Medical Editor: John P. Cunha, DO, FACOEP
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:
- low blood pressure
- weakness, or general feeling of being unwell (malaise)
- respiratory depression
- drug abuse and dependence
- increased intracranial pressure
- decreased mental alertness with impaired mental and/or physical abilities
- lack of energy
- mood changes
- irregular heartbeat
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.
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)