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Climara Pro Side Effects

Generic Name: estradiol / levonorgestrel

Note: This document contains side effect information about estradiol / levonorgestrel. Some of the dosage forms listed on this page may not apply to the brand name Climara Pro.

For the Consumer

Applies to estradiol/levonorgestrel: transdermal patch extended release

Along with its needed effects, estradiol / levonorgestrel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol / levonorgestrel:

Incidence Not Known

  • Acid or sour stomach
  • anxiety
  • backache
  • belching
  • change in vaginal discharge
  • chest pain or discomfort
  • clear or bloody discharge from the nipple
  • confusion
  • cough
  • difficulty with speaking
  • difficulty with swallowing
  • dimpling of the breast skin
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • full or bloated feeling or pressure in the stomach
  • headache
  • heartburn
  • hives, itching, or rash
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • indigestion
  • inverted nipple
  • loss of appetite
  • lump in the breast or under the arm
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • pain or feeling of pressure in the pelvis
  • pain, redness, or swelling in the arm or leg
  • persistent crusting or scaling of the nipple
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness or swelling of the breast
  • slow speech
  • sore on the skin of the breast that does not heal
  • stomach discomfort, upset, or pain
  • sudden shortness of breath or troubled breathing
  • sweating
  • swelling of the abdominal or stomach area
  • tightness in the chest
  • unusual tiredness or weakness
  • vaginal bleeding
  • vomiting

Some side effects of estradiol / levonorgestrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Back pain
  • body aches or pain
  • breast pain
  • burning, itching, redness, skin rash, swelling, or soreness at the application site
  • chills
  • discouragement
  • ear congestion
  • feeling sad or empty
  • fever
  • heavy nonmenstrual vaginal bleeding
  • irritability
  • loss of interest or pleasure
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • tiredness
  • trouble concentrating
  • trouble sleeping

Less Common

  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • excess air or gas in the stomach or intestines
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • itching of the vagina or genital area
  • joint pain
  • lower back or side pain
  • muscle aches and pains
  • muscle pain or stiffness
  • pain during sexual intercourse
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • pounding in the ears
  • shivering
  • slow or fast heartbeat
  • sweating
  • weight gain

Incidence Not Known

  • Hair loss or thinning of the hair
  • pressure in the stomach
  • swelling of the abdominal or stomach area

For Healthcare Professionals

Applies to estradiol / levonorgestrel: transdermal film extended release

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Rash

Postmarketing reports: Alopecia, night sweats, pruritus[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, flatulence, nausea, vomiting

Uncommon (0.1% to 1%): Bloating, abdominal cramps

Postmarketing reports: Abdominal distension[Ref]

Genitourinary

Very common (10% or more): Vaginal bleeding (36.8%)

Common (1% to 10%): Urinary tract infection, vaginitis, mastodynia

Uncommon (0.1% to 1%): Dysmenorrhea, endometrial hyperplasia

Rare (less than 0.1%): Increase in size of uterine fibrosis

Postmarketing reports: Changes in bleeding patterns[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia

Uncommon (0.1% to 1%): Leg cramps[Ref]

Oncologic

Uncommon (0.1% to 1%): Benign breast tumor[Ref]

Psychiatric

Common (1% to 10%): Depression, increase/decrease in libido

Postmarketing reports: Insomnia[Ref]

Respiratory

Respiratory side effects have included bronchitis (4.2%), sinusitis (3.8%), and upper respiratory infection (13.2%).[Ref]

Metabolic

Uncommon (0.1% to 1%): Fluid retention[Ref]

General

The most common adverse events were application site reactions, which usually disappeared 2 to 3 days after patch removal.[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction[Ref]

Other

Common (1% to 10%): Accidental injury, flu syndrome, pain, edema, weight gain

Uncommon (0.1% to 1%): Weight loss, fatigue

Postmarketing reports: Hot flush[Ref]

Nervous system

Uncommon (0.1% to 1%): Migraine

Postmarketing reports: Dizziness, headache[Ref]

Local

Very common (10% or more): Application site reaction (40.6%)[Ref]

Immunologic

Very common (10% or more): Upper respiratory infection (13.2%)

Common (1% to 10%): Infection, sinusitis, bronchitis

Hepatic

Rare (less than 0.1%): Cholelithiasis, cholestatic jaundice[Ref]

References

1. "Product Information. Climara Pro (estradiol-levonorgestrel)." Berlex Laboratories, Wayne, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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