The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as morphine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).
promethazine/codeine syrup – oral, Phenergan w/ codeine
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BRAND NAME(S): Phenergan w/ codeine
WARNING: This medication should not be used in children younger than 6 years due to an increased risk for serious (rarely fatal) slow/shallow breathing (respiratory depression). This infrequent side effect may occur even with usual prescribed doses. The lowest effective dose should be used, and other drugs that may slow down breathing should be avoided. Some manufacturers recommend that promethazine and other drugs that may also slow down breathing (e.g., the codeine in this product) should not be used together in children younger than 16 years. Seek immediate medical attention if you notice symptoms of slow/shallow breathing.
USES: See also Warning Section.This combination medication is used to treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). Promethazine is an antihistamine that relieves watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Codeine is a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough.Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.
HOW TO USE: Take this medication by mouth with or without food, usually every 4 to 6 hours as needed with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication can be taken with food if stomach upset occurs. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor.Use a medication-measuring device to carefully measure the prescribed dose. Do not use a household spoon. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, restlessness, sweating, shaking chills, nausea, vomiting, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.
SIDE EFFECTS: Drowsiness, dizziness, headache, lightheadedness, blurred vision, upset stomach, nausea, constipation, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.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: involuntary behaviors/movements (e.g., fixed upward stare, neck twisting, tongue movements), mental/mood changes (e.g., confusion, hallucinations), ringing in the ears, shaking (tremors), slow/shallow breathing, trouble urinating, weakness.Seek immediate medical attention if any of these rare but very serious side effects occur: dark urine, easy bruising/bleeding, slow heartbeat, persistent nausea/vomiting, severe abdominal pain, yellowing eyes/skin.This drug may infrequently cause a very serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). If you notice any of the following unlikely but very serious side effects, stop taking this medication and seek immediate medical attention: fast/irregular heartbeat, very high fever, mental/mood changes (e.g., confusion, extreme drowsiness), seizure, severe muscle stiffness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 side 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.
PRECAUTIONS: See also Warning section.This medication should not be used in a person who is unconscious or has severe breathing problems (e.g., respiratory depression, hypercapnia).Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison’s disease), blood/immune system problems (e.g., bone marrow depression), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema), diabetes, glaucoma, heart problems (e.g., angina, irregular heartbeat), high blood pressure, liver disease, mental/mood problems (e.g., depression, psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., ulcers, blockage), thyroid disease, trouble urinating (e.g., due to enlarged prostate or urethral stricture), use/abuse of drugs/alcohol.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.)To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.The elderly may be more sensitive to the effects of this drug, especially dizziness, drowsiness, mental/mood changes, and low blood pressure.During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell your doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.This product passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell your doctor immediately if your infant develops increased sleepiness, difficulty feeding, or trouble breathing. Discuss the risks and benefits with your doctor before breast-feeding.
QUESTION
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: epinephrine for low blood pressure, metrizamide, sibutramine.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic drugs (e.g., benztropine, belladonna alkaloids), cancer chemotherapy (e.g., methotrexate), cimetidine, guanethidine, guanadrel, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), narcotic antagonists (e.g., naltrexone, naloxone), quinidine.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.Also report the use of drugs that might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.This medication may interfere with certain laboratory tests (e.g., some pregnancy tests, blood sugar tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, cold/clammy skin, fast/slow/irregular heartbeat, slow/shallow breathing, seizures, fainting.
NOTES: Do not share this medication with others. It is against the law.Do not take this medication for several days before allergy testing because test results can be affected.
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MISSED DOSE: If you are prescribed this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store in a tightly closed container at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Side Effects
See also Warning section.
Drowsiness, dizziness, headache, lightheadedness, blurred vision, upset stomach, nausea, constipation, or dry mouth may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.
Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), involuntary behaviors/movements (such as fixed upward stare, neck twisting, tongue movements), mental/mood changes (such as hallucinations, confusion), ringing in the ears, shaking (tremors), trouble urinating, weakness.
Get medical help right away if you have any very serious side effects, including: nausea/vomiting that doesn’t stop, easy bruising/bleeding, slow heartbeat, severe abdominal pain, yellowing eyes/skin, seizure.
Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion.
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).
A very serious allergic reaction to this drug is rare. However, get medical help right away 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 side effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Warnings
This medication has a risk for abuse and addiction, which can lead to overdose and death. This medication may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.
The risk for severe breathing problems is higher when you start this medication, or if you take the wrong dose or take more of this medication than prescribed. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of this product from your body, which may affect how it works. Be sure you know how to take this product and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or think you may be pregnant. During pregnancy, this medication is not recommended. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn’t stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Precautions
Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to opioid pain relievers (such as morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (such as chronic constipation, ileus, pancreatitis), gallbladder disease, adrenal gland problem (such as Addison’s disease), blood/immune system problems (such as bone marrow depression), brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), breathing problems (such as asthma, emphysema, sleep apnea), diabetes, glaucoma, heart problems (such as angina, irregular heartbeat), high blood pressure, kidney disease, liver disease, mental/mood problems (such as depression, psychosis), obesity, a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (such as ulcers, blockage), thyroid disease, trouble urinating (such as due to enlarged prostate or urethral stricture), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol).
