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Climara

Last reviewed on RxList: 1/30/2017
Climara Side Effects Center

Last reviewed on RxList 01/18/2017

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:

Tell your doctor if you have serious side effects of Climara Transdermal System including:

  • mental/mood changes (such as depression, memory loss),
  • breast lumps,
  • unusual vaginal bleeding (such as spotting, prolonged or recurrent bleeding),
  • increased or new vaginal irritation/itching/odor/discharge,
  • severe stomach or abdominal pain,
  • persistent nausea or vomiting,
  • yellowing eyes or skin,
  • dark urine,
  • swelling hands/ankles/feet, or
  • increased thirst or urination.

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.

Climara Consumer Information

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)

Climara Professional Information

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)

Related Resources for Climara

Read the Climara User Reviews »

© Climara Patient Information is supplied by Cerner Multum, Inc. and Climara Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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