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Minivelle

Last reviewed on RxList: 1/11/2018
Minivelle Side Effects Center

Last reviewed on RxList 1/11/2018

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:

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.

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Minivelle Professional Information

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 therapy:

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

  Vivelle
0.025 mg/day
(N=47)
N (%)
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)
2 N (%)
Placebo
(N=157)
N (%)
Gastrointestinal disorders
Constipation 2 (4.3) 5 (3.8) 4 (3.9) 3 (6.5) 2 (1.5) 4 (2.5)
Dyspepsia 4 (8.5) 12 (9.2) 3 (2.9) 2 (4.3) 0 10 (6.4)
Nausea 2 (4.3) 8 (6.2) 8 (6.2) 0 7 (5.3) 5 (3.2)
General disorders and administration site conditions***
Influenza-like illness 3 (6.4) 6 (4.6) 8 (7.8) 0 3 (2.3) 10 (6.4)
Pain NOS* 0 8 (6.2) 0 2 (4.3) 7 (5.3) 7 (4.5)
Infections and infestations
Influenza 4 (8.5) 4 (3.1) 6 (5.8) 0 10 (7.6) 14 (8.9)
Nasopharyngitis 3 (6.4) 16 (12.3) 10 (9.7) 9 (19.6) 11 (8.3) 24 (15.3)
Sinusitis NOS* 4 (8.5) 17 (13.1) 13 (12.6) 3 (6.5) 7 (5.3) 16 (10.2)
Upper respiratory tract infection NOS* 3 (6.4) 8 (6.2) 11 (10.7) 4 (8.7) 6 (4.5) 9 (5.7)
Investigations
Weight increased 4 (8.5) 5 (3.8) 2 (1.9) 2 (4.3) 0 3 (1.9)
Musculoskeletal and connective tissue disorders
Arthralgia 0 11 (8.5) 4 (3.9) 2 (4.3) 5 (3.8) 9 (5.7)
Back pain 4 (8.5) 10 (7.7) 9 (8.7) 4 (8.7) 14 (10.6) 10 (6.4)
Neck pain 3 (6.4) 4 (3.1) 4 (3.9) 0 6 (4.5) 2 (1.3)
Pain in limb 0 10 (7.7) 7 (6.8) 2 (4.3) 6 (4.5) 9 (5.7)
Nervous system disorders
Headache NOS* 7 (14.9) 35 (26.9) 32 (31.1) 23 (50.0) 34 (25.8) 37 (23.6)
Sinus headache 0 12 (9.2) 5 (4.9) 5 (10.9) 2 (1.5) 8 (5.1)
Psychiatric disorders
Anxiety NEC** 3 (6.4) 5 (3.8) 0 0 2 (1.5) 4 (2.5)
Depression 5 (10.6) 4 (3.1) 7 (6.8) 0 4 (3.0) 6 (3.8)
Insomnia 3 (6.4) 6 (4.6) 4 (3.9) 2 (4.3) 2 (1.5) 9 (5.7)
Reproductive system and breast disorders
Breast tenderness 8 (17.0) 10 (7.7) 8 (7.8) 3 (6.5) 17 (12.9) 0
Dysmenorrhea 0 0 0 3 (6.5) 0 0
Intermenstrual bleeding 3 (6.4) 9 (6.9) 6 (5.8) 0 14 (10.6) 7 (4.5)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 0 4 (3.1) 3 (2.9) 3 (6.5) 6 (4.5) 7 (4.5)
Vascular disorders
Hot flushes NOS* 3 (6.4) 0 3 (2.9) 0 0 6 (3.8)
Hypertension NOS* 2 (4.3) 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).

Postmarketing Experience

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

Breast

Breast enlargement

Cardiovascular

Palpitations, angina unstable

Gastrointestinal

Hemorrhage, diarrhea

Skin

Application site reactions, erythema, rash, hyperhidrosis, pruritis, urticaria

Central Nervous System

Dizziness, paresthesia, migraine, mood swings, emotional disorder, irritability, nervousness

Miscellaneous

Portal vein thrombosis, dyspnea, malaise, fatigue, peripheral edema, muscle spasms, paresthesia oral, swollen tongue, lip swelling, pharyngeal edema

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

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
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© Minivelle Patient Information is supplied by Cerner Multum, Inc. and Minivelle Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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