Phyllocontin Side Effects

Generic Name: aminophylline

Note: This page contains side effects data for the generic drug aminophylline. It is possible that some of the dosage forms included below may not apply to the brand name Phyllocontin.

It is possible that some side effects of Phyllocontin 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 aminophylline: oral solution, oral tablet, oral tablet extended release

Other dosage forms:

As well as its needed effects, aminophylline (the active ingredient contained in Phyllocontin) may cause unwanted side effects that require medical attention.

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

Rare
  • Cracks in the skin
  • loss of heat from the body
  • red, swollen skin
  • scaly skin
  • skin rash
Incidence not known
  • Chest pain or discomfort
  • dizziness
  • fainting
  • fast, slow, or irregular heartbeat
  • increase in urine volume
  • lightheadedness
  • persistent vomiting
  • pounding or rapid pulse
  • seizures
  • shakiness

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

Symptoms of overdose
  • Abdominal or stomach pain
  • blurred vision
  • confusion
  • confusion about identity, place, and time
  • dark-colored urine
  • decrease in frequency of urination
  • decreased urine
  • diarrhea
  • difficulty in passing urine (dribbling)
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • painful urination
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds

Some aminophylline 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
  • Headache
  • irritability
  • restlessness
  • sleeplessness
  • trouble sleeping
  • unable to sleep

For Healthcare Professionals

Applies to aminophylline: compounding powder, intravenous solution, oral solution, oral tablet, oral tablet extended release, rectal suppository

General

Most of the side effects of aminophylline (the active ingredient contained in Phyllocontin) (theophylline) have been dependent on serum concentrations. Generally, theophylline serum concentrations ranging from 10 to 20 mcg/mL are considered therapeutic, and serum concentrations greater than 20 mcg/mL are associated with greater toxicity.[Ref]

There are several factors which may predispose a patient to higher serum concentrations and, thus, toxicity. These factors may include increased age, concomitant drugs which reduce the clearance of theophylline, hypothyroidism, congestive heart failure, liver disease, renal failure, and alterations in smoking habits. One series of patients with theophylline intoxication had recent upper respiratory tract infections.

The nature of acute toxicity of theophylline differs from chronic toxicity. Acute overdose is associated with higher theophylline concentrations and younger patients. In acute overdose the severity of toxicity is correlated with peak serum concentrations. Chronic overdosage is seen more commonly in older patients, and severe toxicity may occur with serum concentrations which are much lower than those seen in severe acute toxicity. In these patients, age is a predictor of severe toxicity.[Ref]

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, vomiting, and abdominal pain. Aminophylline (the active ingredient contained in Phyllocontin) may also cause locally-mediated gastrointestinal upset.[Ref]

Nervous system

The mechanism of theophylline-induced seizures has not been determined. Seizures are generally focal with secondary generalization. Permanent neurologic deficits have been reported and morbidity may be high, especially in the elderly, patients with severe underlying disease, and patients with prolonged, uncontrolled seizure activity. The onset of seizures is not always preceded by less severe symptoms of aminophylline (the active ingredient contained in Phyllocontin) toxicity. Patients with an abnormal neurologic history, including a history of seizures, cerebral infarct, or head trauma, may be predisposed to seizure activity. If theophylline is used in these types of patients, serum concentrations should be monitored closely and maintained in the low, therapeutic range.[Ref]

Nervous system side effects have included generalized seizures, most commonly in patients with elevated serum concentrations, although seizures have occurred at therapeutic concentrations. Theophylline may also cause nervousness and tremor at therapeutic dosages, which become worse as serum concentrations increase.[Ref]

Cardiovascular

Cardiovascular side effects have included increased heart rate which has progressed to atrial tachycardia or ventricular tachycardia. Patients with a history of arrhythmias may be predisposed to this effect. Hypotension has occurred with rapid intravenous administration.[Ref]

Theophylline serum concentrations are a significant predictor of arrhythmias. One study reported multifocal atrial tachycardia in 8% and 16% of patients with a serum concentration between 10 and 20 mcg/mL and greater than 20 mcg/mL, respectively. The onset of serious arrhythmias is not always preceded by less severe signs of theophylline toxicity.[Ref]

Hypersensitivity

Patients are frequently sensitized to ethylenediamine through topical use, as it is used as a preservative in some topical preparations. These patients are generally able to tolerate plain theophylline preparations.[Ref]

Hypersensitivity side effects have included erythematous rash, pruritus, urticaria, and exfoliative erythroderma. These side effects have been more commonly reported in patients sensitive to ethylenediamine component of aminophylline.[Ref]

Metabolic

Metabolic side effects have included hypokalemia, hyperglycemia, respiratory alkalosis, hypophosphatemia, and hypomagnesemia. The magnitude of these abnormalities have been correlated with theophylline concentrations.[Ref]

