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Seasonale (Levonorgestrel / Ethinyl Estradiol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Seasonale (Levonorgestrel / Ethinyl Estradiol) 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 (7)

Reports by Reaction Type

Pain (2)Pulmonary Embolism (2)Drug Effect Decreased (2)Product Substitution Issue (1)Thrombosis (1)Haemorrhage (1)Medication Error (1)Abdominal Distension (1)Muscle Spasms (1)Cardiolipin Antibody Positive (1)Metrorrhagia (1)

Possible Seasonale side effects in 19 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 19 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Thrombosis, Haemorrhage, Abdominal Distension, Muscle Spasms

Drug(s) suspected as cause:
Seasonale
    Indication: Contraception
    Start date: 2012-01-03
    End date: 2012-08-15

Seasonale
    Indication: Muscle Spasms
    Start date: 2012-01-03
    End date: 2012-08-15



Possible Seasonale side effects in female

Reported by a physician from United States on 2012-06-20

Patient: female, weighing 117.5 kg (258.5 pounds)

Reactions: Pulmonary Embolism, Cardiolipin Antibody Positive

Drug(s) suspected as cause:
Seasonale
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Stelara
    Start date: 2010-11-11

Stelara
    Start date: 2003-07-22
    End date: 2004-07-19

Stelara
    Start date: 2010-07-19

Stelara
    Indication: Psoriasis

Other drugs received by patient: INH; Aspirin



Possible Seasonale side effects in

Reported by a individual with unspecified qualification from United States on 2012-03-22

Patient:

Reactions: Medication Error

Drug(s) suspected as cause:
Seasonale



Possible Seasonale side effects in female

Reported by a physician from United States on 2012-02-17

Patient: female

Reactions: Product Substitution Issue, Metrorrhagia

Drug(s) suspected as cause:
Seasonale



Possible Seasonale side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2012-02-14

Patient: 37 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Drug Effect Decreased, Pain

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

Seasonale
    Indication: Dysfunctional Uterine Bleeding

Fentanyl-100
    Dosage: 75 ug/hr, q72 hrs
    Indication: Pain
    Start date: 2011-10-24

Other drugs received by patient: MS Contin; Zanaflex; MS Contin; Solu-Medrol; Klonopin; Demerol; Promethazine



Possible Seasonale side effects in female

Reported by a physician from United States on 2011-12-19

Patient: female, weighing 117.5 kg (258.5 pounds)

Reactions: Pulmonary Embolism

Drug(s) suspected as cause:
Stelara
    Start date: 2003-07-22
    End date: 2004-07-19

Stelara
    Indication: Psoriasis
    Start date: 2010-07-19

Stelara
    Start date: 2010-11-11

Seasonale
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: INH; Aspirin



Possible Seasonale side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2011-11-16

Patient: 37 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Drug Effect Decreased, Pain

Drug(s) suspected as cause:
Seasonale
    Indication: Dysfunctional Uterine Bleeding

Fentanyl-100
    Dosage: 75 ug/hr, q72 hrs
    Indication: Pain
    Start date: 2011-10-24

Seasonale
    Indication: Contraception

Other drugs received by patient: Klonopin; Zanaflex; MS Contin; MS Contin; Demerol; Promethazine; Solu-Medrol

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