Promethazine Side Effects

Brand Names: Phenergan, Phenadoz

Please note - some side effects for Promethazine 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 Promethazine - for the Consumer

Promethazine

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 Promethazine:

Blurred vision; dizziness; drowsiness; dry mouth; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; excessive sweating; fainting; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, delirium, exaggerated sense of well-being, excitability, hysteria, nervousness); seizures; severe of persistent dizziness; shortness of breath or trouble breathing; slow or fast heartbeat; tremor; trouble sleeping; uncontrolled muscle movements; unusual brusing or bleeding; yellowing of skin or eyes.

Promethazine Suppositories

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 Promethazine Suppositories:

Blurred vision; dizziness; drowsiness; dry mouth; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; excessive sweating; fainting; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, delirium, exaggerated sense of well-being, excitability, hysteria, nervousness); seizures; severe of persistent dizziness; shortness of breath or trouble breathing; slow or fast heartbeat; tremor; trouble sleeping; uncontrolled muscle movements; unusual brusing or bleeding; yellowing of skin or eyes.

Promethazine/Codeine 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 Promethazine/Codeine Syrup:

Blurred vision; constipation; dizziness; drowsiness; dry mouth, throat, or nose; headache; nausea; 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; change in the amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; 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.

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 Promethazine Syrup:

Blurred vision; dizziness; drowsiness; dry mouth; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; excessive sweating; fainting; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, delirium, exaggerated sense of well-being, excitability, hysteria, nervousness); seizures; severe of persistent dizziness; shortness of breath or trouble breathing; slow or fast heartbeat; tremor; trouble sleeping; uncontrolled muscle movements; unusual brusing or bleeding; yellowing of skin or eyes.

Promethazine 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 Promethazine Tablets:

Blurred vision; dizziness; drowsiness; dry mouth; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; excessive sweating; fainting; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, delirium, exaggerated sense of well-being, excitability, hysteria, nervousness); seizures; severe of persistent dizziness; shortness of breath or trouble breathing; slow or fast heartbeat; tremor; trouble sleeping; uncontrolled muscle movements; unusual brusing or bleeding; yellowing of skin or eyes.

Promethazine Side Effects - for the Professional

Promethazine

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).

Other

Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported.

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.

Promethazine Tablets

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).

Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported.

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.

Side Effects by Body System

Nervous system

Nervous system side effects have been reported the most frequently. These have included excessive sedation, drowsiness, fatigue, paradoxical excitation, confusion, disorientation, tremors, convulsive seizures, and decreased motor coordination. Extrapyramidal effects (including oculogyric crises, torticollis and tongue protrusion), encephalitic symptoms, convulsions, and psychosis have been rarely reported.

Other

Neuroleptic malignant syndrome has been rarely observed during treatment with promethazine. It usually occurs within the first 30 days after exposure to neuroleptics.

Fever, altered consciousness, labile blood pressure, autonomic dysfunction, and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate ranging from 5% to 20%. Immediate discontinuation of promethazine and intensive monitoring and supportive care are indicated.

Local

Local side effects have been associated with the inadvertent intraarterial injection of promethazine which carries a high risk of distal necrosis and frequently requires amputation of the affected limb. Subcutaneous injection has more rarely caused chemical irritation and necrosis.

Respiratory

Respiratory side effects have rarely included respiratory depression and arrest, especially with parenteral administration of promethazine. Equipment for resuscitation should be available when parenteral promethazine is used. Asthma and nasal stuffiness have also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and dry mouth.

Hypersensitivity

Hypersensitivity side effects have included rare reports of rash, pruritus, hypotension, photosensitivity, and tachycardia.

Hematologic

Hematologic side effects have included rare cases of neutropenia. Leukopenia, thrombocytopenia, thrombocytopenic purpura, and agranulocytosis have also been reported.

Cardiovascular

Cardiovascular side effects have rarely included tachycardia, bradycardia, and increased or decreased blood pressure. Prolongation of the QT interval, heart block, and malignant arrhythmias have been reported in association with other phenothiazines.

Immunologic

Immunologic side effects have included rare reports of a systemic lupus erythematosus syndrome.

Hepatic

Hepatic side effects have included jaundice.

Dermatologic

Dermatologic side effects have included dermatitis, photosensitivity, and urticaria.

Psychiatric

Psychiatric side effects have included hallucinations. Other paradoxical reactions following a single dose have included nightmares, delirium and agitated behavior.

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