Pramipexole First approved as Mirapex

What is pramipexole used for?

From the label: indications and usage

Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: Parkinson's disease (PD) ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson’s Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Conditions named in the indications of pramipexole's FDA labels, with every medicine labeled for each:

• Parkinson's disease

FDA pharmacologic class: Nonergot Dopamine Agonist.

What does the patient leaflet for pramipexole say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while taking pramipexole dihydrochloride tablets?

Do not drink alcohol while taking pramipexole dihydrochloride tablets. It can increase your chance of having serious side effects. See “What are the possible side effects of pramipexole dihydrochloride tablets?” Do not drive a car, operate a machine, or do other dangerous activities until you know how pramipexole dihydrochloride tablets affects you. Sleepiness caused by pramipexole dihydrochloride tablets can happen as late as 1 year after you start your treatment.

From the patient leaflet: How should I store pramipexole dihydrochloride tablets?

Store pramipexole dihydrochloride tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep pramipexole dihydrochloride tablets out of the light. Keep pramipexole dihydrochloride tablets and all medicines out of the reach of children. General Information about the safe and effective use of pramipexole dihydrochloride tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use pramipexole dihydrochloride tablets for a condition for which it was not prescribed. Do not give pramipexole dihydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about pramipexole dihydrochloride tablets. […]

Is there a generic for pramipexole (Mirapex)?

The FDA approved the first generic pramipexole on February 19, 2008. 30 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists pramipexole from 22 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 2 patents for Mirapex ER tablets, the last expiring on September 8, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for pramipexole (Mirapex)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0452 per Pramipexole 0.25 mg tablet, down 1% from $0.0456 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Has pramipexole been recalled?

The FDA's Enforcement Report lists 16 recalls naming pramipexole since 2011: 0 Class I (the most serious), 11 Class II, 5 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

What does the pramipexole label say about other medicines?

The pramipexole label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name pramipexole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Check pramipexole against other medicines

What do FAERS reports show for pramipexole?

The FDA Adverse Event Reporting System holds 19,752 reports that list pramipexole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,654 are coded as a death and 7,004 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

• 1,085
• 1,128
• 1,524
• 1,453
• 1,547
• 1,556
• 1,797
• 1,680
• 1,660
• 1,853
• 1,021

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Drug Ineffective (a use or a product term, not a reaction)1,878
• Fatigue (named in the label)1,419
• Fall1,393
• Nausea (named in the label)1,133
• Pain1,080
• Condition Aggravated (a use or a product term, not a reaction)1,057
• Off Label Use (a use or a product term, not a reaction)1,043
• Dizziness (named in the label)1,003

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as pramipexole?

13 other medicines are given the same way (oral) and in the same FDA class as pramipexole or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as pramipexole

How does pramipexole compare with medicines for the same use?

2 side-by-side pages set pramipexole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

• Bromocriptine
• Ropinirole

What next?

Alternatives to pramipexole

13 medicines for the same use

Other nonergot dopamine agonists

the pharmacologic class, with prices and generics

Pramipexole side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other