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Seasonique (Levonorgestrel / Estradiol / Estradiol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Seasonique 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 (14)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Pain (3)Hot Flush (3)Night Sweats (2)Endometriosis (2)Pulmonary Embolism (2)Menstruation Irregular (2)Fatigue (2)Dizziness (2)Anaemia (2)Bile Duct Obstruction (1)Nasopharyngitis (1)Hepatectomy (1)

Possible Seasonique side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Seasonique



Possible Seasonique side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: female

Reactions: Breast Cancer, Exercise Tolerance Decreased, Scar

Drug(s) suspected as cause:
Seasonique



Possible Seasonique side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Menstruation Irregular, Night Sweats, Hot Flush, Middle Insomnia, Endometriosis, Pain

Drug(s) suspected as cause:
Seasonique
    Indication: Contraception
    Start date: 2011-06-01
    End date: 2012-02-01

Lupron Depot
    Indication: Endometriosis
    Start date: 2010-12-01
    End date: 2011-06-01

Lupron Depot
    Start date: 2012-03-05

Other drugs received by patient: Excedrin (Migraine); Phentermine; Phentermine; Phentermine



Possible Seasonique side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Menstruation Irregular, Night Sweats, Hot Flush, Endometriosis, Pain

Drug(s) suspected as cause:
Lupron Depot
    Start date: 2012-03-05

Seasonique
    Indication: Contraception
    Start date: 2011-06-01
    End date: 2012-02-01

Lupron Depot
    Indication: Endometriosis
    Start date: 2010-12-01
    End date: 2011-06-01

Other drugs received by patient: Excedrin (Migraine); Phentermine; Phentermine; Phentermine



Possible Seasonique side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-16

Patient: female

Reactions: Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seasonique



Possible Seasonique side effects in 30 year old female

Reported by a individual with unspecified qualification from United States on 2012-04-09

Patient: 30 year old female, weighing 80.7 kg (177.6 pounds)

Reactions: Product Substitution Issue, Anaemia, Menorrhagia, Metrorrhagia

Drug(s) suspected as cause:
Seasonique
    Indication: Contraception

Seasonique
    Indication: Haemorrhage



Possible Seasonique side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-12

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Vitamin D Deficiency, Nasopharyngitis, Pain, Bone Pain, Vaginal Haemorrhage, Myalgia, Hot Flush, Fatigue, Chest Pain, Dizziness, Depression, Migraine, Middle Ear Effusion, Nausea, Ear Infection, Muscular Weakness, Musculoskeletal Discomfort, Hypoaesthesia, Paraesthesia, Flushing, Arthralgia, Sensory Disturbance, Renal Pain

Drug(s) suspected as cause:
Lupron Depot
    Indication: Endometriosis
    Start date: 2010-12-30

Seasonique
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-01
    End date: 2011-03-01



Possible Seasonique side effects in 24 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-23

Patient: 24 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Hepatic Adenoma, Benign Intracranial Hypertension, Hepatectomy, Cholecystectomy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Seasonique



Possible Seasonique side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2011-12-28

Patient: 41 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Quality of Life Decreased, Visual Acuity Reduced, Glare, Vision Blurred, Eye Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Seasonique
    Indication: Uterine Leiomyoma
    Start date: 2009-05-01
    End date: 2010-06-01

Seasonique
    Indication: Menorrhagia
    Start date: 2009-05-01
    End date: 2010-06-01



Possible Seasonique side effects in 19 year old female

Reported by a consumer/non-health professional from United States on 2011-12-08

Patient: 19 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Syncope, Fatigue, Dizziness, Headache, Mood Swings

Drug(s) suspected as cause:
Seasonique



Possible Seasonique side effects in 33 year old female

Reported by a consumer/non-health professional from United States on 2011-11-15

Patient: 33 year old female, weighing 129.3 kg (284.4 pounds)

Reactions: Major Depression, Suicidal Ideation

Drug(s) suspected as cause:
Seasonique



Possible Seasonique side effects in

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient:

Reactions: Abdominal Pain, Haematochezia, Pancreatic Haemorrhage, Uterine Pain, Uterine Leiomyoma, Hepatic Haemorrhage

Drug(s) suspected as cause:
Seasonique



Possible Seasonique side effects in female

Reported by a physician from United States on 2011-11-01

Patient: female, weighing 106.3 kg (233.9 pounds)

Reactions: Dysmenorrhoea, Malignant Tumour Excision, Hysterectomy, Endometrial Cancer, Anaemia, Explorative Laparotomy, Gait Disturbance, Concomitant Disease Progression, Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Desogestrel and Ethinyl Estradiol
    Dosage: unk
    Indication: Menorrhagia
    Start date: 2008-07-02

Trib
    Dosage: unk
    Start date: 2003-01-01

Gilenya
    Dosage: dose blinded
    Administration route: Oral
    Start date: 2009-08-26
    End date: 2009-12-09

Gilenya
    Dosage: 0.5mg
    Administration route: Oral
    Start date: 2009-12-10
    End date: 2010-11-10

Seasonique
    Indication: Menorrhagia

Hormones

Seasonique
    Dosage: unk
    Indication: Contraception
    Start date: 2008-02-24



Possible Seasonique side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 27 year old female, weighing 90.3 kg (198.6 pounds)

Reactions: Cholelithiasis, Bile Duct Obstruction, Palpitations, Pulmonary Embolism, Gallbladder Disorder, Gastrooesophageal Reflux Disease, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seasonique
    Dosage: 1 pill
    Administration route: Oral
    Indication: Hypomenorrhoea

Seasonique
    Dosage: 1 pill
    Administration route: Oral
    Indication: Contraception

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