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Medication Errors Associated with Zantac and Zyrtec

Problem: Medication errors have occurred over the last three years
with Zantac and Zyrtec in the pediatric population where Zantac syrup
was prescribed but Zyrtec syrup was dispensed. Zantac is an H2-Blocker
and Zyrtec is an antihistamine. They do not have overlapping dosage
strengths, but they are both available in the syrup dosage form,
Zantac as 150 mg/10 mL and Zyrtec as 5 mg/5 mL. Glaxo Wellcome
manufactures Zantac and Pfizer manufactures Zyrtec and the container
labels do not appear similar. Both are available in 1-pint amber glass
bottles; Zyrtec is also available in a 120 mL bottle. The proprietary
names look alike and sound alike to each other. Such similarities
between Zantac and Zyrtec increase the potential for medication
errors.

The medication error reports are summarized in the following table.

Postmarketing Safety Reports of Medication Errors Associated with
Zantac and Zyrtec

Intended product as written

Dispensed product as written

Outcome

Cause(s)

Zantac syrup
150 mg/10 mL

Zyrtec syrup
5 mg/5 mL

"Violently ill"

Dispensing error: pouring from stock to Rx bottle

Zantac syrup
15 mg/mL

Zyrtec syrup
1 mg/mL

Continuation of reflux-induced sinusitis

Not specified

Zantac

Zyrtec syrup
1.1 mg

Nonserious:
Trouble sleeping

Not specified

Zantac

Zyrtec syrup

Nonserious:
Increased sleep

Not specified

Zantac syrup
1.3 mg

Zyrtec syrup
1.3 mg

Nonserious: Increased thirst, decreased appetite, diarrhea, vomiting

Not specified

Zantac syrup
15 mg

Zyrtec syrup
1 mg

Nonserious: Decreased weight

Not specified

Zantac

Zyrtec syrup
1 mg

Nonserious:
Diarrhea

Dispensing error

The seven errors that have been reported to the FDA were mostly in
pediatric patients ranging in ages from 7 days to 15 months. The
causes, when specified, were due to dispensing errors, where the
incorrect stock bottle of the syrup was chosen from the shelf. The
outcomes of the medication errors were not serious. In one case, a 12
month-old male patient was prescribed 120 mL of Zantac syrup but was
given 120 mL of Zyrtec. The error occurred when the incorrect stock
bottle of Zyrtec syrup was chosen by the technician and poured into
the dispensing bottle labeled as Zantac. The mother noticed that the
baby became "violently ill" but the doctor did not find anything
serious. In another case, a 15 month-old patient was dosed incorrectly
with Zyrtec instead of Zantac for 6 weeks prior to discovery of the
error. The outcome of the error was a continuation of the patient’s
reflux-induced sinusitis. Other cases noted outcomes of sleep
disturbance, increased thirst, decreased appetite, diarrhea, vomiting,
and decreased weight.

Recommendation: Separate the stock bottles of Zantac and Zyrtec syrups
on the shelves. One of the two medications may be placed in a
"fast-mover" section of the pharmacy. Also, inclusion of the
indication on the prescription order may serve as a reminder to select
the correct medication as well as reduce errors due to poor
handwriting.

9/20/00

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FDA/Center for Drug Evaluation and Research
Last Updated: June 21, 2005
Originator: OTCOM/DLIS
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