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ACITRETIN

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Acitretin Adverse Events Reported to the FDA Over Time

How are Acitretin adverse event reports trending over time?

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

Most Common Acitretin Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
78 (4.28%)
Pregnancy
75 (4.11%)
Condition Aggravated
30 (1.64%)
Drug Ineffective
26 (1.43%)
Psoriasis
23 (1.26%)
Drug Interaction
21 (1.15%)
Pregnancy Of Partner
21 (1.15%)
Drug Exposure Before Pregnancy
15 (.82%)
Alopecia
14 (.77%)
Alanine Aminotransferase Increased
13 (.71%)
Headache
13 (.71%)
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Nausea
12 (.66%)
Caesarean Section
11 (.6%)
Depression
11 (.6%)
Pain In Extremity
11 (.6%)
Pustular Psoriasis
11 (.6%)
Cerebrovascular Accident
10 (.55%)
Dermatitis Exfoliative
10 (.55%)
Dizziness
10 (.55%)
Fatigue
10 (.55%)
Live Birth
10 (.55%)
Abortion Induced
9 (.49%)
Asthenia
9 (.49%)
Diarrhoea
9 (.49%)
Drug Administration Error
9 (.49%)
Erythema
9 (.49%)
Liver Function Test Abnormal
9 (.49%)
Pain
9 (.49%)
Cheilitis
8 (.44%)
Congenital Anomaly
8 (.44%)
Convulsion
8 (.44%)
Dry Mouth
8 (.44%)
Gamma-glutamyltransferase Increased
8 (.44%)
Rash
8 (.44%)
Skin Exfoliation
8 (.44%)
Vomiting
8 (.44%)
Weight Decreased
8 (.44%)
Arthralgia
7 (.38%)
Aspartate Aminotransferase Increase...
7 (.38%)
Blister
7 (.38%)
Blood Alkaline Phosphatase Increase...
7 (.38%)
Blood Triglycerides Increased
7 (.38%)
Diabetes Mellitus
7 (.38%)
Hepatic Enzyme Increased
7 (.38%)
Hypercholesterolaemia
7 (.38%)
Hypertension
7 (.38%)
Jaundice
7 (.38%)
Neutropenia
7 (.38%)
Pruritus
7 (.38%)
Rash Generalised
7 (.38%)
Abdominal Pain
6 (.33%)
Blood Bilirubin Increased
6 (.33%)
Completed Suicide
6 (.33%)
Erythrodermic Psoriasis
6 (.33%)
Haematocrit Decreased
6 (.33%)
Haemoglobin Decreased
6 (.33%)
Hepatic Function Abnormal
6 (.33%)
International Normalised Ratio Incr...
6 (.33%)
Intracranial Pressure Increased
6 (.33%)
Leukopenia
6 (.33%)
Malaise
6 (.33%)
Musculoskeletal Stiffness
6 (.33%)
Myalgia
6 (.33%)
No Therapeutic Response
6 (.33%)
Oedema
6 (.33%)
Oedema Peripheral
6 (.33%)
Pyogenic Granuloma
6 (.33%)
Pyrexia
6 (.33%)
Tendonitis
6 (.33%)
Thrombocytopenia
6 (.33%)
Tremor
6 (.33%)
Back Pain
5 (.27%)
Blood Pressure Increased
5 (.27%)
C-reactive Protein Increased
5 (.27%)
Calcinosis
5 (.27%)
Cerebral Haemorrhage
5 (.27%)
Cholelithiasis
5 (.27%)
Constipation
5 (.27%)
Deep Vein Thrombosis
5 (.27%)
Dehydration
5 (.27%)
Depressed Level Of Consciousness
5 (.27%)
Dry Skin
5 (.27%)
Enthesopathy
5 (.27%)
Epistaxis
5 (.27%)
Extraskeletal Ossification
5 (.27%)
Haemorrhage
5 (.27%)
Hyperkeratosis
5 (.27%)
Insomnia
5 (.27%)
Malignant Melanoma
5 (.27%)
Mania
5 (.27%)
Myocardial Infarction
5 (.27%)
Myopathy
5 (.27%)
Myositis
5 (.27%)
Off Label Use
5 (.27%)
Rash Maculo-papular
5 (.27%)
Rectal Haemorrhage
5 (.27%)
Renal Impairment
5 (.27%)
Therapeutic Response Decreased
5 (.27%)
Transient Ischaemic Attack
5 (.27%)
Abortion Spontaneous
4 (.22%)
Anaemia
4 (.22%)

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

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

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

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

Psoriasis
274
Drug Use For Unknown Indication
54
Pustular Psoriasis
27
Keratosis Follicular
23
Product Used For Unknown Indication
21
Ichthyosis
17
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Pityriasis Rubra Pilaris
13
Dermatitis Atopic
6
Rash Papular
6
Prophylaxis
6
Erythrodermic Psoriasis
6
Skin Disorder
6
Squamous Cell Carcinoma
5
Mycosis Fungoides
5
Skin Cancer
5
Ill-defined Disorder
4
Psychiatric Symptom
4
Hyperkeratosis Palmaris And Plantar...
4
Eczema
4
Skin Papilloma
3
Hyperkeratosis
2
Dry Skin
2
Cutaneous Lupus Erythematosus
2
Lichen Planus
2
Psoriatic Arthropathy
2
Neoplasm Prophylaxis
2
Erythrokeratodermia Variabilis
2
Leukoplakia Oral
2
T-cell Lymphoma
1
Subcorneal Pustular Dermatosis
1
Nail Psoriasis
1
Placenta Praevia Haemorrhage
1
Acne
1
Transmission Of Drug Via Semen
1
Exfoliative Rash
1
Benign Familial Pemphigus
1
Keratoacanthoma
1
Wegeners Granulomatosis
1
Pityriasis
1
Leukopenia
1
Epidermodysplasia Verruciformis
1
Thrombocytopenia
1
Dermatitis
1
Dysfunctional Uterine Bleeding
1
Oral Lichen Planus
1
Rash Pustular
1
Sebaceous Hyperplasia
1

Drug Labels

LabelLabelerEffective
SoriataneStiefel Laboratories Inc13-JUL-12

Acitretin Case Reports

What Acitretin 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 Acitretin. 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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