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Vicodin ES

"Jan. 28, 2013 -- It may become more difficult to get prescriptions for drugs containing hydrocodone combined with other pain relievers.

An FDA panel voted 17 to 10 in favor of reclassifying hydrocodone-containing compounds, such as Vico"...

Vicodin ES

Vicodin ES Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vicodin ES (hydrocodone bitartrate and acetaminophen) is used to relieve moderate to severe pain. Hydrocodone is a narcotic pain reliever, and acetaminophen is a non-salicylate analgesic (pain reliever). This medication is available in generic form. Common side effects include nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness.

The usual adult dosage of Vicodin ES is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets. Vicodin ES may interact with antidepressants, MAO inhibitors, atropine, benztropine, dimenhydrinate, glycopyrrolate, mepenzolate, methscopolamine, scopolamine, bladder or urinary medications, bronchodilators, or irritable bowel medications. Tell your doctor all medications you use. During pregnancy, Vicodin ES should be used only when prescribed. Using it near the expected delivery date is not recommended because of the potential for harm to the fetus. Babies born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice symptoms in your newborn, tell the doctor. This medication passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding. The hydrocodone in this medication can be habit-forming. Stopping this drug suddenly may cause withdrawal symptoms.

Our Vicodin ES (hydrocodone bitartrate and acetaminophen) 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 ES 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.

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.

Read the entire detailed patient monograph for Vicodin ES (Hydrocodone Bitartrate and Acetaminophen) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Vicodin ES Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

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 ES (Hydrocodone Bitartrate and Acetaminophen)»

What is Prescribing information?

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

Vicodin ES FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System: Prolonged administration of VICODIN ES (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.

The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Potential effects of high dosage are listed in the OVERDOSAGE section.

DRUG ABUSE AND DEPENDENCE

Misuse, Abuse, and Diversion of Opioids : VICODIN ES (hydrocodone bitartrate and acetaminophen) contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. VICODIN ES (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 ES® (hydrocodone bitartrate and acetaminophen) (hydrocodone bitartrate 7.5 mg and acetaminophen 750 mg), 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 ES (Hydrocodone Bitartrate and Acetaminophen) »

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Vicodin ES - User Reviews

Vicodin ES User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Vicodin ES sorted by most helpful. Patient Discussions FAQs

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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