"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
Zolvit Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Zolvit (hydrocodone bitartrate and acetaminophen) is a combination drug indicated for the relief of moderate to moderately severe pain. Zolvit is available as a generic termed hydrocodone bitartrate and acetaminophen. Common side effects include anxiety, dizziness, and drowsiness.
Zolvit comes in liquid form containing hydrocodone bitartrate 10 mg strength and acetaminophen 300 mg strength per 15 ml, with 7% alcohol; it is available in 16 fluid oz. bottles (473.17 ml). Initial dose is based on weight (see Zolvit Side Effects Drug Center chart). Dosage may be adjusted according to severity of the pain and response of the patient; however, tolerance to hydrocodone can develop with continued use and that the incidence of untoward the effects are dose related. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams. Liver damage may occur with overdoses of Zolvit; the toxic dose of acetaminophen for adults is 10 grams. Toxicity from hydrocodone poisoning includes loss of consciousness, pinpoint pupils, and respiratory depression. Convulsions may occur. Use with CNS depressants may exhibit additive CNS depression. Zolvit should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, 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. Use in pediatric patients under the age of two years has not been established; children two and older may be given weight-based doses of Zolvit.
Our Zolvit 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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zolvit in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- feeling light-headed, fainting;
- confusion, fear, unusual thoughts or behavior;
- seizure (convulsions);
- problems with urination; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- anxiety, dizziness, drowsiness;
- mild nausea, vomiting, upset stomach, constipation;
- headache, mood changes;
- blurred vision;
- ringing in your ears; or
- dry mouth.
Read the entire detailed patient monograph for Zolvit (Hydrocodone Bitartrate and Acetaminophen Oral Solution)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zolvit FDA Prescribing Information: Side Effects
Potential effects of high dosage are also listed in the OVERDOSAGE section.
Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.
Endocrine: Hypoglycemic coma.
Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention.
Hypersensitivity: Allergic reactions.
Musculoskeletal: Skeletal muscle flaccidity.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Skin: Cold and clammy skin, diaphoresis, pruritus, rash.
Drug Abuse And Dependence
Misuse Abuse and Diversion of Opioids
Addiction is a primary, chronic, neurobiologic disease, with genetic psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.
"Drug seeking" behavior is very common in addicts and drug abusers. Drug seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances. ZOLVIT™, like other opioids, may be diverted for nonmedical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Read the entire FDA prescribing information for Zolvit (Hydrocodone Bitartrate and Acetaminophen Oral Solution)
Additional Zolvit Information
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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