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Climara PRO (Estradiol / Levonorgestrel Transdermal) - Side Effects and Adverse Reactions




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.

Table 8: All Treatment Emergent Events Regardless of Relationship Reported at a Frequency of > 3% with Climara Pro in the 1 year Endometrial Hyperplasia Study

Climara Pro

0.045 / 0.015

N = 212


N = 204

Body as a whole
Abdominal pain 9 (4.2) 11 (5.4)
Accidental Injury 7 (3.3) 6 (2.9)
Back pain 13 (6.1) 12 (5.9)
Flu syndrome 10 (4.7) 13 (6.4)
Infection 7 (3.3) 10 (4.9)
Pain 11 (5.2) 13 (6.4)
Hypertension 7 (3.3) 9 (4.4)
Flatulence 8 (3.8) 11 (5.4)
Metabolic and Nutritional Disorders
Edema 8 (3.8) 5 (2.5)
Weight gain 6 (2.8) 10 (4.9)
Arthralgia 9 (4.2) 10 (4.9)
Depression 12 (5.7) 7 (3.4)
Headache 11 (5.2) 14 (6.9)
Bronchitis 9 (4.2) 7 (3.4)
Sinusitis 8 (3.8) 12 (5.9)
Upper Respiratory Infection 28 (13.2) 26 (12.7)
Skin and Appendages
Application site reaction 86 (40.6) 69 (33.8)
Breast pain 40 (18.9) 20 (9.8)
Rash 5 (2.4) 10 (4.9)
Urinary Tract Infection 7 (3.3) 8 (3.9)
Vaginal Bleeding 78 (36.8) 44 (21.6)
Vaginitis 4 (1.9) 6 (2.9)

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.


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.


Below is a sample of reports where side effects / adverse reactions may be related to Climara PRO. The information is not vetted and should not be considered as verified clinical evidence.

Possible Climara PRO side effects / adverse reactions in 54 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-08

Patient: 54 year old female

Reactions: Application Site Rash

Suspect drug(s):
Climara PRO

Possible Climara PRO side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from United States on 2011-11-09

Patient: 58 year old female

Reactions: Application Site Rash

Suspect drug(s):
Climara PRO

Possible Climara PRO side effects / adverse reactions in 65 year old female

Reported by a consumer/non-health professional from United States on 2011-11-16

Patient: 65 year old female

Reactions: Lower Limb Fracture, Fall

Suspect drug(s):
Climara PRO

See index of all Climara PRO side effect reports >>

Drug label data at the top of this Page last updated: 2009-06-03

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