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AMNESTEEM

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Amnesteem Adverse Events Reported to the FDA Over Time

How are Amnesteem adverse event reports trending over time?

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

Most Common Amnesteem Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
776 (7.01%)
Inflammatory Bowel Disease
608 (5.49%)
Pregnancy
434 (3.92%)
Depression
362 (3.27%)
Blood Triglycerides Increased
305 (2.75%)
Arthralgia
250 (2.26%)
Abortion Induced
234 (2.11%)
Headache
233 (2.1%)
Dry Skin
219 (1.98%)
Suicidal Ideation
209 (1.89%)
Anxiety
203 (1.83%)
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Lip Dry
169 (1.53%)
Blood Cholesterol Increased
141 (1.27%)
Colitis Ulcerative
133 (1.2%)
Treatment Noncompliance
129 (1.16%)
Abdominal Pain
127 (1.15%)
Mood Altered
124 (1.12%)
Myalgia
123 (1.11%)
Diarrhoea
108 (.98%)
Aspartate Aminotransferase Increase...
107 (.97%)
Back Pain
101 (.91%)
Rectal Haemorrhage
99 (.89%)
Nausea
96 (.87%)
Alanine Aminotransferase Increased
92 (.83%)
Fatigue
92 (.83%)
Mood Swings
91 (.82%)
Epistaxis
90 (.81%)
Drug Exposure Before Pregnancy
75 (.68%)
Abortion Spontaneous
71 (.64%)
Irritability
69 (.62%)
Acne
68 (.61%)
Drug Ineffective
63 (.57%)
Rash
62 (.56%)
Hepatic Enzyme Increased
59 (.53%)
Dry Eye
58 (.52%)
Chapped Lips
57 (.51%)
Irritable Bowel Syndrome
57 (.51%)
Colitis
56 (.51%)
Vision Blurred
56 (.51%)
Frequent Bowel Movements
54 (.49%)
Anger
52 (.47%)
Intestinal Obstruction
52 (.47%)
Dizziness
51 (.46%)
Liver Function Test Abnormal
49 (.44%)
Pregnancy On Oral Contraceptive
49 (.44%)
Crying
48 (.43%)
Aggression
46 (.42%)
Migraine
45 (.41%)
Unintended Pregnancy
45 (.41%)
Alopecia
44 (.4%)
Haematochezia
44 (.4%)
Insomnia
44 (.4%)
Anaemia
43 (.39%)
Depressed Mood
43 (.39%)
Abdominal Pain Upper
38 (.34%)
Gastrointestinal Disorder
34 (.31%)
Vomiting
34 (.31%)
Convulsion
33 (.3%)
Intestinal Haemorrhage
33 (.3%)
Drug Dose Omission
31 (.28%)
Vaginal Haemorrhage
31 (.28%)
Adverse Event
29 (.26%)
Sinusitis
29 (.26%)
Emotional Distress
28 (.25%)
Abnormal Behaviour
27 (.24%)
Pregnancy Test False Positive
27 (.24%)
Abdominal Discomfort
26 (.23%)
Feeling Abnormal
26 (.23%)
Malaise
26 (.23%)
Pain
26 (.23%)
Pain In Extremity
26 (.23%)
Stress
26 (.23%)
Suicide Attempt
26 (.23%)
Asthenia
25 (.23%)
Death
25 (.23%)
Panic Attack
25 (.23%)
Pregnancy With Contraceptive Device
25 (.23%)
Agitation
24 (.22%)
Disturbance In Attention
24 (.22%)
Dyspnoea
24 (.22%)
Pruritus
24 (.22%)
Drug Ineffective For Unapproved Ind...
23 (.21%)
Gastritis
23 (.21%)
Tinnitus
23 (.21%)
Weight Decreased
23 (.21%)
Ectopic Pregnancy
22 (.2%)
Emotional Disorder
22 (.2%)
Chest Pain
21 (.19%)
Lymphadenopathy
21 (.19%)
Nasal Dryness
21 (.19%)
Urticaria
21 (.19%)
Cheilitis
20 (.18%)
Educational Problem
20 (.18%)
Gastrooesophageal Reflux Disease
20 (.18%)
White Blood Cell Count Increased
20 (.18%)
Decreased Appetite
18 (.16%)
Infectious Mononucleosis
18 (.16%)
White Blood Cell Count Decreased
18 (.16%)
Xerosis
18 (.16%)
Colonic Stenosis
17 (.15%)
Constipation
17 (.15%)

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

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

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

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

Acne
2220
Acne Cystic
402
Drug Use For Unknown Indication
238
Product Used For Unknown Indication
21
Rosacea
15
Hidradenitis
14
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Scar
13
Acne Conglobata
10
Neuroblastoma
7
Keratosis Follicular
5
Brain Neoplasm
4
Sebaceous Hyperplasia
4
Glioblastoma Multiforme
3
Brain Neoplasm Malignant
3
Folliculitis
3
Glioblastoma
2
Cellulitis
2
Medulloblastoma
2
Bone Sarcoma
2
Prostate Cancer
2
Transient Acantholytic Dermatosis
2
Mycosis Fungoides
2
Cutaneous Amyloidosis
2
Steatocystoma Multiplex
2
Alopecia Scarring
1
Neoplasm Malignant
1
Basal Cell Naevus Syndrome
1
Pityriasis Rubra Pilaris
1
Granuloma Annulare
1
Rhabdomyosarcoma
1
Ichthyosis
1
Squamous Cell Carcinoma
1
Sweat Gland Infection
1
Systemic Lupus Erythematosus
1
Psoriasis
1
Brain Stem Glioma
1
Cyst
1
Lichen Planus
1
Acne Fulminans
1
Brain Cancer Metastatic
1
Dermatitis
1
Squamous Cell Carcinoma Of The Cerv...
1

Drug Labels

LabelLabelerEffective
AmnesteemMylan Pharmaceuticals Inc.23-MAY-12
AmnesteemPhysicians Total Care, Inc.25-JUN-12

Amnesteem Case Reports

What Amnesteem 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 Amnesteem. 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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