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Crinone (Progesterone Vaginal) - Side Effects and 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
  Pruitis genital 1 (2%) 4 (6%)

Additional adverse events reported in women at a frequency <5% in Crinone® ART and secondary amenorrhea studies and not listed in the tables above include:

Autonomic Nervous System–mouth dry, sweating increased

Body as a Whole–abnormal crying, allergic reaction, allergy, appetite decreased, asthenia, edema, face edema, fever, hot flushes, influenza-like symptoms, water retention, xerophthalmia

Cardiovascular, General–syncope

Central and Peripheral Nervous System–migraine, tremor

Gastro-Intestinal–dyspepsia, eructation, flatulence, gastritis, toothache

Metabolic and Nutritional–thirst

Musculo-Skeletal System–cramps legs, leg pain, skeletal pain

Neoplasm–benign cyst

Platelet, Bleeding & Clotting–purpura

Psychiatric–aggressive reactions, forgetfulness, insomnia

Red Blood Cell–anemia

Reproductive, Female–dysmenorrhea, premenstrual tension, vaginal dryness

Resistance Mechanism–infection, pharyngitis, sinusitis, urinary tract infection

Respiratory System–asthma, dyspnea, hyperventilation, rhinitis

Skin and Appendages–acne, pruritis, rash, seborrhea, skin discoloration, skin disorder, urticaria

Urinary System–cystitis, dysuria, micturition frequency

Vision Disorders–conjunctivitis

Drug label data at the top of this Page last updated: 2009-11-19

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