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Promethazine should not be used by children younger than 2 years because it may cause serious (possibly fatal) slow/shallow breathing. When this medication is used by children 2 years and older, use the lowest effective dosage and avoid other drugs that affect breathing. Get medical help right away if slow/shallow breathing occurs. In children, drugs for nausea should only be used in cases of prolonged vomiting of a known cause. Avoid use of promethazine in children with liver disease (including possible Reye's syndrome). This medication can cause severe tissue damage, possibly requiring surgery. Tell your health care professional right away if you have burning, pain, redness, swelling, or numbness at or near the injection site. If this occurs, the injection should be stopped and the injection site checked. It is preferred that this medication be given by injection into a muscle. There may be an increased risk of side effects if this medication is given by injection into a vein. This medication must not be given by injection under the skin.

Drowsiness, dizziness, constipation, blurred vision, or dry mouth may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. 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: signs of infection (such as sore throat that doesn't go away, fever, chills), loss of coordination, fainting, confusion, slow heartbeat, shaking (tremor), unusual/uncontrolled movements (such as fixed upward stare, neck twisting, tongue movements), mental/mood changes (such as hallucinations, nervousness, irritability, restlessness, confusion), trouble urinating, easy bleeding/bruising, severe stomach/abdominal pain, yellowing of eyes/skin. Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, seizures. 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 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 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.

Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), metoclopramide. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, 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). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain lab tests (such as some pregnancy tests, blood sugar tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.