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Vicodin ES

Last reviewed on RxList: 7/18/2016
Vicodin ES Side Effects Center

Last reviewed on RxList 02/23/2017

Vicodin ES (hydrocodone bitartrate and acetaminophen) is a combination of a narcotic pain reliever and a non-salicylate analgesic (pain reliever) used to relieve moderate to severe pain. Vicodin ES is available in generic form. Common side effects of Vicodin ES include:

  • nausea,
  • vomiting,
  • upset stomach,
  • constipation,
  • headache,
  • mood changes,
  • blurred vision,
  • ringing in your ears,
  • dry mouth,
  • lightheadedness,
  • anxiety,
  • dizziness, or
  • drowsiness.

Tell your doctor if you have serious side effects of Vicodin ES including:

  • mental/mood changes (such as agitation, confusion, hallucinations),
  • stomach or abdominal pain, or
  • difficulty urinating.

The usual adult dosage of Vicodin ES is one tablet every four to six hours as needed for pain. The total daily dosage of Vicodin ES 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 and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Vicodin ES. Using Vicodin ES near the expected delivery date is not recommended because of the potential for harm to the fetus. Babies born to mothers who have used Vicodin ES may have withdrawal symptoms such as irritability, abnormal or persistent crying, vomiting, or diarrhea. Tell the doctor if you notice withdrawal symptoms in your newborn. Vicodin ES passes into breast milk and may rarely have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. The hydrocodone in this medication can be habit-forming. Withdrawal symptoms may occur if you suddenly stop taking Vicodin ES.

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.

Vicodin ES Consumer Information

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)

Vicodin ES Professional Information

SIDE EFFECTS

The most frequently reported adverse reactions are 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 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 centers (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

Controlled Substance

Hydrocone bitartrate and acetaminophen tablets is classified as a Schedule II controlled substance.

Abuse And Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic 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.

Read the entire FDA prescribing information for Vicodin ES (Hydrocodone Bitartrate and Acetaminophen)

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