Minivelle
FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex »
"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Dyspareunia"...
Read the FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex article »
Minivelle
Minivelle Side Effects Center
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:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Endometrial Cancer [see BOXED WARNING, 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.
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) »
Additional Minivelle Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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