Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Levonorgestrel
Drug ID BADD_D01281
Description Levonorgestrel (LNG) is a synthetic progestogen similar to [Progesterone] used in contraception and hormone therapy.[A181988,T659] Also known as Plan B, it is used as a single agent in emergency contraception, and as a hormonal contraceptive released from an intrauterine device, commonly referred to as an IUD. Some of these devices are known as Jaydess, Kyleena, and Mirena. A subdermal implant of levonorgestrel that slowly releases the hormone over a long-term period is also available.[L7823] In addition to the above uses, levonorgestrel is used as a component of long-term combination contraceptives.[A181991,L7760,L7778] Globally, levonorgestrel is the most commonly used emergency contraceptive. It was initially granted FDA approval in 1982 and was the first emergency contraceptive containing only progesterone, showing high levels of efficacy and a lack of estrogenic adverse effects when compared to older emergency contraceptive regimens.[A181976,A181994,L7760]
Indications and Usage **Emergency contraception** Levonorgestrel, in the single-agent emergency contraceptive form, is indicated for the prevention of pregnancy after the confirmed or suspected failure of contraception methods or following unprotected intercourse. It is distributed by prescription for patients under 17, and over the counter for those above this age.[L7760] This levonorgestrel-only form of contraception is not indicated for regular contraception and must be taken as soon as possible within 72 hours after intercourse.[A181976,L7760] It has shown a lower efficacy when it is used off label within 96 hours.[T659] **Long-term contraception or nonemergency contraception** In addition to the above indication in emergency contraception, levonorgestrel is combined with other contraceptives in contraceptive formulations designed for regular use, for example with ethinyl estradiol.[L7766] It is used in various hormone-releasing intrauterine devices for long-term contraception ranging for a duration of 3-5 years.[L7778,L7781,L7787] Product labeling for Mirena specifically mentions that it is recommended in women who have had at least 1 child.[L7778] A subdermal implant is also available for the prevention of pregnancy for up to 5 years.[L7823] **Hormone therapy and off-label uses** Levonorgestrel is prescribed in combination with estradiol as hormone therapy during menopause to manage vasomotor symptoms and to prevent osteoporosis.[L7805]Off-label, levonorgestrel may be used to treat menorrhagia, endometrial hyperplasia, and endometriosis.[T659]
Marketing Status approved; investigational
ATC Code G03AC03; G03AD01
DrugBank ID DB00367
KEGG ID D00950
MeSH ID D016912
PubChem ID 13109
TTD Drug ID D0BA9U
NDC Product Code 72657-123; 73358-911; 12866-1010; 22552-0047; 44132-004; 50419-424; 68180-853; 69536-162; 69536-200; 69953-515; 71205-361; 72657-108; 66499-0018; 69953-628; 82791-538; 59057-002; 40032-622; 50419-423; 57297-852; 62756-720; 68180-852; 71205-120; 58602-891; 69953-516; 80584-100; 82791-332; 82791-532; 51508-012; 63190-0660; 65089-0036; 50102-211; 50742-352; 58602-892; 62756-718; 62756-723; 69953-617; 44132-012; 51660-999; 70000-0600; 72288-111; 73358-241; 69536-103; 69536-146; 69953-517; 53104-7669; 65129-2003; 43386-622; 0023-5858; 79929-016; 45541-1174; 63190-0850; 50090-5978; 64122-605; 69536-133; 70700-164; 63190-0130; 16714-809; 50419-422; 58602-721; 58602-841; 0536-1142; 45541-1244; 59057-001; 0113-2003; 51660-723; 58602-712
UNII 5W7SIA7YZW
Synonyms Levonorgestrel | l-Norgestrel | l Norgestrel | 18,19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(-)- | D-Norgestrel | D Norgestrel | Microval | duofem | Microlut | Mirena | Norgeston | Norplant-2 | Norplant 2 | Norplant2 | NorLevo | Norplant | Plan B | Vikela | Cerazet | Capronor
Chemical Information
Molecular Formula C21H28O2
CAS Registry Number 797-63-7
SMILES CCC12CCC3C(C1CCC2(C#C)O)CCC4=CC(=O)CCC34
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)
Female sexual dysfunction21.03.02.004; 19.08.05.0010.001986%Not Available
Major depression19.15.01.0030.004728%Not Available
Ocular icterus06.08.03.009; 01.06.04.007; 09.01.01.007--Not Available
Dysplasia08.03.04.0070.002648%Not Available
Dysgraphia17.02.03.006--Not Available
Adnexa uteri pain21.07.04.0060.015318%Not Available
Adnexa uteri mass21.07.04.0050.002364%Not Available
Thyroid mass05.02.01.0030.001418%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Intestinal haemorrhage24.07.02.031; 07.12.03.005--Not Available
Anogenital warts16.26.01.003; 11.05.07.002; 07.19.04.002; 23.10.01.003; 21.10.03.0040.000946%Not Available
Adhesion08.01.03.0480.001418%Not Available
Haemorrhagic ovarian cyst24.07.03.014; 21.11.01.007; 16.04.03.0030.007328%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.034372%
Neurological symptom17.02.05.0100.001418%Not Available
Abdominal symptom07.01.06.0070.001986%Not Available
Adverse event08.06.01.0100.092240%Not Available
Allergic oedema10.01.03.025; 08.01.07.0140.001277%Not Available
Appetite disorder19.09.01.002; 14.03.01.004--Not Available
Benign neoplasm16.02.02.0070.001040%Not Available
Brain neoplasm16.30.01.003; 17.20.01.003--Not Available
Breast disorder21.05.04.0040.000473%Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.0060.000946%Not Available
Cranial nerve disorder17.04.01.0010.000473%Not Available
Gastrointestinal motility disorder07.02.03.0010.001655%Not Available
Genital haemorrhage24.07.03.007; 21.10.05.0020.866710%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Libido disorder21.03.02.006; 19.08.03.0040.002553%Not Available
Limb discomfort15.03.04.0140.009219%Not Available
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