Vagifem (Estradiol Vaginal) - Side Effects and Adverse Reactions

Adverse Reactions

Adverse events generally have been mild: vaginal spotting, vaginal discharge, allergic reaction and skin rash. Adverse events with an incidence of 5% or greater are reported for two comparative trials. Data for patients receiving either VAGIFEM or placebo in the double blind study are listed in Table 5, and data for patients receiving VAGIFEM in the open label comparator study are listed in Table 6.

Table 5: ADVERSE EVENTS REPORTED IN 5% OR GREATER NUMBER OF PATIENTS RECEIVING VAGIFEM^® IN THE PLACEBO CONTROLLED TRIAL.

	VAGIFEM	Placebo
	(n=91)	(n=47)
ADVERSE EVENT	%	%
HEADACHE	9	6
ABDOMINAL PAIN	7	4
UPPER RESPIRATORY
TRACT INFECTION	5	4
MONILIASIS GENITAL	5	2
BACK PAIN	7	6

Table 6: ADVERSE EVENTS REPORTED IN 5% OR GREATER NUMBER OF PATIENTS RECEIVING VAGIFEM^® IN THE OPEN LABEL STUDY.

	VAGIFEM
	(n=80)
ADVERSE EVENT	%
PRURITUS GENITAL	6
HEADACHE	10
UPPER RESPIRATORY
TRACT INFECTION	11

Other adverse events that occurred in 3-5% of VAGIFEM subjects included: allergy, bronchitis, dyspepsia, haematuria, hot flashes, insomnia, pain, sinusitis, vaginal discomfort, vaginitis. A causal relationship to VAGIFEM has not been established.

REPORTS OF SUSPECTED VAGIFEM SIDE EFFECTS / ADVERSE REACTIONS

Possible Vagifem side effects / adverse reactions in 67 year old female

Reported by a physician from United States on 2011-10-31

Patient: 67 year old female

Reactions: Breast Cancer, Hypergammaglobulinaemia Benign Monoclonal, Breast Cancer in Situ

Adverse event resulted in: hospitalization

Suspect drug(s):
Vagifem
    Dosage: 25 ug, qd, vaginal
    Indication: Atrophic Vulvovaginitis

Vagifem

Vagifem

Vagifem
    Dosage: 25 ug, unk, vaginal
    Indication: Atrophic Vulvovaginitis

Other drugs received by patient: Multivite /00067501/(ascorbic Acid, Ergocalciferol, Nicotinamide, Reti; Vitamin C /00008001/ (Ascorbic Acid); Vytorin; Lipitor; Crestor; Calcium Carbonate; Actonel; Vitamin A /00056001/ (Retinol)

Possible Vagifem side effects / adverse reactions in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: 72 year old female weighing 59.0 kg (129.7 pounds)

Reactions: Breast Cancer Recurrent

Suspect drug(s):
Vagifem

Other drugs received by patient: Mobic

Possible Vagifem side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-02-29

Patient: 58 year old female weighing 83.0 kg (182.6 pounds)

Reactions: Vomiting, Chest Discomfort, Dyspnoea, Nausea, Loss of Consciousness, Abdominal Discomfort, Diarrhoea, Chest Pain

Suspect drug(s):
Vagifem

Other drugs received by patient: Prilosec