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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: solution.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Injection route (solution)

Respiratory Depression – Pediatrics. Promethazine 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 Gangrene. Promethazine 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.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine contains sodium metabisulfite. Make sure your doctor knows if you or your child have had an allergic reaction to sulfite in the past.

Check with your doctor right away if you or your child have burning, persistent or worsening pain at the injection site; or any involuntary muscle movements after receiving this medicine.

This medicine may affect blood sugar levels. If you or your child 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 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; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are taking this medicine.

Check with your doctor right away if you or your child have 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.

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.

Promethazine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor right away if you or your child are having convulsions, difficulty in breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a liver problem.

Before you have any medical tests, tell the medical doctor in charge that you or your child are receiving 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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 or nurse immediately if any of the following side effects occur while taking promethazine:

Rare side effects

  • convulsions (seizures)
  • difficult or unusually fast breathing
  • fast heartbeat or irregular pulse
  • high fever
  • high or low 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
  • blood in the urine
  • bloody nose
  • blurred vision
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • cough or hoarseness
  • dark urine
  • decreased awareness or responsiveness
  • difficulty with speaking
  • dizziness
  • double vision
  • drooling
  • fast, pounding, or irregular heartbeat or pulse
  • fever with or without chills
  • fixed position of the eye
  • headache
  • heavier menstrual periods
  • increases and decreases in blood pressure
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • loss of balance control
  • lower back or side pain
  • mimicry of speech or movements
  • muscle trembling, jerking, or stiffness
  • mutism
  • nausea
  • negativism
  • noisy breathing
  • painful or difficult urination
  • peculiar postures or movements, mannerisms, or grimacing
  • pinpoint red spots on the skin
  • restlessness
  • seeing double
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe sleepiness
  • shortness of breath
  • shuffling walk
  • skin rash
  • slow or irregular heartbeat
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiffness of the limbs
  • swollen glands
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • tightness in the chest
  • tremors
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
  • unpleasant breath odor
  • unusual bleeding or bruising
  • vomiting of blood
  • wheezing
  • yellow eyes or skin

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

Symptom of overdose

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, or reddening of the skin
  • continuing ringing or buzzing or other unexplained noise in the ears
  • discoloration of the skin
  • drowsiness
  • dry mouth
  • excitation
  • false or unusual sense of well-being
  • hearing loss
  • hives or welts
  • increased sensitivity of the skin to sunlight
  • lack of coordination
  • loss of strength or energy
  • muscle pain or weakness
  • nasal stuffiness
  • nervousness
  • severe sunburn
  • sleeplessness
  • trouble sleeping
  • 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

Local

Psychiatric

Gastrointestinal

Cardiovascular

Hematologic

Dermatologic

Other

Respiratory

Ocular

Hypersensitivity

Musculoskeletal

Metabolic

Hepatic

Genitourinary

See also:

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

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.