Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Leuprolide acetate
Drug ID BADD_D01260
Description Leuprolide is a synthetic 9-residue peptide analogue of gonadotropin-releasing hormone (GnRH). Unlike the endogenous decapeptide GnRH, leuprolide contains a single D-amino acid (D-leucyl) residue, which helps to increase its circulating half-life from three to four minutes to approximately three hours.[A203222] As a GnRH mimic, leuprolide is capable of binding to the GnRH receptor (GnRHR) and inducing downstream modulation of both gonadotropin hormone and sex steroid levels. Prolonged activation of GnRHR results in significant downregulation of sex steroid levels, which is primarily responsible for the clinical efficacy of leuprolide in diverse conditions, including advanced prostate cancer, endometriosis, and central precocious puberty.[A203126, A203132] Leuprolide was first approved in 1985 as a daily subcutaneous injection under the tradename Lupron™ by Abbvie Endocrine Inc.[L13850] Since this initial approval, various long-acting intramuscular and subcutaneous products have been developed such that patients can be dosed once every six months.[L13781, L13790] Leuprolide remains frontline therapy in all conditions for which it is indicated for use.
Indications and Usage Leuprolide is indicated for the palliative treatment of advanced prostate cancer[L13781, L13790] as well as for the treatment of pediatric patients with central precocious puberty (CPP).[L13784, L13787] Leuprolide mesylate, as an injectable emulsion, is indicated for the treatment of adult patients with advanced prostate cancer.[L34415] In combination with oral [norethisterone] (also known as norethindrone), leuprolide is also indicated for the initial treatment of the symptoms of endometriosis.[L10310] Finally, in combination with iron supplementation, leuprolide is indicated for the preoperative hematological improvement of anemic patients with uterine leiomyomata (uterine fibroids).[L13814]
Marketing Status approved; investigational
ATC Code L02AE02
DrugBank ID DB00007
KEGG ID D00989
MeSH ID D016729
PubChem ID 657180
TTD Drug ID D04ASH
NDC Product Code 0781-4003; 11532-1450; 11532-1456; 41701-013; 51927-0126; 0074-2108; 0074-2440; 0074-3473; 0074-3683; 47335-936; 62935-453; 11532-3338; 59651-089; 62935-163; 72664-611; 11532-1451; 11532-3680; 55150-478; 69097-909; 11532-1454; 11532-3662; 54127-9002; 71052-620; 0074-2282; 62935-753; 11532-1455; 59149-002; 0074-3642; 0074-3663; 0074-3779; 51927-0303; 0074-3575; 0074-3641; 62935-461; 11532-1457; 0074-3346; 11532-1452; 38779-2629; 62935-223; 62935-303; 70121-2537; 11532-1453; 60870-0425; 16714-572; 62935-153; 63629-8821; 0074-9694
UNII 37JNS02E7V
Synonyms Leuprolide | Leuprorelin | Enantone | Leuprolide Acetate | Acetate, Leuprolide | Leuprolide Monoacetate | Monoacetate, Leuprolide | Leuprolide, (L-Leu)-Isomer | Lupron | TAP-144 | TAP 144 | TAP144 | A-43818 | A 43818 | A43818 | Leuprolide, (DL-Leu)-Isomer
Chemical Information
Molecular Formula C61H88N16O14
CAS Registry Number 74381-53-6
SMILES CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC2=CC=C( C=C2)O)NC(=O)C(CO)NC(=O)C(CC3=CNC4=CC=CC=C43)NC(=O)C(CC5=CN=CN5)NC(=O)C6CCC(=O)N 6.CC(=O)O
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)
Influenza11.05.03.001; 22.07.02.001--Not Available
Influenza like illness08.01.03.0100.013623%
Inguinal hernia07.16.02.0010.010899%Not Available
Injection site abscess sterile12.07.03.040; 08.02.03.040--Not Available
Injection site bruising23.03.11.015; 12.07.03.042; 08.02.03.042; 24.07.06.0170.033843%Not Available
Injection site cyst16.02.02.011; 12.07.03.044; 08.02.03.0440.004876%Not Available
Injection site erythema08.02.03.001; 23.03.06.015; 12.07.03.0010.065966%Not Available
Injection site extravasation12.07.03.002; 08.02.03.0020.047036%Not Available
Injection site granuloma23.03.15.003; 12.07.03.003; 08.02.03.0030.008031%Not Available
Injection site haematoma08.02.03.004; 24.07.01.009; 12.07.03.0040.017065%Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.0050.161042%Not Available
Injection site hypersensitivity12.07.03.006; 10.01.03.017; 08.02.03.0060.007314%Not Available
Injection site induration12.07.03.007; 08.02.03.0070.043308%Not Available
Injection site inflammation12.07.03.009; 08.02.03.0080.010182%Not Available
Injection site irritation12.07.03.027; 08.02.03.0270.009751%Not Available
Injection site mass12.07.03.010; 08.02.03.0090.258700%Not Available
Injection site necrosis12.07.03.020; 08.02.03.0200.001434%Not Available
Injection site pain12.07.03.011; 08.02.03.0100.476529%Not Available
Injection site paraesthesia08.02.03.049; 17.02.06.029; 12.07.03.0490.003155%Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.0130.012906%Not Available
Injection site rash23.03.13.010; 12.07.03.032; 08.02.03.0320.009751%Not Available
Injection site reaction12.07.03.015; 08.02.03.0140.031836%
Injection site vesicles23.03.01.024; 12.07.03.051; 08.02.03.0510.009751%Not Available
Injection site warmth12.07.03.036; 08.02.03.036--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intestinal obstruction07.13.01.0020.005019%Not Available
Irritability19.04.02.013; 08.01.03.011--
Joint effusion15.01.02.005--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.054923%
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