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Rogaine Adverse Events Reported to the FDA Over Time

How are Rogaine adverse event reports trending over time?

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

Most Common Rogaine Adverse Events Reported to the FDA

What are the most common Rogaine adverse events reported to the FDA?

Alopecia
118 (3.99%)
Dizziness
98 (3.31%)
Headache
61 (2.06%)
Wrong Drug Administered
61 (2.06%)
Pruritus
59 (1.99%)
Drug Ineffective
46 (1.55%)
Heart Rate Increased
44 (1.49%)
Blood Pressure Increased
40 (1.35%)
Hypersensitivity
39 (1.32%)
Dyspnoea
37 (1.25%)
Palpitations
37 (1.25%)
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Chest Pain
36 (1.22%)
Pain
30 (1.01%)
Underdose
30 (1.01%)
Burning Sensation
29 (.98%)
Swelling Face
29 (.98%)
Erythema
27 (.91%)
Oedema Peripheral
27 (.91%)
Eye Swelling
26 (.88%)
Loss Of Consciousness
26 (.88%)
Rash
26 (.88%)
Condition Aggravated
25 (.84%)
Hair Texture Abnormal
24 (.81%)
Blister
23 (.78%)
Dry Skin
23 (.78%)
Hypertension
23 (.78%)
Off Label Use
23 (.78%)
Skin Disorder
23 (.78%)
Application Site Pruritus
21 (.71%)
Product Quality Issue
21 (.71%)
Insomnia
20 (.68%)
Skin Exfoliation
20 (.68%)
Incorrect Dose Administered
19 (.64%)
Application Site Burn
18 (.61%)
Erectile Dysfunction
18 (.61%)
Weight Increased
18 (.61%)
Fatigue
17 (.57%)
Feeling Abnormal
17 (.57%)
Syncope
17 (.57%)
Vision Blurred
17 (.57%)
Application Site Reaction
16 (.54%)
Arrhythmia
16 (.54%)
Breast Cancer
16 (.54%)
Chest Discomfort
16 (.54%)
Swelling
16 (.54%)
Wrong Technique In Drug Usage Proce...
16 (.54%)
Heart Rate Irregular
15 (.51%)
Paraesthesia
15 (.51%)
Accidental Exposure
14 (.47%)
Anxiety
14 (.47%)
Asthenia
14 (.47%)
Product Counterfeit
14 (.47%)
Skin Irritation
14 (.47%)
Application Site Pain
13 (.44%)
Application Site Rash
13 (.44%)
Application Site Vesicles
13 (.44%)
Atrial Fibrillation
13 (.44%)
Malaise
13 (.44%)
Scab
13 (.44%)
Application Site Erythema
12 (.41%)
Hair Growth Abnormal
12 (.41%)
Impaired Work Ability
12 (.41%)
Application Site Irritation
11 (.37%)
Cerebrovascular Accident
11 (.37%)
Confusional State
11 (.37%)
Depression
11 (.37%)
Hair Colour Changes
11 (.37%)
Skin Discolouration
11 (.37%)
Tinnitus
11 (.37%)
Urticaria
11 (.37%)
Auricular Swelling
10 (.34%)
Dandruff
10 (.34%)
Hip Arthroplasty
10 (.34%)
Hyperhidrosis
10 (.34%)
Nausea
10 (.34%)
Tachycardia
10 (.34%)
Thermal Burn
10 (.34%)
Dermatitis Contact
9 (.3%)
Drug Hypersensitivity
9 (.3%)
Epistaxis
9 (.3%)
Hypotension
9 (.3%)
Nerve Compression
9 (.3%)
Pain Of Skin
9 (.3%)
Psoriasis
9 (.3%)
Rash Erythematous
9 (.3%)
Asthma
8 (.27%)
Cardiac Disorder
8 (.27%)
Convulsion
8 (.27%)
Myocardial Infarction
8 (.27%)
Ocular Hyperaemia
8 (.27%)
Application Site Scab
7 (.24%)
Blood Pressure Decreased
7 (.24%)
Breast Cancer Female
7 (.24%)
Hypertrichosis
7 (.24%)
Hypoaesthesia
7 (.24%)
Irritability
7 (.24%)
Neuropathy Peripheral
7 (.24%)
Overdose
7 (.24%)
Product Label Issue
7 (.24%)
Rash Pruritic
7 (.24%)
Tremor
7 (.24%)

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This graph shows the top adverse events submitted to the FDA for Rogaine, 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 Rogaine 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 Rogaine

What are the most common Rogaine adverse events reported to the FDA?

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ExportShare/Embed Graph Export Export Data

This graph shows the top categories of adverse events submitted to the FDA for Rogaine, 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 Rogaine 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 Rogaine According to Those Reporting Adverse Events

Why are people taking Rogaine, according to those reporting adverse events to the FDA?

Alopecia
579
Product Used For Unknown Indication
45
Hypotrichosis
44
Drug Use For Unknown Indication
38
Hair Growth Abnormal
16
Female Pattern Baldness
8
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Androgenetic Alopecia
5
Accidental Exposure
3
Alopecia Areata
3
Alopecia Effluvium
2
Paternal Drugs Affecting Foetus
2
Alcohol Use
2
Prophylaxis
1
Hair Disorder
1
Male Pattern Baldness
1
Hair Transplant
1
Hair Texture Abnormal
1
Psoriasis
1

Drug Labels

LabelLabelerEffective
Womens Rogaineextra StrengthJohnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.06-MAR-12
Mens Rogaine Extra StrengthJohnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.06-MAR-12
Mens Rogaine Unscented FormulaJohnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.01-AUG-12

Rogaine Case Reports

What Rogaine 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 Rogaine. 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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