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Ella (Ulipristal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ella (Ulipristal) 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 (11)

Reports by Reaction Type

Unintended Pregnancy (4)Maternal Exposure During Pregnancy (3)Drug Ineffective (2)Thirst (2)DRY Mouth (2)Drug Prescribing Error (2)Drug Interaction (1)Pregnancy After Post Coital Contraception (1)Menstrual Disorder (1)Menstruation Irregular (1)Abortion Induced (1)Pregnancy ON Contraceptive (1)

Possible Ella side effects in 28 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-06

Patient: 28 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced, Pregnancy After Post Coital Contraception

Drug(s) suspected as cause:
Ella



Possible Ella side effects in 23 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-06

Patient: 23 year old female

Reactions: Pregnancy ON Oral Contraceptive

Drug(s) suspected as cause:
Ella



Possible Ella side effects in 23 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-06

Patient: 23 year old female

Reactions: Maternal Exposure During Pregnancy, Unintended Pregnancy

Drug(s) suspected as cause:
Ella



Possible Ella side effects in female

Reported by a individual with unspecified qualification from United States on 2012-04-20

Patient: female

Reactions: Maternal Exposure Before Pregnancy, Pregnancy ON Contraceptive

Drug(s) suspected as cause:
Ella



Possible Ella side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2012-03-14

Patient: 27 year old female, weighing 54.9 kg (120.7 pounds)

Reactions: DRY Mouth, Thirst

Drug(s) suspected as cause:
Ella
    Indication: Post Coital Contraception
    Start date: 2011-01-01
    End date: 2011-01-01

Plan B ONE-Step
    Dosage: 1.5 mg (1.5 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Post Coital Contraception
    Start date: 2011-12-02
    End date: 2011-12-02



Possible Ella side effects in 33 year old female

Reported by a consumer/non-health professional from United States on 2012-03-14

Patient: 33 year old female, weighing 58.5 kg (128.7 pounds)

Reactions: Drug Ineffective, Unintended Pregnancy

Drug(s) suspected as cause:
Ella



Possible Ella side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-14

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Drug Ineffective, Unintended Pregnancy

Drug(s) suspected as cause:
Ella
    Dosage: 30 mg (30 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Post Coital Contraception
    Start date: 2011-10-24
    End date: 2011-10-24

Ella
    Dosage: 30 mg (30 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Treatment Failure
    Start date: 2011-10-24
    End date: 2011-10-24



Possible Ella side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2012-03-14

Patient: 27 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Menstrual Disorder, Drug Interaction, Drug Prescribing Error, Hypomenorrhoea

Drug(s) suspected as cause:
Ella
    Dosage: 1 dosage forms (1 dosage forms, 1 in 1 d), oral
    Administration route: Oral
    Indication: Contraception
    Start date: 2011-12-01
    End date: 2011-12-01

Plan B
    Dosage: 1 dosage forms (1 dosage forms, 1 in 1 d), oral
    Administration route: Oral
    Indication: Contraception
    Start date: 2011-12-01
    End date: 2011-12-01



Possible Ella side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20

Patient: 27 year old female, weighing 54.5 kg (119.9 pounds)

Reactions: Menstruation Irregular, Drug Prescribing Error

Drug(s) suspected as cause:
Ella
    Administration route: Oral
    Indication: Post Coital Contraception
    Start date: 2011-12-01
    End date: 2011-12-01

Plan B ONE-Step
    Dosage: 1.5 milligram;
    Administration route: Oral
    Indication: Post Coital Contraception
    Start date: 2011-12-01
    End date: 2011-12-01



Possible Ella side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-07

Patient: female, weighing 54.9 kg (120.9 pounds)

Reactions: DRY Mouth, Thirst

Drug(s) suspected as cause:
Plan B ONE-Step
    Dosage: 1.5 milligram;
    Administration route: Oral
    Indication: Post Coital Contraception
    Start date: 2011-12-02
    End date: 2011-12-02

Ella
    Indication: Post Coital Contraception



Possible Ella side effects in 32 year old female

Reported by a individual with unspecified qualification from Romania on 2011-10-12

Patient: 32 year old female

Reactions: Maternal Exposure During Pregnancy, Unintended Pregnancy

Drug(s) suspected as cause:
Ella

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