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)
Poor quality sleep17.15.04.002; 19.02.05.005---
Uterine mass21.07.01.0120.002931%-
Cystitis noninfective20.03.02.0010.000709%
Pregnancy with contraceptive device08.07.04.001; 18.08.01.0020.502666%-
Metamorphopsia06.02.06.014; 17.17.01.0200.000709%-
Bladder perforation12.02.10.001; 20.03.01.0050.002364%
Pelvic haemorrhage12.01.09.013; 21.07.04.007; 24.07.03.0160.002600%-
Lipoedema14.08.04.0210.000946%-
Lichenoid keratosis23.01.01.0040.001040%-
Pelvic discomfort07.01.06.020; 20.02.03.012; 21.10.01.0120.023261%-
Complication of device insertion08.07.01.0021.353159%-
Exfoliative rash23.03.07.0060.002884%-
Dark circles under eyes06.08.03.019; 08.01.03.0540.000473%-
Vulvovaginal mycotic infection11.03.05.004; 21.14.02.004---
Coital bleeding21.08.02.0150.066190%-
Ovarian haemorrhage21.11.02.006; 24.07.03.0090.000709%
Uterine hyperstimulation18.07.02.008; 21.07.03.0060.000473%-
Thyroid cancer05.02.05.001; 16.24.03.0010.001418%-
Genital discomfort21.10.01.0070.002317%-
Adverse reaction08.06.01.0180.014987%-
Genital swelling21.10.01.0100.001277%-
Vulvovaginal burning sensation21.08.02.0070.005437%-
Occipital neuralgia17.14.01.0130.000709%-
Anal pruritus07.03.03.0020.000473%-
Vulvovaginal pain21.08.02.0090.022883%
Abnormal withdrawal bleeding08.06.02.001; 21.01.01.0080.001513%-
Injury associated with device08.07.01.012; 12.01.08.035---
Vulvovaginal erythema21.08.02.011; 23.03.06.0170.000473%-
Vulvovaginal swelling21.08.02.0160.005768%-
Adnexal torsion21.11.02.0120.002600%-
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