What this pack is
MIRAPEX / MIRAPEX ER is the brand name in this record; pramipexole dihydrochloride immediate-release and extended-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
MIRAPEX / MIRAPEX ERGeneric namepramipexole dihydrochloride immediate-release and extended-release tablets
Mainland China pack-name cue森福罗®Historical or public source cue · verify the current target-market record · Open reference ↗
How this medicine works
The FDA label describes pramipexole as a non-ergot dopamine-receptor agonist selective for the D2 family, with higher affinity for D3 than D2 or D4. Its precise mechanism in Parkinson's disease remains incompletely defined. Mechanism cannot replace diagnosis, benefit assessment or an individual treatment decision.
Read source: United States ↗reviewed 2026-09-06More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- Mainland China pack-name cue
- 森福罗®
- International brand name
- MIRAPEX / MIRAPEX ER
- Generic name
- pramipexole dihydrochloride immediate-release and extended-release tablets
- Dosage-form class
- Historical MIRAPEX immediate-release oral-tablet strengths are 0.125, 0.25, 0.5, 0.75, 1, 1.25 and 1.5 mg; MIRAPEX ER extended-release oral-tablet strengths are 0.375, 0.75, 1.5, 2.25, 3, 3.75 and 4.5 mg. Immediate-release and extended-release products have different release, labelling and use pathways and must not be self-converted, assembled, split, alternated or substituted from total milligrams.
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
Mainland China trade-name search cue:森福罗®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility. Open reference ↗
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
13 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
0.125 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole immediate-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 0.125 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
0.25 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole immediate-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 0.25 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
0.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole immediate-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 0.5 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
0.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole immediate-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 0.75 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
1 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole immediate-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 1 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
1.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole immediate-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 1.5 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
0.375 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole extended-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 0.375 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
0.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole extended-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 0.75 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
1.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole extended-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 1.5 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
2.25 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole extended-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 2.25 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
3 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole extended-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 3 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
3.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole extended-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 3.75 mgPer tablet
United States label · U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10
4.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Form and route
- Pramipexole extended-release tablet · Oral
- Listing review
- Cited product evidence reviewed 2026-09-10; actual marketing, stock and availability are not established.
- Pramipexole dihydrochloride monohydrate
- 4.5 mgPer tablet
PACKAGE-VISUAL STATUS
MIRAPEX pack images withheld: a historical carton document exists, but a complete exact presentation-matched public image set has not been retained
An FDA 2020 document contains the historical MIRAPEX 0.25 mg, NDC 0597-0184-61, 100-tablet carton layout. That single historical carton cannot represent seven immediate-release strengths, seven ER strengths, current generics or another market. To avoid treating a dieline, repackaged image or another strength as an exact current pack, the page withholds pack imagery and does not present a supposed current originator appearance; it retains the official-document route instead.
LABEL READING · NOT A PRESCRIPTION
MIRAPEX / pramipexole enlarged label: separate IR from ER, then review sudden sleep, blood pressure, behaviour and kidney function
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The labels prioritise sudden sleep, somnolence, orthostatic hypotension, impulse-control problems, hallucinations/psychotic-like behaviour, dyskinesia, postural deformity, renal function and withdrawal symptoms. Hallucination risk is higher in older people and renal clearance may decline with age. The page provides a review route, not an individual dose, frequency, taper or formulation switch.
- Sudden sleep can occur during daily activities without clear warning. Falling asleep while driving, eating, talking or another activity, unusual somnolence, altered awareness or accident risk requires stopping hazardous activity and prompt clinical contact; severe acute situations require local emergency help.
- Orthostatic hypotension, dizziness or fainting can occur during initiation or escalation. Older age, dehydration, antihypertensives or other sedating/hypotensive medicines requires priority fall-risk review; do not self-catch up, stop or reschedule.
- Caregivers should also watch for gambling, shopping, eating, sexual or other difficult-to-control urges, and for hallucinations, delusions, confusion or marked behavioural change. Hallucination risk is higher in older adults; this is not a moral failing and should be reported promptly with the complete medicine list.
