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Climara

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Climara




Climara Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/29/2015

Climara (estradiol) Transdermal System is an estrogen hormone used to treat vasomotor, vulvar, and vaginal atrophy symptoms due to menopause, hypoestrogenism, and to prevent postmenopausal osteoporosis. Climara Transdermal System should not be used to prevent cardiovascular disease or dementia. Common side effects of Climara Transdermal System include skin irritation, acne or skin color changes, abdominal pain, nausea, vomiting, upset stomach, constipation bloating, breast swelling and tenderness, nipple discharge, headache, weight changes, increased facial hair, thinning scalp hair, back pain, joint pain, cold symptoms (stuffy nose, sneezing, sinus pain, sore throat), changes in your menstrual periods, or break-through bleeding.

The recommended dosage of Climara is 6.5 cm2 (0.025 mg/day) applied to the skin once a week. St. John's wort, blood thinners, ritonavir, carbamazepine, erythromycin, and Ketozole or other azole antifungals may interact with Climara. Tell your doctor all medications you take. Before taking Climara tell your doctor if you have a history of stroke or blood clot, circulation problems, a bleeding disorder, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. Do not use Climara if you are pregnant. Exercise caution if you take Climara while breastfeeding.

Our Climara (estradiol) Transdermal System 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 in Detail - Patient Information: Side Effects

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 a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, sudden vision changes, problems with speech or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding;
  • a lump in your breast;
  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • upset stomach, bloating, constipation;
  • acne or skin color changes, increased facial hair, thinning scalp hair;
  • mild headache, back pain, joint pain;
  • cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat;
  • breast swelling and tenderness, nipple discharge; or
  • changes in your menstrual periods, break-through bleeding.

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.

Read the entire detailed patient monograph for Climara (Estradiol Transdermal)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Climara Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

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 (Estradiol Transdermal)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Climara FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

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 reflect pooled data from 5 clinical trials of Climara. A total of 614 women were exposed to Climara for 3 months (193 women at 0.025 mg per day, 201 women at 0.05 mg per day, 194 women at 0.1 mg per day) in randomized, double-blind trials of clinical efficacy versus placebo and versus active comparator. All women were postmenopausal, had a serum estradiol level of less than 20 pg/mL, and a minimum of five moderate to severe hot flushes per week or a minimum of 15 hot flushes per week of any severity at baseline. Included in this table are an additional 25 postmenopausal hysterectomized women exposed to Climara 0.025 mg per day for 6 to 24 months (N=16 at 24 months) in a randomized, double-blind, placebo-controlled study of Climara for the prevention of osteoporosis.

Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥5 Percent and More Frequent in Women Receiving Climara

Body System
Adverse Reactions
Climara Placeboc
(N=72)
0.025 mg/daya
(N=219)
0.05 mg/dayb
(N=201)
0.1 mg/dayb
(N=194)
Body as a Whole 21% 39% 37% 29%
  Headache 5% 18% 13% 10%
  Pain 1% 8% 11% 7%
  Back Pain 4% 8% 9% 6%
  Edema 0.5% 13% 10% 6%
Digestive System 9% 21% 29% 18%
  Abdominal Pain 0% 11% 16% 8%
  Nausea 1% 5% 6% 3%
  Flatulence 1% 3% 7% 1%
Musculoskeletal System 7% 9% 11% 4%
  Arthralgia 1% 5% 5% 3%
Nervous System 13% 10% 11% 1%
  Depression 1% 5% 8% 0%
Urogenital System 12% 18% 41% 11%
  Breast Pain 5% 8% 29% 4%
  Leukorrhea 1% 6% 7% 1%
Respiratory System 15% 26% 29% 14%
  URTI 6% 17% 17% 8%
  Pharyngitis 0.5% 3% 7% 3%
  Sinusitis 4% 4% 5% 3%
  Rhinitis 2% 4% 6% 1%
Skin and Appendages 19% 12% 12% 15%
Pruritus 0.5% 6% 3% 6%
a Adverse reactions occurring at rate of ≥5 percent in Climara trials of clinical efficacy versus placebo and versus active comparator; and trial of Climara versus placebo for the prevention of osteoporosis
b Adverse reactions occurring at rate of ≥5 percent in Climara trials of clinical efficacy versus placebo and versus active comparator
c Adverse reactions occurring in placebo group in Climara trial of clinical efficacy versus placebo

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of the Climara 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.

Genitourinary System

Changes in bleeding pattern, pelvic pain

Breast

Breast cancer, breast pain, breast tenderness

Cardiovascular

Changes in blood pressure, palpitations, hot flashes

Gastrointestinal

Vomiting, abdominal pain, abdominal distension, nausea

Skin

Alopecia, hyperhidrosis, night sweats, urticaria, rash

Eyes

Visual disturbances, contact lens intolerance,

Central Nervous System

Depression, migraine, paresthesia, dizziness, anxiety, irritability, mood swings, nervousness, insomnia, headache

Miscellaneous

Fatigue, menopausal symptoms, weight increase, application site reaction, anaphylactic reactions

Read the entire FDA prescribing information for Climara (Estradiol Transdermal)

Climara - User Reviews

Climara 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 sorted by most helpful. Patient Discussions FAQs

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.


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