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PLAN B ONE STEP

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Plan B One Step Adverse Events Reported to the FDA Over Time

How are Plan B One Step adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Plan B One Step, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Plan B One Step is flagged as the suspect drug causing the adverse event.

Most Common Plan B One Step Adverse Events Reported to the FDA

What are the most common Plan B One Step adverse events reported to the FDA?

Menstruation Irregular
7220 (34.99%)
Pelvic Pain
1382 (6.7%)
Nausea
1289 (6.25%)
Menstruation Delayed
939 (4.55%)
Vomiting
874 (4.24%)
Dizziness
572 (2.77%)
Abdominal Pain
571 (2.77%)
Headache
567 (2.75%)
Fatigue
533 (2.58%)
Drug Ineffective
467 (2.26%)
Pregnancy After Post Coital Contrac...
467 (2.26%)
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Breast Tenderness
453 (2.2%)
Vaginal Discharge
380 (1.84%)
Back Pain
274 (1.33%)
Menorrhagia
272 (1.32%)
Breast Pain
258 (1.25%)
Abdominal Pain Upper
224 (1.09%)
Abdominal Distension
215 (1.04%)
Abdominal Pain Lower
195 (.95%)
Diarrhoea
165 (.8%)
Muscle Spasms
125 (.61%)
Haemorrhage
123 (.6%)
Dysmenorrhoea
113 (.55%)
Vaginal Haemorrhage
83 (.4%)
Off Label Use
79 (.38%)
Pollakiuria
78 (.38%)
Abdominal Discomfort
70 (.34%)
Pyrexia
67 (.32%)
Fungal Infection
62 (.3%)
Dysuria
56 (.27%)
Breast Enlargement
53 (.26%)
Nipple Pain
50 (.24%)
Pain
47 (.23%)
Abortion Spontaneous
42 (.2%)
Weight Increased
41 (.2%)
Acne
40 (.19%)
Urinary Tract Infection
40 (.19%)
Adnexa Uteri Pain
39 (.19%)
Blood Urine Present
39 (.19%)
Hot Flush
37 (.18%)
Breast Swelling
36 (.17%)
Flatulence
36 (.17%)
Feeling Abnormal
35 (.17%)
Asthenia
34 (.16%)
Mood Altered
34 (.16%)
Vulvovaginal Pain
34 (.16%)
Vulvovaginal Pruritus
33 (.16%)
Chest Pain
32 (.16%)
Mood Swings
32 (.16%)
Decreased Appetite
31 (.15%)
Anxiety
30 (.15%)
Feeling Hot
30 (.15%)
Pregnancy
30 (.15%)
Migraine
29 (.14%)
Malaise
28 (.14%)
Somnolence
28 (.14%)
Drug Exposure During Pregnancy
26 (.13%)
Dyspepsia
25 (.12%)
Emotional Disorder
25 (.12%)
Hunger
25 (.12%)
Dyspnoea
24 (.12%)
Urticaria
24 (.12%)
Constipation
23 (.11%)
Chills
22 (.11%)
Rash
22 (.11%)
Secretion Discharge
21 (.1%)
Vulvovaginal Burning Sensation
21 (.1%)
Metrorrhagia
20 (.1%)
Nipple Disorder
20 (.1%)
Pain In Extremity
20 (.1%)
Thrombosis
20 (.1%)
Increased Appetite
19 (.09%)
Oropharyngeal Pain
18 (.09%)
Crying
17 (.08%)
Palpitations
17 (.08%)
Pruritus
17 (.08%)
Hypoaesthesia
16 (.08%)
Breast Disorder
15 (.07%)
Depression
15 (.07%)
Hyperhidrosis
14 (.07%)
Nervousness
14 (.07%)
Arthralgia
13 (.06%)
Depressed Mood
13 (.06%)
Haematemesis
13 (.06%)
Premenstrual Syndrome
13 (.06%)
Skin Discolouration
13 (.06%)
Irritability
12 (.06%)
Tremor
12 (.06%)
Vaginal Odour
12 (.06%)
Breast Discomfort
11 (.05%)
Coital Bleeding
11 (.05%)
Flank Pain
11 (.05%)
Stress
11 (.05%)
Amenorrhoea
10 (.05%)
Chest Discomfort
10 (.05%)
Dyspareunia
10 (.05%)
Ovarian Cyst
10 (.05%)
Breast Discharge
9 (.04%)
Chromaturia
9 (.04%)
Epistaxis
9 (.04%)
Expired Drug Administered
9 (.04%)

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This graph shows the top adverse events submitted to the FDA for Plan B One Step, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Plan B One Step is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Plan B One Step

What are the most common Plan B One Step adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Plan B One Step, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Plan B One Step is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Plan B One Step According to Those Reporting Adverse Events

Why are people taking Plan B One Step, according to those reporting adverse events to the FDA?

Post Coital Contraception
10943
Menstruation Irregular
35
Contraception
11
Abortion Induced
11
Product Used For Unknown Indication
6
Menstrual Cycle Management
2
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Anxiety
1
Oral Contraception
1
Pregnancy
1
Pregnancy On Oral Contraceptive
1

Drug Labels

LabelLabelerEffective
Plan B One-stepDuramed Pharmaceuticals, Inc.09-AUG-09
Plan B One-stepRebel Distributors Corp13-SEP-11

Plan B One Step Case Reports

What Plan B One Step safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Plan B One Step. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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