Note: This document contains side effect information about nicotine. Some dosage forms listed on this page may not apply to the brand name Nicorette.

Applies to nicotine: gum, lozenge/troche. Other dosage forms:

• inhalation device
• nasal spray
• transdermal patch extended release

Serious side effects of Nicorette

Along with its needed effects, nicotine (the active ingredient contained in Nicorette) 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 Nicorette

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 Nicorette) 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]