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Nicoderm Adverse Events Reported to the FDA Over Time

How are Nicoderm adverse event reports trending over time?

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

Most Common Nicoderm Adverse Events Reported to the FDA

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

Application Site Erythema
1757 (7.94%)
Application Site Pruritus
1628 (7.35%)
Nicotine Dependence
980 (4.43%)
Nausea
961 (4.34%)
Application Site Irritation
744 (3.36%)
Dizziness
715 (3.23%)
Drug Ineffective
490 (2.21%)
Malaise
421 (1.9%)
Intentional Drug Misuse
410 (1.85%)
Abnormal Dreams
402 (1.82%)
Headache
385 (1.74%)
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Hypersensitivity
379 (1.71%)
Application Site Reaction
376 (1.7%)
Application Site Swelling
376 (1.7%)
Insomnia
369 (1.67%)
Vomiting
350 (1.58%)
Pain In Extremity
315 (1.42%)
Application Site Pain
287 (1.3%)
Application Site Rash
278 (1.26%)
Application Site Dermatitis
273 (1.23%)
Heart Rate Increased
271 (1.22%)
Application Site Urticaria
259 (1.17%)
Feeling Abnormal
221 (1%)
Nightmare
214 (.97%)
Nervousness
207 (.94%)
Tremor
196 (.89%)
Anxiety
181 (.82%)
Fatigue
171 (.77%)
Rash
170 (.77%)
Pruritus
166 (.75%)
Dyspnoea
162 (.73%)
Chest Pain
157 (.71%)
Palpitations
154 (.7%)
Hyperhidrosis
152 (.69%)
Asthenia
145 (.66%)
Dysgeusia
135 (.61%)
Application Site Vesicles
121 (.55%)
Irritability
119 (.54%)
Feeling Jittery
105 (.47%)
Erythema
100 (.45%)
Urticaria
100 (.45%)
Blood Pressure Increased
99 (.45%)
Application Site Papules
97 (.44%)
Application Site Warmth
96 (.43%)
Diarrhoea
96 (.43%)
Myalgia
89 (.4%)
Abdominal Pain Upper
88 (.4%)
Drug Administration Error
88 (.4%)
Application Site Paraesthesia
80 (.36%)
Overdose
80 (.36%)
Paraesthesia
78 (.35%)
Hypoaesthesia
75 (.34%)
Loss Of Consciousness
65 (.29%)
Depression
63 (.28%)
Feeling Hot
63 (.28%)
Pain
62 (.28%)
Dyspepsia
61 (.28%)
Weight Increased
61 (.28%)
Oedema Peripheral
59 (.27%)
Chest Discomfort
58 (.26%)
Somnolence
58 (.26%)
Hypertension
57 (.26%)
Drug Abuser
56 (.25%)
Application Site Discolouration
55 (.25%)
Pruritus Generalised
55 (.25%)
Cough
52 (.23%)
Dermatitis Contact
51 (.23%)
Hallucination
50 (.23%)
Flatulence
46 (.21%)
Psychomotor Hyperactivity
46 (.21%)
Crying
45 (.2%)
Drug Exposure During Pregnancy
45 (.2%)
Muscle Spasms
45 (.2%)
Skin Irritation
45 (.2%)
Drug Withdrawal Syndrome
44 (.2%)
Sleep Disorder
44 (.2%)
Rash Generalised
43 (.19%)
Back Pain
41 (.19%)
Restlessness
41 (.19%)
Anorexia
40 (.18%)
Arthralgia
40 (.18%)
Tension
40 (.18%)
Application Site Dryness
39 (.18%)
Disturbance In Attention
39 (.18%)
Myocardial Infarction
37 (.17%)
Stress
37 (.17%)
Throat Irritation
37 (.17%)
Agitation
36 (.16%)
Euphoric Mood
35 (.16%)
Retching
35 (.16%)
Constipation
34 (.15%)
Dry Mouth
33 (.15%)
Ill-defined Disorder
33 (.15%)
Burning Sensation
32 (.14%)
Vision Blurred
32 (.14%)
Blister
31 (.14%)
Cerebrovascular Accident
31 (.14%)
Anger
30 (.14%)
Hiccups
30 (.14%)
Hot Flush
30 (.14%)
Product Quality Issue
29 (.13%)

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

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

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

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

Drug Use For Unknown Indication
486
Smoking Cessation Therapy
461
Ex-smoker
131
Ex-tobacco User
39
Product Used For Unknown Indication
25
Drug Withdrawal Maintenance Therapy
24
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Tobacco User
23
Tobacco Abuse
8
Tobacco Withdrawal Symptoms
6
Prophylaxis
6
Ill-defined Disorder
5
Parkinsons Disease
2
Nicotine Dependence
2
Increased Appetite
1
Smoker
1

Nicoderm Case Reports

What Nicoderm 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 Nicoderm. 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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