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Evamist (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, Warnings and Precautions ]
  • •Malignant Neoplasms [see Boxed Warning, Warnings and Precautions ( 5.2 )]

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 clinical practice.

In a 12-week, randomized, placebo-controlled trial of Evamist in 454 women, 80 to 90 percent of women randomized to active drug received at least 70 days of therapy and 75 to 85 percent randomized to placebo received at least 70 days of therapy.

The adverse reactions that occurred in at least 5 percent of women in any treatment group are shown in Table 1.

Table 1. Frequency of Adverse Reactions (≥ 5 Percent) in Any Treatment Group in a Controlled Study of Evamist
Frequency n (%)
System Organ Class
Preferred Term
1 Spray 2 Sprays 3 Sprays
Placebo
(N = 77)
Evamist
(N = 76)
Placebo
(N = 76)
Evamist
(N = 74)
Placebo
(N = 75)
Evamist
(N = 76)

Reproductive System and Breast Disorders

Breast tenderness

0 (0)

4 (5)

4 (5)

5 (7)

0 (0)

4 (5)

Nipple pain

0 (0)

2 (3)

0 (0)

5 (7)

0 (0)

1 (1)

Gastrointestinal Disorders

Nausea

5 (7)

1 (1)

1 (1)

2 (3)

4 (5)

2 (3)

Infections and Infestations

Nasopharyngitis

1 (1)

4 (5)

2 (3)

3 (4)

1 (1)

1 (1)

Musculoskeletal and Connective Tissue Disorders

Back pain

1 (1)

2 (3)

2 (3)

4 (5)

1 (1)

2 (3)

Arthralgia

1 (1)

1 (1)

4 (5)

1 (1)

0 (0)

3 (4)

Nervous system

Headache

4 (5)

7 (9)

5 (7)

9 (12)

7 (9)

8 (11)

Application site reactions were reported in 3 out of 226 (1.3%) women treated with Evamist.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Evamist. 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.

Breasts: Breast swelling, breast mass, breast enlargement

Cardiovascular: Heart rate increased

Central nervous system: Dizziness, dysgeusia, paresthesia, lethargy, hypoesthesia

Eyes: Eye irritation, ocular hyperemia

Gastrointestinal: Abdominal pain, diarrhea, constipation, abdominal distension, dry mouth, decreased appetite

Genitourinary system: Vaginal bleeding

Musculoskeletal: Muscle spasms, arthritis

Psychiatric: Insomnia, mood swings, anxiety, irritability, mood altered, depression

Respiratory tract: Cough, dyspnea, dry throat

Skin: Nipple and areola discoloration, usually on the same side of the body as the inner forearm on which Evamist is applied, rash, pruritus, alopecia, urticaria, dry skin, skin discoloration, chloasma

Miscellaneous: Weight increased, malaise, fatigue, asthenia



REPORTS OF SUSPECTED EVAMIST SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Evamist side effects / adverse reactions in 53 year old female

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: 53 year old female weighing 70.3 kg (154.7 pounds)

Reactions: Alopecia, Accidental Exposure

Suspect drug(s):
Evamist



Possible Evamist side effects / adverse reactions in 50 year old female

Reported by a individual with unspecified qualification from United States on 2012-02-29

Patient: 50 year old female

Reactions: Abdominal Pain, Respiratory Disorder, Cerebral Disorder, Blood Lactate Dehydrogenase Increased, Unresponsive TO Stimuli, Continuous Haemodiafiltration, Mental Status Changes, Convulsion, Malaise, Aspartate Aminotransferase Increased, Diarrhoea Haemorrhagic, Colitis, Haemolytic Uraemic Syndrome, Thrombocytopenia, Microangiopathy, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Etanercept (Etanercept)
    Indication: Rheumatoid Arthritis

Evamist
    Dosage: transdermal
    Indication: Product Used FOR Unknown Indication



Possible Evamist side effects / adverse reactions in 50 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-07

Patient: 50 year old female weighing 59.0 kg (129.7 pounds)

Reactions: Treatment Noncompliance, Exposure VIA Direct Contact, Accidental Exposure

Adverse event resulted in: disablity

Suspect drug(s):
Evamist



See index of all Evamist side effect reports >>

Drug label data at the top of this Page last updated: 2014-03-31

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