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METHIMAZOLE

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Methimazole Adverse Events Reported to the FDA Over Time

How are Methimazole adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Methimazole, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Methimazole is flagged as the suspect drug causing the adverse event.

Most Common Methimazole Adverse Events Reported to the FDA

What are the most common Methimazole adverse events reported to the FDA?

Pyrexia
43 (2.44%)
Drug Exposure During Pregnancy
36 (2.04%)
Agranulocytosis
35 (1.99%)
Arthralgia
22 (1.25%)
Dysmorphism
22 (1.25%)
Rash
20 (1.14%)
Asthenia
17 (.96%)
Pruritus
17 (.96%)
Choanal Atresia
16 (.91%)
Hyperthyroidism
16 (.91%)
Caesarean Section
13 (.74%)
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Dyspnoea
13 (.74%)
Jaundice Cholestatic
12 (.68%)
Chills
11 (.62%)
Pancytopenia
11 (.62%)
Premature Baby
11 (.62%)
Cutaneous Vasculitis
10 (.57%)
Leukopenia
10 (.57%)
Lymphadenopathy
10 (.57%)
Muscle Spasms
10 (.57%)
Cholecystitis
9 (.51%)
Heart Rate Increased
9 (.51%)
Neutropenia
9 (.51%)
Pain
9 (.51%)
Renal Failure Acute
9 (.51%)
Tachycardia
9 (.51%)
Thyroid Disorder
9 (.51%)
Alanine Aminotransferase Increased
8 (.45%)
Aplasia Cutis Congenita
8 (.45%)
Drug Hypersensitivity
8 (.45%)
Fatigue
8 (.45%)
Hypothyroidism
8 (.45%)
Jaundice
8 (.45%)
Maternal Drugs Affecting Foetus
8 (.45%)
Nausea
8 (.45%)
Pneumonia
8 (.45%)
Skull Malformation
8 (.45%)
Thrombocytopenia
8 (.45%)
Vomiting
8 (.45%)
Alopecia
7 (.4%)
Aspartate Aminotransferase Increase...
7 (.4%)
Clinodactyly
7 (.4%)
Congenital Anomaly
7 (.4%)
Diarrhoea
7 (.4%)
Exomphalos
7 (.4%)
Haemoglobin Decreased
7 (.4%)
Headache
7 (.4%)
Hepatic Failure
7 (.4%)
Liver Function Test Abnormal
7 (.4%)
Malaise
7 (.4%)
Myalgia
7 (.4%)
Oropharyngeal Pain
7 (.4%)
Pain In Extremity
7 (.4%)
Paraesthesia
7 (.4%)
Stevens-johnson Syndrome
7 (.4%)
Blood Alkaline Phosphatase Increase...
6 (.34%)
Cyanosis
6 (.34%)
Drug Eruption
6 (.34%)
Drug Ineffective
6 (.34%)
Goitre
6 (.34%)
Haematoma
6 (.34%)
Hepatitis
6 (.34%)
Hyperbilirubinaemia
6 (.34%)
Hypotension
6 (.34%)
International Normalised Ratio Incr...
6 (.34%)
Musculoskeletal Stiffness
6 (.34%)
Skin Disorder
6 (.34%)
Skin Lesion
6 (.34%)
Thirst
6 (.34%)
Thyrotoxic Crisis
6 (.34%)
Weight Decreased
6 (.34%)
White Blood Cell Count Decreased
6 (.34%)
Abdominal Pain Upper
5 (.28%)
Acute Generalised Exanthematous Pus...
5 (.28%)
Altered State Of Consciousness
5 (.28%)
Anaemia
5 (.28%)
Chest Discomfort
5 (.28%)
Cholelithiasis
5 (.28%)
Dysphagia
5 (.28%)
Excoriation
5 (.28%)
Febrile Neutropenia
5 (.28%)
Gastrointestinal Haemorrhage
5 (.28%)
Hypersensitivity
5 (.28%)
Infection
5 (.28%)
Insomnia
5 (.28%)
Joint Effusion
5 (.28%)
Medication Error
5 (.28%)
Muscle Disorder
5 (.28%)
Muscular Weakness
5 (.28%)
Necrotising Fasciitis
5 (.28%)
Neonatal Respiratory Distress Syndr...
5 (.28%)
Neutrophil Count Decreased
5 (.28%)
Ovarian Cyst
5 (.28%)
Palpitations
5 (.28%)
Pancreatitis
5 (.28%)
Pancreatitis Acute
5 (.28%)
Red Blood Cell Count Decreased
5 (.28%)
Respiratory Failure
5 (.28%)
Small For Dates Baby
5 (.28%)
Somnolence
5 (.28%)
Swelling
5 (.28%)

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This graph shows the top adverse events submitted to the FDA for Methimazole, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Methimazole is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Methimazole

What are the most common Methimazole adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Methimazole, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Methimazole is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Methimazole According to Those Reporting Adverse Events

Why are people taking Methimazole, according to those reporting adverse events to the FDA?

Hyperthyroidism
247
Basedows Disease
97
Thyroid Disorder
36
Product Used For Unknown Indication
32
Drug Use For Unknown Indication
23
Hypothyroidism
20
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Goitre
6
Toxic Nodular Goitre
6
Ill-defined Disorder
6
Corneal Pigmentation
3
Hypertension
2
Atrial Fibrillation
2
Arthralgia
1
Haemoptysis
1
Nausea
1
Rash
1
Glomerulonephritis
1
Drug Exposure During Pregnancy
1
Thyroid Therapy
1
Upper Respiratory Tract Infection
1
Bipolar I Disorder
1
Thyrotoxic Crisis
1
Thyroid Function Test Abnormal
1
Thyroiditis
1
Thyroxine Increased
1
Mania
1
Oedema
1
Insulin Autoimmune Syndrome
1

Drug Labels

LabelLabelerEffective
MethimazoleNCS HealthCare of KY, Inc dba Vangard Labs13-APR-11
MethimazoleRebel Distributors Corp.18-OCT-11
MethimazoleREMEDYREPACK INC. 01-NOV-11
MethimazolePar Pharmaceutical Inc01-JAN-12
MethimazoleHeritage Pharmaceuticals Inc.16-JAN-12
MethimazoleBoca Pharmacal, Inc.08-MAR-12
TapazoleKing Pharmaceuticals, Inc.12-APR-12
MethimazoleEon Labs, Inc.11-MAY-12
MethimazoleAmerican Health Packaging30-MAY-12
MethimazoleExact-Rx, Inc.11-OCT-12
MethimazoleBryant Ranch Prepack12-OCT-12
MethimazolePhysicians Total Care, Inc.06-FEB-13
TapazoleREMEDYREPACK INC. 18-FEB-13
TapazoleREMEDYREPACK INC. 13-MAR-13
MethimazoleREMEDYREPACK INC. 18-MAR-13

Methimazole Case Reports

What Methimazole safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Methimazole. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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