Hydrocodone and acetaminophen (Oral)

August 3rd, 2021 | drugs

Generic name: acetaminophen/hydrocodone (a-seet-a-MIN-oh-fen, hye-droe-KOE-done bye-TAR-trate)
Drug class: Narcotic analgesic combinations

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.

Commonly used brand name(s)

In the U.S.

Anexsia
Ceta Plus
Co-Gesic
Dolorex Forte
Hycet
Lorcet
Lortab
Maxidone
Norco
Stagesic
Vicodin HP
Zydone

Available Dosage Forms:

Solution
Tablet
Elixir

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Hydrocodone

Uses for hydrocodone and acetaminophen

Hydrocodone and acetaminophen combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Hydrocodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Hydrocodone and acetaminophen is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

Before using hydrocodone and acetaminophen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For hydrocodone and acetaminophen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydrocodone and acetaminophen or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and acetaminophen combination capsules and tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen combination oral solution in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen combination in the elderly. However, elderly patients are more likely to have confusion and drowsiness, and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone and acetaminophen combination.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking hydrocodone and acetaminophen, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydrocodone and acetaminophen with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Nalmefene
Naltrexone
Safinamide

Using hydrocodone and acetaminophen with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Acepromazine
Alfentanil
Almotriptan
Alprazolam
Amifampridine
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anileridine
Aprepitant
Aripiprazole
Armodafinil
Asenapine
Atazanavir
Baclofen
Benperidol
Benzphetamine
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Buprenorphine
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clomipramine
Clonazepam
Clopidogrel
Clorazepate
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Darunavir
Dasabuvir
Delavirdine
Desipramine
Desmopressin
Desvenlafaxine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Dibenzepin
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diltiazem
Diphenhydramine
Diphenoxylate
Dolasetron
Donepezil
Doxepin
Doxylamine
Dronedarone
Droperidol
Duloxetine
Efavirenz
Eletriptan
Enflurane
Enzalutamide
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etravirine
Fenfluramine
Fentanyl
Flibanserin
Fluconazole
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Fosamprenavir
Fosaprepitant
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furazolidone
Gabapentin
Gabapentin Enacarbil
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Idelalisib
Imatinib
Imipramine
Indinavir
Iproniazid
Isocarboxazid
Isoflurane
Isoniazid
Itraconazole
Ivacaftor
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lasmiditan
Lemborexant
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Lorazepam
Lorcaserin
Loxapine
Lumacaftor
Magnesium Oxybate
Meclizine
Melitracen
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methylene Blue
Metoclopramide
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirtazapine
Mitotane
Moclobemide
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nafcillin
Nalbuphine
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nialamide
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Nortriptyline
Olanzapine
Ombitasvir
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxcarbazepine
Oxycodone
Oxymorphone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paregoric
Paritaprevir
Paroxetine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Phenytoin
Piperacetazine
Pipotiazine
Piritramide
Pixantrone
Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
Posaconazole
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Promazine
Promethazine
Propofol
Protriptyline
Quazepam
Quetiapine
Ramelteon
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Rifabutin
Rifampin
Rifapentine
Ritonavir
Rizatriptan
Saquinavir
Scopolamine
Secobarbital
Selegiline
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
St John's Wort
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tapentadol
Telaprevir
Telithromycin
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Tramadol
Tranylcypromine
Trazodone
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Tryptophan
Venlafaxine
Verapamil
Vilazodone
Voriconazole
Vortioxetine
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine

Using hydrocodone and acetaminophen with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol
Carbamazepine
Fosphenytoin
Lixisenatide
Phenytoin
Warfarin
Zidovudine

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydrocodone and acetaminophen with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use hydrocodone and acetaminophen, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Grapefruit Juice
Tobacco

Using hydrocodone and acetaminophen with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use hydrocodone and acetaminophen, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Proper use of hydrocodone and acetaminophen

Take hydrocodone and acetaminophen only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of hydrocodone and acetaminophen is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of hydrocodone and acetaminophen combination. Hydrocodone and acetaminophen should also come with a Medication Guide and patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

