Hydrocodone

Hydrocodone is a strong opioid pain medicine used to manage severe, around-the-clock pain that needs daily, long-term treatment with an opioid, and only when other pain treatments, such as non-opioid medicines, do not control the pain well enough or are not tolerated.

As a single-ingredient medicine, hydrocodone comes in two long-acting, extended-release (ER) forms:

• ER tablets (Hysingla ER and generics), which are taken once a day.
• ER capsules (the discontinued brand Zohydro ER and generics), which are taken twice a day, every 12 hours.

Hydrocodone is also combined with other medicines in separate products, such as acetaminophen or ibuprofen. Hydrocodone ER is not approved for use in children.

Hydrocodone is a full mu-opioid receptor agonist. In plain terms, it attaches to specific opioid receptors in the brain and spinal cord (the central nervous system) to reduce the feeling of pain. Because it is a full agonist, there is no "ceiling" on its pain-relieving effect, which means higher doses keep adding effect but are limited by side effects such as slowed breathing and heavy sedation. The exact way hydrocodone relieves pain is not fully understood.

Hydrocodone ER is long-acting and is not taken on an "as needed" basis. Hydrocodone bitartrate ER first gained FDA approval on October 25, 2013, under the brand name Zohydro ER. It is a Schedule II controlled substance, meaning it has an accepted medical use but a high potential for misuse, abuse, and dependence.

Long-acting opioid pain medicines, such as hydrocodone ER, can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse, which can lead to death. These risks can happen at any dose and at any point during treatment.

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for opioid pain medicines. As part of this program, prescribers are strongly encouraged to complete opioid safety education, counsel patients and caregivers on safe use, storage, and disposal, make sure patients read the Medication Guide with each prescription, and consider tools such as patient-prescriber agreements.

Get emergency help or call 911 right away if you take too much hydrocodone (overdose). Serious or life-threatening breathing problems that can lead to death may occur, especially when you first start hydrocodone, when your dose is changed, or if you take too much. Ask your healthcare provider about medicines such as naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. These medicines are available by prescription, over the counter, or through some community programs. Keep an overdose reversal medicine where family or friends can reach it, and learn how to use it before an emergency happens.

Do not combine hydrocodone with certain other medicines or substances. Taking hydrocodone with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Taking hydrocodone with medicines that affect a certain liver enzyme (CYP3A4) can raise the level of hydrocodone in your body to a dangerous or even fatal level. Always tell your healthcare provider and pharmacist about every medicine you take.

Never give anyone else your hydrocodone. They could die from taking it. Selling or giving away hydrocodone is against the law. Store hydrocodone securely, out of sight and reach of children, and in a place not accessible by others, including visitors to the home. Accidental ingestion of even one dose, especially by a child, can be fatal.

Do not take hydrocodone if you have:

• Severe asthma, trouble breathing, or other serious lung problems
• A bowel blockage, or a narrowing of the stomach or intestines
• An allergy to hydrocodone or to any of the ingredients in your hydrocodone product

Before taking hydrocodone, tell your healthcare provider if you have a history of:

• Head injury or seizures
• Liver, kidney, or thyroid problems
• Problems urinating
• Pancreas or gallbladder problems
• Breathing problems or lung disease, including sleep apnea
• Heart rhythm problems, such as long QT syndrome
• Low blood pressure or fainting spells
• Trouble swallowing, or a narrowing in your throat, esophagus, stomach, or intestines
• Misuse of street or prescription drugs, alcohol addiction, a past opioid overdose, or mental health problems such as depression

Also tell your healthcare provider if you are:

• Pregnant or planning to become pregnant. Using hydrocodone for a long time during pregnancy can cause withdrawal in your newborn (neonatal opioid withdrawal syndrome), which can be life-threatening if not recognized and treated. Hydrocodone may also cause harm to an unborn baby.
• Breastfeeding. Hydrocodone passes into breast milk and may harm your baby. Breastfeeding is not recommended during treatment with hydrocodone ER.
• Planning to have children. Long-term use of hydrocodone may reduce fertility in women and men. It is not known if these effects are reversible.
• Living in a household with small children or with someone who has misused street or prescription drugs. Hydrocodone must be stored securely to prevent accidental ingestion, theft, and misuse.
• Taking any prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydrocodone with certain other medicines can cause serious side effects that could lead to death. This includes medicines that affect serotonin, such as some antidepressants and migraine medicines.

Common side effects

The most common side effects of hydrocodone ER are:

• Constipation
• Nausea and vomiting
• Tiredness
• Dizziness
• Headache
• Sleepiness
• Dry mouth
• Upper respiratory infection (such as a cold)

Constipation is common and often continues with ongoing use, so ask your healthcare provider how to prevent and manage it. Call your healthcare provider if any side effect is severe.

Serious side effects and warnings

Call 911 or get emergency medical help right away if you have:

• Trouble breathing, shortness of breath, or very slow or shallow breathing
• Extreme drowsiness, or being hard to wake up
• Fast heartbeat or chest pain
• Swelling of your face, tongue, or throat (signs of a serious allergic reaction)
• Trouble swallowing, severe heartburn, or a feeling that the tablet is stuck in your throat
• Light-headedness or feeling faint when changing positions
• Agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion (possible signs of a serious drug reaction called serotonin syndrome)

Hydrocodone can also cause other serious problems. Talk to your healthcare provider promptly if you notice any of the following:

• Worsening or new pain. In some people, opioids can make pain worse or increase sensitivity to pain (called opioid-induced hyperalgesia). If your pain increases, if ordinary touch becomes painful, or if you have new pain, do not take more hydrocodone on your own. Talk to your healthcare provider first.
• Adrenal insufficiency. This is a potentially life-threatening hormone problem that has been reported with opioid use, more often after more than a month of use. Signs can include nausea, vomiting, loss of appetite, tiredness, weakness, dizziness, and low blood pressure.
• Low blood pressure. Hydrocodone can cause a drop in blood pressure, including when you stand up, which may lead to dizziness or fainting. Rise slowly from sitting or lying down.
• Breathing problems during sleep. Opioids can cause sleep apnea (pauses in breathing while asleep) and low oxygen levels during sleep. Tell your provider if you or others notice new or worsening breathing problems during sleep.
• Heart rhythm changes. Hydrocodone ER tablets (Hysingla ER) can affect the heart's electrical rhythm (QT prolongation), especially at higher doses. Tell your provider if you have a heart rhythm problem, heart failure, or you take other medicines that affect heart rhythm.
• Seizures. Hydrocodone may increase the risk of seizures, especially in people who already have a seizure disorder.
• Reduced fertility, missed periods, or low sex drive. Long-term opioid use may affect hormone levels and fertility in both women and men.
• Low blood sugar (hypoglycemia). Opioids can cause low blood sugar, especially in people who have diabetes or other risk factors. Call your healthcare provider if you notice signs of low blood sugar such as sweating, shaking, or feeling dizzy or anxious.

These are not all the possible side effects of hydrocodone. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take hydrocodone exactly as prescribed by your healthcare provider. Do not change your dose on your own. Your provider will use the lowest effective dose for the shortest time needed to manage your pain. How often you take it depends on which form you are prescribed.

Hydrocodone extended-release tablets (Hysingla ER and generics)

• Take your prescribed dose once a day, every 24 hours, at about the same time each day.
• Swallow the tablet whole. Do not cut, break, chew, crush, dissolve, snort, or inject it, because this can release a dangerous or fatal dose all at once.
• Take one tablet at a time with enough water to swallow it right away. Do not pre-soak, lick, or wet the tablet before placing it in your mouth, to avoid choking.
• If you miss a dose, take your next dose at your usual time the next day. Do not double up.

Hydrocodone extended-release capsules (Zohydro ER, discontinued, and generics)

• Take your prescribed dose every 12 hours, at about the same times each day.
• Swallow the capsule whole. Do not cut, break, chew, crush, dissolve, snort, or inject it, because this can release a dangerous or fatal dose all at once.
• If you miss a dose, take your next dose at your usual time. Do not double up.

Important for both forms

• If you are not already taking opioids regularly, your provider will start you at a low dose. Higher doses are used only for people who are already tolerant to opioids.
• Call your healthcare provider if the dose you are taking does not control your pain. Do not increase your dose on your own.
• If you have been taking hydrocodone regularly, do not stop suddenly. Stopping or lowering the dose too quickly can cause serious withdrawal symptoms, uncontrolled pain, and, in some cases, thoughts of suicide. Your provider will help you taper (lower the dose slowly) using a plan that is right for you.

Dispose of expired, unwanted, or unused hydrocodone promptly through a drug take-back option if available. If one is not readily available, the disposal method depends on your product. For extended-release tablets, flush them down the toilet. For extended-release capsules, mix them with dirt, cat litter, or coffee grounds, place the mixture in a sealed plastic bag, and throw it in your trash. Visit www.fda.gov/drugdisposal for more information on disposing of unused medicines.

While taking hydrocodone, do not:

• Drive or operate heavy machinery until you know how hydrocodone affects you. It can make you sleepy, dizzy, or lightheaded. With the long-acting forms, blood levels can still be high the next day, so be especially careful.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Combining alcohol with hydrocodone can cause you to overdose and die. With the extended-release capsules in particular, alcohol can cause a dangerous amount of hydrocodone to be released into your body at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or anyone using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, cold or clammy skin, and very slow or stopped breathing.

Your healthcare provider may recommend that you get an opioid overdose reversal medicine, such as naloxone or nalmefene, and keep it with you. A person caring for you can give it if you stop breathing or do not wake up. They must still call 911 and may need to perform CPR while waiting for help, because the effect of a reversal medicine is temporary and the long-acting medicine keeps releasing hydrocodone for many hours. Make sure anyone caring for you knows where you keep it and how to use it.

Hydrocodone can interact with many medicines, sometimes causing serious side effects or death. Always tell your healthcare provider and pharmacist about all the medicines you take, including:

• Other opioids, pain medicines, or prescription cough medicines
• Benzodiazepines, such as Xanax, Valium, Ativan, Klonopin, or Restoril
• Sleeping pills, muscle relaxants, or tranquilizers
• Medicines for depression, anxiety, or other mental health conditions, and other medicines that affect serotonin (such as certain antidepressants, migraine medicines, and the muscle relaxants cyclobenzaprine and metaxalone)
• Monoamine oxidase inhibitors (MAOIs), which should not be used with hydrocodone or within 14 days of stopping an MAOI
• Antibiotics, antifungals, or HIV or hepatitis C medicines, which can change how hydrocodone is broken down in the body
• Seizure medicines such as carbamazepine or phenytoin, or the antibiotic rifampin
• Heart or blood pressure medicines, including diuretics (water pills), and medicines that can affect heart rhythm (the QT interval)
• Cold, allergy, or asthma medicines
• Medicines for nausea, motion sickness, bladder problems, or irritable bowel (anticholinergic medicines)

Some medicines can slow down how hydrocodone is cleared from the body and raise it to dangerous levels, while others can lower its effect or trigger withdrawal. This list is not complete. Always check with your doctor or pharmacist before starting or stopping any medicine, including over-the-counter products, vitamins, and herbal supplements.