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.
This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, constipation, trouble urinating, and slow/shallow breathing. Confusion, dizziness, and drowsiness can increase the risk of falling.
Tell your doctor if you are pregnant or think you may be pregnant. During pregnancy, this product is not recommended. It may harm an unborn baby. Talk to your doctor about the risks and benefits of this medication. See also Warning section.
This product passes into breast milk and may have undesirable effects on a nursing infant (such as unusual sleepiness, difficulty feeding, trouble breathing, or unusual limpness). Consult your doctor before breast-feeding.
What are the side effects of promethazine with codeine cough syrup?
Possible side effects of promethazine with codeine include drowsiness, dizziness, difficulty concentrating, dry mouth, headache , nausea, vomiting, constipation, and sweating.
Other side effects of this medicine can be more serious. Contact your health care professional without delay if you notice any of the following symptoms while taking promethazine/codeine: An unusual or allergic reaction; respiratory depression (decreased breathing); difficulty breathing (short of breath); irregular heartbeat; fever ; muscle stiffness; tremors; increased sweating; seizures ; or jaundice (yellowing of the skin and/or eyes).
In case of an overdose, call your doctor immediately; if your doctor is not available right away, you should go to the nearest emergency room. The poison control center is a good resource for overdose symptoms, along with other useful information in case of an overdose.
What are the risks of taking promethazine and codeine cough syrup?
Here are some of the risks of taking promethazine/codeine and some tips on the safe use of this medicine.
Habit-Forming and Risk of Overdose
Promethazine with codeine contains codeine which is a narcotic ( opioid ) drug. It is designated as a Schedule V controlled substance and can be habit-forming with long-term use. This can happen even if you are taking the medicine at the prescribed doses. There is also a risk of opioid overdose and death. To reduce your risk, take promethazine with codeine at the dosage and duration recommended by your doctor.
Drug Misuse and Abuse
Codeine and promethazine cough syrup is sometimes abused by mixing it with Sprite or alcohol. This mixture has been popularly referred to as “purple drank” or “lean” and is popularized for its euphoric and tranquilizing effects. Never abuse or misuse prescription drugs, as this can put you at risk of very serious side effects.
Breathing Problems
Promethazine/codeine affects breathing and can lead to potentially life-threatening respiratory depression. The risk is higher if you are taking other central nervous system (CNS) depressants like sleeping pills or have health conditions like sleep apnea or lung disease. Tell your doctor if you develop any difficulty breathing while on this medication.
Drowsiness and Dizziness
Taking promethazine/codeine can also cause extreme drowsiness and dizziness. These effects occur with greater intensity if you are taking other medicines that cause these effects, like benzodiazepines ( Valium , Xanax ). Drinking alcohol while on this medication can also worsen side effects. Tell your doctor if you experience any unusual or increased sleepiness while on this medicine. Do not drive, operate machinery, or do anything that requires your full concentration until you know how this medicine affects you.
Drug Interactions
Interactions between promethazine/codeine and certain medicines can lead to very serious side effects. Give your doctor and pharmacist a complete list of your medications, including prescription drugs, over-the-counter medications, herbal products, and dietary supplements, to reduce the risk of drug interactions.
Pregnant Women
Promethazine/codeine is not safe for use during pregnancy. This medication can cause withdrawal symptoms in newborn babies because it contains an opioid (codeine). Talk to your doctor about safer treatment options for cough if you are pregnant or breastfeeding.
Neuroleptic Malignant Syndrome
In a small number of people, promethazine with codeine can cause a rare but life-threatening condition called neuroleptic malignant syndrome (NMS). Taking other drugs, specifically antipsychotic medications, can increase the risk of developing this complication. Symptoms of NMS include high fever, confusion, muscle stiffness, excessive sweating, and abnormal heart rate and blood pressure. Give your healthcare provider a complete list of your medications before starting promethazine/codeine. Seek immediate medical help if you experience any of the above symptoms.
Extrapyramidal Symptoms
Very rarely, taking promethazine/codeine can cause extrapyramidal symptoms (EPS), which are uncontrolled movements like tremors and jerks of the face, tongue, and other parts of the body. Tell your doctor or seek medical attention right away if you notice any unusual movements.
Other Medical Conditions
Promethazine/codeine should be used with caution or avoided in people with a history of certain medical conditions. Tell your doctor if you have a medical problem such as low blood pressure, heart problems, Addison’s disease (adrenal insufficiency), seizures, or low white blood cell count (for example, after undergoing chemotherapy ).
Wrapping Up
Promethazine with codeine is an effective cough suppressant that is available in syrup form. This makes it easy to take for people who have difficulty swallowing pills. The medicine works quickly and is available in a low-cost generic form. However, promethazine/codeine cough syrup can be habit-forming and is not for long-term use. It also cannot be used in children younger than 18 years of age and pregnant women. Drug interactions with other medications can increase the risk of side effects and complications. Always take promethazine/codeine as prescribed by a healthcare professional to ensure the safe use of this medicine.
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf
- https://medlineplus.gov/druginfo/meds/a682284.html
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044#ID337
