Promethazine with Codeine Side Effects

Generic Name: codeine / promethazine

Note: This page contains side effects data for the generic drug codeine / promethazine. It is possible that some of the dosage forms included below may not apply to the brand name Promethazine with Codeine.

It is possible that some side effects of Promethazine with Codeine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to codeine / promethazine: oral syrup

As well as its needed effects, codeine / promethazine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking codeine / promethazine, check with your doctor immediately:

Incidence not known
  • Abdominal or stomach pain
  • bluish lips or skin
  • chills
  • clay-colored stools
  • cold sweats
  • confusion
  • convulsions
  • cough
  • dark urine
  • decrease in the frequency of urination
  • decrease in the urine volume
  • diarrhea
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • headache
  • high fever
  • hives or welts
  • increased sweating
  • irregular, fast or slow, or shallow breathing
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • loss of bladder control
  • nausea
  • noisy breathing
  • not breathing
  • painful urination
  • pale or blue lips, fingernails, or skin
  • rash
  • rectal bleeding
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • seeing, hearing, or feeling things that are not there
  • severe muscle stiffness
  • shakiness in the legs, arms, or hands
  • shortness of breath
  • sweating
  • tightness in the chest
  • tiredness
  • trembling or shaking of the hands or feet
  • unpleasant breath odor
  • unusual tiredness or weakness
  • unusually pale skin
  • vomiting of blood
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking codeine / promethazine, get emergency help immediately:

Symptoms of overdose
  • Cold, clammy skin
  • dry mouth
  • fainting
  • irregular heartbeat
  • no blood pressure or pulse
  • no muscle tone or movement
  • pinpoint pupils (black part of the eye)
  • stopping of the heart
  • unconsciousness

Some codeine / promethazine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not known
  • Bad dreams
  • blurred or loss of vision
  • confusion as to time, place, or person
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty having a bowel movement (stool)
  • disturbed color perception
  • double vision
  • drowsiness
  • false or unusual sense of well-being
  • halos around lights
  • hearing loss
  • holding false beliefs that cannot be changed by fact
  • increased sensitivity of the skin to sunlight
  • night blindness
  • overbright appearance of lights
  • redness or other discoloration of the skin
  • relaxed and calm
  • severe sunburn
  • sleepiness
  • trouble sleeping
  • tunnel vision
  • unusual excitement, nervousness, or restlessness
  • vomiting

For Healthcare Professionals

Applies to codeine / promethazine: oral syrup

Nervous system

Nervous system side effects of codeine have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has been associated with codeine therapy, particularly in the elderly. Nervous system side effects of promethazine are common and include excessive sedation, drowsiness, fatigue, paradoxical excitation, and decreased motor coordination. Extrapyramidal effects (including oculogyric crises, torticollis and tongue protrusion), encephalitic symptoms, convulsions, and psychosis have been rarely reported.[Ref]

Opioids may result in psychotic symptoms in some patients.

One retrospective study of elderly patients who sustained a hip fracture suggested that the relative risk of hip fracture was 1.6 in patients using codeine compared to age-matched non-users.[Ref]

Other

Other side effects of codeine have included withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics, including codeine, and have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating. Other side effects of promethazine have rarely included the neuroleptic malignant syndrome.[Ref]

Fever, altered consciousness, autonomic dysfunction, and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate of about 20%. Immediate discontinuation of promethazine and intensive monitoring and supportive care are indicated.[Ref]

Cardiovascular

Cardiovascular adverse effects of codeine have included hypotension and dizziness. Cardiovascular effects of promethazine have included rarely observed tachycardia, bradycardia, and transient hypotension. Prolongation of the QT interval, heart block, and malignant arrhythmias have been reported in association with other phenothiazines.[Ref]

Gastrointestinal

Gastrointestinal side effects of codeine have included nausea, vomiting, and constipation. Severe constipation and ileus resulting in colonic perforation have been also reported. Four cases of acute pancreatitis have been reported. Gastrointestinal side effects of promethazine have included nausea and vomiting.[Ref]

Genitourinary

Genitourinary side effects of codeine have included urinary retention.[Ref]

Dermatologic

Dermatologic side effects of codeine have included rash. Codeine-induced rash may be related to direct stimulation of histamine release. There are also case reports of severe scarlatiniform eruptions.[Ref]

Renal

Renal side effects of codeine have included acute renal failure (which may respond to naloxone therapy).[Ref]

Immunologic

Immunologic side effects of codeine have included one study of a patient with exercise-induced anaphylaxis and three control subjects. This study found a correlation between codeine wheal size and recent exercise. Immunologic side effects of promethazine have included rare reports of a systemic lupus erythematosus syndrome.[Ref]

Hypersensitivity

Hypersensitivity reactions have included rare reports of rash, pruritus, hypotension, photosensitivity, and tachycardia.[Ref]

Hematologic

Hematologic effects of promethazine have included rare cases of neutropenia.[Ref]

General

The adverse effects of codeine may be more likely and more severe in this patient with liver and renal disease.[Ref]

