Note: This document contains side effect information about nicotine. Some dosage forms listed on this page may not apply to the brand name Nicotrol Inhaler.
Applies to nicotine: gum, lozenge/troche. Other dosage forms:
- inhalation device
- nasal spray
- transdermal patch extended release
Serious side effects of Nicotrol Inhaler
Along with its needed effects, nicotine (the active ingredient contained in Nicotrol Inhaler) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking nicotine:
Less common
- Blurred vision
- dizziness
- headache
- nervousness
- pounding in the ears
Rare
- Fast or irregular heartbeat
- hives, itching, rash, redness, or swelling of the skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking nicotine:
Symptoms of overdose
- Dizziness
- fast heartbeat
- nausea or vomiting
- weakness
Other side effects of Nicotrol Inhaler
Some side effects of nicotine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Mouth sores, blisters, or irritation
- nausea or vomiting
- sore throat
Less common
- Acid or sour stomach
- belching
- diarrhea
- dizziness
- heartburn
- hiccups
- mouth, tooth, jaw, or neck pain
- problems with teeth
- unusual tiredness or weakness
For Healthcare Professionals
Applies to nicotine: compounding powder, inhalation device, nasal spray, oral transmucosal gum, oral transmucosal lozenge, transdermal film extended release.
General
Oral Formulations: The most commonly reported side effects were cough and irritation of the throat and mouth.
Nasal Spray: The most commonly reported side effects included nasal irritation, watering eyes, and cough.
Transdermal Patch: The most commonly reported side effects included local skin reactions (e.g., burning, edema, erythema, irritation, urticaria).[Ref]
Respiratory
Very common (10% or more): Throat irritation (up to 40%), cough (up to 32%)
Common (1% to 10%): Hiccups, nasal congestion, pharyngitis, pharyngolaryngeal pain
Uncommon (0.1% to 1%): Bronchospasm, dysphonia, dyspnea, sneezing, throat tightness, oropharyngeal pain, rhinorrhea
INHALATOR/INHALER:
Very common (10% oR more): Cough (up to 32%), rhinitis (up to 23%)
Common (1% to 10%): Sinusitis, bronchitis, hiccup
MOUTH SPRAY:
Frequency not reported: Cough, nasopharyngitis, hiccups
NASAL SPRAY:
Common (1% to 10%): Cough, throat irritation, dyspnea, epistaxis
Frequency not reported: Hiccup, sneezing, transient epistaxis, pharyngitis, hoarseness, bronchitis, bronchospasm, increased sputum oropharyngeal discomfort and pain
NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Hiccups
TRANSDERMAL PATCH:
Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Dyspnea, upper respiratory tract infections[Ref]
Nervous system
Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Burning sensation, dizziness, dysgeusia, paresthesia
Frequency not reported: Poor concentration
Postmarketing reports: Tremor, seizures
INHALATOR/INHALER:
Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Paresthesia, dizziness
MOUTH SPRAY:
Frequency not reported: Dizziness
NASAL SPRAY:
Very common (10% or more): Headache (up to 18%)
Common (1% to 10%): Dizziness, paresthesia or mouth/head/limb paresthesia
Frequency not reported: Aphasia, numbness, amnesia, migraines, impaired/poor concentration, somnolence, tremor, incoordination, transient changes in taste
NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Dizziness, headache
TRANSDERMAL PATCH:
Common (1% to 10%): Dizziness, headache, motor dysfunction
Uncommon (0.1% to 1%): Paresthesia, dysgeusia, somnolence
Rare (0.01% to 0.1%): Tremor[Ref]
Local
NASAL SPRAY:
Very common (10% or more): Rhinorrhea/nasal irritation or discomfort (up to 94%)
Frequency not reported: Nasal congestion, sinus irritation, transient changes in the sense of smell, runny nose, nasal paresthesia, numbness of nose, nasal ulcer/blister, burning of nose or eyes
TRANSDERMAL PATCH:
Very common (10% or more): Local skin/application site reactions (up to 20%)
Uncommon (0.1% to 1%): Localized myalgia, irritation, burning, edema, pain and discomfort[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, abdominal pain/upper abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence, salivary hypersecretion, constipation, vomiting, oral discomfort, stomatitis, toothache
Uncommon (0.1% to 1%): Eructation, glossitis, oral paresthesia, gingivitis, oral mucosal blistering and exfoliation
Rare (0.01% to 0.1%): Dysphagia, oral hypoesthesia, retching
Frequency not reported: Dry throat, gastrointestinal discomfort, lip pain
Postmarketing reports: Ulcerative/aphthous stomatitis
GUM:
Frequency not reported: Indigestion and heartburn
INHALATOR/INHALER:
Very common (10% or more): Dyspepsia (up to 18%)
Common (1% to 10%): Tooth disorders, taste disturbances, nausea, diarrhea, flatulence, mouth and throat irritation
Frequency not reported: Aphthous stomatitis
MOUTH SPRAY:
Frequency not reported: Constipation, mouth ulceration, gingival bleeding, mouth or throat irritation
NASAL SPRAY:
Common (1% to 10%): Nausea, vomiting, dyspepsia, constipation, stomatitis, flatulence, tooth disorder, gum problems
Frequency not reported: Gastrointestinal discomfort, abdominal pain, nausea, dry mouth, diarrhea, aphthous ulcer
NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Nausea, flatulence, gastritis, dry mouth, stomatitis, esophagitis