In one group of patients with theophylline concentrations greater than 20 mcg/mL, hyperglycemia was present in approximately 50%, hypokalemia in 15%, and hypomagnesemia in 20%. Hyponatremia and hypophosphatemia were seen less frequently.[Ref]

Genitourinary

Genitourinary side effects have included urinary retention.[Ref]

References

1. Shannon M "Predictors of major toxicity after theophylline overdose." Ann Intern Med 119 (1993): 1161-7

2. Milgrom H, Bender B "Current issues in the use of theophylline." Am Rev Respir Dis 147 (1993): s33-9

3. Covelli HD, Knodel AR, Heppner BT "Predisposing factors to apparent theophylline-induced seizures." Ann Allergy 54 (1985): 411-5

4. Aderka D, Shavit G, Garfinkel D, et al "Life-threatening theophylline intoxication in a hypothyroid patient." Respiration 44 (1983): 77-80

5. Schiff GD, Hegde HK, LaCloche L, Hryhorczuk DO "Inpatient theophylline toxicity: preventable factors." Ann Intern Med 114 (1991): 748-53

6. Albert S "Aminophylline toxicity." Pediatr Clin North Am 34 (1987): 61-73

7. Sessler CN "Theophylline toxicity: clinical features of 116 consecutive cases." Am J Med 88 (1990): 567-76

8. "Product Information. Theo-Dur (theophylline)." Schering Laboratories, Kenilworth, NJ.

9. Stoller JL "Oesophageal ulceration and theophylline." Lancet 2 (1985): 328-9

10. Bahls FH, Ma KK, Bird TD "Theophylline-associated seizures with "therapeutic" or low toxic serum concentrations: risk factors for serious outcome in adults." Neurology 41 (1991): 1309-12

11. Buss DC, Marshall RW, Milligan N, Mcqueen I, Compston DAS, Routledge PA "The effect of intravenous aminophylline on essential tremor." Br J Clin Pharmacol 43 (1997): 119-21

12. Hall RC, Beresford TP, Stickney SK, et al "Psychiatric reactions produced by respiratory drugs." Psychosomatics 26 (1985): 605-8,615-6

13. Nakada T, Kwee IL, Lerner AM, Remler MP "Theophylline-induced seizures: clinical and pathophysiologic aspects." West J Med 138 (1983): 371-4

14. Taniguchi A, Ohe T, Shimorura K "Theophylline-induced ventricular tachycardia in a patient with chronic lung disease: sensitivity to verapamil." Chest 96 (1989): 958-9

15. Marchlinski FE, Miller JM "Atrial arrhythmias exacerbated by theophylline: response to verapamil and evidence for triggered activity in man." Chest 88 (1985): 931-4

16. Bittar G, Friedman HS "The arrhythmogenicity of theophylline: a multivariate analysis of clinical determinants." Chest 99 (1991): 1415-20

17. Levine JH, Michael JR, Guarnieri T "Multifocal atrial tachycardia: a toxic effect of theophylline." Lancet 1 (1985): 12-4

18. Patel AK, Skatrud JB, Thomsen JH "Cardiac arrhythmias due to oral aminophylline in patients with chronic obstructive pulmonary disease." Chest 80 (1981): 661-5

19. Mohsenifar Z, Lehrman S, Carson SA, Tashkin D "Two cases of allergy to aminophylline." Ann Allergy 49 (1982): 281-2

20. Bernstein JE, Lorincz AL "Ethylenediamine-induced exfoliative erythroderma." Arch Dermatol 115 (1979): 360-1

21. deShazo RD, Stevenson HC "Generalized dermatitis to aminophylline." Ann Allergy 46 (1981): 152-5

22. Elias JA, Levinson AI "Hypersensitivity reactions to ethylenediamine in aminophylline." Am Rev Respir Dis 123 (1981): 550-2

23. Terzian CG, Simon PA "Aminophylline hypersensitivity apparently due to ethylenediamine." Ann Emerg Med 21 (1992): 312-4

24. Hall KW, Dobson KE, Dalton JG, Ghignone MC, Penner SB "Metabolic abnormalites associated with intentional theophylline overdose." Ann Intern Med 101 (1984): 457-62

25. Hagley MT, Traeger SM, Schuckman H "Pronounced metabolic response to modest theophylline overdose." Ann Pharmacother 28 (1994): 195-6

26. Flack JM, Ryder KW, Strickland D, Whang R "Metabolic correlates of theophylline therapy: a concentration-related phenomenon." Ann Pharmacother 28 (1994): 175-9

27. Prakash M, Washburne JD "Theophylline and urinary retention." Ann Intern Med 94 (1981): 823

28. Clark BG, Vestal RE "Adverse drug reactions in the elderly: case studies." Geriatrics 39 (1984): 53-4,60-3,66

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