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Sotret Adverse Events Reported to the FDA Over Time

How are Sotret adverse event reports trending over time?

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

Most Common Sotret Adverse Events Reported to the FDA

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

Inflammatory Bowel Disease
207 (9.96%)
Anxiety
105 (5.05%)
Depression
75 (3.61%)
Colitis Ulcerative
68 (3.27%)
Lip Dry
45 (2.16%)
Irritable Bowel Syndrome
44 (2.12%)
Blood Triglycerides Increased
42 (2.02%)
Dry Skin
30 (1.44%)
Colitis
29 (1.39%)
Drug Exposure During Pregnancy
28 (1.35%)
Small Intestinal Obstruction
26 (1.25%)
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Pregnancy
25 (1.2%)
Suicidal Ideation
25 (1.2%)
Headache
22 (1.06%)
Mood Altered
21 (1.01%)
Arthralgia
20 (.96%)
Ileitis
20 (.96%)
Blood Cholesterol Increased
19 (.91%)
No Adverse Event
19 (.91%)
Fatigue
18 (.87%)
Gastroenteritis
17 (.82%)
Gastrointestinal Disorder
17 (.82%)
Diarrhoea
16 (.77%)
Mitral Valve Incompetence
15 (.72%)
Pulmonary Valve Incompetence
15 (.72%)
Tricuspid Valve Incompetence
15 (.72%)
Hepatic Enzyme Increased
14 (.67%)
Acne
12 (.58%)
Dry Eye
12 (.58%)
Gastrooesophageal Reflux Disease
12 (.58%)
Myalgia
12 (.58%)
Sacroiliitis
12 (.58%)
Anaemia
11 (.53%)
Arthropathy
11 (.53%)
Chest Pain
11 (.53%)
Iron Deficiency Anaemia
11 (.53%)
Unintended Pregnancy
11 (.53%)
Accidental Exposure
10 (.48%)
Aneurysmal Bone Cyst
10 (.48%)
Dermatitis
10 (.48%)
Dizziness
10 (.48%)
Intestinal Haemorrhage
10 (.48%)
Otitis Media
10 (.48%)
Pain
10 (.48%)
Pneumatosis Intestinalis
10 (.48%)
Xerosis
10 (.48%)
Anal Fissure
9 (.43%)
Anger
9 (.43%)
Arthritis
9 (.43%)
Jaundice
9 (.43%)
Live Birth
9 (.43%)
Nervous System Disorder
9 (.43%)
Platelet Count Increased
9 (.43%)
Rectal Haemorrhage
9 (.43%)
Treatment Noncompliance
9 (.43%)
Ankylosing Spondylitis
8 (.38%)
Chapped Lips
8 (.38%)
Crying
8 (.38%)
Drug Exposure Before Pregnancy
8 (.38%)
Gastrointestinal Neoplasm
8 (.38%)
Haemorrhoids
8 (.38%)
Injury
8 (.38%)
Microcytic Anaemia
8 (.38%)
Panic Attack
8 (.38%)
Pernicious Anaemia
8 (.38%)
Proteinuria
8 (.38%)
Renal Cyst
8 (.38%)
Renal Disorder
8 (.38%)
Serum Ferritin Increased
8 (.38%)
Thalassaemia Trait
8 (.38%)
Vitamin B12 Deficiency
8 (.38%)
Abortion Induced
7 (.34%)
Alanine Aminotransferase Increased
7 (.34%)
Asthma
7 (.34%)
Bipolar Disorder
7 (.34%)
Cardiac Disorder
7 (.34%)
Cheilitis
7 (.34%)
Erythema
7 (.34%)
Foot Fracture
7 (.34%)
Gallbladder Disorder
7 (.34%)
Gastritis
7 (.34%)
Gout
7 (.34%)
Haematochezia
7 (.34%)
Hepatic Congestion
7 (.34%)
Hepatomegaly
7 (.34%)
Hydronephrosis
7 (.34%)
Hypertrichosis
7 (.34%)
Intestinal Obstruction
7 (.34%)
Liver Disorder
7 (.34%)
Lymphadenopathy
7 (.34%)
Mitral Valve Prolapse
7 (.34%)
Night Blindness
7 (.34%)
Renal Lipomatosis
7 (.34%)
Scar
7 (.34%)
Sinus Bradycardia
7 (.34%)
Splenomegaly
7 (.34%)
Trigeminal Neuralgia
7 (.34%)
Upper Respiratory Tract Infection
7 (.34%)
Ventricular Extrasystoles
7 (.34%)
Ventricular Hypertrophy
7 (.34%)
Abdominal Pain
6 (.29%)

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

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

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

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

Acne
341
Drug Use For Unknown Indication
43
Acne Cystic
27
Product Used For Unknown Indication
21
Rosacea
12
Glioblastoma Multiforme
2
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Scar
2
Folliculitis
1
Drug Ineffective
1
Brain Neoplasm Malignant
1

Sotret Case Reports

What Sotret 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 Sotret. 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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