Codeine Side Effects

Please note - some side effects for Codeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Codeine - for the Consumer

Codeine/Guaifenesin

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Guaifenesin:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

Codeine/Pseudoephedrine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Pseudoephedrine:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

Codeine/Guaifenesin/Pseudoephedrine

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Guaifenesin/Pseudoephedrine:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

Codeine/Guaifenesin Liquid

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Guaifenesin Liquid:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

Codeine/Guaifenesin/Phenylephrine Liquid

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Guaifenesin/Phenylephrine Liquid:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

Codeine Phosphate Soluble Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine Phosphate Soluble Tablets:

Constipation; dizziness; drowsiness; flushing; lightheadedness; nausea; sweating; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fast heartbeat; fainting; mental or mood changes; seizures; severe drowsiness or dizziness; slow or shallow breathing; trouble urinating.

Codeine Phosphate Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine Phosphate Solution:

Constipation; dizziness; drowsiness; flushing; lightheadedness; nausea; sweating; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fast heartbeat; fainting; mental or mood changes; seizures; severe drowsiness or dizziness; slow or shallow breathing; trouble urinating.

Codeine/Guaifenesin/Pseudoephedrine Syrup

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Guaifenesin/Pseudoephedrine Syrup:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

Codeine/Phenylephrine/Promethazine Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Phenylephrine/Promethazine Syrup:

Anxiety; blurred vision; constipation; dizziness; drowsiness; dry mouth, throat, or nose; headache; nausea; nervousness; restlessness; tiredness or weakness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; agitation; chest pain; confusion; change in the amount of urine produced; fast, slow, or irregular heartbeat; fainting; hallucinations; loss of coordination; mood or mental changes; muscle pain or stiffness; overexcitement; seizures; severe drowsiness; severe or persistent blurred vision, dizziness, headache, or lightheadedness; slow or irregular breathing; symptoms of infection (eg, fever, chills); tremors; uncontrolled muscle movements (eg, movements of the arms, legs, tongue, eyes); unusual bruising or bleeding; unusual sweating; vision problems; yellowing of the skin or eyes.

Codeine/Phenylephrine/Pyrilamine Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Phenylephrine/Pyrilamine Syrup:

Constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; flushing or redness of face.

Codeine/Diphenhydramine/Phenylephrine Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Diphenhydramine/Phenylephrine Syrup:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes (eg, irritability); persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; vision changes or blurred vision.

Codeine/Pyrilamine Syrup

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Codeine/Pyrilamine Syrup:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; headache; loss of appetite; nausea; thickening of mucus secretions; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision, double vision, or other vision changes; confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; loss of coordination; mood or mental changes; nervousness; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble sleeping; unusual bruising or bleeding; unusual weakness or tiredness.

Side Effects by Body System

General

The side effects have been more likely and more severe in patients with liver and/or renal disease.

Nervous system

Nervous system side effects have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has also been associated with codeine therapy, particularly in the elderly. A case of seizures has been reported with the use of intravenous codeine phosphate.

Opiates may result in psychotic symptoms in some patients.

One retrospective study of elderly patients who sustained a hip fracture suggested that the relative risk of hip fracture was 1.6 in patients using codeine compared to age-matched nonusers.

Other

Other side effects including withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics have been reported. These withdrawal symptoms have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Cardiovascular

Hypotension is rare and has been reported most frequently with high doses.

Cardiovascular side effects have included hypotension and dizziness.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and constipation have been reported frequently. Severe constipation and ileus resulting in colonic perforation have also been reported. Four cases of acute pancreatitis have been reported.

Genitourinary

Genitourinary side effects including urinary retention have been reported.

Dermatologic

Dermatologic side effects including rashes, severe scarlatiniform eruptions, and generalized dermatitis have been reported rarely.

Codeine-induced rashes may be related to direct stimulation of histamine release.

Renal

Renal side effects including acute renal failure (which may respond to naloxone therapy) have been reported in association with codeine therapy.

Immunologic

Immunologic side effects have included one study of a patient with exercise-induced anaphylaxis and three control subjects which found a correlation between codeine wheal size and recent exercise.

Hypersensitivity

Hypersensitivity side effects including a case of codeine phosphate-induced hypersensitivity syndrome have been reported.

Ocular

Ocular side effects including a temporary 26% decrease in pupil diameter following the administration of intravenous codeine have been reported.

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