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Climara (Estradiol Transdermal) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • •Cardiovascular Disorders [see Boxed Warning, and Warnings and Precautions ]
  • •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.

  •  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

Climara

Body System

  •  Adverse Reactions

0.025 mg/day 1 (N=219)

0.05 mg/day 2 (N=201)

0.1 mg/day (N=194)

Placebo 3 (N=72)

Body as a Whole

  •  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

  •  Arthralgia

7%

1%

9%

5%

11%

5%

4%

3%

Nervous System

  •  Depression

13%

1%

10%

5%

11%

8%

1%

0%

Urogenital System

  •  Breast Pain
  •  Leukorrhea

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

  •  Pruritus

19%

0.5%

12%

6%

12%

3%

15%

6%

1 Adverse reactions occurring at rate of ?5 percent in Climara trials of clinical efficacy versus placebo and versus active comparator; and trial of Climara versus placebo for the prevention of osteoporosis
2 Adverse reactions occurring at rate of ?5 percent in Climara trials of clinical efficacy versus placebo and versus active comparator
3 Adverse reactions occurring in placebo group in Climara trial of clinical efficacy versus placebo

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



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



See index of all Climara side effect reports >>

Drug label data at the top of this Page last updated: 2013-10-09

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