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Climara (Estradiol Transdermal) side effects drug center

Climara Side Effects Center

What Is Climara?

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.

What Are Side Effects of Climara?

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.

Dosage for Climara

The recommended dosage of Climara is 6.5 cm2 (0.025 mg/day) applied to the skin once a week.

What Drugs, Substances, or Supplements Interact with Climara?

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.

Climara During Pregnancy and Breastfeeding

Do not use Climara if you are pregnant. Exercise caution if you take Climara while breastfeeding.

Additional Information

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.

Climara Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding, pelvic pain;
  • a breast lump;
  • memory problems, confusion, unusual behavior; or
  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • headache, back pain;
  • stuffy nose, sinus pain, sore throat;
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
  • bloating, stomach cramps, nausea, vomiting;
  • breast pain;
  • redness or irritation where the patch was worn;
  • thinning scalp hair; or
  • fluid retention (swelling, rapid weight gain).

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)

© 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.