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ROACUTAN

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Roacutan Adverse Events Reported to the FDA Over Time

How are Roacutan adverse event reports trending over time?

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

Most Common Roacutan Adverse Events Reported to the FDA

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

Pregnancy
432 (10.99%)
No Adverse Event
358 (9.1%)
Drug Exposure During Pregnancy
155 (3.94%)
Normal Newborn
103 (2.62%)
Acne
75 (1.91%)
Depression
64 (1.63%)
Headache
60 (1.53%)
Abortion Spontaneous
44 (1.12%)
Lip Dry
40 (1.02%)
Abdominal Pain Upper
32 (.81%)
Blood Cholesterol Increased
31 (.79%)
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Dry Skin
31 (.79%)
Scar
31 (.79%)
Nausea
30 (.76%)
Suicidal Ideation
30 (.76%)
Vomiting
30 (.76%)
Weight Decreased
28 (.71%)
Abortion Induced
27 (.69%)
Caesarean Section
27 (.69%)
Suicide Attempt
25 (.64%)
Anxiety
24 (.61%)
Dizziness
22 (.56%)
Drug Exposure Before Pregnancy
22 (.56%)
Dry Mouth
21 (.53%)
Ear Malformation
21 (.53%)
Chapped Lips
19 (.48%)
Drug Ineffective
19 (.48%)
Arthralgia
18 (.46%)
Blood Triglycerides Increased
18 (.46%)
Abdominal Pain
17 (.43%)
Dry Eye
17 (.43%)
Skin Lesion
17 (.43%)
Pain
16 (.41%)
Constipation
15 (.38%)
Ill-defined Disorder
15 (.38%)
Insomnia
15 (.38%)
Myalgia
15 (.38%)
Skin Disorder
15 (.38%)
Stress
15 (.38%)
Aspartate Aminotransferase Increase...
14 (.36%)
Mucosal Dryness
14 (.36%)
Skin Necrosis
14 (.36%)
Weight Increased
14 (.36%)
Back Pain
13 (.33%)
Hypotension
13 (.33%)
Road Traffic Accident
13 (.33%)
Therapeutic Response Decreased
13 (.33%)
Abnormal Behaviour
12 (.31%)
Diarrhoea
12 (.31%)
Fall
12 (.31%)
Influenza
12 (.31%)
Mental Disorder
12 (.31%)
Anal Fissure
11 (.28%)
Convulsion
11 (.28%)
Depressed Mood
11 (.28%)
Depressive Symptom
11 (.28%)
Erythema
11 (.28%)
Hepatic Steatosis
11 (.28%)
Impaired Healing
11 (.28%)
Leukocytosis
11 (.28%)
Panic Attack
11 (.28%)
Premature Separation Of Placenta
11 (.28%)
Pruritus
11 (.28%)
Wound
11 (.28%)
Acne Fulminans
10 (.25%)
Blood Bilirubin Increased
10 (.25%)
Haematochezia
10 (.25%)
Hyperhidrosis
10 (.25%)
Hypoglycaemia
10 (.25%)
Muscular Weakness
10 (.25%)
Pain In Extremity
10 (.25%)
Pneumonia
10 (.25%)
Skin Ulcer
10 (.25%)
Tachycardia
10 (.25%)
Thyroid Neoplasm
10 (.25%)
Vaginal Haemorrhage
10 (.25%)
Blood Test Abnormal
9 (.23%)
Dyspnoea
9 (.23%)
Epistaxis
9 (.23%)
Haemorrhage
9 (.23%)
Skin Atrophy
9 (.23%)
Skin Exfoliation
9 (.23%)
Alopecia
8 (.2%)
Breast Mass
8 (.2%)
Dandy-walker Syndrome
8 (.2%)
Feeling Of Despair
8 (.2%)
Gastritis
8 (.2%)
Inflammation
8 (.2%)
Intracranial Pressure Increased
8 (.2%)
Lymphadenopathy
8 (.2%)
Muscle Disorder
8 (.2%)
Oedema
8 (.2%)
Panic Disorder
8 (.2%)
Photosensitivity Reaction
8 (.2%)
Pregnancy On Oral Contraceptive
8 (.2%)
Pyrexia
8 (.2%)
Thyroid Disorder
8 (.2%)
Vision Blurred
8 (.2%)
Visual Impairment
8 (.2%)
Alanine Aminotransferase Increased
7 (.18%)
Arthropathy
7 (.18%)

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

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

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

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

Acne
800
Drug Use For Unknown Indication
177
Product Used For Unknown Indication
30
Acne Conglobata
2
Acne Cystic
2
Ill-defined Disorder
2
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Oily Skin
2
Sebaceous Gland Disorder
2
Skin Lesion
1
Hidradenitis
1
Oil Acne
1
Skin Disorder
1
Seborrhoea
1
Neuroblastoma
1

Roacutan Case Reports

What Roacutan 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 Roacutan. 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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