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Nicotrol (Nicotine Inhalation) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nicotrol (Nicotine Inhalation) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (404)
Death (3)
Disability (1)

Reports by Reaction Type

Drug Ineffective (98)Cough (33)Dysgeusia (26)Throat Irritation (26)Dyspnoea (23)Feeling Abnormal (22)Malaise (21)Tobacco User (20)Anxiety (20)Nausea (18)Chronic Obstructive Pulmonary Disease (17)Depression (16)

Below are a few examples of reports where side effects / adverse reactions may be related to Nicotrol (Nicotine Inhalation). For a complete list or a specific selection of reports, please use the links above.

Possible Nicotrol side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 52 year old female, weighing 50.8 kg (111.7 pounds)

Reactions: Psychomotor Hyperactivity, Pain, Neck Injury, Fall, Joint Injury, Incorrect Drug Administration Duration, Feeling Abnormal, Hyperthyroidism, Back Injury, RIB Fracture

Drug(s) suspected as cause:
Calcium Carbonate
    Dosage: 1200 mg, 1x/day
    Indication: Mineral Supplementation

Nicotrol
    Dosage: unk
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2011-01-01

Synthroid
    Dosage: unk
    Indication: Hypothyroidism
    End date: 2012-01-01

Synthroid
    Dosage: 88 ug, unk
    Start date: 2012-01-01



Possible Nicotrol side effects in 66 year old female

Reported by a physician from United States on 2012-08-27

Patient: 66 year old female

Reactions: Overdose, Blood Pressure Fluctuation, Clostridial Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lipitor
    Dosage: at bed time
    Administration route: Oral

Lipitor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01

Nicotrol
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-19

Other drugs received by patient: Atenolol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Cheilitis, Malaise, Oropharyngeal Pain

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 61 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Product Quality Issue, Drug Ineffective, Tooth Extraction, Pain, Cerebrovascular Accident, Anxiety, Malaise, Memory Impairment, Emotional Disorder, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nicotrol
    Dosage: unk

Nicotrol
    Dosage: unknown dose three times a day

Nicotrol
    Dosage: unk
    Indication: Smoking Cessation Therapy
    Start date: 2012-01-22

Nicotrol
    Dosage: unknown dose 20 times a day



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in 34 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 34 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Vomiting, Nausea

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Clostridial Infection, Blood Pressure Fluctuation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lipitor
    Dosage: 10 mg, 1x/day nightly
    Administration route: Oral
    Start date: 2012-04-01

Nicotrol
    Dosage: 10 mg, 20 min puffing per cartridge, max 16 cartridge/ day
    Start date: 2012-03-19

Other drugs received by patient: Atenolol



Possible Nicotrol side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 74 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Bedridden, Convulsion

Drug(s) suspected as cause:
Nicotrol
    Dosage: 3 cartridges once a day
    Indication: Smoking Cessation Therapy
    Start date: 2007-01-01
    End date: 2007-01-01

Nicotrol
    Start date: 2011-01-01
    End date: 2011-01-01



Possible Nicotrol side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 63 year old female, weighing 43.5 kg (95.8 pounds)

Reactions: Drug Intolerance, Incorrect Dose Administered, Expired Drug Administered

Drug(s) suspected as cause:
Nicotrol

Other drugs received by patient: Albuterol; Spiriva



Possible Nicotrol side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 70 year old male, weighing 100.0 kg (220.0 pounds)

Reactions: Pruritus, Drug Ineffective, Suicidal Ideation, Aggression, Malaise, Homicidal Ideation, Withdrawal Syndrome, Self-Injurious Ideation

Drug(s) suspected as cause:
Chantix
    Administration route: Oral
    Indication: Smoking Cessation Therapy

Nicotrol
    Indication: Smoking Cessation Therapy

Nicotrol
    Dosage: 3 to 4 packages per day
    Start date: 2012-08-03

Other drugs received by patient: Proair HFA; Zyprexa; Lisinopril



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Cheilitis, Malaise, Oropharyngeal Pain

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 74 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Bedridden, Convulsion

Drug(s) suspected as cause:
Nicotrol
    Dosage: three cartridges a day
    Indication: Smoking Cessation Therapy
    Start date: 2007-01-01
    End date: 2007-01-01

Nicotrol
    Dosage: unk
    Start date: 2011-01-01
    End date: 2011-01-01



Possible Nicotrol side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 70 year old male, weighing 100.0 kg (220.0 pounds)

Reactions: Pruritus, Drug Ineffective, Aggression, Suicidal Ideation, Malaise, Withdrawal Syndrome, Homicidal Ideation, Self-Injurious Ideation

Drug(s) suspected as cause:
Chantix
    Dosage: unk
    Indication: Smoking Cessation Therapy

Nicotrol
    Dosage: 3 to 4 packages per day
    Start date: 2012-08-03

Nicotrol
    Dosage: unk
    Indication: Smoking Cessation Therapy

Other drugs received by patient: Proair HFA; Lisinopril; Zyprexa



Possible Nicotrol side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 57 year old female, weighing 74.8 kg (164.6 pounds)

Reactions: Gallbladder Disorder

Drug(s) suspected as cause:
Nicotrol
    Dosage: unk
    Indication: Smoking Cessation Therapy
    Start date: 2012-08-13

Xanax
    Dosage: unk
    Administration route: Oral
    Indication: Sleep Disorder

Other drugs received by patient: Relafen; Oxycodone; Oxycodone; Soma; Synthroid; Morphine Sulfate; Simvastatin; Oxycodone; Aspirin



Possible Nicotrol side effects in 70 year old female

Reported by a physician from United States on 2012-08-15

Patient: 70 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Dysgeusia, Drug Ineffective

Drug(s) suspected as cause:
Nicotrol
    Dosage: unk, 0 to 16 times/day
    Indication: Smoking Cessation Therapy
    Start date: 2012-05-08
    End date: 2012-06-10

Nicotrol
    Indication: Tobacco Abuse



Possible Nicotrol side effects in 42 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 42 year old female, weighing 94.8 kg (208.5 pounds)

Reactions: Nasal Discomfort, Eye Discharge

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Dysgeusia, Abdominal Discomfort, Malaise

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female, weighing 65.8 kg (144.7 pounds)

Reactions: Oral Mucosal Blistering, Dysphonia, Nausea, Feeling Abnormal

Drug(s) suspected as cause:
Nicotrol

Other drugs received by patient: Aspirin; Zetia; Ranitidine; Plavix; Lyrica; Lyrica; Furosemide



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female

Reactions: Dysgeusia

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in 34 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 34 year old female, weighing 48.5 kg (106.8 pounds)

Reactions: Nasal Discomfort, Drug Dispensing Error

Drug(s) suspected as cause:
Nicotrol
    Dosage: unk, daily
    Indication: Smoking Cessation Therapy
    Start date: 2012-08-06

Nicotrol
    Dosage: unk
    Indication: Smoking Cessation Therapy



Possible Nicotrol side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Pharyngeal Disorder

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Product Quality Issue, Dizziness

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 65.8 kg (144.7 pounds)

Reactions: Oral Mucosal Blistering, Nausea, Dysphonia, Feeling Abnormal

Drug(s) suspected as cause:
Nicotrol

Other drugs received by patient: Plavix; Zetia; Ranitidine; Lyrica; Furosemide; Aspirin



Possible Nicotrol side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 62 year old male, weighing 85.7 kg (188.6 pounds)

Reactions: Tachycardia, Feeling Abnormal, Hypertension

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in 53 year old male

Reported by a physician from United States on 2012-08-01

Patient: 53 year old male

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Nicotrol

Other drugs received by patient: Unknown Medication



Possible Nicotrol side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: male, weighing 72.6 kg (159.6 pounds)

Reactions: Product Quality Issue, Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Dysgeusia, Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Nicotrol



Possible Nicotrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female, weighing 65.8 kg (144.7 pounds)

Reactions: Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Nicotrol
    Dosage: unk, as needed
    Indication: Smoking Cessation Therapy
    Start date: 2007-01-01
    End date: 2009-01-01

Nicotrol
    Dosage: unk, as needed
    Start date: 2012-06-01

Nicotrol
    Dosage: unk
    Start date: 2010-01-01
    End date: 2010-01-01

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