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Pro-Med Side Effects

Generic name: promethazine

Medically reviewed by Drugs.com. Last updated on Feb 5, 2024.

Note: This document contains side effect information about promethazine. Some dosage forms listed on this page may not apply to the brand name Pro-Med.

Applies to promethazine: solution. Other dosage forms:

Warning

Injection route (Solution)

Respiratory Depression – PediatricsPromethazine hydrochloride injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. Caution should be exercised when administering promethazine hydrochloride injection to pediatric patients 2 years of age and older.Severe Tissue Injury, Including GangrenePromethazine hydrochloride injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. In some cases , surgical intervention, including fasciotomy, skin graft, and/or amputation have been required.Due to the risks of intravenous injection, the preferred route of administration of promethazine hydrochloride injection is deep intramuscular injection. Subcutaneous injection is contraindicated.

Serious side effects of Pro-Med

Along with its needed effects, promethazine (the active ingredient contained in Pro-Med) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking promethazine:

Rare

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking promethazine:

Symptom of overdose

Other side effects of Pro-Med

Some side effects of promethazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to promethazine: compounding powder, injectable solution, oral syrup, oral tablet, rectal suppository.

General

The most commonly reported side effect include drowsiness, dizziness, and restlessness.[Ref]

Nervous system

Frequency not reported: Drowsiness, sedation, somnolence, dizziness, extrapyramidal symptoms, incoordination, tremors, convulsive seizures, faintness, headache, neuroleptic malignant syndrome/fatal neuroleptic malignant syndrome, psychomotor impairment, antimuscarinic effects, abnormal movements, central nervous system depression, activation of epileptogenic foci, tardive dyskinesia, tic-like movements of the head and face[Ref]

Local

Frequency not reported: Severe chemical irritation, tissue damage, burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, gangrene[Ref]

Psychiatric

Frequency not reported: Restlessness, anxiety, confusion, disorientation, euphoria, nervousness, insomnia, catatonic-like states, irritability, hysteria, hallucinations, hyperexcitability, nightmares, delirium, agitation/agitated behavior[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, nausea, vomiting, constipation, diarrhea, tongue protrusion, gastric irritation, epigastric distress[Ref]

Cardiovascular

Frequency not reported: Bradycardia, tachycardia, palpitations, hypotension, arrhythmias, circulatory collapse, increased or decreased blood pressure[Ref]

Hematologic

Frequency not reported: Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis, blood dyscrasias, hemolytic anemia, aplastic anemia[Ref]

Dermatologic

Frequency not reported: Dermatitis, photosensitivity, urticaria, rash, pruritus, angioneurotic edema, topical contact dermatitis[Ref]

Other

Frequency not reported: Lassitude, tinnitus, fatigue, tiredness, paradoxical reactions, decreased performance (impaired driving/poor work performance, incoordination, reduced motor skills, impaired information processing)[Ref]

Respiratory

Frequency not reported: Asthma, nasal stuffiness, respiratory depression/fatal respiratory depression, apnea/fatal apnea, marked irregular respiration[Ref]

Ocular

Frequency not reported: Blurred vision, oculogyric crisis, diplopia, angle closure glaucoma[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema, hypersensitivity reactions[Ref]

Musculoskeletal

Frequency not reported: Torticollis, muscle spasms, muscle dyskinesia[Ref]

Metabolic

Frequency not reported: Anorexia, loss of appetite, appetite stimulation[Ref]

Hepatic

Frequency not reported: Jaundice, obstructive jaundice[Ref]

Genitourinary

Frequency not reported: Urinary retention and hesitancy[Ref]

Frequently asked questions

References

1. Product Information. Phenergan (promethazine). Wyeth-Ayerst Laboratories. 2001;PROD.

2. Product Information. Promethazine Hydrochloride (promethazine). ESI Lederle Generics. 2004.

3. Cerner Multum, Inc. UK Summary of Product Characteristics.

4. Cerner Multum, Inc. Australian Product Information.

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.