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CLARAVIS

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Claravis Adverse Events Reported to the FDA Over Time

How are Claravis adverse event reports trending over time?

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

Most Common Claravis Adverse Events Reported to the FDA

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

Unintended Pregnancy
2067 (23.18%)
Drug Exposure During Pregnancy
784 (8.79%)
Treatment Noncompliance
339 (3.8%)
Abortion Induced
248 (2.78%)
Suicidal Ideation
244 (2.74%)
Inflammatory Bowel Disease
229 (2.57%)
Pregnancy
222 (2.49%)
Depression
207 (2.32%)
Abortion Spontaneous
158 (1.77%)
Anxiety
118 (1.32%)
Pregnancy On Oral Contraceptive
108 (1.21%)
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Arthralgia
77 (.86%)
Blood Triglycerides Increased
74 (.83%)
Headache
69 (.77%)
Pregnancy With Contraceptive Device
68 (.76%)
Abdominal Pain
66 (.74%)
Diarrhoea
64 (.72%)
Lip Dry
61 (.68%)
Drug Dose Omission
59 (.66%)
Colitis Ulcerative
55 (.62%)
Drug Exposure Before Pregnancy
55 (.62%)
Suicide Attempt
53 (.59%)
Mood Altered
51 (.57%)
Dry Skin
50 (.56%)
Rectal Haemorrhage
48 (.54%)
Fatigue
43 (.48%)
Pregnancy Test False Positive
43 (.48%)
Irritable Bowel Syndrome
41 (.46%)
Pregnancy On Contraceptive
41 (.46%)
Mood Swings
39 (.44%)
Aggression
36 (.4%)
Drug Ineffective
33 (.37%)
Back Pain
32 (.36%)
Myalgia
32 (.36%)
Aspartate Aminotransferase Increase...
31 (.35%)
Frequent Bowel Movements
30 (.34%)
Nausea
29 (.33%)
Depressed Mood
26 (.29%)
Vaginal Haemorrhage
26 (.29%)
Vomiting
26 (.29%)
Alanine Aminotransferase Increased
25 (.28%)
Crying
25 (.28%)
Dry Eye
25 (.28%)
Epistaxis
25 (.28%)
Anger
24 (.27%)
Blood Cholesterol Increased
24 (.27%)
Colitis
24 (.27%)
Self-injurious Ideation
24 (.27%)
Anaemia
22 (.25%)
Abnormal Behaviour
21 (.24%)
Sinusitis
21 (.24%)
Malaise
20 (.22%)
Abdominal Pain Upper
19 (.21%)
Acne
19 (.21%)
Caesarean Section
19 (.21%)
Chest Pain
19 (.21%)
Decreased Appetite
19 (.21%)
Dizziness
19 (.21%)
Irritability
19 (.21%)
Paternal Drugs Affecting Foetus
19 (.21%)
Inappropriate Schedule Of Drug Admi...
18 (.2%)
Disturbance In Attention
17 (.19%)
Dyspnoea
17 (.19%)
Insomnia
17 (.19%)
No Adverse Event
17 (.19%)
Urinary Tract Infection
17 (.19%)
Chapped Lips
16 (.18%)
Ectopic Pregnancy
16 (.18%)
Educational Problem
16 (.18%)
Injury
16 (.18%)
Pregnancy Of Partner
16 (.18%)
Vision Blurred
16 (.18%)
Maternal Drugs Affecting Foetus
15 (.17%)
Pain
15 (.17%)
Premature Labour
15 (.17%)
Rash
15 (.17%)
Self Injurious Behaviour
15 (.17%)
Weight Decreased
15 (.17%)
Convulsion
14 (.16%)
Migraine
14 (.16%)
Arthropathy
13 (.15%)
Completed Suicide
13 (.15%)
Condition Aggravated
13 (.15%)
Dandy-walker Syndrome
13 (.15%)
Device Breakage
13 (.15%)
Gastrointestinal Disorder
13 (.15%)
Haematochezia
13 (.15%)
Metrorrhagia
13 (.15%)
Road Traffic Accident
13 (.15%)
Stress
13 (.15%)
Upper Respiratory Tract Infection
13 (.15%)
Abdominal Discomfort
12 (.13%)
Dermatitis
12 (.13%)
Intestinal Haemorrhage
12 (.13%)
Menstruation Irregular
12 (.13%)
Off Label Use
12 (.13%)
Treatment Failure
12 (.13%)
Xerosis
12 (.13%)
Blighted Ovum
11 (.12%)
Death
11 (.12%)
Feeling Abnormal
11 (.12%)

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

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

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

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

Acne
804
Drug Use For Unknown Indication
182
Acne Cystic
130
Product Used For Unknown Indication
26
Neuroblastoma
11
Sweat Gland Infection
7
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Keratosis Follicular
6
Brain Neoplasm Malignant
5
Glioblastoma
5
Rosacea
4
Hidradenitis
3
Brain Neoplasm
3
Glioblastoma Multiforme
3
Hyperkeratosis Palmaris And Plantar...
3
Scar
3
Skin Disorder
2
Folliculitis
2
Acne Conglobata
2
Metastases To Meninges
1
Prophylaxis
1
Pinealoblastoma
1
Pityriasis Rubra Pilaris
1
Brain Stem Glioma
1
Dermatitis Acneiform
1
Nodule
1
Prostate Cancer
1
Recurrent Cancer
1
Neoplasm Malignant
1
Acne Fulminans
1
Anaplastic Astrocytoma
1
Off Label Use
1
Psoriasis
1
Medulloblastoma
1
Squamous Cell Carcinoma Of The Cerv...
1
Cyst
1

Drug Labels

LabelLabelerEffective
ClaravisPhysicians Total Care, Inc.31-MAR-10
ClaravisBarr Laboratories, Inc.01-FEB-13

Claravis Case Reports

What Claravis 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 Claravis. 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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