Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Progesterone
Drug ID BADD_D01852
Description Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss [A175609]. Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization [T481], [A175612] as well as in other formulations to promote and support pregnancy. Please see [Medroxyprogesterone acetate], [Megestrol acetate], [Dydrogesterone] and [Hydroxyprogesterone] entries for information on various other forms of progesterone. Pharmaceutical progesterone is made from a plant source as a starting material and is chemically identical to progesterone of human ovarian origin [FDA label]. Progesterone is available in gelatinized capsule form, vaginal gel form, tablet form, vaginal insert form, and injection form, all used for various purposes [Label,F3898,F3904,F3901,F3907].
Indications and Usage **Gelatinized capsules** The gelatinized capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea [FDA label]. **Vaginal gel** Progesterone gel (8%) is indicated as progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency. The lower concentration progesterone gel (4%) is used in the treatment of secondary amenorrhea, with the use of the 8% concentration if there is no therapeutic response to the 4% gel [F3898]. **Vaginal insert** This form is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women [F3901]. **Injection (intramuscular)** This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer [F3907]. **Tablets, contraceptive** The tablet form of progesterone in contraceptive formulations is indicated for the prevention of pregnancy [F3904].
Marketing Status approved; vet_approved
ATC Code G03DA04
DrugBank ID DB00396
KEGG ID D00066
MeSH ID D011374
PubChem ID 5994
TTD Drug ID D07BSQ
NDC Product Code 72989-373; 76420-267; 76420-282; 22552-0049; 38779-0043; 38779-0057; 49452-6079; 51552-1248; 51927-5124; 62991-1124; 77382-0030; 43857-0120; 55150-306; 55714-9004; 59651-152; 69452-234; 71205-684; 71335-1913; 72189-217; 0009-5023; 16637-0040; 38779-3247; 43647-134; 51552-1279; 68981-005; 43598-350; 50090-5928; 55566-6500; 63629-7475; 65162-807; 68071-2770; 70518-3286; 0591-3128; 71335-1432; 71335-1443; 71335-1990; 72189-204; 76420-059; 11014-0042; 11014-0043; 43598-349; 48087-0057; 51508-007; 51927-1046; 82393-102; 43857-0103; 63083-1538; 69452-233; 69543-374; 65162-808; 68071-2832; 69543-372; 69543-375; 71205-902; 71205-903; 76420-058; 0009-0105; 10888-8109; 11014-0425; 51552-0006; 51552-1066; 51927-0009; 44911-0047; 69452-149; 69543-373; 71205-293; 0009-0052; 10888-8110; 11014-0039; 51552-0738; 51927-9017; 64025-9801; 76420-682; 79572-029; 59651-153; 69452-148; 71335-0835; 72189-347; 76420-072; 0009-5620; 48087-0105; 51552-0829; 60870-0248; 77382-0140; 16714-158; 43742-0851; 63629-8530; 70518-3392; 70700-163; 71205-669; 71335-9739; 76420-073; 76420-281; 0009-0081; 12875-9937; 51508-002; 60592-607; 43857-0084; 68788-8296; 70700-162; 70700-286; 76420-574; 11014-0189; 12875-9242; 16637-0030; 38779-0310; 38779-2708; 38779-3169; 46144-101; 73309-164; 16714-157; 0023-6150; 63323-261; 68071-2768; 68071-2840; 68788-8295; 70518-2560; 71335-1406; 82653-003; 11014-0051; 43742-1375; 49452-6061; 60722-3010; 73377-048; 75882-923; 76420-683; 77382-0050; 0143-9725; 50090-6475; 0023-6151; 72989-372; 82653-004; 83027-0073; 0009-0078
UNII 4G7DS2Q64Y
Synonyms Progesterone | Pregnenedione | Progesterone, (17 alpha)-Isomer | Progesterone, (9 beta,10 alpha)-Isomer | Progesterone, (13 alpha,17 alpha)-(+-)-Isomer
Chemical Information
Molecular Formula C21H30O2
CAS Registry Number 57-83-0
SMILES CC(=O)C1CCC2C1(CCC3C2CCC4=CC(=O)CCC34C)C
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)
Vomiting07.01.07.0030.001568%
Vulvovaginal discomfort21.08.02.0050.000979%Not Available
Vulvovaginal dryness21.08.02.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Withdrawal bleed21.01.01.010; 08.06.02.005--Not Available
Xerophthalmia14.12.03.002; 06.06.03.008--Not Available
Musculoskeletal disorder15.03.05.025--Not Available
Peripheral swelling02.05.04.015; 08.01.03.053--Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000125%Not Available
Breast discomfort21.05.05.007--Not Available
Lymphatic disorder01.09.01.003--Not Available
Foetor hepaticus09.01.05.006; 07.01.06.026--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Walking disability26.01.01.009--Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.000276%Not Available
Growth retardation15.03.05.016; 14.03.02.031; 05.03.02.0070.000640%
Affect lability19.04.01.001--Not Available
Transaminases increased13.03.04.036--Not Available
Foetal death18.01.02.003; 08.04.01.0110.000376%
Haemorrhage24.07.01.0020.000402%Not Available
Postmenopausal haemorrhage24.07.03.002; 21.02.01.0020.000125%Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.004--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.0050.001832%
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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