Synthroid Levothyroxine Sodium

Get an overview of SYNTHROID (levothyroxine sodium tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Synthroid can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Synthroid.

Drug Basics

Brand Name: Synthroid

Generic Name: LEVOTHYROXINE SODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2019-06-03

indications & usage

Hypothyroidism

SYNTHROID is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression

SYNTHROID is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

  • Limitations of Use:
  • SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.4)].
  • SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

adverse reactions

Adverse reactions associated with SYNTHROID therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) , Overdosage (10)]. 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, muscle spasm
  • Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest
  • Respiratory: dyspnea
  • Gastrointestinal: diarrhea, vomiting, abdominal cramps, elevations in liver function tests
  • Dermatologic: hair loss, flushing, rash
  • Endocrine: decreased bone mineral density
  • Reproductive: menstrual irregularities, impaired fertility

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

adverse reactions in children

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.

hypersensitivity reactions

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

patient counseling information

Inform the patient of the following information to aid in the safe and effective use of SYNTHROID:

Dosing and Administration

  • Instruct patients to take SYNTHROID only as directed by their healthcare provider.
  • Instruct patients to take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.
  • Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take SYNTHROID tablets within 4 hours of these agents.
  • Instruct patients to notify their healthcare provider if they are pregnant or breastfeeding or are thinking of becoming pregnant while taking SYNTHROID.

Important Information

  • Inform patients that it may take several weeks before they notice an improvement in symptoms.
  • Inform patients that the levothyroxine in SYNTHROID is intended to replace a hormone that is normally produced by the thyroid gland. Generally, replacement therapy is to be taken for life.
  • Inform patients that SYNTHROID should not be used as a primary or adjunctive therapy in a weight control program.
  • Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations.
  • Instruct patients to notify their physician of any other medical conditions they may have, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while they are taking SYNTHROID. If they have diabetes, instruct patients to monitor their blood and/or urinary glucose levels as directed by their physician and immediately report any changes to their physician. If patients are taking anticoagulants, their clotting status should be checked frequently.
  • Instruct patients to notify their physician or dentist that they are taking SYNTHROID prior to any surgery.

Adverse Reactions

© 2018 AbbVie Inc.

AbbVie Inc.

North Chicago, IL 60064, U.S.A.

03-B792 November 2018

NDC 0074-4552-11

Synthroid®

Levothyroxine Sodium Tablets, USP

50 mcg (0.05 mg)

100 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rx only abbvie

carton synthroid 50mcg 100ct hud.jpg

NDC 0074-6624-11

Synthroid®

Levothyroxine Sodium Tablets, USP

100 mcg (0.1 mg)

100 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rx only abbvie

carton synthroid 100mcg 100ct hud.jpg

NDC 0074-7148-11

Synthroid®

Levothyroxine Sodium Tablets, USP

200 mcg (0.2 mg)

100 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rx only abbvie

carton synthroid 200mcg 100ct hud.jpg

NDC 0074-3727-90

Synthroid®

Levothyroxine Sodium Tablets, USP

137 mcg (0.137 mg)

90 Tablets

Rx only abbvie

label synthroid 137mcg 90ct.jpg

NDC 0074-4341-19

Synthroid®

Levothyroxine Sodium Tablets, USP

25 mcg (0.025 mg)

1000 Tablets

Rx only abbvie

label synthroid 25mcg 1000ct .jpg

NDC 0074-5182-19

Synthroid®

Levothyroxine Sodium Tablets, USP

75 mcg (0.075 mg)

1000 Tablets

Rx only abbvie

label synthroid 75mcg 1000ct.jpg

NDC 0074-6594-90

Synthroid®

Levothyroxine Sodium Tablets, USP

88 mcg (0.088 mg)

90 Tablets

Rx only abbvie

label synthroid 88mcg 90ct.jpg

NDC 0074-7068-19

Synthroid®

Levothyroxine Sodium Tablets, USP

125 mcg (0.125 mg)

1000 Tablets

Rx only abbvie

label synthroid 125mcg 1000ct.jpg

NDC 0074-7069-90

Synthroid®

Levothyroxine Sodium Tablets, USP

150 mcg (0.15 mg)

90 Tablets

Rx only abbvie

label synthroid 150mcg 90ct.jpg

NDC 0074-7070-19

Synthroid®

Levothyroxine Sodium Tablets, USP

175 mcg (0.175 mg)

1000 Tablets

Rx only abbvie

label synthroid 175mcg 1000ct.jpg

NDC 0074-7149-90

Synthroid®

Levothyroxine Sodium Tablets, USP

300 mcg (0.3 mg)

90 Tablets

Rx only abbvie

label synthroid 300mcg 90ct.jpg

NDC 0074-9296-19

Synthroid®

Levothyroxine Sodium Tablets, USP

112 mcg (0.112 mg)

1000 Tablets

Rx only abbvie

label synthroid 112mcg 1000ct.jpg

NDC 0074-4341-72

2 cards x 7 tablets

orange 25mcg (0.025mg) Synthroid

Synthroid ®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton synthroid 25mcg 14ct sample.jpg

NDC 0074-4552-90

Synthroid®

Levothyroxine Sodium Tablets, USP

50 mcg

(0.05mg)

90 Tablets

Rx only abbvie

label synthroid 50mcg 90ct.jpg

NDC 0074-5182-72 2 cards x 7 tablets

violet 75 mcg (0.075 mg) Synthroid

Synthroid®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton synthroid 75mcg 14ct sample.jpg

NDC 0074-9296-72 2 cards x 7 tablets

rose 112mcg (0.112 mg) Synthroid

Synthroid®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton synthroid 112mcg 14ct sample.jpg

NDC 0074-7148-90

Synthroid®

Levothyroxine Sodium Tablets, USP

200 mcg

(0.2 mg)

90 Tablets

Rx only abbvie

label synthroid 200mcg 90ct.jpg

NDC 0074-6624-72 2 cards x 7 tablets

yellow 100 mcg (0.1mg) Synthroid

Synthroid®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton synthroid 100mcg 14ct sample.jpg

NDC 0074-6624-90

Synthroid®

Levothyroxine Sodium Tablets, USP

100 mcg

(0.1 mg)

90 Tablets

Rx only abbvie

label synthroid 100mcg 90ct.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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