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Vicodin Side Effects

Generic name: acetaminophen / hydrocodone

Medically reviewed by Drugs.com. Last updated on Jun 30, 2023.

Note: This document provides detailed information about Vicodin Side Effects associated with acetaminophen / hydrocodone. Some dosage forms listed on this page may not apply specifically to the brand name Vicodin.

Applies to acetaminophen / hydrocodone: oral elixir, oral solution, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (solution)

Hydrocodone bitartrate and acetaminophen oral solution has the potential for addiction, abuse, and misuse, which can lead to overdose and death.

Assess each patient's risk before prescribing, and monitor for development of these behaviors and conditions.

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.

Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation or following a dose increase.

Accidental ingestion of hydrocodone bitartrate and acetaminophen oral solution, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen.

Prolonged use of hydrocodone bitartrate and acetaminophen oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

Monitor patients receiving hydrocodone bitartrate and acetaminophen oral solution and any CYP3A4 inhibitor or inducer for signs of respiratory depression or sedation.

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death, most often with the use of acetaminophen at doses that exceed 4000 mg/day, and involving more than 1 acetaminophen-containing product.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for patients with inadequate alternative treatment options.

Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.

Oral route (tablet)

Hydrocodone bitartrate and acetaminophen has the potential for addiction, abuse, and misuse, which can lead to overdose and death.

Assess each patient's risk before prescribing, and monitor for development of these behaviors and conditions.

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.

Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation or following a dose increase.

Accidental ingestion of hydrocodone bitartrate and acetaminophen, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen.

Prolonged use of hydrocodone bitartrate and acetaminophen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

Monitor patients receiving hydrocodone bitartrate and acetaminophen and any CYP3A4 inhibitor or inducer for signs of respiratory depression or sedation.

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death, most often with the use of acetaminophen at doses that exceed 4000 mg/day, and involving more than 1 acetaminophen-containing product.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for patients with inadequate alternative treatment options.

Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.

Precautions

It is very important that your doctor check your or your child's progress while using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: cold, clammy skin, coughing that sometimes produces a pink frothy sputum, dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before you or your child have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of certain tests may be affected by this medicine.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight. Check with your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Vicodin

Along with its needed effects, acetaminophen / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / hydrocodone:

More common side effects

  • dizziness
  • lightheadedness

Incidence not known

  • agitation
  • back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • blood in vomit
  • bluish lips or skin
  • chills
  • choking
  • confusion
  • cough
  • dark urine
  • darkening of the skin
  • decrease in the frequency of urination
  • decrease in urine volume
  • diarrhea
  • difficult or trouble breathing
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • fainting
  • fast heartbeat
  • fever
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • hoarseness
  • irregular, fast or slow, or shallow breathing
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • mental depression
  • nausea
  • nosebleeds
  • not breathing
  • overactive reflexes
  • painful or difficult urination
  • pale or blue lips, fingernails, or skin
  • pinpoint red spots on the skin
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red irritated eyes
  • red skin lesions, often with a purple center
  • restlessness
  • severe or continuing stomach pain
  • shivering
  • skin rash, hives, or itching
  • sore throat
  • sore tongue
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • trembling or shaking
  • twitching
  • unable to speak
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting
  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / hydrocodone:

Symptoms of overdose

Other side effects of Vicodin

Some side effects of acetaminophen / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • drowsiness
  • relaxed and calm feeling
  • sleepiness

Incidence not known

  • belching
  • changes in mood
  • difficulty having a bowel movement
  • fear or nervousness
  • feeling of indigestion
  • hearing loss
  • impaired hearing
  • pain in the chest below the breastbone
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For healthcare professionals

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral tablet.

General adverse events

The most commonly reported adverse reactions include light-headedness, dizziness, sedation, nausea and vomiting.[Ref]

Nervous system

Hydrocodone-acetaminophen:

Opioids:

Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Cardiovascular

Hepatic

Gastrointestinal

Dermatologic

Renal

Hematologic

Hypersensitivity

Respiratory

Metabolic

Genitourinary

Endocrine

Opioids:

Other

Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.[Ref]

Musculoskeletal

Psychiatric

See also:

References

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3. (2017) "Product Information. Lortab (acetaminophen-hydrocodone)." Akorn Inc

4. (2017) "Product Information. Acetaminophen-Hydrocodone Bitartrate (acetaminophen-hydrocodone)." Mikart Inc

5. Morrison AB (1979) "Toxicity and abuse of hydrocodone bitartrate." Can Med Assoc J, 120, p. 1338

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7. Fricke J, Halladay SC, Bynum L, Francisco CA (1993) "Pain relief after dental impaction surgery using ketorolac, hydrocodone plus acetaminophen, or placebo." Clin Ther, 15, p. 500-9

8. Sackner MA (1984) "Effects of hydrocodone bitartrate on breathing pattern of patients with chronic obstructive pulmonary disease and restrictive lung disease." Mt Sinai J Med, 51, p. 222-6

9. Seeff LB, Cuccherini BA, Zimmerman HJ, Adler E, Benjamin SB (1986) "Acetaminophen hepatotoxicity in alcoholics." Ann Intern Med, 104, p. 399-404

10. Jackson CH, MacDonald NC, Cornett JW (1984) "Acetaminophen: a practical pharmacologic overview." Can Med Assoc J, 131, p. 25-37

11. Black M (1984) "Acetaminophen hepatotoxicity." Annu Rev Med, 35, p. 577-93

12. Kaysen GA, Pond SM, Roper MH, Menke DJ, Marrama MA (1985) "Combined hepatic and renal injury in alcoholics during therapeutic use of acetaminophen." Arch Intern Med, 145, p. 2019-23

13. O'Dell JR, Zetterman RK, Burnett DA (1986) "Centrilobular hepatic fibrosis following acetaminophen-induced hepatic necrosis in an alcoholic." JAMA, 255, p. 2636-7

14. Minton NA, Henry JA, Frankel RJ (1988) "Fatal paracetamol poisoning in an epileptic." Hum Toxicol, 7, p. 33-4

15. Keaton MR (1988) "Acute renal failure in an alcoholic during therapeutic acetaminophen ingestion." South Med J, 81, p. 1163-6

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19. Thomas RH, Munro DD (1986) "Fixed drug eruption due to paracetamol." Br J Dermatol, 115, p. 357-9

20. Guin JD, Haynie LS, Jackson D, Baker GF (1987) "Wandering fixed drug eruption: a mucocutaneous reaction to acetaminophen." J Am Acad Dermatol, 17, p. 399-402

21. Gabriel R, Caldwell J, Hartley RB (1982) "Acute tubular necrosis, caused by therapeutic doses of paracetamol?" Clin Nephrol, 18, p. 269-71

22. Segasothy M, Suleiman AB, Puvaneswary M, Rohana A (1988) "Paracetamol: a cause for analgesic nephropathy and end-stage renal disease." Nephron, 50, p. 50-4

23. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J (1980) "Thrombocytopenia from acetaminophen." N Engl J Med, 303, p. 47

24. Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH (2007) "Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen." Blood, 109, p. 3608-9

25. Settipane RA, Stevenson DD (1989) "Cross sensitivity with acetaminophen in aspirin-sensitive subjects with asthma." J Allergy Clin Immunol, 84, p. 26-33

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27. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K (1993) "Acetaminophen-induced eosinophilic pneumonia." Chest, 104, p. 291-2

28. Cohen J, Tattersfield H, Lloyd D, Cantopher T (1990) "A request for a strong analgesic." Practitioner, 234, p. 691-4

Frequently asked questions

Further information

Vicodin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.