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Pramipexole

Pramipexole is a non-ergot dopamine agonist used to treat Parkinson’s disease and, in the immediate-release tablet, moderate-to-severe primary Restless Legs Syndrome.

Brand names MirapexMirapex ERPramipexole dihydrochloridePramipexole Dihydrochloride Extended-Release
Drug class Nonergot Dopamine Agonist
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 37 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026
Pramipexole at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Pramipexole is a dopamine agonist (it stimulates the brain's dopamine receptors) for Parkinson's disease and, as the immediate-release tablet, moderate-to-severe restless legs syndrome. It has been a familiar choice since the late 1990s, is available generically, and in Parkinson's is used alone or with levodopa. It is usually reasonably well tolerated when the dose is raised slowly, and nausea, dizziness, sleepiness and constipation are what people notice most. Watch for sudden sleep onset, dozing off without warning during daily activities like driving, as late as a year after starting, and don't drive if you feel drowsy.

Clinical pearls

  • Report dizziness on standing, hallucinations, and new urges to gamble, spend, binge eat or have sex early.
  • Don't stop it suddenly, and if you miss several days, ask whether the slow dose build-up needs to restart.
  • Swallow the extended-release tablets (Mirapex ER) whole, never chewed, crushed or split.
  • Metoclopramide (Reglan) and older antipsychotics such as haloperidol block dopamine and can make pramipexole work less well.
How you get itPrescription only
Comes asTablet, Extended-release tablet
Earliest FDA record1997
Companies listing it with the FDA22
FDA label last updatedOct 13, 2016
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Pramipexole, written from its FDA label.

What Pramipexole is used for

▾

Pramipexole is used for the following conditions, depending on the product:

  • Parkinson’s disease: pramipexole dihydrochloride tablets and extended-release tablets.
  • Moderate-to-severe primary Restless Legs Syndrome: pramipexole dihydrochloride tablets only (not the extended-release tablets).

How Pramipexole works

▾

Pramipexole is a non-ergot dopamine agonist. It mimics dopamine by activating dopamine receptors, binding most strongly to a subtype called D3. In Parkinson’s disease, it is believed to work by stimulating dopamine receptors in the striatum, a brain area involved in movement.

The exact way it helps Parkinson’s disease and RLS is not known.

Pramipexole dosage

▾

Pramipexole is taken by mouth, with or without food. Doses are started low and raised slowly.

  • Immediate-release tablets: for Parkinson’s disease, taken in divided doses three times a day. For RLS, taken 2 to 3 hours before bedtime.
  • Extended-release tablets: taken once daily and swallowed whole.
  • If therapy was interrupted for a significant time, you may need to restart the dose build-up.
  • People with kidney problems may need lower or less frequent dosing.

Follow your prescriber and the label.

