cetirizine
Brand names: Zyrtec
Cetirizine (Zyrtec) is an antihistamine medicine. It helps relieve allergy symptoms.
Drug Pricing (NADAC)
Generic Price
$0.02/unit
Generic Available
Yes (44 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats allergy symptoms.
Common side effects
Headache, Fatigue
Key warnings
Ask a doctor before use if you have liver or kidney disease.
How It Works
Cetirizine blocks histamine in your body. Histamine is a natural substance that causes allergy symptoms. By blocking it, cetirizine reduces these symptoms.
How to Take It
You can take this medicine with or without water. Chew or crush the tablets completely before swallowing. Children 2 to under 6 years old: Chew and swallow 1 tablet (2.5 mg) once a day. If needed, the dose can be increased to 2 tablets (5 mg) once a day, or 1 tablet (2.5 mg) every 12 hours. Adults and children 6 years and over: Chew and swallow 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending upon severity of symptoms. Adults 65 years and over: Chew and swallow 2 tablets (5 mg) once daily.
Pregnancy & Breastfeeding
Ask a doctor if you are pregnant or breastfeeding before taking this medicine. It is not known if cetirizine will harm your unborn baby or pass into breast milk.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take more medicine than prescribed in a 24-hour period.
Storage
Store between 68° to 77°F (20° to 25°C). Do not use if the blister unit is torn or broken.
Side Effects (from patient reports)
Based on 101,043 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 72,729 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
72,729
Death-Related Reports
7,810
Hospitalization Reports
22,963
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 12,976 |
| 2 | FATIGUE | 12,861 |
| 3 | PAIN | 12,124 |
| 4 | RASH | 9,771 |
| 5 | OFF LABEL USE | 9,340 |
| 6 | ABDOMINAL DISCOMFORT | 9,317 |
| 7 | ALOPECIA | 9,237 |
| 8 | RHEUMATOID ARTHRITIS | 8,675 |
| 9 | SYSTEMIC LUPUS ERYTHEMATOSUS | 8,466 |
| 10 | PEMPHIGUS | 8,274 |
| 11 | SWELLING | 7,934 |
| 12 | HYPERSENSITIVITY | 7,746 |
| 13 | GLOSSODYNIA | 7,743 |
| 14 | PRURITUS | 7,514 |
| 15 | ARTHRALGIA | 7,475 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Ask a doctor before use if you have liver or kidney disease. Children under 2 years of age should ask a doctor before use.
Known Drug Interactions
7.5 Drugs Without Clinically Significant Interactions with Efavirenz No dosage adjustment is recommended when efavirenz is given with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine), paroxetine, and raltegravir.
Mechanism: These drugs do not interfere with how the body processes each other.
What to do: No dosage adjustments are needed if you take these two medicines together.
Common Questions
Can children take this medicine?
Can I take this with food?
How often can I take this medicine?
What should I do if I take too much?
Can I drive while taking this medicine?
Can I take this medicine if I have kidney problems?
Can I take this medicine if I have liver problems?
How long does it take for this medicine to work?
Can I take this with other allergy medicines?
What if my symptoms don't improve?
What are the common side effects of cetirizine?
Does cetirizine interact with other medications?
What drug class is cetirizine?
Is cetirizine safe during pregnancy?
Has cetirizine been recalled?
Active Recalls
Tablet/Capsules Imprinted with Wrong ID
JB Chemicals and Pharmaceuticals Ltd
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Related Medications in Second-Generation Antihistamine
Other drugs grouped near cetirizine — same-class peers and common alternatives.
azelastine
Astelin, Astepro
Azelastine nasal spray is an antihistamine medicine.
Compare with cetirizine →
budesonide nasal
Rhinocort
Rhinocort is a nasal spray that helps relieve allergy symptoms.
Compare with cetirizine →
chlorpheniramine
Chlor-Trimeton
Chlorpheniramine is an antihistamine medicine.
Compare with cetirizine →
ciclesonide nasal
Omnaris, Zetonna
Omnaris Nasal Spray is a medicine that helps treat allergy symptoms in your nose.
Compare with cetirizine →
desloratadine
Clarinex
Desloratadine is an antihistamine medicine.
Compare with cetirizine →
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What the FDA Data Shows for cetirizine
The FDA label for cetirizine (sold under brand names such as Zyrtec) classifies it as an over-the-counter product in the Second-Generation Antihistamine class. This medicine treats allergy symptoms. Official labeling lists 2 commonly reported side effects, including Headache, Fatigue.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 101,043 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.02.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 7, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages