Phenadoz Side Effects
Generic name: promethazine
Medically reviewed by Drugs.com. Last updated on May 8, 2024.
Note: This document provides detailed information about Phenadoz Side Effects associated with promethazine. Some dosage forms listed on this page may not apply specifically to the brand name Phenadoz.
Applies to promethazine: rectal suppository.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Rectal route (suppository)
Promethazine hydrochloride 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 hydrochloride in pediatric patients less than 2 years of age.
A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.
Caution should be exercised when administering promethazine hydrochloride to pediatric patients 2 years or age and older.
It is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects .
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor .
This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, antidepressants, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.
Check with your doctor right away if you have symptoms of pale or blue lips, fingernails, or skin; difficult or troubled breathing; irregular, fast, slow, or shallow breathing; or shortness of breath. These could be signs of a condition called respiratory depression .
Check with your doctor right away and stop taking your medicine (if directed by your doctor) if you have muscle stiffness, fever, difficult or fast breathing, seizures, fast heartbeat, increased sweating, loss of bladder control, unusually pale skin, or tiredness or weakness. These may be symptoms of a serious condition called neuroleptic malignant syndrome (NMS) .
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine .
This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections .
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .
This medicine controls nausea and vomiting. For this reason, it may cover up some of the signs of overdose caused by other medicines or the symptoms of encephalopathy or Reye's syndrome. This will make it difficult for your doctor to diagnose these conditions. Make sure your doctor knows that you are using this medicine .
Serious side effects of Phenadoz
Along with its needed effects, promethazine (the active ingredient contained in Phenadoz) 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 immediately if any of the following side effects occur while taking promethazine:
Stop taking promethazine and get emergency help immediately if any of the following effects occur:
Rare side effects
- convulsions (seizures)
- difficult or unusually fast breathing
- fast heartbeat or irregular pulse
- high fever
- high or low (irregular) blood pressure
- increased sweating
- loss of bladder control
- severe muscle stiffness
- unusually pale skin
- unusual tiredness or weakness
Incidence not known
- abdominal or stomach pain
- black, tarry stools
- bleeding gums
- blood in urine or stools
- bloody nose
- blurred vision
- chest pain or discomfort
- chills
- clay-colored stools
- confusion as to time, place, or person
- cough or hoarseness
- dark urine
- decreased awareness or responsiveness
- difficulty or troubled breathing
- double vision
- fast, pounding, or irregular heartbeat or pulse
- fever with or without chills
- fixed position of eye
- headache
- heavier menstrual periods
- high fever
- holding false beliefs that cannot be changed by fact
- hyperexcitability
- increased or decreased blood pressure
- increased sweating
- irregular, fast or slow, or shallow breathing
- itching
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- loss of appetite
- loss of bladder control
- lower back or side pain
- mimicry of speech or movements
- mutism
- nasal stuffiness
- nausea
- negativism
- nightmares
- noisy breathing
- not breathing
- painful or difficult urination
- pale or blue lips, fingernails, or skin
- peculiar postures or movements, mannerisms or grimacing
- pinpoint red spots on skin
- seeing double
- seeing, hearing, or feeling things that are not there
- seizures
- severe muscle stiffness
- severe sleepiness
- shortness of breath
- skin rash
- slow or irregular heartbeat
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- sticking out of tongue
- swollen glands
- tightness in chest
- tremors
- uncontrolled twisting movements of neck
- unpleasant breath odor
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- vomiting of blood
- wheezing
- yellow eyes or skin
Symptoms of overdose
- discouragement
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- dry mouth
- excessive muscle tone
- feeling of warmth
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- muscle tension or tightness
- overactive reflexes
- pupils of eyes large and not moving or responding to light
- redness of the face, neck, arms and occasionally, upper chest
- shakiness and unsteady walk
- sudden death
- trouble concentrating
- trouble sleeping
- unconsciousness
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual paleness
Other side effects of Phenadoz
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
- blistering, crusting, irritation, itching, or reddening of skin
- continuing ringing or buzzing or other unexplained noise in ears
- cracked, dry, scaly skin
- dizziness
- drowsiness
- excitation
- false or unusual sense of well-being
- hearing loss
- hives or welts
- increased sensitivity of skin to sunlight
- lack of coordination
- loss of strength or energy
- muscle pain or weakness
- redness or other discoloration of skin
- relaxed and calm
- sunburn
- swelling
- unable to sleep
- vomiting
For healthcare professionals
Applies to promethazine: compounding powder, injectable solution, oral syrup, oral tablet, rectal suppository.
General adverse events
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]
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References
1. (2001) "Product Information. Phenergan (promethazine)." Wyeth-Ayerst Laboratories
2. (2004) "Product Information. Promethazine Hydrochloride (promethazine)." ESI Lederle Generics
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
Frequently asked questions
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More about Phenadoz (promethazine)
- Check interactions
- Compare alternatives
- Reviews (1)
- Dosage information
- During pregnancy
- Drug class: antihistamines
- Breastfeeding
Patient resources
Other brands
Phenergan, Promethegan, Antinaus 50
Professional resources
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Further information
Phenadoz side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.