Dosing details from the FDA-approved label

From the Pramipexole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Extended-release tablets: general dosing (Parkinson's disease, normal renal function)
    • Starting dose is 0.375 mg given once per day
    • Dosages may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments
    • Taken orally once daily, with or without food
    • Swallow whole, do not chew, crush, or divide
    • Maximum: 4.5 mg per day
    • Assess therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment
  • Extended-release tablets: moderate renal impairment (creatinine clearance between 30 and 50 mL/min)
    • Initially taken every other day
    • After careful assessment of therapeutic response and tolerability, may increase to daily dosing after one week, then titrate in 0.375 mg increments
    • Maximum: 2.25 mg per day
    • Dose adjustment no more frequently than at weekly intervals
  • Extended-release tablets: switching from immediate-release pramipexole tablets
    • May be switched overnight at the same daily dose
    • Dose adjustment may be needed in some patients
  • Extended-release tablets: discontinuation
    • May be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg
    • Thereafter reduced by 0.375 mg per day
  • Immediate-release tablets: Parkinson's disease, normal renal function
    • Start at 0.375 mg/day in three divided doses, not increased more frequently than every 5 to 7 days: week 1 0.125 mg three times a day, week 2 0.25 mg three times a day, week 3 0.5 mg three times a day, week 4 0.75 mg three times a day, week 5 1 mg three times a day, week 6 1.25 mg three times a day, week 7 1.5 mg three times a day
    • Maintenance 1.5 to 4.5 mg/
    • Maximum: 4.50 mg total daily dose (1.5 mg three times a day)
    • When used with levodopa, a reduction of the levodopa dosage should be considered
  • Immediate-release tablets: Parkinson's disease, normal to mild renal impairment (creatinine Cl >50 mL/min)
    • Starting dose 0.125 mg three times a day
    • Maximum: 1.5 mg three times a day
  • Immediate-release tablets: Parkinson's disease, moderate renal impairment (creatinine Cl 30 to 50 mL/min)
    • Starting dose 0.125 mg twice a day
    • Maximum: 0.75 mg three times a day
  • Immediate-release tablets: Parkinson's disease, severe renal impairment (creatinine Cl 15 to 30 mL/min)
    • Starting dose 0.125 mg once daily
    • Maximum: 1.5 mg once daily
    • Data not available for
  • Immediate-release tablets: Restless Legs Syndrome
    • Taken 2-3 hours before bedtime: step 1 0.125 mg
    • Step 2 (if needed) 0.25 mg
    • Step 3 (if needed) 0.5 mg
    • Maximum: 0.5 mg
    • Dosing interval is 4-7 days (14 days in patients with CrCl 20-60 mL/min)
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Pramipexole dihydrochloride extended-release tablets are taken once daily, with or without food ( 2.1 ) Tablets must be swallowed whole and must not be chewed, crushed, or divided ( 2.1 ) Starting dose is 0.375 mg given once daily ( 2.2 ) Dose may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. Assess therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment ( 2.2 ) Patients may be switched overnight from immediate-release pramipexole tablets to pramipexole dihydrochloride extended-release tablets at the same daily dose. Dose adjustment may be needed in some patients ( 2.3 ) Pramipexole dihydrochloride extended-release tablets should be discontinued gradually ( 2.2 ) 2.1 General Dosing Considerations Pramipexole dihydrochloride extended-release tablets are taken orally once daily, with or without food. Pramipexole dihydrochloride extended-release tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with pramipexole dihydrochloride extended-release tablets has occurred, re-titration of therapy may be warranted. 2.2 Recommended Dosage The starting dose is 0.375 mg given once per day. Based on efficacy and tolerability, dosages may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. In clinical trials, dosage was initiated at 0.375 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 4.5 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment [ see Clinical Studies ( 14 ) ]. Due to the flexible dose design used in clinical trials, specific dose-response information could not be determined [ see Clinical Studies ( 14 ) ]. Pramipexole dihydrochloride extended-release tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day [ see Warnings and Precautions ( 5.10 , 5.11 ) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Pramipexole side effects

▾

Most side effects were mild or moderate in studies. Common ones include:

Common side effects

  • Nausea
  • Dizziness
  • Sleepiness (somnolence)
  • Trouble sleeping (insomnia)
  • Constipation
  • Weakness or tiredness (asthenia)
  • Hallucinations
  • Uncontrolled movements (dyskinesia) when used with levodopa
  • Dry mouth

When to get medical help

  • Call your doctor if you fall asleep suddenly during daily activities, even without feeling sleepy first.
  • Get help if you feel faint or dizzy when standing up, especially as your dose goes up.
  • Tell your doctor about new or strong urges to gamble, spend money, binge eat or have sex.
  • Report hallucinations or odd, psychotic-like behavior.
  • Tell your doctor if movements get worse or if your posture becomes abnormal.

Call your doctor about sudden sleep episodes, fainting, hallucinations or new compulsive urges.

Pramipexole warnings and precautions

▾
  • Falling asleep suddenly: can happen without warning, including while driving. Avoid driving and risky activities if you become sleepy.
  • Low blood pressure on standing: watch for this, especially as the dose rises.
  • Compulsive behaviors: gambling, spending, binge eating or sexual urges may develop. They often ease when the dose is lowered or the drug stopped.
  • Hallucinations: more likely in older adults.
  • Dyskinesia and postural deformity: may be caused or worsened.

Pramipexole interactions

▾

These can affect how pramipexole works or how you feel on it:

  • Dopamine blockers (phenothiazines, butyrophenones, thioxanthenes, metoclopramide): may weaken its effect.
  • Cimetidine: raises pramipexole levels and may increase sleepiness.
  • Alcohol and sedating medicines: can add to drowsiness.
  • Levodopa: your prescriber may lower the levodopa dose.

Interactions listed in the FDA-approved label

From the Pramipexole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Dopamine antagonists (neuroleptics such as phenothiazines, butyrophenones, thioxanthenes; metoclopramide): Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists may diminish the effectiveness of pramipexole.
Read the label’s full interactions text

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.