The dose of hydrocodone and acetaminophen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of hydrocodone and acetaminophen. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For moderate to severe pain:
- For oral dosage form (capsules):
  - Adults—1 or 2 capsules every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 capsules per day.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (elixir):
  - Adults and children 14 years of age and older and weighing 46 kilograms (kg) and more—11.25 milliliters (mL) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL per day.
  - Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL per day.
  - Children 7 to 9 years of age and weighing 23 to 31 kg—5.6 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL per day.
  - Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL per day.
  - Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL per day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (7.5 milligrams [mg] per 325 mg per 15 mL solution):
  - Adults and children 14 years of age and older and weighing 46 kg and more—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
  - Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
  - Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
  - Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day.
  - Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (10 milligrams [mg] per 325 mg per 15 mL solution):
  - Adults—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
  - Children 14 years of age and older and weighing 46 kg and more—11.25 mL (2 and 1/4 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL (13 and 1/2 teaspoonfuls) per day.
  - Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
  - Children 7 to 9 years of age and weighing 23 to 31 kg—5.6 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL (6 and 1/2 teaspoonfuls) per day.
  - Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
  - Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL (1/2 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL (3 and 1/4 teaspoonfuls) per day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (5 milligrams [mg] per 325 mg tablets):
  - Adults—
    - Lortab®: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 12 tablets per day.
    - Norco® 5/325: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 tablets per day.
    - Generic: Dose depends on the strength of the tablet and must be determined by your doctor.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (7.5 mg per 325 mg tablets):
  - Adults—
    - Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day.
    - Norco® 7.5/325: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day.
    - Generic: Dose depends on the strength of the tablet and must be determined by your doctor.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (10 mg per 325 mg tablets):
  - Adults—
    - Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day.
    - Norco® 10/325: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day.
    - Generic: Dose depends on the strength of the tablet and must be determined by your doctor.
  - Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of hydrocodone and acetaminophen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of hydrocodone and acetaminophen oral solution or Norco®, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Hydrocodone can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm .

Precautions while using hydrocodone and acetaminophen

It is very important that your doctor check your or your child's progress while using hydrocodone and acetaminophen, 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 hydrocodone and acetaminophen 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 hydrocodone and acetaminophen.

Hydrocodone and acetaminophen 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 hydrocodone and acetaminophen.

Hydrocodone and acetaminophen 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 hydrocodone and acetaminophen, get emergency help at once. Signs of an overdose include: 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.

Hydrocodone and acetaminophen 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 hydrocodone and acetaminophen.

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.

Serious skin reactions can occur with hydrocodone and acetaminophen. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using hydrocodone and acetaminophen.

Hydrocodone and acetaminophen 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 hydrocodone and acetaminophen.

Hydrocodone and acetaminophen may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how hydrocodone and acetaminophen 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 hydrocodone and acetaminophen. The results of certain tests may be affected by hydrocodone and acetaminophen.

Do not change your dose or suddenly stop using hydrocodone and acetaminophen 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, such as stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using hydrocodone and acetaminophen 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 the following symptoms: 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 hydrocodone and acetaminophen.

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 hydrocodone and acetaminophen may cause infertility (unable to have children). Talk with your doctor before using hydrocodone and acetaminophen 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.

Hydrocodone and acetaminophen side effects

Along with its needed effects, a medicine 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:

More common

Dizziness
lightheadedness

Incidence not known

Back, leg, or stomach pains
black, tarry stools
bleeding gums
blood in the urine or stools
blood in vomit
bluish lips or skin
chills
choking
cough
dark urine
decrease in the frequency of urination
decrease in urine volume
difficult or trouble breathing
difficulty in passing urine (dribbling)
difficulty with swallowing
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
light-colored stools
loss of appetite
lower back or side pain
nausea
nosebleeds
not breathing
painful or difficult urination
pale or blue lips, fingernails, or skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
severe or continuing stomach pain
skin rash, hives, or itching
sore throat
sore tongue
sores, ulcers, or white spots on the lips or in the mouth
tightness in the chest
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:

Symptoms of overdose

Bloody or cloudy urine
change in consciousness
chest pain or discomfort
cold and clammy skin
decreased awareness or responsiveness
extreme drowsiness
general feeling of discomfort or illness
increased sweating
irregular heartbeat
lightheadedness, dizziness, or fainting
loss of consciousness
no blood pressure or pulse
no muscle tone or movement
not breathing
severe sleepiness
slow or irregular heartbeat
stopping of heart
sudden decrease in the amount of urine
unpleasant breath odor

Some side effects 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: