Drug information for NICODERM CQ
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
FILM, EXTENDED RELEASE; TRANSDERMAL
14MG/24HR
Over The Counter
(Reference Drug)
NICOTINE
Nicotine
SANOFI AVENTIS US
20165
2007-11-19 Review
2007-04-20 Letter
2007-04-19 Label
2006-09-20 Letter
2006-09-18 Label
2002-08-13 Letter
FILM, EXTENDED RELEASE; TRANSDERMAL
21MG/24HR
Over The Counter
(Reference Drug)
NICOTINE
Nicotine
SANOFI AVENTIS US
"
FILM, EXTENDED RELEASE; TRANSDERMAL
7MG/24HR
Over The Counter
(Reference Drug)
NICOTINE
Nicotine
SANOFI AVENTIS US
"
Drug Adverse Effects information for NICODERM CQ
Role code
Indications
Reaction
# Reports
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ANXIETY
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
CHEST PAIN
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
DYSPNOEA
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
EXPIRED DRUG ADMINISTERED
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ILL-DEFINED DISORDER
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
OXYGEN SATURATION DECREASED
1
PS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
TREMOR
1
PS
EX-TOBACCO USER
ANXIETY
1
PS
EX-TOBACCO USER
CHEST PAIN
1
PS
EX-TOBACCO USER
DYSPNOEA
1
PS
EX-TOBACCO USER
EXPIRED DRUG ADMINISTERED
1
PS
EX-TOBACCO USER
ILL-DEFINED DISORDER
1
PS
EX-TOBACCO USER
OXYGEN SATURATION DECREASED
1
PS
EX-TOBACCO USER
TREMOR
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ANGINA PECTORIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ANGIOEDEMA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERSENSITIVITY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
RASH
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
THROMBOSIS
1
PS
SMOKING CESSATION THERAPY
ABDOMINAL DISCOMFORT
1
PS
SMOKING CESSATION THERAPY
AGITATION
1
PS
SMOKING CESSATION THERAPY
ANGINA PECTORIS
1
PS
SMOKING CESSATION THERAPY
ANXIETY
1
PS
SMOKING CESSATION THERAPY
APPLICATION SITE IRRITATION
1
PS
SMOKING CESSATION THERAPY
APPLICATION SITE PRURITUS
1
PS
SMOKING CESSATION THERAPY
APPLICATION SITE RASH
1
PS
SMOKING CESSATION THERAPY
ASTHMA
1
PS
SMOKING CESSATION THERAPY
BRONCHITIS
1
PS
SMOKING CESSATION THERAPY
CONDITION AGGRAVATED
1
PS
SMOKING CESSATION THERAPY
CONFUSIONAL STATE
2
PS
SMOKING CESSATION THERAPY
COUGH
1
PS
SMOKING CESSATION THERAPY
CRYING
2
PS
SMOKING CESSATION THERAPY
DEPRESSED LEVEL OF CONSCIOUSNESS
2
PS
SMOKING CESSATION THERAPY
DEPRESSION
1
PS
SMOKING CESSATION THERAPY
DIARRHOEA
1
PS
SMOKING CESSATION THERAPY
DRUG INEFFECTIVE
1
PS
SMOKING CESSATION THERAPY
DYSGEUSIA
1
PS
SMOKING CESSATION THERAPY
DYSPNOEA
1
PS
SMOKING CESSATION THERAPY
EXPIRED DRUG ADMINISTERED
3
PS
SMOKING CESSATION THERAPY
FEELING ABNORMAL
3
PS
SMOKING CESSATION THERAPY
GASTRIC DISORDER
1
PS
SMOKING CESSATION THERAPY
IRRITABILITY
1
PS
SMOKING CESSATION THERAPY
MANIA
1
PS
SMOKING CESSATION THERAPY
MIDDLE INSOMNIA
1
PS
SMOKING CESSATION THERAPY
NICOTINE DEPENDENCE
1
PS
SMOKING CESSATION THERAPY
NIGHTMARE
2
PS
SMOKING CESSATION THERAPY
PANIC ATTACK
1
PS
SMOKING CESSATION THERAPY
PARAESTHESIA
2
PS
SMOKING CESSATION THERAPY
PAROSMIA
1
PS
SMOKING CESSATION THERAPY
PRODUCT QUALITY ISSUE
1
PS
SMOKING CESSATION THERAPY
SUICIDAL IDEATION
1
SS
EX-TOBACCO USER
ABDOMINAL DISCOMFORT
5
SS
EX-TOBACCO USER
APPLICATION SITE BURN
2
SS
EX-TOBACCO USER
APPLICATION SITE ERYTHEMA
2
SS
EX-TOBACCO USER
APPLICATION SITE PAIN
2
SS
EX-TOBACCO USER
APPLICATION SITE PRURITUS
2
SS
EX-TOBACCO USER
APPLICATION SITE VESICLES
2
SS
EX-TOBACCO USER
DERMATITIS CONTACT
2
SS
EX-TOBACCO USER
DRUG ADMINISTRATION ERROR
10
SS
EX-TOBACCO USER
DYSPEPSIA
4
SS
EX-TOBACCO USER
EXPIRED DRUG ADMINISTERED
2
SS
EX-TOBACCO USER
FLATULENCE
3
SS
EX-TOBACCO USER
HEADACHE
3
SS
EX-TOBACCO USER
HICCUPS
2
SS
EX-TOBACCO USER
HYPERSENSITIVITY
2
SS
EX-TOBACCO USER
INSOMNIA
2
SS
EX-TOBACCO USER
LOOSE TOOTH
3
SS
EX-TOBACCO USER
MALAISE
2
SS
EX-TOBACCO USER
NAUSEA
5
SS
EX-TOBACCO USER
NICOTINE DEPENDENCE
5
SS
EX-TOBACCO USER
OEDEMA PERIPHERAL
3
SS
EX-TOBACCO USER
OESOPHAGEAL PAIN
2
SS
EX-TOBACCO USER
OROPHARYNGEAL PAIN
3
SS
EX-TOBACCO USER
PRODUCT QUALITY ISSUE
7
SS
EX-TOBACCO USER
URTICARIA
2
SS
SMOKING CESSATION THERAPY
APPLICATION SITE PRURITUS
4
SS
SMOKING CESSATION THERAPY
APPLICATION SITE RASH
4
SS
SMOKING CESSATION THERAPY
APPLICATION SITE REACTION
4
SS
SMOKING CESSATION THERAPY
CONFUSIONAL STATE
2
SS
SMOKING CESSATION THERAPY
DEPRESSED LEVEL OF CONSCIOUSNESS
2
SS
SMOKING CESSATION THERAPY
DRUG INEFFECTIVE
6
SS
SMOKING CESSATION THERAPY
EXPIRED DRUG ADMINISTERED
2
SS
SMOKING CESSATION THERAPY
FEELING ABNORMAL
2
SS
SMOKING CESSATION THERAPY
INTENTIONAL DRUG MISUSE
4
SS
SMOKING CESSATION THERAPY
LUNG NEOPLASM MALIGNANT
2
SS
SMOKING CESSATION THERAPY
NICOTINE DEPENDENCE
6
SS
SMOKING CESSATION THERAPY
PARAESTHESIA
2
C
CONVULSION
INTENTIONAL DRUG MISUSE
1
C
CONVULSION
OVERDOSE
1
C
CONVULSION
TOXICITY TO VARIOUS AGENTS
1
C
MULTIPLE SCLEROSIS
ASTHENIA
1
C
MULTIPLE SCLEROSIS
CYSTITIS
1
C
MULTIPLE SCLEROSIS
MOOD SWINGS
1
C
MULTIPLE SCLEROSIS
MULTIPLE SCLEROSIS RELAPSE
1
C
MULTIPLE SCLEROSIS
PNEUMONIA
1
C
MULTIPLE SCLEROSIS
PSYCHOTIC BEHAVIOUR
1
C
MULTIPLE SCLEROSIS
PYELONEPHRITIS
1
C
MULTIPLE SCLEROSIS
SEPSIS
1
C