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.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Pramipexole

▾
  • No contraindications are listed.
  • Tell your doctor about kidney problems, sleep disorders or daytime drowsiness.
  • Pregnancy: human data are inadequate, and animal data suggest possible fetal harm.
  • Breastfeeding: milk production is expected to be reduced, and effects on the infant are unknown.
  • Children: safety and effectiveness have not been evaluated.
  • Older adults: the drug clears more slowly and hallucinations are more common.

Pramipexole overdose

▾

There is little clinical experience with significant overdose. In one case, a person took a high dose for 2 days. Their pulse rose but their blood pressure stayed stable. There is no known antidote. Treatment is supportive care, which may include stomach lavage, IV fluids and heart monitoring.

What Pramipexole does in the body

▾

In a study of healthy volunteers given rapidly increased doses, no effect on the QT interval (a heart rhythm measure) was seen. However, the study could not fully confirm its sensitivity. Blood pressure and pulse rose modestly during the rapid dose increase. This was not seen in Parkinson’s patients whose doses were raised as the label recommends.

How your body processes Pramipexole

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Pramipexole is well absorbed, with bioavailability over 90%. Immediate-release tablets peak in about 2 hours. Food does not change how much is absorbed but delays the peak by about 1 hour. The half-life is about 8 hours in young adults and about 12 hours in older adults. Extended-release tablets peak at about 6 hours and are taken once daily.

How to store Pramipexole

▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° and 30°C (59° and 86°F) . Protect from light. Store in a safe place out of the reach of children.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

21

Supplements & herbs that interact with Pramipexole

21 supplements and herbal products have documented interactions with Pramipexole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 11
  • Minor · 9
Every supplement checked against Pramipexole — ranked by severity The full interaction hub: 1 major · 11 moderate · 9 minor · every one linked to its full report. Check Pramipexole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Pramipexole: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Pramipexole — the kind of thing our pharmacy team would talk through with you at the counter.

What is pramipexole used for?

▾
It treats Parkinson’s disease. The immediate-release tablet is also approved for moderate-to-severe primary Restless Legs Syndrome. The extended-release tablet is for Parkinson’s disease only.

How should I take it?

▾
Take it by mouth, with or without food, exactly as prescribed. Extended-release tablets are once daily and must be swallowed whole. Your dose is raised slowly, so don’t change it on your own.

Is it safe to drive on pramipexole?

▾
Be careful. Some people fell asleep suddenly during daily activities, including driving, sometimes with no warning. If you feel sleepy, don’t drive, and tell your doctor right away. Alcohol and sedating medicines can make this worse.

What side effects should I expect?

▾
Common ones are nausea, dizziness, sleepiness, trouble sleeping, constipation and weakness. Call your doctor if you have hallucinations, fainting, or new strong urges to gamble, spend, binge eat or have sex.

Can I take it with other medicines?

▾
Tell me everything you take. Dopamine blockers like metoclopramide and certain antipsychotics may make it work less well. Cimetidine can raise pramipexole levels. If you take levodopa, your doctor may lower that dose.

What if I’m pregnant or breastfeeding?

▾
Talk with your doctor first. There isn’t enough human data on pregnancy, and animal data suggest possible harm. Pramipexole is also expected to reduce milk production.

Is Pramipexole available over the counter?

▾
No. Pramipexole is a prescription medicine: every Pramipexole product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Pramipexole first available?

▾
The earliest FDA record we hold for Pramipexole is from 1997: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Pramipexole was first used.

Who makes Pramipexole?

▾
22 companies currently list Pramipexole products in the FDA's NDC Directory, including Alembic Pharmaceuticals Limited, Alembic Pharmaceuticals Inc., Macleods Pharmaceuticals Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Pramipexole on HelloPharmacist

Detailed data & references for Pramipexole Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Pramipexole forms and strengths (how it comes)

Pramipexole is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Pramipexole inactive ingredients by manufacturer.