TRANSDERMAL PATCH:
Common (1% to 10%): Nausea, vomiting, abdominal pain, dyspepsia
Rare (0.01% to 0.1%): Gastrointestinal discomfort, constipation, diarrhea, flatulence, dry mouth
Frequency not reported: Aphthous stomatitis[Ref]
Psychiatric
Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Abnormal dreams
Frequency not reported: Dysphoria, depression/depressed mood, irritability, aggression, frustration/anger, restlessness/impatience, anxiety, cravings/urges to smoke, nighttime awakenings/sleep disturbances
Postmarketing reports: Nervousness
INHALATOR/INHALER:
Common (1% to 10%): Withdrawal symptoms/syndrome, anxiety, sleep disorder, depression, drug dependence
MOUTH SPRAY:
Frequency not reported: Dysphoria, depression/depressed mood, irritability, frustration/anger, difficulty concentrating, restlessness/impatience, insomnia, anxiety
NASAL SPRAY:
Common (1% to 10%): Anxiety, irritability, restlessness, emotional lability, insomnia, withdrawal symptoms, cravings/urges to smoke
Frequency not reported: Confusion, aggression, dysphoria, depression, apathy, nighttime awakenings/sleep disturbances, increased dreaming, feelings of dependence
NICOTINE BITARTRATE LOZENGE:
Frequency not reported: Insomnia, nicotine (the active ingredient contained in Nicotrol Inhaler) dependence, withdrawal symptoms
TRANSDERMAL PATCH:
Common (1% to 10%): Agitation, anxiety, nervousness, insomnia, abnormal dreams
Uncommon (0.1% to 1%): Attention disturbance, affect lability, irritability, depressed mood, confusion
Frequency not reported: Sleep disturbances[Ref]
Hypersensitivity
Common (1% to 10%): Hypersensitivity reactions
Rare (0.01% to 0.1%): Allergic reactions and angioedema
Frequency not reported: Anaphylactic reactions
NASAL SPRAY:
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Angioedema, anaphylactic reactions
NICOTINE BITARTRATE LOZENGE:
Rare (0.01% to 0.1%): Hypersensitivity, anaphylactic reactions
TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Hypersensitivity reaction
Rare (0.01% to 0.1%): Anaphylactic reaction, angioedema[Ref]
Other
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Asthenia, malaise
Postmarketing reports: Influenza-type illness
GUM:
Frequency not reported: Denture damage
INHALATOR/INHALER:
Common (1% to 10%): Influenza-like symptoms, fatigue, pain, fever
NASAL SPRAY:
Uncommon (0.1% to 1%): Fatigue, malaise
Frequency not reported: Asthenia, pain, earache, calming sensation, abnormal taste or use of dosage form
TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Asthenia/asthenic conditions, malaise, fatigue[Ref]
Ocular
Frequency not reported: Blurred vision, increased lacrimation
NASAL SPRAY:
Common (1% to 10%): Increased lacrimation/watering eyes
Frequency not reported: Eye irritation, abnormal vision
TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Blurred vision[Ref]
Genitourinary
NASAL SPRAY:
Common (1% to 10%): Dysmenorrhea
Frequency not reported: Menstrual disorder[Ref]
Immunologic
INHALATOR/INHALER:
Common (1% to 10%): Allergy
NASAL SPRAY:
Frequency not reported: Allergy[Ref]
Dermatologic
Uncommon (0.1% to 1%): Flushing, hyperhidrosis, pruritus, rash, urticaria, dry skin
Frequency not reported: Erythema
NASAL SPRAY:
Common (1% to 10%): Hyperhidrosis/increased sweating, pruritus, rash, acne
Uncommon (0.1% to 1%): Flushing/facial flushing
Frequency not reported: Erythema, urticaria
NICOTINE BITARTRATE LOZENGE:
Rare (0.01% to 0.1%): Angioneurotic edema
TRANSDERMAL PATCH:
Common (1% to 10%): Pruritus, rash, urticaria with/without vesicles
Uncommon (0.1% to 1%): Flushing/hot flush, hyperhidrosis
Rare (0.01% to 0.1%): Erythema, skin discoloration, cutaneous vasculitis
Frequency not reported: Angioneurotic edema[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
Very rare (less than 0.01%): Reversible atrial fibrillation
Frequency not reported: Bradycardia/decreased heart rate, atrial fibrillation
INHALATOR/INHALER:
Common (1% to 10%): Chest discomfort, hypertension
NICOTINE BITARTRATE LOZENGE:
Uncommon (0.1% to 1%): Palpitations
Rare (0.01% to 0.1%): Atrial arrhythmia
MOUTH SPRAY:
Frequency not reported: Presyncopal symptoms
NASAL SPRAY:
Common (1% to 10%): Palpitations, chest discomfort/tightness and pain
Uncommon (0.1% to 1%): Hypertension
Very rare (less than 0.01%): Reversible atrial fibrillation
Frequency not reported: Tachycardia, peripheral edema, decreased heart rate/bradycardia
TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
Very rare (less than 0.01%): Reversible atrial fibrillation[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Jaw pain, musculoskeletal pain
Frequency not reported: Muscle tightness
INHALATOR/INHALER:
Common (1% to 10%): Myalgia, back pain, jaw and neck pain
NASAL SPRAY:
Common (1% to 10%): Back pain, arthralgia
Frequency not reported: Myalgia
TRANSDERMAL PATCH:
Common (1% to 10%): Myalgia, arthritis
Uncommon (0.1% to 1%): Arthralgia, muscle cramp, back pain
Rare (0.01% to 0.1%): Pain in extremity[Ref]
Metabolic
Frequency not reported: Increased appetite, weight gain
MOUTH SPRAY:
Frequency not reported: Increased appetite, weight gain
NASAL SPRAY:
Frequency not reported: Weight gain, increased appetite[Ref]
Hematologic
NASAL SPRAY:
Frequency not reported: Purpura[Ref]
