Codeine / pyrilamine Side Effects

For the Consumer

Applies to codeine / pyrilamine: oral syrup

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Feeling very sleepy.
• Feeling confused.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Seizures.
• Very bad belly pain.
• Very bad headache.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Feeling very tired or weak.

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:

• Feeling sleepy.
• Feeling nervous and excitable.
• Hard stools (constipation).
• Dizziness.
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.
• Dry mouth.
• Dry nose.
• Thickening of mucus in nose or throat.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to codeine / pyrilamine: oral liquid

General

The most common side effects may include drowsiness, dizziness, and dry mouth.^[Ref]

Respiratory

Frequency not reported: Respiratory depression

Nervous system

Frequency not reported: Drowsiness

Gastrointestinal

Frequency not reported: Constipation, dry mouth

Psychiatric

Frequency not reported: Excitability

Cardiovascular

Codeine:
Frequency not reported: blood pressure changes, syncope

Genitourinary

Frequency not reported: Urinary retention

Ocular

Frequency not reported: Blurred vision

Some side effects of codeine / pyrilamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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