Side Effects of Crinone (progesterone)

Crinone (intravaginal progesterone gel) is used to supplement or replace progesterone in infertile women with progesterone deficiency who are receiving treatment utilizing assisted reproductive technology (ART). Crinone intravaginal gel is also used to treat secondary amenorrhea (absence of menses).

Progesterone is a female hormone and is the principal progestational hormone. Progestational hormones prepare the uterus to receive and sustain a fertilized egg. Progesterone

• promotes the development of the mammary glands,
• causes changes in the endometrium which lines the uterus,
• relaxes uterine smooth muscles,
• blocks ovulation within the ovaries, and
• maintains pregnancy.

Common side effects of Crinone include

• bloating,
• stomach pain or cramps,
• dizziness,
• drowsiness,
• tired feeling,
• headache,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• pain in the vaginal or rectal area,
• pain during intercourse,
• loss of interest in sex,
• breast swelling or tenderness,
• joint or muscle pain,
• increased night-time urination,
• vaginal discharge,
• vaginal burning, and
• vaginal itching.

Serious side effects of Crinone include

• sudden headache,
• numbness or weakness (especially on one side of the body),
• shortness of breath, or problems with vision, speech, or balance;
• chest pain or heavy feeling,
• pain spreading to the arm or shoulder;
• pain or swelling in one or both legs;
• stomach pain,
• loss of appetite,
• dark urine, clay-colored stools, yellowing of the skin or eyes (jaundice);
• swelling in your hands, ankles, or feet;
• fever, chills, body aches, flu symptoms;
• a breast lump; and
• symptoms of depression (sleep problems, weakness, mood changes).

There are no drug interactions listed for Crinone intravaginal gel. Crinone intravaginal gel has been used to support embryo implantation and to maintain pregnancies as part of an ART treatment regimen.

Progestins are secreted in breast milk. Consult your doctor before breastfeeding.

Crinone (progesterone) gel is a bioadhesive vaginal gel contained in single-use, one-piece polyethylene vaginal applicators. Crinone is indicated as treatment for infertile women with progesterone deficiency and women with secondary amenorrhea. Crinone is available as a generic drug.

Common side effects of Crinone include

• bloating,
• stomach pain,
• dizziness,
• drowsiness,
• tired feeling,
• headache,
• nausea,
• vomiting,
• stomach cramps,
• diarrhea,
• constipation,
• pain in your vaginal or rectal area,
• pain during intercourse,
• loss of interest in sex,
• breast swelling or tenderness,
• joint or muscle pain,
• increased night-time urination,
• vaginal discharge,
• vaginal burning, and
• vaginal itching.

Tell your doctor if you have serious side effects of Crinone including

• sudden headache, numbness or weakness (especially on one side of the body):
• shortness of breath, or problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder;
• pain or swelling in one or both legs;
• stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• fever, chills, body aches, flu symptoms;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

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)

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)

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

No drug interactions have been assessed with Crinone.