Tirosint (Levothyroxine Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage (see PRECAUTIONS and OVERDOSAGE). They include the following:

General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;
Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia;
Musculoskeletal: tremors, muscle weakness;
Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest;
Respiratory: dyspnea;
Gastrointestinal: diarrhea, vomiting, abdominal cramps and elevations in liver function tests;
Dermatologic: hair loss, flushing;
Endocrine: decreased bone mineral density;
Reproductive: menstrual irregularities, impaired fertility.

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height.

Seizures have been reported rarely with the institution of levothyroxine therapy.

Inadequate levothyroxine dosage will produce or fail to ameliorate the signs and symptoms of hypothyroidism.

Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO TIROSINT

Possible Tirosint side effects / adverse reactions in 70 year old female

Reported by a physician from Italy on 2007-02-05

Patient: 70 year old female

Reactions: Electrocardiogram QT Prolonged, Psychotic Disorder, Extrasystoles, Hypotension, Nuchal Rigidity, Coma, Neuroleptic Malignant Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Seroquel
    Administration route: Oral
    Indication: Bipolar I Disorder
    End date: 2007-01-05

Seroquel
    Administration route: Oral
    Start date: 2007-01-05
    End date: 2007-01-13

Lithium Carbonate
    Indication: Bipolar I Disorder
    End date: 2007-01-13

Lithium Carbonate
    Start date: 2007-01-15
    End date: 2007-01-16

Nitroglycerina Band AID
    Indication: Ischaemic Cardiomyopathy

Cabaser
    Administration route: Oral
    End date: 2007-01-13

Leponex
    Administration route: Oral
    End date: 2007-01-13

Congescor
    Indication: Ischaemic Cardiomyopathy
    End date: 2007-01-13

Cardirene
    Administration route: Oral
    Indication: Ischaemic Cardiomyopathy

Prelectal
    Administration route: Oral
    Indication: Ischaemic Cardiomyopathy

Tirosint
    Administration route: Oral
    Indication: Thyroid Disorder

Remeron
    Indication: Bipolar I Disorder
    Start date: 2007-01-05
    End date: 2007-01-13

Cimbalta
    Indication: Bipolar I Disorder
    Start date: 2007-01-05
    End date: 2007-01-13

Other drugs received by patient: Depakote

Possible Tirosint side effects / adverse reactions in 70 year old female

Reported by a physician from Italy on 2007-02-16

Patient: 70 year old female

Reactions: Electrocardiogram QT Prolonged, Psychotic Disorder, Extrasystoles, Hypotension, Nuchal Rigidity, Coma, Neuroleptic Malignant Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Seroquel
    Administration route: Oral
    Indication: Bipolar I Disorder
    End date: 2007-01-05

Seroquel
    Administration route: Oral
    Start date: 2007-01-05
    End date: 2007-01-13

Lithium Carbonate
    Indication: Bipolar I Disorder
    End date: 2007-01-13

Lithium Carbonate
    Start date: 2007-01-15
    End date: 2007-01-16

Nitroglycerina Band AID
    Indication: Ischaemic Cardiomyopathy

Cabaser
    Administration route: Oral
    End date: 2007-01-13

Clozapine
    Administration route: Oral
    End date: 2007-01-13

Congescor
    Indication: Ischaemic Cardiomyopathy
    End date: 2007-01-13

Cardirene
    Administration route: Oral
    Indication: Ischaemic Cardiomyopathy

Prelectal
    Administration route: Oral
    Indication: Ischaemic Cardiomyopathy

Tirosint
    Administration route: Oral
    Indication: Thyroid Disorder

Remeron
    Indication: Bipolar I Disorder
    Start date: 2007-01-05
    End date: 2007-01-13

Cimbalta
    Indication: Bipolar I Disorder
    Start date: 2007-01-05
    End date: 2007-01-13

Other drugs received by patient: Depakote