NICOTINE POLARILEX

N/A

Manufactured by AmerisourceBergen (Good Neighbor Pharmacy) 46122

31,749 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NICOTINE POLARILEX

NICOTINE POLARILEX is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AmerisourceBergen (Good Neighbor Pharmacy) 46122. The most commonly reported adverse reactions for NICOTINE POLARILEX include DRUG INEFFECTIVE, NAUSEA, OVERDOSE, FOETAL EXPOSURE DURING PREGNANCY, PRODUCT ADHESION ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NICOTINE POLARILEX.

Top Adverse Reactions

DRUG INEFFECTIVE1,484 reports
NAUSEA998 reports
OVERDOSE752 reports
FOETAL EXPOSURE DURING PREGNANCY733 reports
PRODUCT ADHESION ISSUE717 reports
NICOTINE DEPENDENCE712 reports
HEADACHE683 reports
TREATMENT NONCOMPLIANCE662 reports
TOXICITY TO VARIOUS AGENTS586 reports
DYSPNOEA572 reports
PAIN572 reports
MALAISE567 reports
MACULAR DEGENERATION548 reports
DIZZINESS533 reports
OFF LABEL USE515 reports
ANXIETY508 reports
FATIGUE439 reports
MATERNAL EXPOSURE DURING PREGNANCY435 reports
DRUG DEPENDENCE434 reports
VOMITING422 reports
CONSTIPATION406 reports
PYREXIA406 reports
PRODUCT QUALITY ISSUE395 reports
INSOMNIA367 reports
DRUG ABUSE364 reports
DRUG WITHDRAWAL SYNDROME NEONATAL364 reports
WEIGHT DECREASED364 reports
ABDOMINAL PAIN362 reports
DRUG INTERACTION348 reports
DIARRHOEA327 reports
DEPRESSION326 reports
PREMATURE BABY322 reports
ERYTHEMA317 reports
ANAEMIA299 reports
DYSPEPSIA295 reports
RASH294 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE287 reports
PNEUMONIA278 reports
ASTHENIA275 reports
PRODUCT USE ISSUE269 reports
FEELING ABNORMAL266 reports
ACUTE KIDNEY INJURY262 reports
DEATH261 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS259 reports
CHEST PAIN257 reports
PREMATURE DELIVERY249 reports
CHRONIC SINUSITIS237 reports
FALL236 reports
HYPOTENSION233 reports
COUGH231 reports
DRUG DOSE OMISSION231 reports
LOSS OF CONSCIOUSNESS230 reports
PARAESTHESIA ORAL228 reports
INFUSION RELATED REACTION227 reports
PRURITUS227 reports
INCORRECT DRUG ADMINISTRATION DURATION223 reports
TREMOR222 reports
RECTAL HAEMORRHAGE221 reports
CHRONIC KIDNEY DISEASE216 reports
CONFUSIONAL STATE212 reports
HYPERTENSION212 reports
APPLICATION SITE ERYTHEMA211 reports
COLITIS207 reports
PAIN IN EXTREMITY207 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE206 reports
SOMNOLENCE205 reports
PROCEDURAL PAIN203 reports
HAEMATOCHEZIA202 reports
HYPERHIDROSIS200 reports
ABNORMAL DREAMS198 reports
PALPITATIONS198 reports
RENAL FAILURE198 reports
COLITIS ULCERATIVE197 reports
FREQUENT BOWEL MOVEMENTS194 reports
UNDERDOSE194 reports
ORAL CANDIDIASIS192 reports
INTENTIONAL DRUG MISUSE190 reports
APPLICATION SITE PRURITUS187 reports
HYPERSENSITIVITY187 reports
CONDITION AGGRAVATED186 reports
INCORRECT DOSE ADMINISTERED185 reports
PRODUCT DOSE OMISSION185 reports
ARTHRALGIA183 reports
DRUG WITHDRAWAL SYNDROME183 reports
PROCTITIS183 reports
VAGINAL DISCHARGE182 reports
WEIGHT INCREASED182 reports
FEMALE GENITAL TRACT FISTULA181 reports
RADICULOPATHY180 reports
DECREASED APPETITE178 reports
VAGINAL FLATULENCE177 reports
LOW BIRTH WEIGHT BABY175 reports
SUICIDAL IDEATION175 reports
INTENTIONAL PRODUCT MISUSE173 reports
MYOCARDIAL INFARCTION173 reports
BACK PAIN172 reports
EXPOSURE DURING PREGNANCY167 reports
TACHYCARDIA162 reports
COMPLETED SUICIDE159 reports
PARAESTHESIA155 reports

Report Outcomes

Out of 14,527 classified reports for NICOTINE POLARILEX:

Serious 70.3%Non-Serious 29.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female7,463 (56.4%)
Male5,694 (43.0%)
Unknown70 (0.5%)

Reports by Age

Age 58264 reports
Age 59255 reports
Age 65244 reports
Age 60238 reports
Age 56228 reports
Age 52211 reports
Age 54208 reports
Age 64203 reports
Age 55200 reports
Age 62200 reports
Age 71194 reports
Age 57192 reports
Age 63183 reports
Age 50181 reports
Age 61180 reports
Age 51175 reports
Age 68174 reports
Age 53170 reports
Age 47167 reports
Age 66164 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with NICOTINE POLARILEX?

This profile reflects 31,749 FDA FAERS reports that mention NICOTINE POLARILEX. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NICOTINE POLARILEX?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, NAUSEA, OVERDOSE, FOETAL EXPOSURE DURING PREGNANCY, PRODUCT ADHESION ISSUE, NICOTINE DEPENDENCE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NICOTINE POLARILEX?

Labeling and FAERS entries often list AmerisourceBergen (Good Neighbor Pharmacy) 46122 in connection with NICOTINE POLARILEX. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.