Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Levothyroxine sodium
Drug ID BADD_D01286
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 D01010; D11113
MeSH ID D013974
PubChem ID 23615408
TTD Drug ID D06RGG
NDC Product Code 72865-244; 82347-0035; 82347-0040; 0904-6951; 0904-6955; 0904-6956; 76003-0649; 0074-3727; 0074-5182; 16729-456; 33342-396; 43602-417; 47781-668; 47781-671; 50090-4688; 50090-5821; 50090-6115; 51655-128; 51655-453; 51655-557; 55154-3559; 55154-4376; 60793-854; 60793-858; 60793-860; 60846-801; 60846-805; 60846-806; 60846-809; 63629-2092; 66794-201; 68071-2531; 68180-966; 68180-970; 68788-7764; 68788-7942; 68788-7969; 69238-1835; 0480-8682; 69238-1838; 69238-1839; 69238-1840; 0480-8693; 0480-8701; 0527-3282; 0527-3283; 0527-4961; 71205-382; 71205-543; 71335-1435; 71335-1456; 71335-1734; 71335-1861; 71335-1998; 71335-2090; 71335-9617; 71858-0040; 71858-0045; 71858-0050; 71858-0110; 71858-0125; 72189-163; 72189-250; 72305-025; 72305-050; 72305-075; 72305-137; 72865-241; 82347-0055; 68513-4341; 68513-7069; 68513-9296; 16729-452; 31722-285; 31722-289; 31722-293; 31722-295; 33342-404; 47781-640; 49502-378; 50090-6089; 51655-484; 51655-513; 51655-576; 51655-583; 51655-723; 51655-727; 52652-1950; 55154-3562; 60846-802; 60846-810; 60846-812; 63187-851; 0378-1805; 0378-1809; 0378-1815; 0378-1821; 68071-5227; 68180-967; 68788-7929; 68788-7944; 0480-8722; 0527-4956; 0527-4962; 71205-018; 71205-232; 71205-242; 71205-353; 71335-1465; 71335-1827; 71858-0012; 71858-0017; 71858-0020; 71858-0113; 71858-0135; 72305-112; 72865-236; 72865-237; 72865-243; 72865-245; 82347-0025; 82347-0045; 46014-1083; 48087-0140; 68513-7068; 0074-6594; 0074-7148; 16729-458; 31722-291; 33342-398; 33342-400; 42292-039; 42292-040; 43602-426; 43602-427; 43602-428; 47781-646; 47781-649; 47781-654; 47781-659; 47781-662; 51655-479; 51655-528; 51655-696; 51655-923; 55466-113; 60846-808; 61919-872; 63323-885; 63629-2088; 68071-2698; 69238-1163; 69238-1164; 69238-1169; 69238-1836; 0527-3287; 0527-4954; 0527-4960; 71335-1512; 71335-1637; 71858-0055; 71858-0150; 72305-088; 72305-200; 55154-5381; 60687-464; 60687-519; 60793-857; 60793-859; 63629-2091; 63629-9188; 0378-1807; 0378-1811; 68788-7704; 69238-1832; 0480-8704; 0527-3285; 0527-3289; 0527-4951; 70934-895; 71205-512; 71335-1423; 71335-1828; 71335-1945; 71858-0105; 72789-272; 72789-297; 72865-238; 72865-242; 0904-6949; 51927-0276; 67891-002; 0074-7149; 16729-448; 16729-454; 16729-457; 33342-394; 33342-397; 33342-403; 42292-041; 47781-651; 50090-4668; 50090-5887; 50090-6100; 51655-485; 51655-544; 51655-783; 55154-3560; 55154-3563; 55154-5380; 60687-475; 60687-497; 60793-850; 63187-459; 0378-1803; 68071-2278; 68788-7943; 68788-7953; 69238-1168; 69238-1177; 69238-1178; 69238-1831; 0480-8687; 0480-8690; 0480-8710; 0480-8718; 0527-4952; 0527-4959; 70518-2658; 70518-3154; 71205-222; 71205-642; 71205-655; 71335-1438; 71335-1966; 71335-1987; 71335-2007; 71335-2138; 71858-0005; 71858-0155; 72189-155; 82347-0020; 0904-6950; 0904-6953; 68513-5182; 68513-7149; 0074-7070; 31722-294; 43353-296; 43602-420; 43602-425; 47781-643; 50090-6090; 50090-6104; 51079-444; 51655-578; 51655-604; 51655-694; 51655-924; 51655-997; 53808-1113; 60687-453; 60687-541; 60687-563; 63323-895; 63629-2089; 68071-2532; 68071-2802; 68071-5235; 68180-969; 68788-8382; 69238-1277; 0480-8725; 0527-4955; 0527-4958; 71205-261; 71205-352; 71205-354; 71335-1947; 71858-0013; 71858-0035; 71858-0115; 71858-0120; 72189-346; 82347-0030; 82347-0060; 43858-410; 57297-977; 68513-7070; 68513-7155; 0074-4341; 0074-7069; 16729-455; 31722-284; 33342-393; 33342-395; 33342-402; 43602-421; 50090-5792; 50090-6101
UNII 9J765S329G
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 C15H11I4NNaO4+
CAS Registry Number 55-03-8
SMILES C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)CC(C(=O)O)N.[Na+]
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)
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Blood pressure increased13.14.03.005--Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Diarrhoea07.02.01.001--
Dyspnoea22.02.01.004; 02.11.05.003--
Epiphysiolysis15.02.02.002; 12.04.03.003--Not Available
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Heart rate increased13.14.04.002--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hyperthyroidism14.11.01.011; 05.02.02.001--
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infertility21.03.02.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Irritability19.04.02.013; 08.01.03.011--
Liver function test abnormal13.03.04.030--Not Available
Menstruation irregular21.01.01.005; 05.05.01.008--
Muscular weakness17.05.03.005; 15.05.06.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
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