References

1. Bradley CM, Nicholson AN "Effects of a mu-opoiod receptor agonist (codeine phosphate) on visuo-motor coordination and dynamic visual acuity in man." Br J Clin Pharmacol 22 (1986): 507-12

2. Malek-Ahmadi P, Ramsey ML "Acute psychosis associated with codeine and acetaminophen: a case report." Neurobehav Toxicol Teratol 7 (1985): 193-4

3. Cox RG "Hypoxaemia and hypotension after intravenous codeine phosphate." Can J Anaesth 41 (1994): 1211-3

4. McAllister CJ, Scowden EB, Stone WJ "Toxic psychosis induced by phenothiazine administration in patients with chronic renal failure." Clin Nephrol 10 (1978): 191-5

5. Redpath JB, Pleuvry BJ "Double-blind comparison of the respiratory and sedative effects of codeine phosphate and (+/-)-glaucine phosphate in human volunteers." Br J Clin Pharmacol 14 (1982): 555-8

6. Stambaugh JE Jr, McAdams J "Comparison of the analgesic efficacy and safety of oral ciramadol, codeine, and placebo in patients with chronic cancer pain." J Clin Pharmacol 27 (1987): 162-6

7. Wood CD, Manno JE, Manno BR, Redetzki HM, Wood M, Vekovius WA "Side effects of antimotion sickness drugs." Aviat Space Environ Med 55 (1984): 113-6

8. Fisher SE "Encephalitic reaction to promethazine." J Pediatr 80 (1972): 896-7

9. Tenenbein M "The neuroleptic malignant syndrome: occurrence in a 15-year-old boy and recovery with bromocriptine therapy." Pediatr Neurosci 12 (1985): 161-4

10. "Multum Information Services, Inc. Expert Review Panel"

11. Max MB, Schafer SC, Culnane M, et al "Association of pain relief with drug side effects in postherpeticneuralgia: a single-dose study of clonidine, codeine, ibuprofen, and placebo." Clin Pharmacol Ther 43 (1988): 363-71

12. Schwinghammer TL, Kroboth FJ, Juhl RP "Extrapyramidal reaction secondary to oral promethazine." Clin Pharm 3 (1984): 83-5

13. "Product Information. Phenergan with Codeine (codeine-promethazine)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

14. Shorr RI, Griffin MR, Daugherty JR, Ray WA "Opioid analgesics and the risk of hip fracture in the elderly: codeine and propoxyphene." J Gerontol 47 (1992): m111-5

15. de Groot AC, Conemans J "Allergic urticarial rash from oral codeine." Contact Dermatitis 14 (1986): 209-14

16. Nicholson AN "Central effects of H1 and H2 antihistamines." Aviat Space Environ Med 56 (1985): 293-8

17. "Product Information. Calcidrine (codeine)." Abbott Pharmaceutical, Abbott Park, IL.

18. Parke TJ, Nandi PR, Bird KJ, Jewkes DA "Profound hypotension following intravenous codeine phosphate: three case reports and some recommendations." Anaesthesia 47 (1992): 852-4

19. Matske GR, Chan GL, Abraham PA "Codeine dosage in renal failure." Clin Pharm 5 (1986): 15-6

20. Hastier P, Buckley MJM, Peten EP, Demuth N, Dumas R, Demarquay JF, CaroliBosc FX, Delmont JP "A new source of drug-induced acute pancreatitis: Codeine." Am J Gastroenterol 95 (2000): 3295-8

21. Stringer MD, Greenfield S, McIrvine AJ "Stercoral perforation of the colon following postoperative analgesia." J R Soc Med 80 (1987): 115-6

22. Gonzalogarijo MA, Revengaarranz F "Fixed drug eruption due to codeine." Br J Dermatol 135 (1996): 498-9

23. Hunskaar S, Dragsund S "Scarlatiniform rash and urticaria due to codeine." Ann Allergy 54 (1985): 240-1

24. Hill SA, Quinn K, Shelly MP, Park GR "Reversible renal failure following opioid administration." Anaesthesia 46 (1991): 938-9

25. Park GR, Shelly MP, Quinn K, Roberts P "Dihydrocodeine: a reversible cause of renal failure?" Eur J Anaesthesiol 6 (1989): 303-14

26. Barnes JN, Williams AJ, Tomson MJ, et al "Dihydrocodeine in renal failure: further evidence for an important role of the kidney in the handling of opioid drugs." Br Med J (Clin Res Ed) 290 (1985): 740-2

27. Fabius AJ, Gaulhofer WK "Systemic lupus erythematosus induced by psychotropic drugs." Acta Rheumatol Scand 17 (1971): 137-47

28. Lin RY, Barnard M "Skin testing with food, codeine, and histamine in exercise-induced anaphylaxis." Ann Allergy 70 (1993): 475-8

29. "Product Information. Phenergan (promethazine)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

30. Mills PJ "Anaphylactoid reaction to oral premedication with temazepam and promethazine ." Anaesthesia 43 (1988): 66

31. Findlay JW, Jones EC, Butz RF, Welch RM "Plasma codeine and morphine concentrations after therapeutic oral doses of codeine-containing analgesics." Clin Pharmacol Ther 24 (1978): 60-8

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