Levothyroxine is used to treat hypothyroidism (low thyroid hormone). Levothyroxine is given when your thyroid does not produce enough of this hormone on its own.

Levothyroxine is also used to treat or prevent goiter (enlarged thyroid gland), which can be caused by hormone imbalances, radiation treatment, surgery, or cancer.

There are many brands and forms of levothyroxine available. Not all brands are listed on this leaflet.

Levothyroxine may also be used for purposes not listed in this medication guide.

You may not be able to use levothyroxine if you have certain medical conditions. Tell your doctor if you have an untreated or uncontrolled adrenal gland disorder, a thyroid disorder called thyrotoxicosis, or if you have any recent or current symptoms of a heart attack.

Levothyroxine should not be used to treat obesity or weight problems.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Levothyroxine oral is taken by mouth. Levothyroxine injection is given as an infusion into a vein. Levothyroxine is usually given by injection only if you are unable to take the medicine by mouth.

Levothyroxine oral works best if you take it on an empty stomach, 30 to 60 minutes before breakfast. Follow your doctor's dosing instructions and try to take the medicine at the same time each day.

Swallow the tablet or capsule whole, with a full glass (8 ounces) of water. The levothyroxine tablet may dissolve very quickly and could swell in your throat.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Levothyroxine doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

It may take several weeks before your body starts to respond to levothyroxine. Keep using this medicine even if you feel well. You may need to use levothyroxine for the rest of your life.

You may need frequent medical tests. Tell any doctor, dentist, or surgeon who treats you that you are using levothyroxine.

Store at room temperature away from moisture and heat. Use Tirosint-Sol within 3 months after opening the pouch.

Do not share this medicine with another person, even if they have the same symptoms you have.

Levothyroxine should not be used to treat obesity or weight problems. Dangerous side effects or death can occur from the misuse of levothyroxine, especially if you are taking any other weight-loss medications or appetite suppressants.

Since thyroid hormone occurs naturally in the body, almost anyone can use levothyroxine. However, you may not be able to use levothyroxine if you have certain medical conditions. Tell your doctor if you have:

• an untreated or uncontrolled adrenal gland disorder;

• a thyroid disorder called thyrotoxicosis; or

• symptoms of a heart attack (chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling).

Tell your doctor if you have ever had:

• a thyroid nodule;

• heart disease, a blood clot, or a blood-clotting disorder;

• diabetes (insulin or oral diabetes medication doses may need to be changed when you start using levothyroxine);

• kidney disease;

• anemia (lack of red blood cells);

• osteoporosis, or low bone mineral density;

• problems with your pituitary gland; or

• any food or drug allergies.

Tell your doctor if you have recently received radiation therapy with iodine (such as I-131).

If you become pregnant while using levothyroxine, do not stop using the medicine without your doctor's advice. Having low thyroid hormone levels during pregnancy could harm both mother and baby. Your dose needs may be different during pregnancy.

Tell your doctor if you are breastfeeding. Your dose needs may be different while you are nursing.

Do not give this medicine to a child without medical advice. Tirosint is not approved for use by anyone younger than 6 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, leg cramps, tremors, feeling nervous or irritable, chest pain, shortness of breath, and fast or pounding heartbeats.

Avoid the following food products, which can make your body absorb less levothyroxine: grapefruit juice, infant soy formula, soybean flour, cotton seed meal, walnuts, and high-fiber foods.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Levothyroxine may cause serious side effects. Call your doctor at once if you have:

• fast or irregular heartbeats;

• chest pain, pain spreading to your jaw or shoulder;

• shortness of breath;

• fever, hot flashes, sweating;

• tremors, or if you feel unusually cold;

• weakness, tiredness, sleep problems (insomnia);

• memory problems, feeling depressed or irritable;

• headache, leg cramps, muscle aches;

• feeling nervous or irritable;

• dryness of your skin or hair, hair loss;

• irregular menstrual periods; or

• vomiting, diarrhea, appetite changes, weight changes.

Certain side effects may be more likely in older adults.

Common side effects of levothyroxine may include:

• chest pain, irregular heartbeats;

• shortness of breath;

• headache, leg cramps, muscle pain or weakness;

• tremors, feeling nervous or irritable, trouble sleeping;

• increased appetite;

• feeling hot;

• weight loss;

• changes in your menstrual periods;

• diarrhea; or

• skin rash, partial hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other medicines can be affected by your thyroid hormone levels. Certain other medicines may also increase or decrease the effects of levothyroxine.

If you use any of the following drugs, avoid taking them within 4 hours before or 4 hours after you use levothyroxine:

• calcium carbonate (Alka-Mints, Caltrate, Os-Cal, Oyster Shell Calcium, Rolaids Soft Chew, Tums, and others);

• cholestyramine, colesevelam, colestipol;

• ferrous sulfate iron supplement;

• sucralfate;

• sodium polystyrene sulfonate (Kalexate, Kayexalate, Kionex);

• stomach acid reducers--esomeprazole, lansoprazole, omeprazole, rabeprazole, Nexium, Prilosec, Prevacid, Protonix, Zegerid, and others; or

• antacids that contain aluminum or magnesium--Gaviscon, Maalox, Milk of Magnesia, Mintox, Mylanta, Pepcid Complete, and others.

Many drugs can affect levothyroxine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.