Tablet

By mouth
Brands Pramipexole Dihydrochloride
How this form is used
What it may be used for
  • Pramipexole dihydrochloride tablets are indicated for Parkinson’s disease.
  • Pramipexole dihydrochloride tablets are indicated for moderate-to-severe primary Restless Legs Syndrome.
Important instructions
  • Pramipexole dihydrochloride tablets are taken by mouth, with or without food.
  • For Parkinson’s disease, pramipexole dihydrochloride tablets are increased gradually and given in divided doses three times daily.
  • For Restless Legs Syndrome, pramipexole dihydrochloride tablets are taken 2 to 3 hours before bedtime.
Available strengths 6 strengths
224 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Pramipexole Dihydrochloride
How this form is used
What it may be used for
  • Pramipexole dihydrochloride extended-release tablets are indicated for Parkinson’s disease.
Important instructions
  • Pramipexole dihydrochloride extended-release tablets are taken once daily, with or without food.
  • Pramipexole dihydrochloride extended-release tablets must be swallowed whole, not chewed, crushed or divided.
  • Pramipexole dihydrochloride extended-release tablets should be stopped gradually.
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
98 FDA-listed product records ⓘ

Pramipexole on the U.S. market: products, makers and brands

How Pramipexole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

22 companies list 137 Pramipexole product records with the FDA, mostly as tablet, extended-release tablet; the earliest marketing or approval year on record is 1997. Brand names on the directory include Mirapex, Mirapex ER, Pramipexole dihydrochloride and 1 more; the rest are generics.

2
Dose forms ⓘ
22
Labelers (makers, repackagers, distributors)
3
Brand names
137
FDA-listed product records ⓘ
1997
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Alembic Pharmaceuticals Limited12%
Alembic Pharmaceuticals Inc.9%
Macleods Pharmaceuticals Limited9%
Bryant Ranch Prepack7%
Ingenus Pharmaceuticals, LLC5%
Aurobindo Pharma Limited4%
Other makers53%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Pramipexole is used (Medicaid data)

A general measure of how commonly Pramipexole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Pramipexole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

188,853
Medicaid prescriptions filled (Q1–Q4 2025)
$2.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pramipexole prescribed? Of the 1,601 medications we measure, Pramipexole ranks #401 by Medicaid prescriptions — more than 75% of them.

Where Pramipexole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Pramipexole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.5 mg oral tablet is the most-dispensed Pramipexole product — about 26% of these Medicaid prescriptions.

pramipexole dihydrochloride 0.5 MG Oral Tablet Most dispensed

48,968 Medicaid prescriptions (Q1–Q4 2025) 26% of Pramipexole prescriptions shown $527,894 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 5 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859044

pramipexole dihydrochloride 0.25 MG Oral Tablet

47,579 Medicaid prescriptions (Q1–Q4 2025) 25% of Pramipexole prescriptions shown $512,593 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 5 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859040

pramipexole dihydrochloride 0.125 MG Oral Tablet

43,415 Medicaid prescriptions (Q1–Q4 2025) 23% of Pramipexole prescriptions shown $458,406 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 5 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859033

pramipexole dihydrochloride 1 MG Oral Tablet

29,864 Medicaid prescriptions (Q1–Q4 2025) 16% of Pramipexole prescriptions shown $354,599 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 5 of 47 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859052

pramipexole dihydrochloride 0.75 MG Oral Tablet

9,290 Medicaid prescriptions (Q1–Q4 2025) 5% of Pramipexole prescriptions shown $113,149 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 2 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858625

pramipexole dihydrochloride 1.5 MG Oral Tablet

9,005 Medicaid prescriptions (Q1–Q4 2025) 5% of Pramipexole prescriptions shown $112,169 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 4 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859048

24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet

233 Medicaid prescriptions (Q1–Q4 2025) <1% of Pramipexole prescriptions shown $21,458 gross reimbursement (before rebates) ≈ $92 per prescription (gross)

Summed across the 3 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 901541

24 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral Tablet

218 Medicaid prescriptions (Q1–Q4 2025) <1% of Pramipexole prescriptions shown $17,131 gross reimbursement (before rebates) ≈ $79 per prescription (gross)

Summed across the 4 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 901546

24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet

174 Medicaid prescriptions (Q1–Q4 2025) <1% of Pramipexole prescriptions shown $21,927 gross reimbursement (before rebates) ≈ $126 per prescription (gross)

Summed across the 3 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 901550

24 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral Tablet

70 Medicaid prescriptions (Q1–Q4 2025) <1% of Pramipexole prescriptions shown $8,575 gross reimbursement (before rebates) ≈ $123 per prescription (gross)

Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1114479

24 HR pramipexole dihydrochloride 3 MG Extended Release Oral Tablet

37 Medicaid prescriptions (Q1–Q4 2025) <1% of Pramipexole prescriptions shown $4,580 gross reimbursement (before rebates) ≈ $124 per prescription (gross)

Summed across the 1 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 901555

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pramipexole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 40 of 324 listed Pramipexole NDCs with Medicaid activity.

