- Clinician Information:
Rezira Side Effects Center
Medical Editor: William C. Shiel Jr., MD, FACP, FACR
Rezira (hydrocodone bitartrate and pseudoephedrine hydrochloride is indicated for relief of cough and nasal congestion associated with common cold. Common side effects with Rezira use can include respiratory depression, drug abuse and dependence, increased intracranial pressure, decreased mental alertness with impaired mental and/or physical abilities, as well as nausea and vomiting and constipation. Rezira should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma.
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 nursing 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 nursing 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
Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:
- Respiratory depression [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]
- Drug dependence [see WARNINGS AND PRECAUTIONS]
- Increased intracranial pressure [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]
- Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
- Paralytic ileus [see WARNINGS AND PRECAUTIONS]
Use of pseudoephedrine, a sympathomimetic amine, may result in the following:
- Central nervous system effects such as insomnia, dizziness, weakness, tremor, or convulsions [see WARNINGS AND PRECAUTIONS]
- Cardiovascular system effects such as arrhythmias, or increased blood pressure, cardiovascular collapse with accompanying hypotension [see WARNINGS AND PRECAUTIONS]
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.
Dermatological System: Skin rash, pruritus.
Read the entire FDA prescribing information for Rezira (Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride) »
Additional Rezira Information
- Rezira Drug Interactions Center: pseudoephedrine-hydrocodone oral
- Rezira Side Effects Center
- Rezira FDA Approved Prescribing Information including Dosage
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.
Find out what women really need.