Applies to phenylephrine / promethazine: oral solution, oral syrup.
Warning
- Do not give this drug to a child younger than 2 years of age. It may cause very bad and sometimes deadly breathing problems.
- Use with care in children 2 years of age and older. Talk with the doctor.
- Before your child takes this drug, tell the doctor if your child is taking any drugs that can cause breathing problems. There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
Serious side effects
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Fast or slow heartbeat.
- Trouble passing urine.
- Feeling very tired or weak.
- Hallucinations (seeing or hearing things that are not there).
- Mood changes.
- Ringing in ears.
- Seizures.
- Any unexplained bruising or bleeding.
- Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
- Change in eyesight.
- Yellow skin or eyes.
- A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
- This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
- Low white blood cell counts have rarely happened with this drug. This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
Other side effects
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling sleepy.
- Dizziness.
- Feeling tired or weak.
- Feeling nervous and excitable.
- Dry mouth.
- Upset stomach or throwing up.
- Not able to sleep.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to phenylephrine/promethazine: oral syrup.
General
One of the most commonly reported adverse reactions has included drowsiness.[Ref]
Nervous system
Promethazine:
Frequency not reported: Sedation, sleepiness, somnolence, dizziness, tremor, weakness, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion, incoordination, seizures, neuroleptic malignant syndrome
Phenylephrine:
Frequency not reported: Dizziness, tremor, weakness[Ref]
Psychiatric
Promethazine:
Frequency not reported: Euphoria, confusion, disorientation, restlessness, anxiety, nervousness, excitation, catatonic-like states, hysteria, hallucinations, nightmares, insomnia, delirium, agitated behavior
Phenylephrine:
Frequency not reported: Restlessness, anxiety, nervousness
Cardiovascular
Promethazine:
Frequency not reported: Increased or decreased blood pressure, tachycardia, bradycardia, faintness
Phenylephrine:
Frequency not reported: Hypertension[Ref]
Ocular
Promethazine:
Frequency not reported: Blurred vision, diplopia[Ref]
Gastrointestinal
Promethazine:
Frequency not reported: Dry mouth, nausea, vomiting[Ref]
Hematologic
Promethazine:
Frequency not reported: Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis[Ref]
Dermatologic
Promethazine:
Frequency not reported: Dermatitis, photosensitivity, urticaria, angioneurotic edema[Ref]
Respiratory
Promethazine:
Frequency not reported: Respiratory distress, asthma, nasal stuffiness, apnea
Phenylephrine:
Frequency not reported: Respiratory distress[Ref]
Hepatic
Promethazine:
Frequency not reported: Jaundice
Other
Promethazine:
Frequency not reported: Lassitude, tinnitus, fatigue
Phenylephrine:
Frequency not reported: Precordial pain
