Climara Pro
FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex »
"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Dyspareunia"...
Read the FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex article »
Climara Pro
Climara Pro Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Climara Pro (estradiol/levonorgestrel) is used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women. This medication will not prevent dementia, heart attack, heart disease, or stroke. It is a combination of female hormones. Common side effects include skin redness/irritation at the application site, abdominal pain, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.
A Climara Pro patch with a dose of 0.045 mg estradiol / 0.015 mg levonorgestrel (22 sq cm) is worn continuously on the lower abdomen. A new system should be applied weekly during a 28-day cycle. Climara Pro may interact with anticoagulants (blood thinners). Tell your doctor all medications and supplements you use. Climara Pro must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding. Our Climara Pro (estradiol/levonorgestrel) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Climara Pro in Detail - Patient Information: Side Effects
Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of the following serious side effects:
- signs of a blood clot (sharp chest pain, coughing up blood, shortness of breath, pain in your calf);
- signs of a heart attack (crushing chest pain, left-arm numbness);
- signs of a stroke (sudden severe headache, problems with vision or speech, weakness, numbness);
- nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- new or changing breast lumps.
Other less serious side effects are more likely to occur, such as:
- nausea and vomiting;
- tender or swollen breasts;
- swelling of the hands or feet;
- darkened spots on the skin of your face;
- contact lens discomfort;
- vaginal irritation or discomfort;
- headache, depressed mood;
- a skin rash or reaction where the patch is worn; or
- changes in your menstrual periods.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Climara Pro (Estradiol, Levonorgestrel Transdermal) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Climara Pro Overview - Patient Information: Side Effects
Skin redness/irritation at the application site, abdominal pain, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.
This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Climara Pro (Estradiol, Levonorgestrel Transdermal)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Climara Pro FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
See BOXED WARNINGS, WARNINGS and PRECAUTIONS.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Irritation potential of Climara Pro (estradiol, levonorgestrel transdermal) was assessed in a 3-week irrita-tion study. The study compared the irritation of a Climara Pro (estradiol, levonorgestrel transdermal) placebo patch (22 cm2) to a Climara® placebo (25 cm2). Visual assessments of irritation were made on Day 7 of each wear period, approximately 30 minutes after patch removal using a 7-point scale (0 = no evidence of irritation; 1 = minimal erythema, barely perceptible; 2 = definite erythema, readily visible, or minimal edema, or minimal papular response; 3-7 = erythema and papules, edema, vesicles, strong extensive reaction).
The mean irritation scores were 0.13 (week 1), 0.12 (week 2), and 0.06 (week 3) for the Climara Pro (estradiol, levonorgestrel transdermal) placebo. The mean scores for the Climara placebo were 0.2 (week 1), 0.26 (week 2), 0.12 (week 3). There were no irritation scores greater than 2 at any timepoint in any subject.
In controlled clinical trials, withdrawals due to application site reactions occurred in 6 (2.1%) of subjects in the 12-week symptom study and in 71 (8.5%) of subjects in the 1-year endometri-al protection study.
The following additional adverse reactions have been reported with estrogen and/or estrogen/progestin therapy:
Genitourinary system
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyper-plasia; endometrial cancer.
Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.
Skin
Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
Eyes
Retinal vascular thrombosis, intolerance to contact lenses.
Central nervous system
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
Miscellaneous
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the entire FDA prescribing information for Climara Pro (Estradiol, Levonorgestrel Transdermal) »
Additional Climara Pro Information
Climara Pro - User Reviews
Climara Pro User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Climara Pro sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.
Updated & New