- Pramipexole is eliminated mainly by the kidneys, so renal function affects clearance. Older people or those with changing kidney function cannot copy another person's milligrams, tablet count or frequency; the site does not generate a plan from age, creatinine or eGFR.
- Levodopa co-use can worsen dyskinesia. Immediate-release and ER pramipexole, ropinirole, rotigotine patches and other dopaminergic medicines cannot be self-combined, rotated or substituted by shared mechanism or milligrams. Dopamine antagonists may also affect response, so a pharmacist should review the full list.
- The labels describe withdrawal symptoms and clinician-directed gradual discontinuation. Abrupt stopping or rapid reduction can be associated with fever, altered consciousness, rigidity, anxiety, depression, fatigue, pain, insomnia and other symptoms. Do not self-stop or copy a taper from the page.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-06
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 4
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. generic label for pramipexole dihydrochloride immediate-release tablets (updated 31 Mar 2026) ↗Current regulatory record · reviewed 2026-09-06
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-09-06FDA: prescribing information for MIRAPEX pramipexole dihydrochloride immediate-release tablets (NDA 020667; Jul 2021 version) ↗reviewed 2026-09-06
- FDA · United States · Regulatory product record or label archive · 2026-09-06FDA: prescribing information for MIRAPEX ER pramipexole dihydrochloride extended-release tablets (NDA 022421; Jul 2021 version) ↗reviewed 2026-09-06
- FDA · United States · Regulatory product record or label archive · 2026-09-02FDA Orange Book, 46th Edition (2026): strengths, RLD identity and discontinued status for MIRAPEX NDA 020667 and MIRAPEX ER NDA 022421 ↗Current regulatory record · reviewed 2026-09-02
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about MIRAPEX / MIRAPEX ER (pramipexole dihydrochloride immediate-release and extended-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
MIRAPEX / MIRAPEX ER is the brand in this record and pramipexole dihydrochloride immediate-release and extended-release tablets is the active-ingredient name. Check both with the dosage form (Historical MIRAPEX immediate-release oral-tablet strengths are 0.125, 0.25, 0.5, 0.75, 1, 1.25 and 1.5 mg; MIRAPEX ER extended-release oral-tablet strengths are 0.375, 0.75, 1.5, 2.25, 3, 3.75 and 4.5 mg. Immediate-release and extended-release products have different release, labelling and use pathways and must not be self-converted, assembled, split, alternated or substituted from total milligrams.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. generic label for pramipexole dihydrochloride immediate-release tablets (updated 31 Mar 2026) ↗Current regulatory record · reviewed 2026-09-06
- FDA: prescribing information for MIRAPEX pramipexole dihydrochloride immediate-release tablets (NDA 020667; Jul 2021 version) ↗reviewed 2026-09-06
- FDA: prescribing information for MIRAPEX ER pramipexole dihydrochloride extended-release tablets (NDA 022421; Jul 2021 version) ↗reviewed 2026-09-06
- FDA Orange Book, 46th Edition (2026): strengths, RLD identity and discontinued status for MIRAPEX NDA 020667 and MIRAPEX ER NDA 022421 ↗Current regulatory record · reviewed 2026-09-02
HOW IT WORKS · NOT A TREATMENT PLAN
How pramipexole works: a dopamine D2-family agonist with higher affinity for D3
- Related dopamine action does not make medicines identical. Pramipexole cannot be self-converted, combined or rotated by milligrams with levodopa/carbidopa, ropinirole, rotigotine, apomorphine or another Parkinson's medicine.
- Immediate-release and ER tablets share an ingredient but differ in release structure. Even when a historical label includes clinician-directed conversion information, it does not permit self-switching by total milligrams, splitting or changing frequency; ER tablets are swallowed whole.
