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 Levothyroxine is indicated as replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Marketing Status approved
ATC Code H03AA01
DrugBank ID DB00451
KEGG ID D08125
MeSH ID D013974
PubChem ID 5819
TTD Drug ID D06RGG
NDC Product Code 43742-0955
UNII Q51BO43MG4
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Fine motor skill dysfunction17.01.02.0200.000005%Not Available
Mental fatigue19.21.02.012; 17.03.03.0060.000034%Not Available
Critical illness08.01.03.0650.000013%Not Available
Tongue discomfort07.14.02.0190.000024%Not Available
Selective eating disorder14.03.02.024; 19.09.01.0120.000015%Not Available
Acrophobia19.06.03.0120.000005%Not Available
Allergic reaction to excipient10.01.01.0350.000013%Not Available
Bell's palsy17.04.03.011--Not Available
Cardiac dysfunction02.11.01.0040.000007%Not Available
Cerebral venous sinus thrombosis24.01.04.021; 17.08.03.0060.000005%Not Available
Decompensated hypothyroidism14.11.01.050; 05.02.03.0100.000022%Not Available
Defaecation disorder07.02.03.008--Not Available
Drug effect less than expected08.06.01.036--Not Available
Electric shock sensation17.02.07.024; 08.06.02.023--Not Available
Fear of injection19.06.03.0160.000011%Not Available
Fear-related avoidance of activities19.06.03.0190.000007%Not Available
Gait inability08.01.02.011; 17.02.05.0690.000032%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000038%Not Available
Hair growth rate abnormal23.02.06.0120.000011%Not Available
Heavy menstrual bleeding21.01.03.0050.000052%Not Available
Hemiparaesthesia17.02.06.0450.000005%Not Available
Hyperaesthesia teeth07.09.06.005--Not Available
Idiopathic intracranial hypertension17.07.02.0110.000010%Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.000005%Not Available
Immune-mediated myositis15.05.01.012; 10.02.01.0880.000037%Not Available
Intermenstrual bleeding21.01.01.0150.000029%Not Available
Mucosal disorder08.01.06.0290.000010%Not Available
Myocardial injury02.04.02.0460.000005%Not Available
Near death experience19.10.05.007; 17.02.04.023--Not Available
Neonatal thyrotoxicosis18.04.06.0080.000007%Not Available
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ADReCS-Target
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