LEVOCETIRIZINE DIHYDROCHLORIDE

N/A

Manufactured by Chattem, Inc.

44,826 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chattem, Inc.. The most commonly reported adverse reactions for LEVOCETIRIZINE DIHYDROCHLORIDE include DRUG INEFFECTIVE, SOMNOLENCE, FATIGUE, HEADACHE, PRURITUS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEVOCETIRIZINE DIHYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE2,988 reports
SOMNOLENCE2,121 reports
FATIGUE1,663 reports
HEADACHE1,326 reports
PRURITUS1,210 reports
NAUSEA1,082 reports
DYSPNOEA1,058 reports
DIARRHOEA1,003 reports
DIZZINESS885 reports
COUGH779 reports
RASH763 reports
INSOMNIA754 reports
ARTHRALGIA746 reports
PYREXIA714 reports
OFF LABEL USE710 reports
MALAISE699 reports
PAIN698 reports
VOMITING639 reports
FALL599 reports
FEELING ABNORMAL590 reports
ASTHENIA550 reports
URTICARIA539 reports
SINUSITIS519 reports
PRODUCT DOSE OMISSION ISSUE505 reports
HYPERSENSITIVITY498 reports
COVID 19467 reports
PNEUMONIA458 reports
CONDITION AGGRAVATED442 reports
NO ADVERSE EVENT442 reports
DECREASED APPETITE438 reports
ASTHMA437 reports
ABDOMINAL PAIN429 reports
ABDOMINAL PAIN UPPER420 reports
PRODUCT USE IN UNAPPROVED INDICATION418 reports
BLOOD PRESSURE INCREASED414 reports
ANXIETY405 reports
MYALGIA391 reports
THERAPEUTIC RESPONSE DECREASED380 reports
CHILLS376 reports
SEPSIS341 reports
INJECTION SITE PAIN331 reports
CONSTIPATION327 reports
VISION BLURRED326 reports
TACHYCARDIA319 reports
ALTERED STATE OF CONSCIOUSNESS314 reports
NASOPHARYNGITIS312 reports
RHINORRHOEA311 reports
ERYTHEMA310 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION309 reports
PAIN IN EXTREMITY309 reports
BACK PAIN308 reports
EYE PAIN308 reports
PRODUCT USE ISSUE307 reports
WEIGHT INCREASED303 reports
DEPRESSION299 reports
HAEMORRHAGIC STROKE291 reports
WEIGHT DECREASED291 reports
URINARY TRACT INFECTION285 reports
CARDIO RESPIRATORY ARREST276 reports
ILLNESS271 reports
SYNCOPE263 reports
DRY SKIN262 reports
MUSCLE SPASMS259 reports
HEAD DISCOMFORT255 reports
NASAL CONGESTION255 reports
BRONCHITIS252 reports
TINNITUS249 reports
OROPHARYNGEAL PAIN240 reports
DRUG HYPERSENSITIVITY238 reports
ANAEMIA235 reports
ASCITES235 reports
OCULAR DISCOMFORT234 reports
BLINDNESS233 reports
COMA230 reports
HAEMATEMESIS225 reports
CHEST PAIN223 reports
MIGRAINE223 reports
ABDOMINAL DISCOMFORT220 reports
DERMATITIS ATOPIC220 reports
PRESYNCOPE219 reports
DRY MOUTH218 reports
LOSS OF CONSCIOUSNESS216 reports
AMAUROSIS FUGAX215 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS213 reports
HYPERTENSION211 reports
INFECTION209 reports
ALOPECIA208 reports
PERIPHERAL SWELLING207 reports
GAIT DISTURBANCE206 reports
GENERALISED OEDEMA206 reports
HAEMATURIA206 reports
PALPITATIONS205 reports
DIPLOPIA201 reports
INFLUENZA196 reports
PARAESTHESIA195 reports
EPISTAXIS191 reports
DEATH189 reports
SNEEZING188 reports
URINARY TRACT DISORDER188 reports
CHEST DISCOMFORT185 reports

Report Outcomes

Out of 22,799 classified reports for LEVOCETIRIZINE DIHYDROCHLORIDE:

  • Serious: 9,255 reports (40.6%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 13,544 reports (59.4%)
Serious 40.6%Non-Serious 59.4%

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

Female12,725 (70.8%)
Male5,235 (29.1%)
Unknown22 (0.1%)

Reports by Age

Age 64239 reports
Age 66239 reports
Age 60237 reports
Age 65233 reports
Age 61232 reports
Age 57224 reports
Age 55221 reports
Age 59220 reports
Age 62214 reports
Age 56208 reports
Age 53206 reports
Age 54198 reports
Age 67198 reports
Age 63196 reports
Age 58195 reports
Age 70191 reports
Age 68189 reports
Age 69187 reports
Age 52180 reports
Age 71180 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 LEVOCETIRIZINE DIHYDROCHLORIDE?

This profile reflects 44,826 FDA FAERS reports that mention LEVOCETIRIZINE DIHYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LEVOCETIRIZINE DIHYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, SOMNOLENCE, FATIGUE, HEADACHE, PRURITUS, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LEVOCETIRIZINE DIHYDROCHLORIDE?

Labeling and FAERS entries often list Chattem, Inc. in connection with LEVOCETIRIZINE DIHYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Chattem, Inc.

Explore other medications manufactured by Chattem, Inc. and compare their safety profiles:

CAMPHOR, MENTHOLDOXYLAMINE SUCCINATEFEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDELIDOCAINE HCLLIDOCAINE, MENTHOLMENTHOLMENTHOL, CAMPHORSELENIUM SULFIDETRIAMCINOLONE ACETONIDE (78/100)TROLAMINE SALICYLATE

View all Chattem, Inc. drugs →

Drugs Also Linked to DRUG INEFFECTIVE

The following drugs share commonly reported adverse reactions with LEVOCETIRIZINE DIHYDROCHLORIDE:

0XYGENABACAVIR SULFATEABATACEPTABEMACICLIBABIRATERONE ACETATEACETAMINOPHENACETAMINOPHEN 500 MGACETAMINOPHEN 500MGACETAMINOPHEN AND CODEINEACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEACETAMINOPHEN AND IBUPROFENACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE

View all drugs reporting DRUG INEFFECTIVE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsChattem, Inc. PortfolioDRUG INEFFECTIVE in Other DrugsSOMNOLENCE in Other DrugsFATIGUE in Other Drugs
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.