Home FDA labels ab1523af-0bbb-4231-a12c-ac52e3ec91cd Crinone openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Crinone
Generic name PROGESTERONE
Manufacturer Allergan, Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 75e97aa1-daa4-45f9-b2e2-1a371302914e
SPL ID ab1523af-0bbb-4231-a12c-ac52e3ec91cd
Version 11
Effective date 2024-05-21
Source export date 2026-09-28
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:38:20 Harmonized routes table Harmonized routes VAGINAL
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warnings WARNINGS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose.
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adverse reactions ADVERSE REACTIONS Assisted Reproductive Technology In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3. TABLE 3 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Twice Daily Study COL1620-007US (n = 61) Body as a Whole Bloating 7% Cramps NOS 15% Pain 8% Central and Peripheral Nervous System Dizziness 5% Headache 13% Gastro-Intestinal System Nausea 7% Reproductive, Female Breast Pain 13% Moniliasis Genital 5% Vaginal Discharge 7% Skin and Appendages Pruritus Genital 5% In a second clinical study of 139 women using Crinone 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in ≥ 5% of the women are shown in Table 4. TABLE 4 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Once Daily Study COL1620-F01 (n = 139) Body as a Whole Abdominal Pain 12% Perineal Pain Female 17% Central and Peripheral Nervous System Headache 17% Gastro-Intestinal System Constipation 27% Diarrhea 8% Nausea 22% Vomiting 5% Musculo-Skeletal System Arthralgia 8% Psychiatric Depression 11% Libido Decreased 10% Nervousness 16% Somnolence 27% Reproductive, Female Breast Enlargement 40% Dyspareunia 6% Urinary System Nocturia 13% Secondary Amenorrhea In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone 4% or 8% every other day for six doses. Treatment-emergent adverse events during estrogen and Crinone treatment that occurred in 5% or more of women are shown in Table 5. TABLE 5 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Estrogen Treatment and Crinone Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US Estrogen + Crinone 4% n = 62 Estrogen + Crinone 8% n = 65 Body as a Whole Abdominal Pain 3 (5%) 6 (9%) Appetite Increased 3 (5%) 5 (8%) Bloating 8 (13%) 8 (12%) Cramps NOS 12 (19%) 17 (26%) Fatigue 13 (21%) 14 (22%) Central and Peripheral Nervous System Headache 12 (19%) 10 (15%) Gastro-Intestinal System Nausea 5 (8%) 4 (6%) Musculo-Skeletal System Back Pain 5 (8%) 2 (3%) Myalgia 5 (8%) 0 (0%) Psychiatric Depression 12 (19%) 10 (15%) Emotional Lability 14 (23%) 14 (22%) Sleep Disorder 11 (18%) 12 (18%) Reproductive, Female Vaginal Discharge 7 (11%) 2 (3%) Resistance Mechanism Upper Respiratory Tract Infection 3 (5%) 5 (8%) Skin and Appendages Pruritus Genital 1 (2%) 4 (6%)
adverse reactions table <table><caption>TABLE 3 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Twice Daily Study COL1620-007US (n = 61)</caption><col width="211"/><col width="140"/><tbody><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Body as a Whole </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Bloating</td><td styleCode="Toprule Lrule Rrule " align="center"> 7%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Cramps NOS</td><td styleCode="Toprule Lrule Rrule " align="center"> 15%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Pain</td><td styleCode="Toprule Lrule Rrule " align="center"> 8%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Central and Peripheral Nervous System </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Dizziness</td><td styleCode="Toprule Lrule Rrule " align="center"> 5%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Headache</td><td styleCode="Toprule Lrule Rrule " align="center"> 13%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Gastro-Intestinal System </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Nausea</td><td styleCode="Toprule Lrule Rrule " align="center"> 7%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Reproductive, Female </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Breast Pain</td><td styleCode="Toprule Lrule Rrule " align="center"> 13%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Moniliasis Genital</td><td styleCode="Toprule Lrule Rrule " align="center"> 5%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Vaginal Discharge</td><td styleCode="Toprule Lrule Rrule " align="center"> 7%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Skin and Appendages </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Pruritus Genital</td><td styleCode="Toprule Lrule Rrule " align="center"> 5%</td></tr></tbody></table>
adverse reactions table <table><caption>TABLE 4 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Crinone 8% Once Daily Study COL1620-F01 (n = 139)</caption><col width="211"/><col width="140"/><tbody><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Body as a Whole </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Abdominal Pain</td><td styleCode="Toprule Lrule Rrule " align="center"> 12%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Perineal Pain Female</td><td styleCode="Toprule Lrule Rrule " align="center"> 17%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Central and Peripheral Nervous System</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Headache</td><td styleCode="Toprule Lrule Rrule " align="center"> 17%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Gastro-Intestinal System </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Constipation</td><td styleCode="Toprule Lrule Rrule " align="center"> 27%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Diarrhea</td><td styleCode="Toprule Lrule Rrule " align="center"> 8%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Nausea</td><td styleCode="Toprule Lrule Rrule " align="center"> 22%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Vomiting</td><td styleCode="Toprule Lrule Rrule " align="center"> 5%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Musculo-Skeletal System</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Arthralgia</td><td styleCode="Toprule Lrule Rrule " align="center"> 8%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Psychiatric </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Depression</td><td styleCode="Toprule Lrule Rrule " align="center"> 11%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Libido Decreased</td><td styleCode="Toprule Lrule Rrule " align="center"> 10%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Nervousness</td><td styleCode="Toprule Lrule Rrule " align="center"> 16%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Somnolence</td><td styleCode="Toprule Lrule Rrule " align="center"> 27%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Reproductive, Female </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Breast Enlargement</td><td styleCode="Toprule Lrule Rrule " align="center"> 40%</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Dyspareunia</td><td styleCode="Toprule Lrule Rrule " align="center"> 6%</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="2"> Urinary System</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Nocturia</td><td styleCode="Toprule Lrule Rrule " align="center"> 13%</td></tr></tbody></table>
adverse reactions table <table><caption>TABLE 5 Treatment-Emergent Adverse Events in ≥ 5% of Women Receiving Estrogen Treatment and Crinone Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US</caption><col width="244"/><col width="178"/><col width="178"/><tbody><tr><td styleCode="Toprule Lrule Rrule "> </td><td styleCode="Toprule Lrule Rrule "><content styleCode="bold">Estrogen + Crinone 4% </content><content styleCode="bold"> n = 62 </content></td><td styleCode="Toprule Lrule Rrule " align="center"><content styleCode="bold">Estrogen + Crinone 8% </content><content styleCode="bold"> n = 65</content> </td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3">Body as a Whole </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Abdominal Pain </td><td styleCode="Toprule Lrule Rrule " align="center"> 3 (5%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 6 (9%)</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Appetite Increased</td><td styleCode="Toprule Lrule Rrule " align="center"> 3 (5%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 5 (8%)</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Bloating</td><td styleCode="Toprule Lrule Rrule " align="center"> 8 (13%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 8 (12%)</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Cramps NOS</td><td styleCode="Toprule Lrule Rrule " align="center">12 (19%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 17 (26%)</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Fatigue</td><td styleCode="Toprule Lrule Rrule " align="center"> 13 (21%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 14 (22%)</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3"> Central and Peripheral Nervous System</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Headache</td><td styleCode="Toprule Lrule Rrule " align="center"> 12 (19%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 10 (15%)</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3"> Gastro-Intestinal System</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Nausea</td><td styleCode="Toprule Lrule Rrule " align="center"> 5 (8%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 4 (6%)</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3"> Musculo-Skeletal System</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Back Pain</td><td styleCode="Toprule Lrule Rrule " align="center"> 5 (8%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 2 (3%)</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Myalgia</td><td styleCode="Toprule Lrule Rrule " align="center"> 5 (8%)</td><td styleCode="Toprule Lrule Rrule " align="center"> 0 (0%)</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3"> Psychiatric</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Depression</td><td styleCode="Toprule Lrule Rrule " align="center">12 (19%)</td><td styleCode="Toprule Lrule Rrule " align="center">10 (15%)</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Emotional Lability</td><td styleCode="Toprule Lrule Rrule " align="center">14 (23%) </td><td styleCode="Toprule Lrule Rrule " align="center">14 (22%) </td></tr><tr><td styleCode="Toprule Lrule Rrule "> Sleep Disorder</td><td styleCode="Toprule Lrule Rrule " align="center">11 (18%) </td><td styleCode="Toprule Lrule Rrule " align="center">12 (18%)</td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3"> Reproductive, Female</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Vaginal Discharge</td><td styleCode="Toprule Lrule Rrule " align="center"> 7 (11%)</td><td styleCode="Toprule Lrule Rrule " align="center">2 (3%) </td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3"> Resistance Mechanism</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Upper Respiratory Tract Infection</td><td styleCode="Toprule Lrule Rrule " align="center"> 3 (5%)</td><td styleCode="Toprule Lrule Rrule " align="center">5 (8%) </td></tr><tr><td styleCode="Toprule Lrule Rrule " colspan="3"> Skin and Appendages</td></tr><tr><td styleCode="Toprule Lrule Rrule "> Pruritus Genital</td><td styleCode="Toprule Lrule Rrule " align="center"> 1 (2%)</td><td styleCode="Toprule Lrule Rrule " align="center">4 (6%) </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.