MedPath

Methimazole

Generic Name
Methimazole
Brand Names
Tapazole
Drug Type
Small Molecule
Chemical Formula
C4H6N2S
CAS Number
60-56-0
Unique Ingredient Identifier
554Z48XN5E

Overview

Methimazole is a thionamide antithyroid agent that inhibits the synthesis of thyroid hormones. It was first introduced as an antithyroid agent in 1949 and is now commonly used in the management of hyperthyroidism, particularly in those for whom more aggressive options such as surgery or radioactive iodine therapy are inappropriate. On a weight basis, methimazole is 10 times more potent than the other major antithyroid thionamide used in North America, propylthiouracil, and is the active metabolite of the pro-drug carbimazole, which is an antithyroid medication used in the United Kingdom and parts of the former British Commonwealth. Traditionally, methimazole has been preferentially used over propylthiouracil due to the risk of fulminant hepatotoxicity carried by the latter, with propylthiouracil being preferred in pregnancy due to a perceived lower risk of teratogenic effects. Despite documented teratogenic effects in its published labels, the true teratogenicity of methimazole appears to be unclear and its place in therapy may change in the future.

Indication

In the United States, methimazole is indicated for the treatment of hyperthyroidism in patients with Graves' disease or toxic multinodular goiter for whom thyroidectomy or radioactive iodine therapy are not appropriate treatment options. Methimazole is also indicated for the amelioration of hyperthyroid symptoms in preparation for thyroidectomy or radioactive iodine therapy. In Canada, methimazole carries the above indications and is also indicated for the medical treatment of hyperthyroidism regardless of other available treatment options.

Associated Conditions

  • Graves' Disease
  • Hyperthyroidism
  • Toxic multinodular goiter

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Preferred Pharmaceuticals Inc.
68788-8226
ORAL
5 mg in 1 1
8/2/2023
American Health Packaging
60687-680
ORAL
10 mg in 1 1
2/7/2023
Bryant Ranch Prepack
71335-0883
ORAL
10 mg in 1 1
3/24/2022
Bryant Ranch Prepack
63629-9251
ORAL
10 mg in 1 1
2/28/2022
Par Pharmaceutical, Inc.
49884-641
ORAL
10 mg in 1 1
5/3/2022
Bryant Ranch Prepack
63629-2224
ORAL
10 mg in 1 1
8/11/2023
State of Florida DOH Central Pharmacy
53808-0850
ORAL
10 mg in 1 1
9/25/2013
Chartwell RX, LLC
62135-205
ORAL
5 mg in 1 1
12/12/2022
Bryant Ranch Prepack
63629-9250
ORAL
5 mg in 1 1
2/28/2022
Rebel Distributors Corp.
42254-009
ORAL
10 mg in 1 1
7/6/2010

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
THYROZOL TABLET 5 mg
SIN09589P
TABLET, FILM COATED
5 mg
12/22/1997
THYROZOL TABLET 10 mg
SIN09588P
TABLET, FILM COATED
10 mg
12/22/1997

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
LICA TAB 5MG
N/A
N/A
N/A
4/28/1982

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
JAMP METHIMAZOLE
02490633
Tablet - Oral
10 MG
8/21/2021
METHIMAZOLE TABLETS USP
Endo Operations Ltd.
02489716
Tablet - Oral
5 MG
N/A
APO-METHIMAZOLE
02258935
Tablet - Oral
5 MG
3/18/2005
MAR-METHIMAZOLE
marcan pharmaceuticals inc
02480107
Tablet - Oral
5 MG
10/19/2018
DOM-METHIMAZOLE
dominion pharmacal
02265869
Tablet - Oral
5 MG
N/A
PHL-METHIMAZOLE
pharmel inc
02265850
Tablet - Oral
5 MG
N/A
TAPAZOLE
Endo Operations Ltd.
00015741
Tablet - Oral
5 MG
12/31/1951
METHIMAZOLE TABLETS USP
Endo Operations Ltd.
02489732
Tablet - Oral
20 MG
N/A
JAMP METHIMAZOLE
02490625
Tablet - Oral
5 MG
8/21/2020
MAR-METHIMAZOLE
marcan pharmaceuticals inc
02480115
Tablet - Oral
10 MG
10/19/2018

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TIRODRIL 5mg COMPRIMIDOS
Laboratorio Estedi S.L.
24700
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TIRODRIL 10 MG COMPRIMIDOS
Laboratorio Estedi S.L.
84928
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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