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Finacea Adverse Events Reported to the FDA Over Time

How are Finacea adverse event reports trending over time?

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

Most Common Finacea Adverse Events Reported to the FDA

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

Burning Sensation
59 (6.71%)
Erythema
57 (6.48%)
Rosacea
55 (6.26%)
Pruritus
35 (3.98%)
Rash
25 (2.84%)
Skin Irritation
23 (2.62%)
Skin Burning Sensation
22 (2.5%)
Skin Disorder
22 (2.5%)
Acne
21 (2.39%)
Dry Skin
19 (2.16%)
Paraesthesia
17 (1.93%)
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Vision Blurred
14 (1.59%)
Application Site Paraesthesia
13 (1.48%)
Alopecia
12 (1.37%)
Angina Pectoris
12 (1.37%)
Application Site Irritation
12 (1.37%)
Mass
12 (1.37%)
Mood Altered
12 (1.37%)
Nervousness
12 (1.37%)
Onychomycosis
12 (1.37%)
Pain In Extremity
12 (1.37%)
Weight Increased
12 (1.37%)
Hypersensitivity
11 (1.25%)
Pain
11 (1.25%)
Skin Exfoliation
11 (1.25%)
Drug Ineffective
10 (1.14%)
Facial Pain
10 (1.14%)
Oral Herpes
10 (1.14%)
Abdominal Pain
9 (1.02%)
Application Site Pain
9 (1.02%)
Fatigue
9 (1.02%)
Sensation Of Heaviness
9 (1.02%)
Skin Discolouration
9 (1.02%)
No Adverse Event
8 (.91%)
Adverse Event
7 (.8%)
Pain Of Skin
6 (.68%)
Swelling Face
6 (.68%)
Hypertrichosis
5 (.57%)
Affect Lability
4 (.46%)
Application Site Dryness
4 (.46%)
Application Site Erythema
4 (.46%)
Application Site Rash
4 (.46%)
Dermatitis Contact
4 (.46%)
Feeling Hot
4 (.46%)
Rash Macular
4 (.46%)
Urticaria
4 (.46%)
Abnormal Sensation In Eye
3 (.34%)
Application Site Burn
3 (.34%)
Blister
3 (.34%)
Blood Pressure Systolic Increased
3 (.34%)
Chemical Burn Of Skin
3 (.34%)
Dermatitis
3 (.34%)
Dizziness
3 (.34%)
Dyspnoea
3 (.34%)
Eye Irritation
3 (.34%)
Eye Pain
3 (.34%)
Eye Swelling
3 (.34%)
Nausea
3 (.34%)
Nephrolithiasis
3 (.34%)
Ocular Hyperaemia
3 (.34%)
Rash Erythematous
3 (.34%)
Renal Failure Acute
3 (.34%)
Renal Tubular Necrosis
3 (.34%)
Skin Warm
3 (.34%)
Suffocation Feeling
3 (.34%)
Tremor
3 (.34%)
Appendicectomy
2 (.23%)
Application Site Discharge
2 (.23%)
Application Site Pruritus
2 (.23%)
Asthenia
2 (.23%)
Asthma
2 (.23%)
Cellulitis
2 (.23%)
Chest Discomfort
2 (.23%)
Diabetic Neuropathy
2 (.23%)
Drug Use For Unknown Indication
2 (.23%)
Dysgeusia
2 (.23%)
Flushing
2 (.23%)
Haemorrhage
2 (.23%)
Headache
2 (.23%)
Inflammation
2 (.23%)
Malignant Melanoma
2 (.23%)
Medication Residue
2 (.23%)
Non-cardiac Chest Pain
2 (.23%)
Oedema Peripheral
2 (.23%)
Photosensitivity Reaction
2 (.23%)
Rash Papular
2 (.23%)
Rash Pustular
2 (.23%)
Retinal Vein Occlusion
2 (.23%)
Scar
2 (.23%)
Seborrhoea
2 (.23%)
Skin Cancer
2 (.23%)
Skin Reaction
2 (.23%)
Sunburn
2 (.23%)
Thermal Burn
2 (.23%)
Toe Amputation
2 (.23%)
Treatment Noncompliance
2 (.23%)
Visual Impairment
2 (.23%)
Vomiting
2 (.23%)
Wheezing
2 (.23%)
Abortion Induced
1 (.11%)
Abortion Spontaneous
1 (.11%)

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

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

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

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

Rosacea
162
Drug Use For Unknown Indication
72
Acne
24
Product Used For Unknown Indication
23
Rash
4
Skin Discolouration
2
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Skin Disorder
2
Dermatitis Contact
1
Eczema
1
Unevaluable Event
1
Pruritus
1
Erythema
1
Folliculitis
1
Rash Macular
1
Systemic Lupus Erythematosus Rash
1
Dermatitis
1
Skin Irritation
1
Acne Cystic
1

Drug Labels

LabelLabelerEffective
FinaceaPhysicians Total Care, Inc.31-AUG-10
FinaceaIntendis Inc.20-OCT-10
FinaceaIntendis Inc.20-OCT-10
FinaceaIntendis Inc.12-APR-11
FinaceaBayer HealthCare Pharmaceuticals Inc.18-DEC-12

Finacea Case Reports

What Finacea 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 Finacea. 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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