Nicotine Side Effects
Medically reviewed by Drugs.com. Last updated on Mar 10, 2025.
For healthcare professionals
Applies to nicotine: compounding powder, inhalation device, nasal spray, oral transmucosal gum, oral transmucosal lozenge, transdermal film extended release.
General adverse events
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 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]
References
1. (2001) "Product Information. Habitrol (nicotine)." Basel Pharmaceuticals
2. (2001) "Product Information. Nicoderm (nicotine)." Hoechst Marion Roussel
3. (2022) "Product Information. ProStep (nicotine)." Lederle Laboratories
4. (2001) "Product Information. Nicorette (nicotine)." SmithKline Beecham
5. (2001) "Product Information. Nicotrol (nicotine)." McNeil Pharmaceutical
6. (2001) "Product Information. Nicotrol NS (nicotine)." McNeil Pharmaceutical
7. "Product Information. Nicoderm C-Q (nicotine)." SmithKline Beecham
8. (2003) "Product Information. Commit (nicotine)." GlaxoSmithKline Healthcare
9. Cerner Multum, Inc. "UK Summary of Product Characteristics."
10. Cerner Multum, Inc. "Australian Product Information."
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Patient resources
- Nicotine Gum and Lozenges drug information
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Other brands
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Professional resources
- Nicotine monograph
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- Nicotine Transdermal System (FDA)
- Nicotine Transdermal System Step 1 (FDA)
Other brands
Nicoderm CQ, Nicorette, Nicotrol Inhaler, Nicotrol NS
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Further information
Nicotine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.