Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Levothyroxine
Drug ID BADD_D01285
Description Levothyroxine is a synthetically produced form of thyroxine, a major endogenous hormone secreted by the thyroid gland.[F4633] Also known as L-thyroxine or the brand name product Synthroid, levothyroxine is used primarily to treat hypothyroidism, a condition where the thyroid gland is no longer able to produce sufficient quantities of the thyroid hormones T4 (tetraiodothyronine or thyroxine) and T3 (triiodothyronine or [DB00279]), resulting in diminished down-stream effects of these hormones. Without sufficient quantities of circulating thyroid hormones, symptoms of hypothyroidism begin to develop such as fatigue, increased heart rate, depression[A179620], dry skin and hair, muscle cramps, constipation, weight gain, memory impairment, and poor tolerance to cold temperatures.[F4636,A35722] In response to Thyroid Stimulating Hormone (TSH) release by the pituitary gland, a normally functioning thyroid gland will produce and secrete T4, which is then converted through deiodination (by type I or type II 5′-deiodinases)[A179941] into its active metabolite T3. While T4 is the major product secreted by the thyroid gland, T3 exerts the majority of the physiological effects of the thyroid hormones; T4 and T3 have a relative potency of ~1:4 (T4:T3).[F4633] T4 and T3 act on nearly every cell of the body, but have a particularly strong effect on the cardiac system.[A179935] As a result, many cardiac functions including heart rate, cardiac output, and systemic vascular resistance are closely linked to thyroid status.[A179938] Prior to the development of levothyroxine, [DB09100] or desiccated thyroid, used to be the mainstay of treatment for hypothyroidism. However, this is no longer recommended for the majority of patients due to several clinical concerns including limited controlled trials supporting its use. Desiccated thyroid products contain a ratio of T4 to T3 of 4.2:1, which is significantly lower than the 14:1 ratio of secretion by the human thyroid gland. This higher proportion of T3 in desiccated thyroid products can lead to supraphysiologic levels of T3 which may put patients at risk of thyrotoxicosis if thyroid extract therapy is not adjusted according to the serum TSH.[A35722, F4636]
Indications and Usage For use alone or in combination with antithyroid agents to treat hypothyroidism, goiter, chronic lymphocytic thyroiditis, myxedema coma, and stupor.
Marketing Status Prescription; Discontinued
ATC Code H03AA01
DrugBank ID DB00451
KEGG ID D01010
MeSH ID D013974
PubChem ID 5819
TTD Drug ID D06RGG
NDC Product Code 43742-0955
Synonyms Thyroxine | O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodotyrosine | Thyroxin | 3,5,3',5'-Tetraiodothyronine | T4 Thyroid Hormone | Thyroid Hormone, T4 | Synthrox | Levothyroxine Sodium | Sodium Levothyroxine | Thyrax | Tiroidine | Tiroxina Leo | Unithroid | Eferox | Eltroxin | Thevier | Eltroxine | Euthyrox | Eutirox | L-Thyrox | L Thyrox | L-Thyroxin beta | L Thyroxin beta | L-Thyroxin Henning | L Thyroxin Henning | Levothyroxine | O-(4-Hydroxy-3,5-diiodophenyl) 3,5-diiodo-L-tyrosine | L-Thyroxine | L Thyroxine | L-3,5,3',5'-Tetraiodothyronine | Levoxine | Levoxyl | Lévothyrox | L-Thyroxine Roche | L Thyroxine Roche | Levo-T | Levo T | Levothroid | Novothyral | Berlthyrox | Dexnon | Novothyrox | Oroxine | Synthroid | Levothyroxin Deladande | Levothyroxin Delalande | Levothyroid
Chemical Information
Molecular Formula C15H11I4NO4
CAS Registry Number 51-48-9
SMILES C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)CC(C(=O)O)N
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.000448%Not Available
Abdominal distension07.01.04.0010.000460%
Abdominal pain07.01.05.0020.000690%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.000690%
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abnormal weight gain14.03.02.0100.000057%Not Available
Abortion18.01.01.0010.000092%Not Available
Abortion spontaneous18.01.04.0010.000920%Not Available
Acne23.02.01.0010.000092%Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000023%Not Available
Adrenal insufficiency14.11.01.004; 05.01.02.0010.000080%
Adrenocortical insufficiency acute05.01.02.005; 14.11.01.0200.000103%Not Available
Affective disorder19.04.04.0010.000287%Not Available
Ageusia17.02.07.001; 07.14.03.0030.000057%Not Available
Aggression19.05.01.0010.000586%Not Available
Agitation19.06.02.001; 17.02.05.0120.000287%
Agranulocytosis01.02.03.0010.000149%Not Available
Alanine aminotransferase increased13.03.01.0030.000161%
Alcohol abuse19.07.02.0070.000023%Not Available
Alopecia23.02.02.0010.002517%
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia19.20.01.001; 17.03.02.0010.000701%
Amylase increased13.05.01.0090.000023%
Anaemia01.03.02.001--
Anaemia macrocytic14.12.01.002; 01.03.02.0020.000034%Not Available
Anal fistula07.11.05.0020.000034%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
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