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Prempro (Conjugated Estrogens / Medroxyprogesterone) - Side Effect Reports to FDA

 
 



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

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 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 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 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 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 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 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 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 2012-08-20

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 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 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

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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