What this pack is
TAPAZOLE is the brand name in this record; methimazole is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
TAPAZOLEGeneric namemethimazole
How this medicine works
The product monograph explains that methimazole inhibits thyroid-hormone synthesis but does not inactivate hormone already stored in the thyroid or circulating in blood. Improvement may therefore take time; the mechanism cannot be used to self-increase, stop or decide that thyroid status has normalised.
Read source: Canada ↗reviewed 2026-08-31More 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.
- International brand name
- TAPAZOLE
- Source-scoped market brand names
- TAPAZOLE · United StatesHistorical public record ↗Historical 5 mg and 10 mg RLD products under NDA 007517 are currently listed as discontinued; this is not a current brand-supply record.
- TAPAZOLE · CanadaHistorical public record ↗The 5 mg and 10 mg products were both listed Cancelled Post Market on 16 Jul 2026; the 19 Dec 2025 product monograph remains a dated label archive.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- methimazole
- Dosage-form class
- Historical brand oral tablets: methimazole 5 mg or 10 mg per tablet. The 5 mg and 10 mg figures are amounts per tablet, not a personal tablet count supplied by the site. U.S., Canadian and current generic records must be reviewed separately.
- 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 →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
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.
4 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 · Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)
Methimazole 5 mg per tablet; historical U.S. RLD currently listed as discontinued
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.
- Product code
- NDA 007517 / Product 002
- Form and route
- TAPAZOLE methimazole 5 mg oral tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- methimazole
- 5 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or adjustment instruction
United States label · Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)
Methimazole 10 mg per tablet; historical U.S. RLD currently listed as discontinued
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.
- Product code
- NDA 007517 / Product 004
- Form and route
- TAPAZOLE methimazole 10 mg oral tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- methimazole
- 10 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or adjustment instruction
CA · Health Canada product monograph dated 19 Dec 2025; DPD status dated 16 Jul 2026
Methimazole 5 mg per tablet; DPD listed Cancelled Post Market on 16 Jul 2026
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.
- Product code
- DIN 00015741
- Form and route
- TAPAZOLE methimazole 5 mg oral tablet (historical Canadian brand record) · oral (historical Canadian regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- methimazole
- 5 mgproduct-monograph amount per tablet; not an individual's tablet count, frequency or adjustment instruction
CA · Health Canada product monograph dated 19 Dec 2025; DPD status dated 16 Jul 2026
Methimazole 10 mg per tablet; DPD listed Cancelled Post Market on 16 Jul 2026
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.
- Product code
- DIN 02296039
- Form and route
- TAPAZOLE methimazole 10 mg oral tablet (historical Canadian brand record) · oral (historical Canadian regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- methimazole
- 10 mgproduct-monograph amount per tablet; not an individual's tablet count, frequency or adjustment instruction
PACKAGE-VISUAL STATUS
No official principal pack image was obtained one-to-one for the four historical product identities
The page lists the historical U.S. and Canadian 5 mg / 10 mg product identities only from the FDA Orange Book, Health Canada DPD and product monograph. Current generics, retail images, old advertising and look-alike white round tablets are not substituted for brand packaging. Colour, imprint, pack count and authenticity require the actual product and its matching current label.
LABEL READING · NOT A PRESCRIPTION
TAPAZOLE label reading: fever, chills or sore throat must not be dismissed as an ordinary cold
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 product monograph places agranulocytosis and liver toxicity in the serious warnings. Fever, chills, sore throat, repeated infection, jaundice, dark urine, right-upper abdominal pain or unusual fatigue requires timely assessment through local urgent and clinical services. Do not use the website alone to stop, switch, make up or wait.
- 5 mg and 10 mg are amounts of methimazole per tablet, not the number of tablets to take. An individual plan depends on thyroid function, cause, age, pregnancy, other medicines and monitoring results; the site does not convert laboratory values into tablet counts.
- Fever, chills, sore throat, mouth ulcers or frequent infection may relate to severe white-cell reduction. Do not self-continue, stop or mask it with an antibacterial because it resembles a cold; contact the prescriber or local urgent service promptly as directed by the label.
- Yellow skin or eyes, dark urine, right-upper abdominal pain, persistent nausea or vomiting, marked appetite loss or unusual fatigue may signal liver injury and needs prompt professional assessment.
- Tell the prescribing team promptly about pregnancy, plans for pregnancy or possible pregnancy; the label highlights first-trimester risk. The site does not choose methimazole, propylthiouracil or another option for an individual.
- Warfarin or another anticoagulant, theophylline and medicines that may affect white cells, liver or thyroid status belong on one complete list for review. Changes in thyroid status itself may alter monitoring needs for co-medications.
- The historical TAPAZOLE brand records and current same-ingredient generics are not one visual package. A white round tablet, a score or the same mg figure cannot establish authenticity, manufacturer or interchangeability.
