Nicotine Side Effects
Medically reviewed by Drugs.com. Last updated on Feb 19, 2024.
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 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]
Frequently asked questions
- How long does nicotine withdrawal last?
- How long does nicotine stay in your system?
- What are the side effects of vaping?
More about nicotine
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (198)
- Drug images
- Latest FDA alerts (1)
- Dosage information
- During pregnancy
- Support group
- Drug class: smoking cessation agents
- Breastfeeding
Patient resources
- Nicotine Gum and Lozenges drug information
- Nicotine nasal, inhalation
- Nicotine transdermal
- Nicotine (Inhalation) (Advanced Reading)
- Nicotine (Nasal) (Advanced Reading)
Other brands
Nicoderm CQ, Nicorette, Nicotrol Inhaler, Leader Nicotine Polacrilex, ... +4 more
Professional resources
- Nicotine monograph
- Nicorette Lozenge (FDA)
- Nicotine Patch (FDA)
- Nicotine Transdermal System (FDA)
- Nicotine Transdermal System Step 1 (FDA)
Other brands
Nicoderm CQ, Nicorette, Nicotrol Inhaler, Nicotrol NS
Related treatment guides
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."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.