Common Chantix Side Effects


The most commonly reported Chantix side effects (click to view or check a box to report):

Nausea (7596)
Abnormal Dreams (3846)
Depression (3787)
Insomnia (2840)
Anxiety (2400)
Headache (2330)
Feeling Abnormal (2289)
Vomiting (2205)
Malaise (1869)
Dizziness (1850)
Fatigue (1793)
Suicidal Ideation (1742)
Constipation (1435)
Anger (1305)
Agitation (1221)
Irritability (1159)
Nightmare (1155)
Abdominal Pain Upper (1116)
Flatulence (1109)
Aggression (1106)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Chantix Side Effects Reported to FDA



Chantix Side Effect Report#9998990
Depressed Mood, Depression, Anger, Affect Lability
This is a report of a 30-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Chantix (dosage: NA, start time:
Feb 24, 2014), combined with: NA. and developed a serious reaction and side effect(s): Depressed Mood, Depression, Anger, Affect Lability after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Chantix treatment in male patients, resulting in Depressed Mood side effect.
Chantix Side Effect Report#9997763
Paranoia
This report suggests a potential Chantix Paranoia side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Chantix (dosage: 0.5 Mg, 1x/day) starting 201402. After starting Chantix the patient began experiencing various side effects, including: ParanoiaAdditional drugs used concurrently: NA. Although Chantix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Paranoia, may still occur.
Chantix Side Effect Report#9997745
Abnormal Dreams
This Abnormal Dreams problem was reported by a consumer or non-health professional from US. A 28-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2008 this consumer started treatment with Chantix (dosage: Unk). The following drugs were being taken at the same time: NA. When using Chantix, the patient experienced the following unwanted symptoms/side effects: Abnormal DreamsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abnormal Dreams, may become evident only after a product is in use by the general population.
Chantix Side Effect Report#9992755
Abdominal Discomfort, Nausea
This Abdominal Discomfort side effect was reported by a consumer or non-health professional from US. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Chantix (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Metoprolol (Unk)
  • Lovastatin (Unk)
.After starting to take Chantix the consumer reported adverse symptoms, such as: Abdominal Discomfort, NauseaThese side effects may potentially be related to Chantix.
Chantix Side Effect Report#9992623
Abnormal Dreams
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Chantix (dosage: 0.5 Mg, 1x/day, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Abnormal Dreams after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Chantix treatment in female patients, resulting in Abnormal Dreams side effect.
Chantix Side Effect Report#9992420
Delusion, Abdominal Discomfort, Feeling Abnormal, Asthenia
This report suggests a potential Chantix Delusion side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Chantix (dosage: Unk) starting
Mar 01, 2014. After starting Chantix the patient began experiencing various side effects, including: Delusion, Abdominal Discomfort, Feeling Abnormal, AstheniaAdditional drugs used concurrently: NA. Although Chantix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Delusion, may still occur.
Chantix Side Effect Report#9992366
Pneumonia, Malaise, Weight Decreased, Headache
This Pneumonia problem was reported by a consumer or non-health professional from US. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201402 this consumer started treatment with Chantix (dosage: Unk). The following drugs were being taken at the same time: NA. When using Chantix, the patient experienced the following unwanted symptoms/side effects: Pneumonia, Malaise, Weight Decreased, HeadacheThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonia, may become evident only after a product is in use by the general population.
Chantix Side Effect Report#9991587
Depression, Negative Thoughts, Lethargy, Nausea
This Depression side effect was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Chantix (drug dosage: 0.5 Mg, Daily), which was initiated on 201403. Concurrently used drugs: NA..After starting to take Chantix the consumer reported adverse symptoms, such as: Depression, Negative Thoughts, Lethargy, NauseaThese side effects may potentially be related to Chantix.
Chantix Side Effect Report#9991247
Abdominal Pain Upper
This is a report of a 33-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Chantix (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Abdominal Pain Upper after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Chantix treatment in male patients, resulting in Abdominal Pain Upper side effect.
Chantix Side Effect Report#9990261
Abdominal Discomfort, Mood Swings
This report suggests a potential Chantix Abdominal Discomfort side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Chantix (dosage: 1 Mg, Unk) starting NS. After starting Chantix the patient began experiencing various side effects, including: Abdominal Discomfort, Mood SwingsAdditional drugs used concurrently:
  • Symbicort (84.5 Mg, 2x/day)
  • Atenolol (25 Mg, 1x/day)
Although Chantix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Discomfort, may still occur.
Chantix Side Effect Report#9980982
Swelling
This Swelling problem was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: bronchitis. On NS this consumer started treatment with Chantix (dosage: Unk). The following drugs were being taken at the same time: NA. When using Chantix, the patient experienced the following unwanted symptoms/side effects: SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Swelling, may become evident only after a product is in use by the general population.
Chantix Side Effect Report#9980819
Pulmonary Embolism, Breast Abscess
This Pulmonary Embolism side effect was reported by a consumer or non-health professional from US. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Chantix (drug dosage: 0.5 Mg + 1.0 Mg 1 Qd X3d; 1 Bid X78), which was initiated on
Aug 28, 2013. Concurrently used drugs: NA..After starting to take Chantix the consumer reported adverse symptoms, such as: Pulmonary Embolism, Breast AbscessThese side effects may potentially be related to Chantix.
Chantix Side Effect Report#9978168
Headache, Irritability, Insomnia
