ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
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•Cardiovascular Disorders [see Boxed Warning, and Warnings and Precautions ]
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•Malignant Neoplasms [see Boxed Warning, and Warnings and Precautions]
Clinical Trials Experience
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.
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The data described below reflect pooled data from 5 clinical trials of Climara. A total of 614 women were exposed to Climara for 3 months (193 women at 0.025 mg per day, 201 women at 0.05 mg per day, 194 women at 0.1 mg per day) in randomized, double-blind trials of clinical efficacy versus placebo and versus active comparator. All women were postmenopausal, had a serum estradiol level of less than 20 pg/mL, and a minimum of five moderate to severe hot flushes per week or a minimum of 15 hot flushes per week of any severity at baseline. Included in this table are an additional 25 postmenopausal hysterectomized women exposed to Climara 0.025 mg per day for 6 to 24 months (N=16 at 24 months) in a randomized, double-blind, placebo-controlled study of Climara for the prevention of osteoporosis.
Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥5 Percent and More Frequent in Women Receiving Climara
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Climara
|
|
Body System
|
0.025 mg/day
(N=219)
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0.05 mg/day
(N=201)
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0.1 mg/day
(N=194)
|
Placebo
(N=72)
|
Body as a Whole
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Headache
-
Pain
-
Back Pain
-
Edema
|
21%
5%
1%
4%
0.5%
|
39%
18%
8%
8%
13%
|
37%
13%
11%
9%
10%
|
29%
10%
7%
6%
6%
|
Digestive System
-
Abdominal Pain
-
Nausea
-
Flatulence
|
9%
0%
1%
1%
|
21%
11%
5%
3%
|
29%
16%
6%
7%
|
18%
8%
3%
1%
|
Musculoskeletal System
|
7%
1%
|
9%
5%
|
11%
5%
|
4%
3%
|
Nervous System
|
13%
1%
|
10%
5%
|
11%
8%
|
1%
0%
|
Urogenital System
|
12%
5%
1%
|
18%
8%
6%
|
41%
29%
7%
|
11%
4%
1%
|
Respiratory System
-
URTI
-
Pharyngitis
-
Sinusitis
-
Rhinitis
|
15%
6%
0.5%
4%
2%
|
26%
17%
3%
4%
4%
|
29%
17%
7%
5%
6%
|
14%
8%
3%
3%
1%
|
Skin and Appendages
|
19%
0.5%
|
12%
6%
|
12%
3%
|
15%
6%
|
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of the Climara transdermal system. 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.
Genitourinary System
Changes in bleeding pattern, pelvic pain
Breast
Breast cancer, breast pain, breast tenderness
Cardiovascular
Changes in blood pressure, palpitations, hot flashes
Gastrointestinal
Vomiting, abdominal pain, abdominal distension, nausea
Skin
Alopecia, hyperhidrosis, night sweats, urticaria, rash
Eyes
Visual disturbances, contact lens intolerance,
Central Nervous System
Depression, migraine, paresthesia, dizziness, anxiety, irritability, mood swings, nervousness, insomnia, headache
Miscellaneous
Fatigue, menopausal symptoms, weight increase, application site reaction, anaphylactic reactions
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REPORTS OF SUSPECTED CLIMARA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Climara. The information is not vetted and should not be considered as verified clinical evidence.
Possible Climara side effects / adverse reactions in 54 year old female
Reported by a lawyer from United States on 2011-10-04
Patient: 54 year old female
Reactions: Breast Cancer, Nervous System Disorder, Injury
Suspect drug(s):
Aygestin
Dosage: unk
Start date: 1997-01-01
End date: 2007-01-01
Aygestin
Cenestin
Dosage: unk
Administration route: Oral
Start date: 1997-01-01
End date: 2007-01-01
Climara
Dosage: unk
Start date: 1997-01-01
End date: 2007-01-01
Estrace
Dosage: unk
Start date: 1997-01-01
End date: 2007-01-01
Estradiol
Dosage: unk
Administration route: Oral
Start date: 1997-01-01
End date: 2007-01-01
Estradiol Transdermal
Dosage: unk
Start date: 1997-01-01
End date: 2007-01-01
Premarin
Dosage: unk
Administration route: Oral
Start date: 1997-01-01
End date: 2007-01-01
Premphase (Premarin;cycrin 14/14)
Dosage: unk
Start date: 1997-01-01
End date: 2007-01-01
Prometrium
Dosage: unk
Start date: 1997-01-01
End date: 2007-01-01
Other drugs received by patient: Vitamin TAB; Avelox; Levaquin; Ziac
Possible Climara side effects / adverse reactions in 59 year old female
Reported by a consumer/non-health professional from United States on 2011-10-10
Patient: 59 year old female weighing 63.0 kg (138.6 pounds)
Reactions: Dermatitis Bullous
Suspect drug(s):
Climara
Indication: Hormone Replacement Therapy
Climara
Dosage: 1 mg, qd
Indication: Hot Flush
Start date: 2003-01-01
End date: 2011-08-09
Possible Climara side effects / adverse reactions in 60 year old female
Reported by a physician from United States on 2011-10-14
Patient: 60 year old female
Reactions: Asthma, Hot Flush, Nightmare
Suspect drug(s):
Climara
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