"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
Vicodin Side Effects Center
Pharmacy Editor: Omudhome Ogbru, PharmD
Vicodin (hydrocodone/acetaminophen) is a combination of the narcotic hydrocodone and non-narcotic pain reliever acetaminophen. It is used for the relief of moderate to moderately severe pain. A generic version is available. The most frequent adverse reactions of Vicodin include lightheadedness, dizziness, sedation, nausea, and vomiting. Other side effects include drowsiness, constipation, and spasm of the ureter, which can lead to difficulty in urinating. Hydrocodone can impair thinking and the physical abilities required for driving or operating machinery. Hydrocodone can depress breathing, and should be used with caution in elderly, debilitated patients, and in patients with serious lung disease. Vicodin may be habit forming. Mental and physical dependence can occur, but are unlikely when used for short-term.
The usual dose of Vicodin for adults is 1 to 2 tablets or capsules every 4 to 6 hours as needed. Combining alcohol and other sedatives with hydrocodone can lead to increased sedation and even cause confusion. Combining carbamazepine with acetaminophen may increase the risk of liver toxicity. There are no adequate studies of Vicodin in pregnant women. Vicodin is excreted in breast milk, and, therefore should be used cautiously by nursing mothers.
Our Vicodin 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.
Vicodin 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 Vicodin (Hydrocodone Bitartrate and Acetaminophen) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Vicodin Overview - Patient Information: Side Effects
Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, severe stomach/abdominal pain, difficulty urinating.
Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Vicodin (Hydrocodone Bitartrate and Acetaminophen)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vicodin FDA Prescribing Information: Side Effects
The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Gastrointestinal System: Prolonged administration of VICODIN (hydrocodone bitartrate and acetaminophen) Tablets may produce constipation.
Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. (see OVERDOSAGE).
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological: Skin rash, pruritus.
Potential effects of high dosage are listed in the OVERDOSAGE section.
Drug Abuse And Dependence
Misuse, Abuse, and Diversion of Opioids: VICODIN® (hydrocodone bitartrate and acetaminophen) (hydrocodone bitartrate and acetaminophen, 5 mg/500 mg) contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. VICODIN (hydrocodone bitartrate and acetaminophen) , and other opioids used in analgesia can be abused and are subject to criminal diversion.
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 non-medical purposes, often in combination with other psychoactive substances. VICODIN (hydrocodone bitartrate and acetaminophen) , like other opioids, may be diverted for non-medical 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 Vicodin (Hydrocodone Bitartrate and Acetaminophen) »
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