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Vivelle-DOT (Estradiol) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

      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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

      The following adverse events have been reported with Vivelle-Dot® (estradiol transdermal system) therapy:

Table 3 Summary of Most Frequently Reported Adverse Experiences/Medical Events Regardless of Relationship Reported at a Frequency ≥5%
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)
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) 4 (3.9) 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 a small number of patients (3.2% or less of patients across treatment groups.)

      The following additional adverse reactions have been reported with estrogen and/or progestin therapy:

1.       Genitourinary system. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.

2.       Breasts. Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

3.       Cardiovascular. Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

4.       Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.

5.       Skin. Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

6.       Eyes. Retinal vascular thrombosis; intolerance to contact lenses.

7.       Central nervous system. Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

8.       Miscellaneous. Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.



REPORTS OF SUSPECTED VIVELLE-DOT SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Vivelle-DOT side effects / adverse reactions in 63 year old female

Reported by a consumer/non-health professional from United States on 2011-10-21

Patient: 63 year old female

Reactions: Eye Irritation, Urticaria, Petechiae, Pyrexia, Erythema, Arthropathy, Lymph Node Pain, Feeling Hot, Oedema Mucosal, Musculoskeletal Stiffness, Oropharyngeal Blistering, Blister, Cough, Pain in Extremity, Rash, Arthralgia, Dysphonia, Ocular Hyperaemia, Genital Swelling

Suspect drug(s):
Plaquenil
    Administration route: Oral
    Indication: Autoimmune Disorder

Mobic
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Neurontin
    Administration route: Oral
    Indication: Arthralgia

Immune Globulin Intravenous (Human)
    Indication: Combined Immunodeficiency
    Start date: 2010-06-01
    End date: 2011-10-01

Vivelle-DOT
    Indication: Hormone Replacement Therapy

Klonopin
    Administration route: Oral
    Indication: Restless Legs Syndrome

Gammagard Liquid
    Indication: Combined Immunodeficiency
    Start date: 2011-10-02
    End date: 2011-10-06



Possible Vivelle-DOT side effects / adverse reactions in 48 year old female

Reported by a physician from United States on 2011-10-25

Patient: 48 year old female

Reactions: Small Intestinal Obstruction, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Vivelle-DOT



Possible Vivelle-DOT side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-11-18

Patient: 60 year old female weighing 61.7 kg (135.7 pounds)

Reactions: Aphagia, Asthma, Nightmare, Increased Upper Airway Secretion, Upper-Airway Cough Syndrome, Upper Respiratory Tract Inflammation, Hot Flush, Insomnia, DRY Throat, DRY Mouth, Nasal Dryness, Cough, Aphonia

Suspect drug(s):
Climara
    Dosage: 0375 mg, unk
    Indication: Hysterectomy
    Start date: 2011-01-01
    End date: 2011-10-03

Climara
    Dosage: 0.375 mg, unk
    Indication: Autonomic Nervous System Imbalance
    Start date: 2000-01-01

Vivelle-DOT
    Dosage: 0.275 mg, q2wk
    Indication: Hysterectomy
    Start date: 2011-01-01

Other drugs received by patient: Losartan



See index of all Vivelle-DOT side effect reports >>

Drug label data at the top of this Page last updated: 2012-02-17

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