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Important Safety Information
WARNING: You should not use thyroid hormone, including LEVOXYL® (levothyroxine sodium), alone or with other drugs to treat obesity or for weight loss. The normal daily doses of thyroid hormone are not effective for weight loss if your thyroid function is normal. If you take larger-than-normal doses of thyroid hormone you may get serious or even life-threatening side effects, particularly if you also take certain stimulant weight loss drugs.

You should not use LEVOXYL:

  • If you have untreated or known overactive thyroid of any cause, heart attack or untreated low adrenal gland function.
  • If you are allergic to any of the inactive ingredients in the tablets. Notify your physician if you experience hives, itching, rash, flushing, swelling of the throat, abdominal pain, nausea, vomiting, diarrhea, fever, joint pain, or wheezing, as these may be the symptoms of an allergic reaction.
  • For the treatment of male or female infertility unless this condition is due to low thyroid function.
  • In a certain type of goiter or for thyroid small masses (particularly in the elderly or those with heart and blood vessel disease), if the TSH level is already lowered. If the TSH level is not lowered, LEVOXYL should be used with caution.

To avoid, under- or over-treatment with LEVOXYL, carefully follow the dosage instructions given by your health care provider. Do not discontinue or change the amount you take or how often you take it, unless directed to do so by your physician. Because many drugs interact with levothyroxine sodium, your doctor may need to make adjustments in dosing to maintain therapeutic response.

Long-term therapy with LEVOXYL, especially in women after menopause may decrease bone mineral density.

Tell your physician if you are allergic to any foods or medicines, are pregnant or intend to become pregnant, are breast-feeding or are taking any other medications, including prescription and over-the-counter preparations. If you become pregnant while taking LEVOXYL, it is likely that your dose will need to be increased while you are pregnant.

Tell your physician of any other medical conditions you may have, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems. Your dose of medications used to control these other conditions may need to be adjusted while you are taking LEVOXYL.

While taking LEVOXYL, there is a risk of high blood pressure, heart failure, heart attack, and cardiac arrest, as well as growth changes in children.

Tell your physician if you experience any of the following adverse events, or any other unusual medical events:

  • Rapid or irregular heartbeat
  • Chest pain
  • Shortness of breath
  • Leg cramps
  • Headache
  • Nervousness
  • Irritability
  • Sleeplessness
  • Tremors
  • Change in appetite
  • Weight gain or loss
  • Vomiting
  • Diarrhea
  • Excessive sweating
  • Heat intolerance
  • Fever
  • Changes in menstrual periods
  • Hives or skin rash
  • Partial temporary hair loss

Take LEVOXYL in the morning on an empty stomach, at least one-half hour before eating any food. It is very important that you take the tablet with a full glass of water to avoid choking, gagging, tablet getting stuck in your throat or difficulty swallowing.

 
Indications
LEVOXYL is used as replacement or supplemental therapy in low thyroid function (hypothyroidism) of any cause, except transient hypothyroidism during the recovery phase of subacute thyroiditis. It is also used in the treatment or prevention of certain types of goiters and, as additional therapy, in the management of a specific thyroid cancer.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.