Skip to Content

Acetaminophen / pheniramine / phenylephrine Side Effects

For the Consumer

Applies to acetaminophen/pheniramine/phenylephrine: oral packet

What are some side effects that I need to call my doctor about right away?

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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

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:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.

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 acetaminophen/pheniramine/phenylephrine: oral powder for reconstitution

Hepatic

Frequency not reported: Hepatotoxic action and nephrotoxicity with prolonged high dose use[Ref]

Cardiovascular

Frequency not reported: Palpitations, blood pressure increase[Ref]

Nervous system

Frequency not reported: Hyperexcitability, drowsiness, dizziness, accommodative palsy, sleep disorder[Ref]

Hematologic

Frequency not reported: Changes in blood count with prolonged high dose use[Ref]

Hypersensitivity

Frequency not reported: Possible allergic reactions (skin rash, pruritus, hives, angioedema)[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, stomach pain, dry mouth[Ref]

Genitourinary

Frequency not reported: Urinary retention[Ref]

Ocular

Frequency not reported: Increase in intraocular pressure[Ref]

References

1. "Product Information. Theraflu Cold & Sore Throat (APAP/pheniramine/phenylephrine)." Novartis Consumer Health, Parsippany, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.