MUSCLE SPASMS
ASTHENIA
2
C
MUSCLE SPASMS
CYSTITIS
2
C
MUSCLE SPASMS
MOOD SWINGS
2
C
MUSCLE SPASMS
MULTIPLE SCLEROSIS RELAPSE
2
C
MUSCLE SPASMS
PNEUMONIA
2
C
MUSCLE SPASMS
PSYCHOTIC BEHAVIOUR
2
C
MUSCLE SPASMS
PYELONEPHRITIS
2
C
MUSCLE SPASMS
SEPSIS
2
C
NON-SMALL CELL LUNG CANCER
ANAEMIA
3
C
NON-SMALL CELL LUNG CANCER
DECREASED APPETITE
3
C
NON-SMALL CELL LUNG CANCER
DEHYDRATION
3
C
NON-SMALL CELL LUNG CANCER
FATIGUE
3
C
NON-SMALL CELL LUNG CANCER
HYPOTENSION
3
C
NON-SMALL CELL LUNG CANCER
NEUTROPHIL COUNT DECREASED
3
C
NON-SMALL CELL LUNG CANCER
WHITE BLOOD CELL COUNT DECREASED
3
C
ORAL HERPES
INTENTIONAL DRUG MISUSE
1
C
ORAL HERPES
OVERDOSE
1
C
ORAL HERPES
TOXICITY TO VARIOUS AGENTS
1
C
PAIN
ASTHENIA
3
C
PAIN
CYSTITIS
3
C
PAIN
INTENTIONAL DRUG MISUSE
3
C
PAIN
MOOD SWINGS
3
C
PAIN
MULTIPLE SCLEROSIS RELAPSE
3
C
PAIN
OVERDOSE
3
C
PAIN
PNEUMONIA
3
C
PAIN
PSYCHOTIC BEHAVIOUR
3
C
PAIN
PYELONEPHRITIS
3
C
PAIN
SEPSIS
3
C
PAIN
TOXICITY TO VARIOUS AGENTS
3
C
RESPIRATORY TRACT CONGESTION
ASTHENIA
1
C
RESPIRATORY TRACT CONGESTION
CYSTITIS
1
C
RESPIRATORY TRACT CONGESTION
MOOD SWINGS
1
C
RESPIRATORY TRACT CONGESTION
MULTIPLE SCLEROSIS RELAPSE
1
C
RESPIRATORY TRACT CONGESTION
PNEUMONIA
1
C
RESPIRATORY TRACT CONGESTION
PSYCHOTIC BEHAVIOUR
1
C
RESPIRATORY TRACT CONGESTION
PYELONEPHRITIS
1
C
RESPIRATORY TRACT CONGESTION
SEPSIS
1
C
SLEEP APNOEA SYNDROME
ASTHENIA
1
C
SLEEP APNOEA SYNDROME
CYSTITIS
1
C
SLEEP APNOEA SYNDROME
MOOD SWINGS
1
C
SLEEP APNOEA SYNDROME
MULTIPLE SCLEROSIS RELAPSE
1
C
SLEEP APNOEA SYNDROME
PNEUMONIA
1
C
SLEEP APNOEA SYNDROME
PSYCHOTIC BEHAVIOUR
1
C
SLEEP APNOEA SYNDROME
PYELONEPHRITIS
1
C
SLEEP APNOEA SYNDROME
SEPSIS
1
C
SLEEP DISORDER
ASTHENIA
1
C
SLEEP DISORDER
CYSTITIS
1
C
SLEEP DISORDER
MOOD SWINGS
1
C
SLEEP DISORDER
MULTIPLE SCLEROSIS RELAPSE
1
C
SLEEP DISORDER
PNEUMONIA
1
C
SLEEP DISORDER
PSYCHOTIC BEHAVIOUR
1
C
SLEEP DISORDER
PYELONEPHRITIS
1
C
SLEEP DISORDER
SEPSIS
1
C
SMOKING CESSATION THERAPY
INTENTIONAL DRUG MISUSE
1
C
SMOKING CESSATION THERAPY
OVERDOSE
1
C
SMOKING CESSATION THERAPY
TOXICITY TO VARIOUS AGENTS
1
C
TOBACCO ABUSE
ASTHENIA
1
C
TOBACCO ABUSE
CYSTITIS
1
C
TOBACCO ABUSE
MOOD SWINGS
1
C
TOBACCO ABUSE
MULTIPLE SCLEROSIS RELAPSE
1
C
TOBACCO ABUSE
PNEUMONIA
1
C
TOBACCO ABUSE
PSYCHOTIC BEHAVIOUR
1
C
TOBACCO ABUSE
PYELONEPHRITIS
1
C
TOBACCO ABUSE
SEPSIS
1
C
WHEEZING
ASTHENIA
1
C
WHEEZING
CYSTITIS
1
C
WHEEZING
MOOD SWINGS
1
C
WHEEZING
MULTIPLE SCLEROSIS RELAPSE
1
C
WHEEZING
PNEUMONIA
1
C
WHEEZING
PSYCHOTIC BEHAVIOUR
1
C
WHEEZING
PYELONEPHRITIS
1
C
WHEEZING
SEPSIS
1
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