Climara Pro Side Effects

Please note - some side effects for Climara Pro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Climara Pro - for the Consumer

Climara Pro Weekly Patch

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Climara Pro Weekly Patch:

Headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; stomach cramps or bloating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; breast pain; calf pain or tenderness; changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing of blood; dizziness; fainting; mental or mood changes (eg, severe depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe, persistent, or unusual vaginal bleeding; slurred speech; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Climara Pro Side Effects - for the Professional

Climara Pro

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.

Irritation potential of Climara Pro was assessed in a 3-week irritation study. The study compared the irritation of a Climara Pro placebo patch (22 cm2) to a Climara placebo (25 cm2). Visual assessments of irritation were made on Day 7 of each wear period, approximately 30 minutes after patch removal using a 7-point scale (0 = no evidence of irritation; 1 = minimal erythema, barely perceptible; 2 = definite erythema, readily visible, or minimal edema, or minimal papular response; 3-7 = erythema and papules, edema, vesicles, strong extensive reaction).

The mean irritation scores were 0.13 (week 1), 0.12 (week 2), and 0.06 (week 3) for the Climara Pro placebo. The mean scores for the Climara placebo were 0.2 (week 1), 0.26 (week 2), 0.12 (week 3). There were no irritation scores greater than 2 at any timepoint in any subject.

In controlled clinical trials, withdrawals due to application site reactions occurred in 6 (2.1%) of subjects in the 12-week symptom study and in 71 (8.5%) of subjects in the 1-year endometrial protection study.

The following additional adverse reactions have been reported with estrogen and/or estrogen/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 gallbladder 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; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of estrogen/progestin-containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included myocardial infarction and stroke as well as venous thrombosis and pulmonary embolism. Hypertension has been reported in 3.3 % of patients in one study.

Dermatologic

Dermatologic side effects have included application site reactions (40.6%) and rash (2.4%).

Gastrointestinal

Gastrointestinal side effects have included flatulence (3.8%).

Genitourinary

Genitourinary side effects have included urinary tract infection (3.3%), vaginal bleeding (36.8%), breast pain (18.9%), and vaginitis (1.9%).

Musculoskeletal

Musculoskeletal side effects have included back pain (6.1%) and arthralgia (4.2%).

Oncologic

Oncologic side effects have included endometrial and breast cancer.

Psychiatric

Psychiatric side effects have included depression (5.7%) and headache (5.2%).

Respiratory

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

Metabolic

Metabolic side effects have included edema (3.8%) and weight gain (2.8%)

General

General side effects have included infection (3.3%), abdominal pain (4.2%), flu syndrome (4.7%), pain (5.2%), and accidental injury (3.3%).

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, and anaphylactoid/anaphylactic reactions.

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