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 checkHealth Canada · Canada · Regulatory product record or current product monograph · 2026-08-31
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
- Canada · 1
- United States · 1
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 routeHealth Canada: TAPAZOLE 5 mg / 10 mg product monograph and patient medication information (19 Dec 2025) ↗reviewed 2026-08-31
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 · 2026-08-29FDA Orange Book: historical TAPAZOLE / methimazole NDA 007517 RLD records for 5 mg and 10 mg ↗reviewed 2026-08-29
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 TAPAZOLE (methimazole). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
TAPAZOLE is the brand in this record and methimazole is the active-ingredient name. Check both with the dosage form (Historical brand oral tablets: methimazole 5 mg or 10 mg per tablet. The 5 mg and 10 mg figures are amounts per tablet, not a personal tablet count supplied by the site. U.S., Canadian and current generic records must be reviewed separately.) 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How methimazole works: it reduces new thyroid-hormone synthesis but does not immediately remove hormone already present
- Palpitations, tremor, heat intolerance, weight or sleep change may arise from hyperthyroidism, hypothyroidism, another illness or medicines. Similar symptoms do not justify self-combining, alternating or offsetting an antithyroid medicine with levothyroxine.
- Methimazole, propylthiouracil and carbimazole are not one product interchangeable milligram for milligram. Brand, active ingredient, strength, market and label must be checked together.
- The page explains why monitoring matters but does not interpret an individual's laboratory results or provide stopping, reduction, make-up, alternating or course decisions.
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.
- FDA Orange Book: historical TAPAZOLE / methimazole NDA 007517 RLD records for 5 mg and 10 mg ↗reviewed 2026-08-29
- Health Canada: current Drug Product Database (DPD) access page; search TAPAZOLE 5 mg / DIN 00015741 in the database ↗Official lookup entry · reviewed 2026-09-13
- Health Canada: current Drug Product Database (DPD) access page; search TAPAZOLE 10 mg / DIN 02296039 in the database ↗Official lookup entry · reviewed 2026-09-13
- Health Canada: TAPAZOLE 5 mg / 10 mg product monograph and patient medication information (19 Dec 2025) ↗reviewed 2026-08-31
- Health Canada: current Drug Product Database (DPD) access page; search methimazole 5 mg in the database ↗Official lookup entry · reviewed 2026-09-13
- Health Canada: current Drug Product Database (DPD) access page; search methimazole 10 mg in the database ↗Official lookup entry · reviewed 2026-09-13
SOURCE-TRACEABLE ARCHIVE
TAPAZOLEmethimazole
This page links to public primary-source material for TAPAZOLE. 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
Earliest Canadian market date for TAPAZOLE 5 mg
Health Canada DPD records 31 Dec 1951 as the earliest market date for DIN 00015741. This is historical brand chronology, not current supply.
Health Canada: current Drug Product Database (DPD) access page; search TAPAZOLE 5 mg / DIN 00015741 in the database ↗Historical U.S. approval of TAPAZOLE NDA 007517
Orange Book lists the historical 5 mg and 10 mg products as RLD and discontinued, with a determination that they were not withdrawn for safety or effectiveness reasons.
FDA Orange Book: historical TAPAZOLE / methimazole NDA 007517 RLD records for 5 mg and 10 mg ↗Canadian product monograph revised
The dated monograph covers 5 mg and 10 mg tablets, serious warnings, patient information and mechanism. An accessible document does not establish current brand supply.
Health Canada: TAPAZOLE 5 mg / 10 mg product monograph and patient medication information (19 Dec 2025) ↗Canadian 5 mg and 10 mg brand DINs moved to Cancelled Post Market
DPD displays Cancelled Post Market for DIN 00015741 and 02296039. This live status supersedes the stale Marketed value in the imported 26 Aug 2026 index.
Health Canada: current Drug Product Database (DPD) access page; search TAPAZOLE 10 mg / DIN 02296039 in the database ↗
MARKET SCOPE
Market-record boundary
United States
Historical RLD; currently discontinuedThe 5 mg and 10 mg products are historical RLDs under NDA 007517 and are listed discontinued; this is not current brand stock or a purchase route.
Canada
Brand 5 mg and 10 mg both Cancelled Post MarketBoth DPD status dates are 16 Jul 2026. Current marketed same-ingredient generics require their own DIN and label review and do not inherit TAPAZOLE package identity.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local brand, approval, supply, packaging, authenticity or interchangeability is inferred from the names methimazole, thiamazole, 甲巯咪唑 or 甲硫咪唑.
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.
RECORD FAQ
Record questions
Are fever and sore throat just a cold?
While taking methimazole, these cannot be treated as an ordinary cold alone because the label lists fever, chills, sore throat and frequent infection as warning features of agranulocytosis. Contact the prescriber or local urgent service promptly as directed by the label; the site cannot replace a blood test.
Does halving a 5 mg tablet equal 2.5 mg, and can I do that myself?
Do not decide this from the website. Historical brand and current generic products, scores and labelled amounts may differ. A pharmacist must check the exact product label and prescription before any splitting decision.
Can the medicine be stopped immediately once thyroid tests are normal?
Do not self-stop. Methimazole affects new hormone synthesis, while existing hormone, disease cause, relapse risk and the monitoring plan still require professional judgement. The site does not interpret personal results or create a stopping plan.
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.