May 27, 2017
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"Common colds are the main reason that children miss school and adults miss work. Each year in the United States, there are millions of cases of the common cold. Adults have an average of 2-3 colds per year, and children have even more.




Rezira Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 03/27/2017

Rezira (hydrocodone bitartrate and pseudoephedrine hydrochloride) is a combination of an opioid antitussive and a sympathomimetic amine indicated for relief of cough and nasal congestion associated with common cold. Common side effects of Rezira include:

Rezira is for oral use only. Rezira should be dosed at 5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours. Measure Rezira with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose. No specific drug interaction studies have been conducted with Rezira. There are no adequate and well controlled studies of Rezira in pregnant women. Rezira should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Caution should be exercised when Rezira is administered to breastfeeding mothers. Hydrocodone and pseudoephedrine are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfeeding infants from Rezira Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Our Rezira Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rezira FDA Prescribing Information: Side Effects
(Adverse Reactions)


Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:

Use of pseudoephedrine, a sympathomimetic amine, may result in the following:

The most common adverse reactions are central nervous system and cardiovascular reactions and include the following: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, sleeplessness, tremor or arrhythmia.

Other adverse reactions include:

Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation.

Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention.

Cardiovascular System: Fast, slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitation, shock-like state, syncope.

Dermatological System: Skin rash, pruritus.

Read the entire FDA prescribing information for Rezira (Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride)

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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