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Aygestin (Norethindrone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aygestin (Norethindrone) 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 (9)

Reports by Reaction Type

Breast Cancer (2)Breast Cancer Female (2)Deep Vein Thrombosis (2)Night Sweats (1)Anaphylactic Shock (1)Pulmonary Embolism (1)Headache (1)Vaginal Haemorrhage (1)Abdominal Discomfort (1)Chest Pain (1)Injury (1)Crying (1)

Possible Aygestin side effects in female

Reported by a lawyer from United States on 2012-07-10

Patient: female, weighing 67.0 kg (147.4 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Aygestin
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-04-01

Medroxyprogesterone Acetate
    Dosage: unk
    Start date: 2000-07-01
    End date: 2003-02-01

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2000-07-01
    End date: 2003-02-01

Premarin
    Dosage: unk
    Administration route: Oral
    Start date: 2000-07-01
    End date: 2003-02-01

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-04-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-04-01
    End date: 2000-07-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2000-07-01
    End date: 2003-02-01

Other drugs received by patient: Prinivil; Acetylsalicylic Acid; Albuterol; Combivent; Flonase; Lisinopril



Possible Aygestin side effects in female

Reported by a lawyer from United States on 2012-07-05

Patient: female, weighing 67.0 kg (147.4 pounds)

Reactions: Breast Cancer Metastatic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aygestin
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-04-01

Cycrin
    Indication: Hormone Replacement Therapy

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2000-07-01
    End date: 2003-02-01

Medroxyprogesterone Acetate
    Dosage: unk
    Start date: 2000-07-01
    End date: 2003-02-01

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-04-01

Premarin
    Dosage: unk
    Administration route: Oral
    Start date: 2000-07-01
    End date: 2003-02-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-04-01
    End date: 2000-07-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2000-07-01
    End date: 2003-02-01

Other drugs received by patient: Acetylsalicylic Acid; Prinivil; Flonase; Lisinopril; Combivent; Albuterol; Singulair



Possible Aygestin side effects in female

Reported by a lawyer from United States on 2012-07-05

Patient: female, weighing 67.0 kg (147.4 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Aygestin
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-04-01

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2000-07-01
    End date: 2003-02-01

Medroxyprogesterone Acetate
    Dosage: unk
    Start date: 2000-07-01
    End date: 2003-02-01

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-04-01

Premarin
    Dosage: unk
    Administration route: Oral
    Start date: 2000-07-01
    End date: 2003-02-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-04-01
    End date: 2000-07-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2000-07-01
    End date: 2003-02-01

Other drugs received by patient: Flonase; Prinivil; Lisinopril; Acetylsalicylic Acid; Albuterol; Combivent



Possible Aygestin side effects in female

Reported by a physician from United States on 2012-04-12

Patient: female

Reactions: Anaphylactic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aygestin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01

Lupron Depot
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01



Possible Aygestin side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female

Reactions: Breast Cancer

Drug(s) suspected as cause:
Aygestin
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Cenestin
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Climara
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Estrace
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Premarin
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Premphase (Premarin;cycrin 14 / 14)
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Prometrium
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01



Possible Aygestin side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-08

Patient: 35 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Anaemia, Pulmonary Embolism, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aygestin
    Indication: Uterine Haemorrhage
    Start date: 2012-02-09
    End date: 2012-02-14

Aygestin
    Indication: Uterine Haemorrhage
    Start date: 2012-02-14
    End date: 2012-02-23

Tranexamic Acid
    Dosage: (two tablets three times a day oral)
    Administration route: Oral
    Indication: Menorrhagia
    Start date: 2012-02-17
    End date: 2012-02-21

Other drugs received by patient: Vitamin D; Zinc Sulfate; Daily Vitamins; Folic Acid; Vitamin B-12; COD Liver OIL



Possible Aygestin side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-24

Patient: female, weighing 92.6 kg (203.8 pounds)

Reactions: Dysmenorrhoea, Night Sweats, Arthralgia, Chest Pain, Pollakiuria, Headache, Crying

Drug(s) suspected as cause:
Aygestin
    Indication: Night Sweats
    Start date: 2011-01-18
    End date: 2011-01-24

Aygestin
    Indication: Prophylaxis

Lupron Depot
    Indication: Endometriosis
    Start date: 2011-01-18

Other drugs received by patient: Fiber; Glucophage; Multi-Vitamins



Possible Aygestin side effects in female

Reported by a physician from United States on 2011-10-24

Patient: female, weighing 79.5 kg (174.8 pounds)

Reactions: Back Pain, Abdominal Discomfort, Paraesthesia, Vaginal Haemorrhage, Deep Vein Thrombosis

Drug(s) suspected as cause:
Aygestin
    Indication: Menopausal Symptoms

Lupron Depot
    Indication: Uterine Leiomyoma
    Start date: 2011-03-01
    End date: 2011-04-27

Other drugs received by patient: Prozac; Unknown ADD Back Therapy; Prozac



Possible Aygestin side effects in 54 year old female

Reported by a lawyer from United States on 2011-10-04

Patient: 54 year old female

Reactions: Breast Cancer, Nervous System Disorder, Injury

Drug(s) suspected as cause:
Aygestin
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Aygestin

Cenestin
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Climara
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Estrace
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol Transdermal
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Premarin
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Premphase (Premarin;cycrin 14 / 14)
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Prometrium
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Other drugs received by patient: Vitamin TAB; Avelox; Levaquin; Ziac

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