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Minivelle

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Minivelle

Minivelle Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Minivelle (estradiol transdermal system) is a form of the female hormone estrogen, used to treat moderate to severe vasomotor symptoms due to menopause. Common side effects include skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.

The initial dose of Minivelle should be 0.0375 mg per day applied to the skin twice weekly. Place the adhesive side of Minivelle on a clean, dry area on the lower abdomen. Replace twice weekly (every 3-4 days). Minivelle may interact with other drugs. Tell your doctor all medications and supplements you use. Minivelle should not be used during pregnancy or breastfeeding. Consult your doctor if you are pregnant or nursing.

Our Minivelle (estradiol transdermal system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Minivelle FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in labeling:

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.

There were no clinical trials conducted with MINIVELLE. MINIVELLE is bioequivalent to Vivelle®. The following adverse reactions are reported with Vivelle:

Table 1: Summary of Most Frequently Reported Adverse Reactions (Vivelle versus Placebo) Regardless of Relationship Reported at a Frequency > 5 Percent

  Vivelle 0.0375 mg/day†
(N=130) N (%)
Vivelle 0.05 mg/day†
(N=103) N (%)
Vivelle 0.075 mg/day†
(N=46) N (%)
Vivelle 0.1 mg/day†
(N=132) N (%)
Placebo
(N=157) N (%)
Gastrointestinal disorders
Constipation 5 (3.8) 4 (3.9) 3 (6.5) 2 (1.5) 4 (2.5)
Dyspepsia 12 (9.2) 3 (2.9) 2 (4.3) 0 10 (6.4)
Nausea 8 (6.2) 4 (3.9) 0 7(5.3) 5 (3.2)
General disorders and administration site conditions***
Influenza-like illness 6 (4.6) 8 (7.8) 0 3 (2.3) 10 (6.4)
Pain NOS* 8 (6.2) 0 2 (4.3) 7 (5.3) 7(4.5)
Infections and infestations
Influenza 4 (3.1) 6 (5.8) 0 10 (7.6) 14 (8.9)
Nasopharyngitis 16 (12.3) 10 (9.7) 9 (19.6) 11 (8.3) 24 (15.3)
Sinusitis NOS* 17 (13.1) 13 (12.6) 3 (6.5) 7(5.3) 16 (10.2)
Upper respiratory tract infection NoS* 8 (6.2) 11 (10.7) 4 (8.7) 6 (4.5) 9(5.7)
Investigations
Weight increased 5 (3.8) 2 (1.9) 2 (4.3) 0 3 (1.9)
Musculoskeletal and connective tissue disorders
Arthralgia 11 (8.5) 4 (3.9) 2 (4.3) 5 (3.8) 9 (5.7)
Back pain 10 (7.7) 9 (8.7) 4 (8.7) 14 (10.6) 10 (6.4)
Neck pain 4 (3.1) 4 (3.9) 0 6 (4.5) 2 (1.3)
Pain in limb 10 (7.7) 7(6.8) 2 (4.3) 6 (4.5) 9 (5.7)
Nervous system disorders
Headache NOS* 35 (26.9) 32 (31.1) 23 (50.0) 34 (25.8) 37 (23.6)
Sinus headache 12 (9.2) 5 (4.9) 5 (10.9) 2 (1.5) 8 (5.1)
Psychiatric disorders
Anxiety NEC** 5 (3.8) 0 0 2 (1.5) 4 (2.5)
Depression 4 (3.1) 7(6.8) 0 4 (3.0) 6 (3.8)
Insomnia 6 (4.6) 4 (3.9) 2 (4.3) 2 (1.5) 9(5.7)
Reproductive system and breast disorders
Breast tenderness 10 (7.7) 8 (7.8) 3 (6.5) 17 (12.9) 0
Dysmenorrhea 0 0 3 (6.5) 0 0
Intermenstrual bleeding 9 (6.9) 6 (5.8) 0 14 (10.6) 7(4.5)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 4 (3.1) 3 (2.9) 3 (6.5) 6 (4.5) 7(4.5)
Vascular disorders
Hot flushes NOS* 0 3 (2.9) 0 0 6 (3.8)
Hypertension NOS* 0 3 (2.9) 0 0 2 (1.3)
† Represents milligrams of estradiol delivered daily by each system
*NOS represents not otherwise specified
**NEC represents not elsewhere classified
***Application site erythema and application site irritation were observed in 3.2% or less of patients across treatment groups.

During the clinical pharmacology studies with MINIVELLE, 35 percent or less of subjects experienced barely perceptible erythema. No transdermal systems were removed due to irritation. Three subjects (2.2 percent) reported mild discomfort while wearing MINIVELLE (N=136).

Read the entire FDA prescribing information for Minivelle (Estradiol Transdermal System) »

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