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Plan B (Levonorgestrel) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of Plan B (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two tablets taken 12 hours later).

The most common adverse events (>10%) in the clinical trial for women receiving Plan B included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%). Table 1 lists those adverse events that were reported in ≥ 5% of Plan B users.

Table 1: Adverse Events in ≥ 5%of Women, by % Frequency

Plan B

Levonorgestrel

N=977 (%)

Nausea 23.1
Abdominal Pain 17.6
Fatigue 16.9
Headache 16.8
Heavier Menstrual Bleeding 13.8
Lighter Menstrual Bleeding 12.5
Dizziness 11.2
Breast Tenderness 10.7
Vomiting 5.6
Diarrhea 5.0

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Plan B. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders
Abdominal Pain, Nausea, Vomiting

General Disorders and Administration Site Conditions
Fatigue

Nervous System Disorders
Dizziness, Headache

Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain



REPORTS OF SUSPECTED PLAN B SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Plan B. The information is not vetted and should not be considered as verified clinical evidence.

Possible Plan B side effects / adverse reactions in 42 year old female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: 42 year old female

Reactions: Blighted Ovum, Maternal Exposure Before Pregnancy, Abortion Spontaneous, Vaginal Haemorrhage

Suspect drug(s):
Amnesteem
    Administration route: Oral
    End date: 2011-04-03

Amnesteem
    Administration route: Oral
    End date: 2011-04-03

Claravis
    Administration route: Oral
    Start date: 2011-01-05

Plan B
    Indication: Contraception
    Start date: 2011-04-29
    End date: 2011-04-29

Other drugs received by patient: Benadryl; Mirapex; Prazosin HCL; Adderall 5; Neurontin; Vicodin; Ibuprofen (Advil)



Possible Plan B side effects / adverse reactions in 28 year old female

Reported by a consumer/non-health professional from United States on 2011-10-20

Patient: 28 year old female weighing 90.0 kg (198.0 pounds)

Reactions: Ovarian Cyst, Pregnancy After Post Coital Contraception, Abortion Spontaneous

Adverse event resulted in: hospitalization

Suspect drug(s):
Plan B



Possible Plan B side effects / adverse reactions in 18 year old female

Reported by a consumer/non-health professional from Canada on 2011-10-21

Patient: 18 year old female

Reactions: Swelling Face, Dizziness, Throat Tightness

Suspect drug(s):
Plan B



See index of all Plan B side effect reports >>

Drug label data at the top of this Page last updated: 2012-04-23

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