KG-Fed Pediatric Expectorant Side Effects
Generic Name: codeine / guaifenesin / pseudoephedrine
Note: This document contains side effect information about codeine / guaifenesin / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name KG-Fed Pediatric Expectorant.
For the Consumer
Applies to codeine / guaifenesin / pseudoephedrine: oral liquid, oral solution, oral syrup
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Very bad dizziness or passing out.
- Chest pain or pressure or a fast heartbeat.
- Trouble breathing, slow breathing, or shallow breathing.
- Noisy breathing.
- Feeling very sleepy.
- Feeling confused.
- A heartbeat that does not feel normal.
- Hallucinations (seeing or hearing things that are not there).
- Mood changes.
- Very bad belly pain.
- Very bad headache.
- Trouble passing urine.
- Change in eyesight.
- Very upset stomach or throwing up.
- Very hard stools (constipation).
- Feeling very tired or weak.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling nervous and excitable.
- Not able to sleep.
- Hard stools (constipation).
- Feeling sleepy.
- Upset stomach or throwing up.
- Sweating a lot.
- Feeling tired or weak.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Frequency not reported: CNS depression, lightheadedness, dizziness, sedation, headache, convulsions, weakness
Frequency not reported: Restlessness, dizziness, weakness, headache, drowsiness, tremor[Ref]
Hypotension is rare and has been reported most frequently with high doses of codeine.
Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]
Frequency not reported: Nausea, vomiting, constipation, biliary tract spasm, increased colonic motility, toxic dilation
Frequency not reported: Oliguria, urinary retention, antidiuretic effect
Frequency not reported: Urinary retention[Ref]
Frequency not reported: Hypersensitivity reactions (pruritus, urticaria)
Frequency not reported: Fixed drug eruptions[Ref]
Frequency not reported: Rash
Frequency not reported: Rash
Frequency not reported: Fixed drug eruption in the form of erythematous nodular patches, rash[Ref]
Frequency not reported: Visual disturbances
Frequency not reported: Angle-closure glaucoma
Frequency not reported: Euphoria, dysphoria, transient hallucination, disorientation
Respiratory depression has been associated with antitussive use of codeine in young children. Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy. Further investigation has shown these patients to be ultra-rapid metabolizers of codeine. Children with obstructive sleep apnea who are treated with codeine appear to be particularly sensitive to the respiratory depressant effects of codeine.
Frequency not reported: Respiratory depression
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2. de Groot AC, Conemans J "Allergic urticarial rash from oral codeine." Contact Dermatitis 14 (1986): 209-14
3. "Product Information. Robitussin (guaifenesin)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
4. Gill ND, Shield A, Blazevich AJ, Zhou S, Weatherby RP "Muscular and cardiorespiratory effects of pseudoephedrine in human athletes." Br J Clin Pharmacol 50 (2000): 205-13
5. Gordon RD, Ballantine DM, Bachmann AW "Effects of repeated doses of pseudoephedrine on blood pressure and plasma catecholamines in normal subjects and in patients with phaeochromocytoma." Clin Exp Pharmacol Physiol 19 (1992): 287-90
6. Mores N, Campia U, Navarra P, Cardillo C, Preziosi P "No cardiovascular effects of single-dose pseudoephedrine in patients with essential hypertension treated with beta-blockers." Eur J Clin Pharmacol 55 (1999): 251-4
7. "Product Information. Robitussin-DAC Syrup (codeine/guaifenesin/PSE)" Whitehall-Robins, Madison, NJ.
8. Dowd J, Bailey D, Moussa K, Nair S, Doyle R, CulpepperMorgan JA "Ischemic colitis associated with pseudoephedrine: Four cases." Am J Gastroenterol 94 (1999): 2430-4
9. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J "Systemic contact dermatitis from pseudoephedrine." Contact Dermatitis 24 (1991): 86-8
10. Vidal C, Prieto A, PerezCarral C, Armisen M "Nonpigmenting fixed drug eruption due to pseudoephedrine." Ann Allergy Asthma Immunol 80 (1998): 309-10
11. Quan MB, Chow WC "Nonpigmenting fixed drug eruption after pseudoephedrine." Int J Dermatol 35 (1996): 367-70
12. Shelley WB, Shelley ED "Nonpigmenting fixed drug eruption as a distinctive reaction pattern: examples caused by sensitivity to pseudoephedrine hydrochloride and tetrahydrozoline." J Am Acad Dermatol 17 (1987): 403-7
13. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40
14. Gonzalogarijo MA, Revengaarranz F "Fixed drug eruption due to codeine." Br J Dermatol 135 (1996): 498-9
15. Hunskaar S, Dragsund S "Scarlatiniform rash and urticaria due to codeine." Ann Allergy 54 (1985): 240-1
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.