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pramipexole

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Brand names: Mirapex

Dopamine Agonist Rx

Pramipexole extended-release tablets help treat Parkinson's disease. It belongs to a class of drugs called dopamine agonists.

Drug Pricing (NADAC)

Generic Price

$0.04/unit

Generic Available

Yes (13 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine treats Parkinson's disease.

Common side effects

Feeling sleepy, Feeling sick to your stomach, Constipation

Key warnings

Pramipexole can make you fall asleep suddenly, even during normal daily activities.

How It Works

Pramipexole works by acting like dopamine in the brain. Dopamine is a chemical that helps control movement. By mimicking dopamine, this medicine helps reduce Parkinson's symptoms.

How to Take It

Take pramipexole extended-release tablets once a day. You can take it with or without food. Swallow the tablet whole; do not chew, crush, or divide it. Your doctor may change your dose over time.

Pregnancy & Breastfeeding

This medicine may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine passes into breast milk. Pramipexole may also reduce breast milk production.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store at room temperature (68° to 77°F) and keep away from high humidity. Keep out of reach of children.

Side Effects (from patient reports)

Based on 8,808 FDA adverse event reports.

The medicine is not working
1,349
Falling down
1,066
Feeling tired
1,043
Feeling sick to your stomach
832
Aches and pains
795
Condition getting worse
788
Seeing or hearing things that are not there
754
Using the medicine for something it is not approved for
737
Feeling lightheaded or unsteady
734
Difficulty breathing
710

FDA Adverse Event Report Analysis

Detailed analysis of 14,399 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

14,399

Death-Related Reports

1,206

Hospitalization Reports

5,034

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 8,046 (61%)
Male 5,146 (39%)

Age Distribution

0–17 92
18–44 697
45–64 3,138
65–74 3,174
75+ 2,846

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 1,349
2 FALL 1,066
3 FATIGUE 1,043
4 NAUSEA 832
5 PAIN 795
6 CONDITION AGGRAVATED 788
7 HALLUCINATION 754
8 OFF LABEL USE 737
9 DIZZINESS 734
10 DYSPNOEA 710
11 DYSKINESIA 643
12 GAIT DISTURBANCE 642
13 HEADACHE 593
14 TREMOR 576
15 DEATH 565

Reactions in Death Reports

DEATH 565
COMPLETED SUICIDE 80
PARKINSON^S DISEASE 61
PNEUMONIA 60
OFF LABEL USE 54
HALLUCINATION 52
DYSPNOEA 51
GENERAL PHYSICAL HEALTH DETERIORATION 50
FALL 48
FATIGUE 47

Reactions in Hospitalization Reports

FALL 516
DRUG INEFFECTIVE 431
FATIGUE 426
DYSPNOEA 423
PNEUMONIA 409
PAIN 385
CONDITION AGGRAVATED 351
OFF LABEL USE 325
NAUSEA 303
ASTHENIA 299

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Pramipexole can make you fall asleep suddenly, even during normal daily activities. Tell your doctor if this happens. Pramipexole can also cause compulsive behaviors like gambling or overeating. Watch for these changes and tell your doctor if they occur.

Known Drug Interactions

7 DRUG INTERACTIONS Dopamine antagonists: May diminish the effectiveness of pramipexole (7.1). 7.1 Dopamine Antagonists Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride extended-release tablets.

Mechanism: Pramipexole works by acting like dopamine in the brain, while dopamine antagonists block those same spots. Because they work against each other, the antagonist can stop pramipexole from working correctly.

What to do: Your doctor may need to avoid using these drugs together or adjust your treatment because they can cancel each other out.

7.1 Dopamine Antagonists Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride extended-release tablets.

Mechanism: Metoclopramide blocks the same receptors that pramipexole is trying to activate. This prevents pramipexole from doing its job effectively.

What to do: Talk to your doctor before taking these together, as metoclopramide may make your pramipexole treatment less effective.

Common Questions

Can I cut the tablet in half?
No, swallow the tablet whole. Do not chew, crush, or divide it.
What should I do if I feel dizzy?
Be careful when standing up, especially when you first start taking this medicine. Dizziness is a common side effect.
Can I drink alcohol while taking this medicine?
Talk to your doctor. Alcohol may increase sleepiness.
How long does it take for this medicine to work?
It may take a few weeks to see the full benefits of this medicine. Talk to your doctor if your symptoms do not improve.
What if I start having hallucinations?
Tell your doctor right away if you start seeing or hearing things that are not there.
Can I drive while taking this medicine?
Be careful driving or operating machinery until you know how this medicine affects you. It can cause sleepiness.
What should I do if I develop new or worsening uncontrolled movements?
Tell your doctor if you experience uncontrolled movements, as your dose may need to be adjusted.
Is it okay to suddenly stop taking this medicine?
No, you should not stop taking this medicine suddenly. Your doctor will slowly lower your dose to prevent withdrawal symptoms.
What if I have kidney problems?
Tell your doctor if you have kidney problems. Your dose may need to be adjusted.
Can this medicine affect my blood pressure?
Yes, this medicine can cause low blood pressure, especially when you stand up. Be careful when standing.
What are the common side effects of pramipexole?
The most commonly reported side effects of pramipexole include Feeling sleepy, Feeling sick to your stomach, Constipation, Dizziness, Feeling tired. Based on 8,808 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does pramipexole interact with other medications?
Yes, pramipexole has 2 known drug interactions. Notable interactions include dopamine, metoclopramide. Always inform your doctor about all medications you are taking.
What drug class is pramipexole?
pramipexole belongs to the Dopamine Agonist drug class. It requires a prescription (Rx). This medicine treats Parkinson's disease.
Is pramipexole safe during pregnancy?
This medicine may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for pramipexole

The FDA label for pramipexole (sold under brand names such as Mirapex) classifies it as a prescription-only medication in the Dopamine Agonist class. This medicine treats Parkinson's disease. Official labeling lists 12 commonly reported side effects, including Feeling sleepy, Feeling sick to your stomach, Constipation.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 8,808 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.04.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: August 31, 2021

All federal data sources used on this page