"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.
Climara Pro Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Climara Pro (estradiol/levonorgestrel) transdermal patch is a combination of female hormones used to treat menopause symptoms such as hot flashes, and to prevent osteoporosis (bone loss) in menopausal women. Climara Pro will not prevent dementia, heart attack, heart disease, or stroke. Common side effects of Climara Pro include patch application site reactions (skin redness, irritation, or skin rash), abdominal pain, nausea, vomiting, bloating, breast tenderness or swelling, headache, weight changes, swelling of the hands or feet, darkened spots on the skin of your face, contact lens discomfort, vaginal irritation or discomfort, depression, or changes in your menstrual periods.
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
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
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 data described below is from a one-year, prospective, multicenter, double blind, double dummy, randomized, controlled trial investigating the effect of three different dosage combinations of E2/LNG versus E2 alone on the development of endometrial hyperplasia. All women were postmenopausal, had a serum estradiol level of less than 20 pg/mL, and the sample included both symptomatic and asymptomatic women. The data below includes all adverse reactions reported at a frequency of > 3% in the E2/LNG 0.045 / 0.015 group (the approved dosage for Climara Pro, N=212) and the E2 alone group (N=204).
Table 1: All Treatment Emergent Reactions Regardless
of Relationship Reported at a Frequency of > 3% with Climara Pro in the
1-year Endometrial Hyperplasia Studya)
|Body System Adverse Reaction||Climara Pro 0.045 / 0.015
Na = 212
N = 204
|Body as a Whole|
|Abdominal pain||9 (4.2)||11 (5.4)|
|Accidental injury||7 (3.3)||6 (2.9)|
|Back pain||13 (6.1)||12 (5.9)|
|Flu syndrome||10 (4.7)||13 (6.4)|
|Infection||7 (3.3)||10 (4.9)|
|Pain||11 (5.2)||13 (6.4)|
|Hypertension||7 (3.3)||9 (4.4)|
|Flatulence||8 (3.8)||11 (5.4)|
|Metabolic and Nutritional|
|Edema||8 (3.8)||5 (2.5)|
|Weight gain||6 (2.8)||10 (4.9)|
|Arthralgia||9 (4.2)||10 (4.9)|
|Depression||12 (5.7)||7 (3.4)|
|Headache||11 (5.2)||14 (6.9)|
|Bronchitis||9 (4.2)||7 (3.4)|
|Sinusitis||8 (3.8)||12 (5.9)|
|Upper respiratory infection||28 (13.2)||26 (12.7)|
|Skin and Appendages|
|Application site reaction||86 (40.6)||69 (33.8)|
|Breast pain||40 (18.9)||20 (9.8)|
|Rash||5 (2.4)||10 (4.9)|
|Urinary Tract Infection||7 (3.3)||8 (3.9)|
|Vaginal Bleeding||78 (36.8)||44 (21.6)|
|Vaginitis||4 (1.9)||6 (2.9)|
|aN = total number of subjects in a treatment group; n = number of subjects with event.|
Irritation potential of Climara Pro was assessed in a 3-week irritation study. The study compared the irritation of a Climara Pro placebo patch (22 cm²) to a 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 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 percent) of subjects in the 12week symptom study and in 71 (8.5 percent) of subjects in the 1-year endometrial protection study.
The following adverse reactions have been identified during post-approval use of the Climara Pro transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Changes in bleeding patterns
Abdominal distension,* abdominal pain,* nausea
Central Nervous System
Dizziness, headache, insomnia
Application site reaction,* weight increased, anaphylactic reaction
* Combined two or more similar ARs
Read the entire FDA prescribing information for Climara Pro (Estradiol, Levonorgestrel Transdermal)
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