This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prempro and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (472)
Death (5)
Life Threatening Events (6)
Disability (27)
Reports by Reaction Type
Breast Cancer Female (75),
Hot Flush (56),
Drug Ineffective (47),
Depression (41),
Breast Cancer (30),
Anxiety (27),
Feeling Abnormal (25),
Headache (24),
Insomnia (19),
Malaise (18),
Irritability (18),
Breast Cancer Metastatic (18)
Below are a few examples of reports where side effects / adverse reactions may be related to Prempro. For a complete list or a specific selection of reports, please use the links above.
Possible Prempro side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 65 year old female, weighing 61.2 kg (134.6 pounds)
Reactions: Product Quality Issue, Metrorrhagia
Drug(s) suspected as cause:
Prempro
Other drugs received by patient: Aspirin; Lipitor; Niaspan; Lansoprazole; Premarin; Ibuprofen; Fluticasone
Possible Prempro side effects in 51 year old female
Reported by a physician from United States on 2012-08-27
Patient: 51 year old female, weighing 66.7 kg (146.7 pounds)
Reactions: Pain in Extremity, Muscle Spasms
Drug(s) suspected as cause:
Prempro
Dosage: 1 df, 1x/day (0.45/1.5 mg )
Administration route: Oral
Indication: Hot Flush
Start date: 2012-07-30
End date: 2012-08-06
Prempro
Indication: Postmenopause
Other drugs received by patient: Meclizine; Doxycycline Hydrochloride
Possible Prempro side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 63 year old female, weighing 78.9 kg (173.6 pounds)
Reactions: Irritability, Hot Flush, Drug Ineffective, Abdominal Distension, Metrorrhagia
Drug(s) suspected as cause:
Prempro
Other drugs received by patient: Lisinopril; Diltiazem
Possible Prempro side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Premarin
Dosage: unk
Prempro
Dosage: unk
Possible Prempro side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Therapeutic Response Unexpected
Drug(s) suspected as cause:
Lyrica
Dosage: unk
Prempro
Dosage: unk
Possible Prempro side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female
Reactions: Malaise, Influenza
Drug(s) suspected as cause:
Prempro
Possible Prempro side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 60 year old female
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Prempro
Possible Prempro side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Pneumonia
Drug(s) suspected as cause:
Prempro
Possible Prempro side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 66 year old female, weighing 63.5 kg (139.7 pounds)
Reactions: Malabsorption, Medication Residue
Drug(s) suspected as cause:
Prempro
Other drugs received by patient: Ziac
Possible Prempro side effects in 50 year old female
Reported by a physician from United States on 2012-08-21
Patient: 50 year old female, weighing 178.0 kg (391.6 pounds)
Reactions: Wrong Drug Administered, Drug Dispensing Error, Menopause
Drug(s) suspected as cause:
Premarin
Dosage: 1.25 mg, 1 tablet, unk
Administration route: Oral
Start date: 2012-08-07
End date: 2012-08-07
Prempro
Dosage: 0.625/2.5 mg, 1x/day
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-03-01
End date: 2012-08-02
Possible Prempro side effects in 53 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 53 year old female, weighing 53.5 kg (117.7 pounds)
Reactions: Sleep Disorder, Drug Ineffective, Feeling Abnormal, Asthenia
Drug(s) suspected as cause:
Prempro
Dosage: 0.625/2.5 mg, once daily
Administration route: Oral
Indication: Hot Flush
Start date: 2012-01-01
Prempro
Dosage: 0.45/1.5 mg, once daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-03-01
End date: 2012-01-01
Possible Prempro side effects in 57 year old female
Reported by a physician from United States on 2012-08-21
Patient: 57 year old female, weighing 61.2 kg (134.6 pounds)
Reactions: Medication Residue
Drug(s) suspected as cause:
Premphase 14 / 14
Dosage: 1 df, 1x/day (0.625/5 mg)
Administration route: Oral
Indication: Postmenopause
Start date: 2012-06-13
Prempro
Dosage: 1 df, 1x/day (0.625/2.5 mg)
Administration route: Oral
Indication: Postmenopause
End date: 2012-05-01
Other drugs received by patient: Micardis; Motrin; Omeprazole
Possible Prempro side effects in 50 year old female
Reported by a lawyer from United States on 2012-08-21
Patient: 50 year old female, weighing 63.0 kg (138.6 pounds)
Reactions: Anxiety, Breast Cancer Recurrent
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Prempro
Other drugs received by patient: Alprazolam; Ciprofloxacin; Wellbutrin; Wellbutrin
Possible Prempro side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 56 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Fatigue, Feeling Cold
Drug(s) suspected as cause:
Prempro
Possible Prempro side effects in 62 year old female
Reported by a lawyer from United States on 2012-08-21
Patient: 62 year old female
Reactions: Emotional Distress, Breast Cancer Female
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prempro
Dosage: 0.625/2.5mg
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-08-01
End date: 2001-03-30