This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Chantix (dosage: Unk, start time: 201402), combined with: NA. and developed a serious reaction and side effect(s): Headache, Irritability, Insomnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Chantix treatment in female patients, resulting in Headache side effect.
Chantix Side Effect Report#9978138
Nasopharyngitis, Malaise
This report suggests a potential Chantix Nasopharyngitis side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Chantix (dosage: Unk) starting 2014. After starting Chantix the patient began experiencing various side effects, including: Nasopharyngitis, MalaiseAdditional drugs used concurrently: NA. Although Chantix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nasopharyngitis, may still occur.
Chantix Side Effect Report#9976005
Nightmare
This Nightmare problem was reported by a consumer or non-health professional from US. A 44-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Chantix (dosage: Unk). The following drugs were being taken at the same time: NA. When using Chantix, the patient experienced the following unwanted symptoms/side effects: NightmareAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nightmare, may become evident only after a product is in use by the general population.
Chantix Side Effect Report#9976003
Restlessness, Pain, Abnormal Dreams
This Restlessness side effect was reported by a consumer or non-health professional from US. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Chantix (drug dosage: Unk), which was initiated on
Dec 31, 2013. Concurrently used drugs: NA..After starting to take Chantix the consumer reported adverse symptoms, such as: Restlessness, Pain, Abnormal DreamsThese side effects may potentially be related to Chantix.
Chantix Side Effect Report#9975996
Stevens-johnson Syndrome, Burning Mouth Syndrome, Migraine
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Chantix (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Stevens-johnson Syndrome, Burning Mouth Syndrome, Migraine after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Chantix treatment in female patients, resulting in Stevens-johnson Syndrome side effect.
Chantix Side Effect Report#9975965
Hallucination
This report suggests a potential Chantix Hallucination side effect(s) that can have serious consequences. A 52-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Chantix (dosage: Unk) starting 201312. After starting Chantix the patient began experiencing various side effects, including: HallucinationAdditional drugs used concurrently:
  • Lisinopril W/hydrochlorothiazide (Unk, 1x/day)
Although Chantix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hallucination, may still occur.
Chantix Side Effect Report#9975816
Myocardial Infarction, Angina Pectoris, Limb Discomfort, Hypoaesthesia, Depression, Anxiety, Abnormal Dreams, Loss Of Employment, Tobacco User
This Myocardial Infarction problem was reported by a consumer or non-health professional from US. A 32-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2013 this consumer started treatment with Chantix (dosage: 0.5 Mg, 1x/day). The following drugs were being taken at the same time: NA. When using Chantix, the patient experienced the following unwanted symptoms/side effects: Myocardial Infarction, Angina Pectoris, Limb Discomfort, Hypoaesthesia, Depression, Anxiety, Abnormal Dreams, Loss Of Employment, Tobacco UserThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Infarction, may become evident only after a product is in use by the general population.
Chantix Side Effect Report#9973073
Pneumonia, Rib Fracture, Lung Disorder, Cough, Nausea
This Pneumonia side effect was reported by a consumer or non-health professional from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Chantix (drug dosage: 0.5 Mg, 1x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Chantix the consumer reported adverse symptoms, such as: Pneumonia, Rib Fracture, Lung Disorder, Cough, NauseaThese side effects may potentially be related to Chantix. The patient was hospitalized.
Chantix Side Effect Report#9973010
Nightmare
This is a report of a 65-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Chantix (dosage: 0.5 Mg, 1x/day, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Nightmare after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Chantix treatment in male patients, resulting in Nightmare side effect.
Chantix Side Effect Report#9972962
Acromegaly, Ageusia, Anosmia, Pyrexia, Nausea, Urticaria
This report suggests a potential Chantix Acromegaly side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Chantix (dosage: 2 Df, Unk) starting
Mar 10, 2012. After starting Chantix the patient began experiencing various side effects, including: Acromegaly, Ageusia, Anosmia, Pyrexia, Nausea, UrticariaAdditional drugs used concurrently: NA. Although Chantix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acromegaly, may still occur.
Chantix Side Effect Report#9970724
Tension, Hallucination, Visual, Paranoia, Anxiety, Muscle Twitching, Muscle Spasms, Mania
This Tension problem was reported by a consumer or non-health professional from US. A 26-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 24, 2014 this consumer started treatment with Chantix (dosage: Taken By Mouth). The following drugs were being taken at the same time: NA. When using Chantix, the patient experienced the following unwanted symptoms/side effects: Tension, Hallucination, Visual, Paranoia, Anxiety, Muscle Twitching, Muscle Spasms, ManiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tension, may become evident only after a product is in use by the general population.
Chantix Side Effect Report#9954417
Grand Mal Convulsion, Convulsion, Pneumonia, Cough, Dyspnoea Exertional, Stress, Malaise, Bronchitis, Influenza
This Grand Mal Convulsion side effect was reported by a consumer or non-health professional from US. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: ex-tobacco user,chronic obstructive pulmonary disease.The patient was prescribed Chantix (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Advair (Unk)
.After starting to take Chantix the consumer reported adverse symptoms, such as: Grand Mal Convulsion, Convulsion, Pneumonia, Cough, Dyspnoea Exertional, Stress, Malaise, Bronchitis, InfluenzaThese side effects may potentially be related to Chantix.
Chantix Side Effect Report#9953941
Nausea
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Chantix (dosage: Unk, start time:
Feb 09, 2014), combined with:
  • Lisinopril (10 Mg, Unk)
and developed a serious reaction and side effect(s): Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Chantix treatment in male patients, resulting in Nausea side effect.


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The appearance of Chantix on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Chantix Side Effects for Women?

Women Side Effects Reports
Nausea 6115
Abnormal Dreams 2562
Depression 2554
Insomnia 1906
Vomiting 1808
Headache 1750
Anxiety 1647
Feeling Abnormal 1560
Malaise 1449
Fatigue 1292

What are common Chantix Side Effects for Men?

Men Side Effects Reports
Nausea 1459
Abnormal Dreams 1270
Depression 1195
Insomnia 923
Anxiety 746
Feeling Abnormal 724
Suicidal Ideation 606
Dizziness 584
Headache 571
Aggression 545

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Chantix reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Chantix Safety Alerts, Active Ingredients, Usage Information

    NDC 0069-0468
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name CHANTIX
    Name varenicline tartrate
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 20060510
    Labeler Pfizer Laboratories Div Pfizer Inc
    Active Ingredient(s) VARENICLINE TARTRATE
    Strength(s) 0.5
    Unit(s) mg/1
    Pharma Class Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA]

    Chantix Dosage, Warnings, Usage.

    Side Effects reported to FDA: 32200

    Chantix safety alerts: 2012 2011 2009 2008 2007

    Reported deaths: 635

    Reported hospitalizations: 2937

    Chantix (Varenicline): Safety Communication - Updated Safety Review On The Risk of Cardiovascular Adverse Events

     

    [Posted 12/12/2012]

    AUDIENCE: Family Practice, Cardiology, Patient

    ISSUE: FDA is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical trials that compared patients who received the smoking cessation drug Chantix (varenicline) to patients who received a placebo (an inactive treatment). A higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) was observed in patients using Chantix compared to placebo. These events were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance.

    BACKGROUND: Chantix is a prescription medicine used to help adults quit smoking that works by blocking the effects of nicotine (from smoking) on the brain. FDA first notified the public about a possible increased risk of cardiovascular adverse events with Chantix in its June 2011 Drug Safety Communication (DSC). FDA required the manufacturer of Chantix to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug, and believes it is important to let health care professionals and patients know about the results of this study. The meta-analysis findings of cardiovascular risk are similar to the findings in the smoking cessation clinical trial of patients with stable cardiovascular disease that was described in FDA’s June 16, 2011 DSC. The Warnings and Precautions section of the Chantix label has been updated to include the results of the meta-analysis.

    RECOMMENDATION: Health care professionals are advised to weigh the risks of Chantix against the benefits of its use. It is important to note that smoking is a major risk factor for cardiovascular disease, and Chantix is effective in helping patients to quit smoking and abstain from it for as long as one year. The health benefits of quitting smoking are immediate and substantial.

    Patients taking Chantix should contact their health care professional if they experience new or worsening symptoms of cardiovascular disease, such as chest pain, shortness of breath, calf pain when walking, or sudden onset of weakness, numbness, or difficulty speaking. Patients should also contact their health care professional if they have any questions or concerns about Chantix.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


    [12/12/2012 - Drug Safety Communication - FDA]

    Previous MedWatch Alerts:


    [07/22/2011 - Drug Safety Communication - FDA]
    [06/16/2011 - Drug Safety Communication - FDA]

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