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.
- 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. - Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. - Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure. - Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gall bladder disease; pancreatitis; enlargement of hepatic hemangiomas. - Skin
Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash. - Eyes
Retinal vascular thrombosis, intolerance to contact lenses. - Central nervous system
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia. - 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.