Compare Pramipexole products

A representative set of FDA-listed product records for Pramipexole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 137 of 137 products — FDA National Drug Code Directory. See every product, package size and price: browse all 137 Pramipexole NDCs →

Pramipexole side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pramipexole — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Pramipexole are fatigue, fall, nausea; about 74% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

19,752
Reports mentioning it
74%
Reported as serious
12
Distinct effects shown
Most reported effects
Fatigue
1,419
Fall
1,393
Nausea
1,133
Pain
1,080
Condition Aggravated
1,057
Dizziness
1,003
Hallucination
994
Dyspnoea
944
Headache
882
Gait Disturbance
830
Age groups
Elderly · 1,956Adult · 1,280Neonate · 24Child · 4

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pramipexole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Pramipexole FDA approval history

How Pramipexole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Pramipexole was first approved by the FDA in 1997 (Brand: MIRAPEX · Boehringer Ingelheim); the first generic version was approved in 2008. It remains available in U.S. pharmacies today.

1997
Brand approved
Brand: MIRAPEX · Boehringer Ingelheim
2008
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Pramipexole recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Pramipexole recalls since July 2021.

✅No Pramipexole recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Pramipexole RxCUI 746741 2 dose forms · 13 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 901533 In current FDA listings

Look up RxCUI 746741 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Pramipexole costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 0.25 mg $0.045 per tablet NDC details & price history
Tablet · Oral 0.5 mg $0.057 per tablet NDC details & price history
Tablet · Oral 1 mg $0.062 per tablet NDC details & price history
Tablet · Oral 0.125 mg $0.039 per tablet NDC details & price history
Tablet · Oral 1.5 mg $0.060 per tablet NDC details & price history
Tablet · Oral 0.75 mg $0.072 per tablet NDC details & price history
Tablet, Extended Release · Oral 0.375 mg $0.948 per tablet NDC details & price history
Tablet, Extended Release · Oral 0.75 mg $0.718 per tablet NDC details & price history
Tablet, Extended Release · Oral 4.5 mg $1.66 per tablet NDC details & price history
Tablet, Extended Release · Oral 3 mg $1.48 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Pramipexole brand names

Pramipexole is sold under 4 brand names in the FDA directory — Mirapex, Mirapex ER, Pramipexole dihydrochloride, Pramipexole Dihydrochloride Extended-Release. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Mirapex Mirapex ER Pramipexole dihydrochloride Pramipexole Dihydrochloride Extended-Release

Who makes Pramipexole: manufacturers and labelers

22 companies list Pramipexole products with the FDA. By number of product records, the largest are Alembic Pharmaceuticals Limited, Alembic Pharmaceuticals Inc., Macleods Pharmaceuticals Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Alembic Pharmaceuticals Limited 17 Alembic Pharmaceuticals Inc. 12 Macleods Pharmaceuticals Limited 12 Bryant Ranch Prepack 10 Ingenus Pharmaceuticals, LLC 7 Aurobindo Pharma Limited 6 Camber Pharmaceuticals, Inc. 6 Glenmark Pharmaceuticals Inc., USA 6 Golden State Medical Supply, Inc. 6 NorthStar RxLLC 6 Rising Pharma Holdings, Inc. 6 ScieGen Pharmaceuticals Inc 6 Strides Pharma Science Limited 6 Torrent Pharmaceuticals Limited 6 Unichem Pharmaceuticals (USA), Inc. 6 Dr. Reddy's Laboratories Limited 5 A-S Medication Solutions 4 American Health Packaging 3 NCS HealthCare of KY, LLC dba Vangard Labs 2 Vitruvias Therapeutics, Inc. 2 Xiamen LP Pharmaceutical Co., Ltd. 2 Major Pharmaceuticals 1

Pramipexole drug class (RxNorm)

Pramipexole belongs to the Nonergot Dopamine Agonist class.

Pharmacologic class Nonergot Dopamine Agonist
Drug family (ATC) Dopamine agonists
How it works Dopamine Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Pramipexole page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 13, 2016
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pramipexole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pramipexole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
37
Finished products in the current FDA directory
137
Companies listing them (makers, repackagers, distributors)
22
FDA labeler codes behind them ⓘ
24
Linked representative label ⓘ
Camber Pharmaceuticals, Inc.
Linked label effective
Oct 13, 2016
Composite sections available
23
Linked SPL Set ID
a7405a56-de1c-4875-b57f-210c991474ba
Linked SPL Document ID
540a17f8-b64d-41e1-a96b-d55bc8c48f3d
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Camber Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →