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Promethazine, Phenylephrine and Codeine (Promethazine Hydrochloride / Phenylephrine Hydrochloride / Codeine Phosphate) - Side Effects and Adverse Reactions




Nervous System CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances and convulsions.

Cardiovascular Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics).

Gastrointestinal Nausea, vomiting, constipation and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported.

Genitourinary Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics).

Allergic Infrequent pruritus, giant urticaria, angioneurotic edema and laryngeal edema.

Other Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness.


Central Nervous System - Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic Dermatitis, photosensitivity, urticaria.

Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal Dry mouth, nausea, vomiting, jaundice.

Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal) (see WARNINGS-Promethazine- Respiratory Depression).

Other Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS-Promethazine- Neuroleptic Malignant Syndrome).

Paradoxical Reactions Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.


Nervous System Restlessness, anxiety, nervousness and dizziness.

Cardiovascular Hypertension (see WARNINGS).

Other Precordial pain, respiratory distress, tremor and weakness.

Drug label data at the top of this Page last updated: 2008-05-28

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