Crinone Side Effects
Generic Name: progesterone,prochieve,progestins
Please note - some side effects for Crinone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Crinone - for the Consumer
Crinone Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Crinone Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Crinone Gel:Breast enlargement; breast pain; changes in sex drive; constipation; cramps; depression; diarrhea; difficult or painful sexual intercourse; drowsiness; fatigue; fluid retention/bloating; headache; increased appetite; joint pain; nausea; nervousness; pain around vaginal area; sleep disorder; urination at night; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; calf/leg pain or tenderness; change in emotions, mood, or behavior; chest pain; coughing blood; dizziness; fainting; inflammation of the eye; numbness of arm or leg; one-sided weakness; pain in the groin; partial or complete loss of vision; seizure; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; tremor; unusual vaginal discharge or odor; vaginal itching; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopCrinone Side Effects - for the Professional
Crinone
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.
| 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.
| 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.
| 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%) |
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, pruritus, rash, seborrhea, skin discoloration, skin disorder, urticaria
Urinary System–cystitis, dysuria, micturition frequency
Vision Disorders–conjunctivitis
TopSide Effects by Body System - for Healthcare Professionals
Genitourinary
Genitourinary side effects have included breast tenderness (27%), urinary problems (11%), vaginal discharge (10%), vaginal dryness (6%), breast pain (6%), breast carcinoma (2%), breast excisional biopsy (2%), breast enlargement, leukorrhea, uterine fibroid, vaginal dryness, fungal vaginitis, vaginitis, dysuria, cystitis, and urinary tract infection
Nervous system
Nervous system side effects have included headache (31%), dizziness (15%), confusion, somnolence, asthenia, increased sweating, nervousness, migraine, tremor, and speech disorder. Syncope (with and without hypotension) have been reported.
Cardiovascular
Cardiovascular side effects have included chest pain (7%), hypertension, angina pectoris, syncope, and palpitations.
Gastrointestinal
Gastrointestinal side effects have included abdominal pain (20%), bloating (8%), diarrhea (8%), nausea (8%), constipation (3%), dyspepsia, dry mouth, gastroenteritis, hemorrhagic rectum, hiatus hernia, and vomiting. The side effects reported during clinical studies evaluating the use of progesterone gel 8% have included constipation (27%), nausea (22%), and diarrhea (8%).
Musculoskeletal
Musculoskeletal side effects have included joint pain (20%), musculoskeletal pain (12%), back pain (8%), arthritis, leg cramps, hypertonia, muscle disorder, and myalgia.
Psychiatric
Psychiatric side effects have included depression (19%), anxiety, impaired concentration, insomnia, forgetfulness, and personality disorder.
Respiratory
Respiratory side effects have included cough (8%), bronchitis, nasal congestion, pharyngitis, pneumonitis, and sinusitis.
Dermatologic
Dermatologic side effects have included acne, pruritus, rash, skin discoloration, seborrhea, verruca, and wound debridement during therapy.
Additional dermatologic side effects have included case reports of familial autoimmune dermatitis.
Ocular
Ocular side effects have included abnormal vision.
Hepatic
Hepatic side effects including reversible cases of hepatitis, elevated transaminases, and cholecystectomy have been reported.
Other
Other side effects have included viral infection (12%), hot flashes (11%), fatigue (8%), irritability (8%), worry (8%), night sweats (7%), earache, tooth disorder, anorexia, increased appetite, peripheral edema, edema, accidental injury, fever, abscess, lymphadenopathy, and herpes simplex.
Immunologic
Immunologic side effects have included autoimmune dermatitis during the luteal phase of the menstrual cycle. Test results using interferon gamma release in vivo and vitro tests confirmed the diagnosis.
Local
Local side effects have included pain, irritation, and redness at the injection site.
TopMore Crinone resources
- Crinone Advanced Consumer (Micromedex) - Includes Dosage Information
- Crinone Prescribing Information (FDA)
- Crinone Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Progesterone Natural MedFacts for Professionals (Wolters Kluwer)
- Progesterone Professional Patient Advice (Wolters Kluwer)
- Progesterone Prescribing Information (FDA)
- Progesterone Monograph (AHFS DI)
- Progesterone MedFacts Consumer Leaflet (Wolters Kluwer)
- Endometrin Prescribing Information (FDA)
- Endometrin Insert MedFacts Consumer Leaflet (Wolters Kluwer)
- Endometrin Consumer Overview
- Prochieve Prescribing Information (FDA)
- Prochieve Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Progestins Monograph (AHFS DI)
- Prometrium Prescribing Information (FDA)
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
