DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Plan B One-Step (Levonorgestrel) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials 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.

Plan B One-Step was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the Plan B One-Step group, and 1,377 women in the Plan B group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Plan B One-Step group and 1.4% in Plan B group were lost to follow-up.

The most common adverse events (>10%) in the clinical trial for women receiving Plan B One-Step included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of Plan B One-Step users.

Table 1. Adverse Events in > 4% of Women, by % Frequency

Most Common Adverse Events

(MedDRA)

Plan B One-Step

N = 1359 (%)

Heavier menstrual bleeding 30.9
Nausea 13.7
Lower abdominal pain 13.3
Fatigue 13.3
Headache 10.3
Dizziness 9.6
Breast tenderness 8.2
Delay of menses (> 7 days) 4.5

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). 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 ONE-STEP SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Plan B ONE-Step side effects / adverse reactions in 25 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 25 year old female weighing 68.1 kg (149.8 pounds)

Reactions: Menstruation Irregular, Menstruation Delayed

Suspect drug(s):
Plan B ONE-Step



Possible Plan B ONE-Step side effects / adverse reactions in 48 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 48 year old female weighing 52.2 kg (114.9 pounds)

Reactions: Menstruation Irregular, Pelvic Pain

Suspect drug(s):
Plan B ONE-Step



Possible Plan B ONE-Step side effects / adverse reactions in 25 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 25 year old female weighing 57.7 kg (126.8 pounds)

Reactions: Menstruation Irregular, Menstruation Delayed

Suspect drug(s):
Plan B ONE-Step



See index of all Plan B ONE-Step side effect reports >>

Drug label data at the top of this Page last updated: 2013-11-21

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017