Over-the-counter medication · Second-Generation Antihistamine
cetirizine
Also sold as Zyrtec. This medicine treats allergy symptoms.
Data updated 2026-05-15
- 72,729
- FDA reportsOften reported
- 1
- InteractionFew interactions
- 2
- Recall records
What the data shows
cetirizine (Zyrtec) is an over-the-counter Second-Generation Antihistamine, more reported than most tracked drugs (72,729 FDA reports), with 1 documented drug interaction.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
cetirizine (Zyrtec) is an over-the-counter Second-Generation Antihistamine. This medicine treats allergy symptoms.
Cetirizine (Zyrtec) is an antihistamine medicine. It helps relieve allergy symptoms.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: CETIRIZINE HCL 1 MG/ML SOLN
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +52.3% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.0267/ML | - | 1 |
| December 18, 2024 | $0.0407/ML | +52.3% | 7 |
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.
The sections below are summarized in plain English from cetirizine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 72,729 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for cetirizine, by number of reports
- Fatigue
Fatigue
12,861 reports
- Pain
Pain
12,124 reports
- Rash
Rash
9,771 reports
- Abdominal Discomfort
Abdominal Discomfort
9,317 reports
- Alopecia
Alopecia
9,237 reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
8,675 reports
- Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
8,466 reports
- Pemphigus
Pemphigus
8,274 reports
- Swelling
Swelling
7,934 reports
- Hypersensitivity
Hypersensitivity
7,746 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for cetirizine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where cetirizine sits
cetirizine has more FDA adverse-event reports than 81% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is cetirizine; the line is the median (50th percentile).
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
Reports Mentioning Death
7,810
10.7% of reports — not proof of cause
Hospitalization Reports
22,963
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FATIGUE | 12,861 |
| 3 | PAIN | 12,124 |
| 4 | RASH | 9,771 |
| 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 |
| 16 | HEADACHE | 7,470 |
| 17 | DYSPNOEA | 7,156 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for cetirizine?
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for cetirizine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 72,729.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.74%.
- apixaban Δ 0.05 pts · 62,650 reports · Direct Oral Anticoagulant (Factor Xa Inhibitor) 10.79%death share
- nateglinide Δ 0.09 pts · 1,302 reports · Meglitinide 10.83%death share
- ramelteon Δ 0.13 pts · 7,215 reports · Melatonin Receptor Agonist 10.87%death share
- hydroxychloroquine Δ 0.13 pts · 71,900 reports · Disease-Modifying Antirheumatic Drug (DMARD) 10.87%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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 72,729 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 7, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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