Recommended Topic Related To:

Climara

"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.

The statement was published in the April issue "...

Climara

Climara

Climara Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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 should not be used to prevent cardiovascular disease or dementia. Common side effects of Climara include skin irritation, abdominal pain, nausea, vomiting, bloating, breast tenderness, headache, and weight changes.

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, confusion, problems with vision, speech, or balance;
  • pain or swelling in your lower leg;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes); or
  • a lump in your breast.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;
  • swollen breasts;
  • acne or skin color changes;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • migraine headaches or dizziness;
  • vaginal pain, dryness, or discomfort;
  • swelling of your ankles or feet;
  • depression; 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

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.

Summary of Most Frequently Reported Adverse Experiences/Medical Events ( ≥ 5%) by Treatment Groups

AE per Body System Climara Placebo
(N=72)
0.025 mg/day
(N=219)
0.05 mg/day
(N=201)
0.1 mg/day
(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%
Gastro-Intestinal 9% 21% 29% 18%
  Abdominal Pain 0% 11% 16% 8%
  Nausea 1% 5% 6% 3%
  Flatulence 1% 3% 7% 1%
Musculo-Skeletal 7% 9% 11% 4%
  Arthralgia 1% 5% 5% 3%
Psychiatric 13% 10% 11% 1%
  Depression 1% 5% 8% 0%
Reproductive 12% 18% 41% 11%
  Breast Pain 5% 8% 29% 4%
  Leukorrhea 1% 6% 7% 1%
Respiratory 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%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Climara (estradiol transdermal) : a few cases in which there were a combination of the symptoms of generalized hives or rash with swelling of the throat or eyelid edema. 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.

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

  1. 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 hyperplasia; endometrial cancer.
  2. Breasts
    Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
  3. Cardiovascular
    Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
  4. Gastrointestinal
    Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gall bladder disease; pancreatitis; enlargement of hepatic hemangiomas.
  5. Skin
    Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
  6. Eyes
    Retinal vascular thrombosis, intolerance to contact lenses.
  7. Central nervous system
    Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
  8. Miscellaneous
    Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

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

A A A

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.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations