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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

CHLORCYCLIZINE: 15 Adverse Event Reports & Safety Profile

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15
Total FAERS Reports
3 (20.0%)
Deaths Reported
9
Hospitalizations
15
As Primary/Secondary Suspect
4
Life-Threatening
Magna Pharmaceuticals, Inc.
Manufacturer

Route: ORAL · Manufacturer: Magna Pharmaceuticals, Inc. · HUMAN OTC DRUG · FDA Label: Available

What Are the Most Common CHLORCYCLIZINE Side Effects?

#1 Most Reported
Overdose
10 reports (66.7%)
#2 Most Reported
Serotonin syndrome
9 reports (60.0%)
#3 Most Reported
Rhabdomyolysis
9 reports (60.0%)

All CHLORCYCLIZINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Overdose 10 66.7% 1 9
Hyperthermia 9 60.0% 0 9
Rhabdomyolysis 9 60.0% 0 9
Serotonin syndrome 9 60.0% 0 9
Toxic encephalopathy 7 46.7% 0 7
Tachycardia 6 40.0% 0 6
Toxicity to various agents 5 33.3% 1 1

Who Reports CHLORCYCLIZINE Side Effects? Age & Gender Data

Gender: 0.0% female, 100.0% male. Average age: 34.8 years. Most reports from: US. View detailed demographics →

What Is CHLORCYCLIZINE Used For?

IndicationReports
Product used for unknown indication 10

Official FDA Label for CHLORCYCLIZINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage & Administration

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet by mouth every 6-8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: ½ tablet by mouth every 6-8 hours, not to exceed 1½ tablets in 24 hours, or as directed by a doctor Children under 6 years of age Consult a doctor

Warnings

Warnings Do not exceed recommended dosage. Do not use this product If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes melitus difficulty in urination due to enlargement of the prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Active Ingredient

Active Ingredients (in each immediate-release tablet)

Purpose

Chlorcyclizine HCl 25 mg Antihistamine Pseudoephedrine HCl 60 mg Nasal Decongestant

Inactive Ingredients

Inactive ingredients Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate