Drug information for EVAMIST

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SPRAY; TRANSDERMAL 1.53MG/SPRAY Prescription  (Reference Drug) ESTRADIOL Estradiol KV PHARM 22014
2011-11-01 Label

2011-10-31 Letter

2010-08-09 Other Important Information from FDA

2009-04-22 Review

2009-04-22 Summary Review

2008-11-03 Letter

2008-04-16 Letter

2008-04-16 Label

2007-07-31 Letter

2007-07-30 Label

Drug Adverse Effects information for EVAMIST

Role code Indications Reaction # Reports
PS MENOPAUSAL SYMPTOMS ACCIDENTAL EXPOSURE 1
PS MENOPAUSAL SYMPTOMS ALOPECIA 1
C DEPRESSION ABDOMINAL PAIN 1
C DEPRESSION ALANINE AMINOTRANSFERASE INCREASED 1
C DEPRESSION ANTINUCLEAR ANTIBODY POSITIVE 1
C DEPRESSION ARTHRALGIA 1
C DEPRESSION ASPARTATE AMINOTRANSFERASE INCREASED 1
C DEPRESSION ASTHENIA 1
C DEPRESSION BACK PAIN 1
C DEPRESSION BLISTER 1
C DEPRESSION BLOOD ALKALINE PHOSPHATASE INCREASED 1
C DEPRESSION CARDIAC ENZYMES INCREASED 1
C DEPRESSION CHEST DISCOMFORT 1
C DEPRESSION CHROMATURIA 1
C DEPRESSION CONSTIPATION 1
C DEPRESSION CONVULSION 1
C DEPRESSION DISABILITY 1
C DEPRESSION DIZZINESS 1
C DEPRESSION DRUG INEFFECTIVE 1
C DEPRESSION FALL 1
C DEPRESSION GAIT DISTURBANCE 1
C DEPRESSION GASTROINTESTINAL DISORDER 1
C DEPRESSION HAEMATOMA 1
C DEPRESSION HEADACHE 1
C DEPRESSION HEMIPARESIS 1
C DEPRESSION INJURY 1
C DEPRESSION JOINT INSTABILITY 1
C DEPRESSION LIVER DISORDER 1
C DEPRESSION LOSS OF CONSCIOUSNESS 1
C DEPRESSION LUNG DISORDER 1
C DEPRESSION MEDICATION ERROR 1
C DEPRESSION MUSCLE INJURY 1
C DEPRESSION NEUROPATHY PERIPHERAL 1
C DEPRESSION OEDEMA PERIPHERAL 1
C DEPRESSION PAIN 1
C DEPRESSION PNEUMONIA 1
C DEPRESSION RENAL FAILURE 1
C DEPRESSION RHABDOMYOLYSIS 1
C DEPRESSION SYNCOPE 1
C DEPRESSION URINE OUTPUT INCREASED 1
C DEPRESSION YELLOW SKIN 1
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