signs and symptoms of PD, including slowness, stiffness, shakiness, and imbalance)
Moderate-to-severe restless legs syndrome (RLS) - immediate-release tablets only
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Alembic Pharmaceuticals Inc. (2023). PRAMIPEXOLE DIHYDROCHLORIDE tablet [package insert]. DailyMed.
Alembic Pharmaceuticals Inc. (2023). PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release [package insert]. DailyMed.
Rabinak, C. A., et al. (2010). Dopamine agonist withdrawal syndrome in Parkinson disease. Archives of Neurology.
Seeman, P. (2015). Parkinson's disease treatment may cause impulse-control disorder via dopamine D3 receptors. Synapse.
U.S. Food and Drug Administration. (n.d.) Drugs@FDA: FDA-approved drugs.
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