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LEVOTHYROX

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Levothyrox Adverse Events Reported to the FDA Over Time

How are Levothyrox adverse event reports trending over time?

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

Most Common Levothyrox Adverse Events Reported to the FDA

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

Renal Failure Acute
31 (2.33%)
Dyspnoea
24 (1.8%)
Anaemia
21 (1.58%)
Fall
19 (1.43%)
Drug Interaction
15 (1.13%)
Gastrointestinal Haemorrhage
14 (1.05%)
Pyrexia
14 (1.05%)
Haemoglobin Decreased
13 (.98%)
Cough
11 (.83%)
Drug Exposure During Pregnancy
11 (.83%)
Eosinophilia
11 (.83%)
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International Normalised Ratio Incr...
11 (.83%)
Asthenia
10 (.75%)
C-reactive Protein Increased
10 (.75%)
Hyperkalaemia
10 (.75%)
Lung Disorder
10 (.75%)
Peritoneal Haemorrhage
10 (.75%)
Bradycardia
9 (.68%)
Cardio-respiratory Arrest
9 (.68%)
Disorientation
9 (.68%)
Hypotension
9 (.68%)
Malaise
9 (.68%)
Metabolic Acidosis
9 (.68%)
Overdose
9 (.68%)
Pruritus
9 (.68%)
Rectal Haemorrhage
9 (.68%)
Vomiting
9 (.68%)
Cardiac Failure
8 (.6%)
Cholestasis
8 (.6%)
Confusional State
8 (.6%)
Convulsion
8 (.6%)
Faecal Vomiting
8 (.6%)
General Physical Health Deteriorati...
8 (.6%)
Haematuria
8 (.6%)
Loss Of Consciousness
8 (.6%)
Pelvic Pain
8 (.6%)
Toxic Skin Eruption
8 (.6%)
Urticaria
8 (.6%)
Atrioventricular Block Complete
7 (.53%)
Blood Thyroid Stimulating Hormone I...
7 (.53%)
Cytolytic Hepatitis
7 (.53%)
Dermatitis Bullous
7 (.53%)
Head Injury
7 (.53%)
Hypothermia
7 (.53%)
Lymphopenia
7 (.53%)
Oedema Peripheral
7 (.53%)
Agitation
6 (.45%)
Dermatitis Exfoliative
6 (.45%)
Dialysis
6 (.45%)
Generalised Erythema
6 (.45%)
Haemorrhoids
6 (.45%)
Hypokalaemia
6 (.45%)
Hypovolaemia
6 (.45%)
Interstitial Lung Disease
6 (.45%)
Myocardial Ischaemia
6 (.45%)
Night Sweats
6 (.45%)
Oedema
6 (.45%)
Osteonecrosis
6 (.45%)
Papilloedema
6 (.45%)
Visual Acuity Reduced
6 (.45%)
Abdominal Pain
5 (.38%)
Coma
5 (.38%)
Deep Vein Thrombosis
5 (.38%)
Dysphagia
5 (.38%)
Epistaxis
5 (.38%)
Hyperlactacidaemia
5 (.38%)
Localised Oedema
5 (.38%)
Lymphadenopathy
5 (.38%)
Mitral Valve Incompetence
5 (.38%)
Multi-organ Failure
5 (.38%)
Pancreatitis Acute
5 (.38%)
Pulmonary Embolism
5 (.38%)
Rash Maculo-papular
5 (.38%)
Renal Failure
5 (.38%)
Somnolence
5 (.38%)
Staphylococcal Infection
5 (.38%)
Thrombocytopenia
5 (.38%)
Tongue Oedema
5 (.38%)
Tremor
5 (.38%)
Tuberculosis
5 (.38%)
Urinary Tract Infection
5 (.38%)
Accidental Overdose
4 (.3%)
Anaemia Haemolytic Autoimmune
4 (.3%)
Areflexia
4 (.3%)
Atrial Fibrillation
4 (.3%)
Blood Alkaline Phosphatase Increase...
4 (.3%)
Blood Creatinine Increased
4 (.3%)
Blood Pressure Diastolic Decreased
4 (.3%)
Cardiac Murmur
4 (.3%)
Coagulopathy
4 (.3%)
Decreased Appetite
4 (.3%)
Depressed Level Of Consciousness
4 (.3%)
Diarrhoea
4 (.3%)
Electrocardiogram Qt Prolonged
4 (.3%)
Extrapyramidal Disorder
4 (.3%)
Fatigue
4 (.3%)
Haematoma
4 (.3%)
Hepatitis
4 (.3%)
Hypercalcaemia
4 (.3%)
Hyperhidrosis
4 (.3%)
Hyponatraemia
4 (.3%)

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This graph shows the top adverse events submitted to the FDA for Levothyrox, 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 Levothyrox 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 Levothyrox

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

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This graph shows the top categories of adverse events submitted to the FDA for Levothyrox, 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 Levothyrox 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 Levothyrox According to Those Reporting Adverse Events

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

Hypothyroidism
418
Drug Use For Unknown Indication
148
Product Used For Unknown Indication
50
Thyroid Disorder
37
Thyroidectomy
29
Hypopituitarism
17
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Autoimmune Thyroiditis
14
Hyperthyroidism
13
Goitre
9
Thyroid Neoplasm
9
Blood Thyroid Stimulating Hormone D...
9
Thyroiditis
8
Primary Hypothyroidism
8
Secondary Hypothyroidism
5
Ill-defined Disorder
4
Basedows Disease
4
Post Procedural Hypothyroidism
3
Thyroidectomy Partial
2
Hormone Replacement Therapy
2
Hypophysectomy
2
Hiv Infection
2
Unevaluable Event
2
Thyroid Cancer
2
Supplementation Therapy
1
Thyroid Operation
1
Hypothalamo-pituitary Disorders
1
Congenital Hypothyroidism
1
Blood Thyroid Stimulating Hormone A...
1
Bipolar I Disorder
1

Levothyrox Case Reports

What Levothyrox 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 Levothyrox. 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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