- D3 activity does not imply a need for whole-genome screening. The current label does not make whole-genome screening a routine prerequisite for everyone; kidney function, symptoms, tolerability and the complete medicine list require review for the actual question.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. generic label for pramipexole dihydrochloride immediate-release tablets (updated 31 Mar 2026) ↗Current regulatory record · reviewed 2026-09-06
- FDA: prescribing information for MIRAPEX pramipexole dihydrochloride immediate-release tablets (NDA 020667; Jul 2021 version) ↗reviewed 2026-09-06
- FDA: prescribing information for MIRAPEX ER pramipexole dihydrochloride extended-release tablets (NDA 022421; Jul 2021 version) ↗reviewed 2026-09-06
- FDA: historical MIRAPEX immediate-release 0.25 mg, NDC 0597-0184-61, 100-tablet carton label (2020 approval document) ↗reviewed 2026-09-06
- FDA Orange Book, 46th Edition (2026): strengths, RLD identity and discontinued status for MIRAPEX NDA 020667 and MIRAPEX ER NDA 022421 ↗Current regulatory record · reviewed 2026-09-02
SOURCE-TRACEABLE ARCHIVE
MIRAPEX / MIRAPEX ERpramipexole dihydrochloride immediate-release and extended-release tablets
This page links to public primary-source material for MIRAPEX / MIRAPEX ER. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval of MIRAPEX immediate-release tablets
The Orange Book lists 1 July 1997 for the initial 0.125, 0.25, 1, 1.25 and 1.5 mg approvals and retains several strengths as historical RLD products.
FDA Orange Book, 46th Edition (2026): strengths, RLD identity and discontinued status for MIRAPEX NDA 020667 and MIRAPEX ER NDA 022421 ↗U.S. approval of MIRAPEX ER
The 0.375, 0.75, 1.5, 3 and 4.5 mg ER tablets under NDA 022421 were approved on this date; 2.25 and 3.75 mg followed in 2011.
FDA Orange Book, 46th Edition (2026): strengths, RLD identity and discontinued status for MIRAPEX NDA 020667 and MIRAPEX ER NDA 022421 ↗FDA updated behavioural, hallucination and withdrawal warnings for IR and ER
Both labels retain sudden-sleep, orthostatic-hypotension, impulse-control and hallucination warnings and add or strengthen withdrawal information.
FDA: prescribing information for MIRAPEX pramipexole dihydrochloride immediate-release tablets (NDA 020667; Jul 2021 version) ↗Current U.S. generic label updated
The current DailyMed immediate-release generic label supplies current safety reading without replacing historical MIRAPEX brand identity.
DailyMed (NLM): current U.S. generic label for pramipexole dihydrochloride immediate-release tablets (updated 31 Mar 2026) ↗
MARKET SCOPE
Market-record boundary
United States — MIRAPEX immediate-release
Historical originator/RLD; brand rows currently discontinuedAll seven strengths are historical brand records. Accessible labels and carton documents do not establish current brand stock.
United States — MIRAPEX ER
Historical ER RLD; brand rows currently discontinuedSeven ER strengths belong to separate NDA 022421 and cannot be automatically merged with immediate-release tablets by name or total milligrams.
Mainland China, EU, Japan and other markets
Exact market-product records not yet establishedNo local approval, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. NDAs, historical trade names, strengths or a shared generic name.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
Mainland China trade-name search cue: 森福罗®
This cue helps read packaging and search official records. It does not establish current approval, holder, strength, originator relationship, supply or sale eligibility. Open historical reference ↗
RECORD FAQ
Record questions
Does 0.25 mg mean two 0.125 mg tablets per day?
The page cannot make that conversion. Milligrams are the labelled amount per tablet; individual tablet count, frequency and IR/ER form require professional confirmation from the exact prescription, indication, kidney function, symptoms and full medicine list.
Can immediate-release tablets be switched to the same total milligrams of MIRAPEX ER?
A webpage cannot authorise this. Release structure, labelled use and administration pathway differ. Clinician-directed conversion content in a historical label is not permission to self-switch formulations.
What if hallucinations, sudden sleep or unusual urges occur?
Stop driving and other hazardous activities, contact the prescribing team promptly, and have a caregiver describe changes and the full medicine list. Severe altered awareness, an accident, fall injury or another acute danger requires local emergency help; do not abruptly stop the medicine yourself.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.