Provera
Dosage: 10 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-05-01
End date: 1996-08-01
Other drugs received by patient: Aspirin
Possible Prempro side effects in 53 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 53 year old female, weighing 53.5 kg (117.7 pounds)
Reactions: Drug Ineffective, Sleep Disorder, Feeling Abnormal, Asthenia
Drug(s) suspected as cause:
Prempro
Dosage: 0.625/2.5 mg, once daily
Administration route: Oral
Indication: Hot Flush
Start date: 2012-01-01
Prempro
Dosage: 0.45/1.5 mg, once daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-03-01
End date: 2012-01-01
Possible Prempro side effects in 42 year old
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 42 year old
Reactions: Back Disorder
Drug(s) suspected as cause:
Prempro
Possible Prempro side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Hot Flush, Incontinence, Drug Intolerance, Headache, Feeling Abnormal, Ill-Defined Disorder, Nervousness
Drug(s) suspected as cause:
Premarin
Dosage: unk
Prempro
Dosage: unk
Progesterone
Dosage: unk
Possible Prempro side effects in 52 year old female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 52 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Alopecia
Drug(s) suspected as cause:
Prempro
Other drugs received by patient: Pentasa; Folic Acid; Nexium; Vitamin B-12
Possible Prempro side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 60 year old female
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Prempro
Possible Prempro side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: female
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Premarin
Dosage: unk
Prempro
Dosage: unk
Possible Prempro side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 57 year old female, weighing 51.7 kg (113.7 pounds)
Reactions: Fungal Infection
Drug(s) suspected as cause:
Prempro
Dosage: 0.625 mg, unk
Indication: Hot Flush
Prempro
Dosage: 0.45 mg, unk
Start date: 2012-06-01
Possible Prempro side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 57 year old female, weighing 51.7 kg (113.7 pounds)
Reactions: Fungal Infection
Drug(s) suspected as cause:
Prempro
Dosage: 0.625 mg, unk
Indication: Hot Flush
Prempro
Dosage: 0.45 mg, 1x/day
Start date: 2012-06-01
Possible Prempro side effects in 53 year old female
Reported by a lawyer from United States on 2012-08-17
Patient: 53 year old female
Reactions: Anxiety, Breast Cancer Female, Depression
Drug(s) suspected as cause:
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Premarin
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1988-01-01
End date: 1996-01-01
Prempro
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-01-01
End date: 2002-01-01
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1988-01-01
End date: 1996-01-01
Possible Prempro side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 57 year old female, weighing 51.7 kg (113.7 pounds)
Reactions: Fungal Infection
Drug(s) suspected as cause:
Prempro
Dosage: 0.625 mg, unk
Indication: Hot Flush
Prempro
Dosage: 0.45 mg, daily
Start date: 2012-06-01
End date: 2012-08-01
Possible Prempro side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: female, weighing 51.7 kg (113.7 pounds)
Reactions: Blood Pressure Increased
Drug(s) suspected as cause:
Prempro
Possible Prempro side effects in 67 year old female
Reported by a lawyer from United States on 2012-08-17
Patient: 67 year old female, weighing 74.0 kg (162.8 pounds)
Reactions: Emotional Distress, Breast Cancer Female
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Premarin
Dosage: 0.625 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1983-01-01
End date: 1998-01-01
Premphase 14 / 14
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Prempro
Dosage: 0.625/2.5mg
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1998-01-01
End date: 2001-01-01
Provera
Dosage: 10 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1983-01-01
End date: 1998-01-01
Other drugs received by patient: Atenolol; Potassium Chloride; Zantac; Lasix
Possible Prempro side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 57 year old female, weighing 51.7 kg (113.7 pounds)
Reactions: Irritability, Fungal Infection
Drug(s) suspected as cause:
Prempro
Dosage: 0.625 mg, unk
Indication: Hot Flush
Prempro
Dosage: 0.45 mg, 1x/day
Start date: 2012-06-01
Possible Prempro side effects in
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient:
Reactions: Poor Quality Sleep, Hypersensitivity, Malaise, Nasopharyngitis, Stress, Cough
Drug(s) suspected as cause:
Effexor XR
Dosage: unk
Prempro
Dosage: unk
Possible Prempro side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 50 year old female, weighing 178.0 kg (391.6 pounds)
Reactions: Wrong Drug Administered, Drug Dispensing Error, Menopause
Drug(s) suspected as cause:
Premarin
Dosage: 1.25 mg, unk, 1 tablet
Administration route: Oral
Start date: 2012-08-07
End date: 2012-08-07
Prempro
Dosage: 0.625/2.5 mg, 1x/day
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-03-01
End date: 2012-08-02
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