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Prodrin Side Effects

Generic name: acetaminophen / caffeine / isometheptene mucate

Medically reviewed by Drugs.com. Last updated on Jan 21, 2024.

Note: This document provides detailed information about Prodrin Side Effects associated with acetaminophen / caffeine / isometheptene mucate. Some dosage forms listed on this page may not apply specifically to the brand name Prodrin.

Applies to acetaminophen / caffeine / isometheptene mucate: oral capsule, oral tablet.

Important warnings This medicine can cause some serious health issues

You should not use this medicine if you have liver disease, severe kidney disease, heart disease, high blood pressure, or glaucoma.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days.

A dangerous drug interaction could occur.

MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medicine than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen/caffeine/isometheptene mucate: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Managing side effects (general information)

For healthcare professionals

Applies to acetaminophen / caffeine / isometheptene mucate: oral capsule, oral tablet.

General adverse events

General side effects including caffeinism have been reported. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). Caffeine may cause anxiety and panic in panic disorder patients and may aggravate PMS.[Ref]

Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. It has also been reported that chronic, heavy caffeine ingestion may be associated with depression.[Ref]

Hepatic

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis have been reported in alcoholic patients with the use of acetaminophen. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.[Ref]

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Other

Other side effects including an increased incidence of fibrocystic breast disease have been reported with caffeine use.[Ref]

In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.[Ref]

Gastrointestinal

Gastrointestinal side effects have been rare with the use of acetaminophen, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with the use of acetaminophen. In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.[Ref]

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Renal

Renal side effects have been rare with the use of acetaminophen and have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A recent case control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.[Ref]

Hypersensitivity

Hypersensitivity side effects, including anaphylaxis and fixed drug eruptions, have been reported rarely in association with acetaminophen use.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Dermatologic

Dermatologic side effects including erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have also been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

Respiratory

Respiratory side effects including a case of acetaminophen-induced eosinophilic pneumonia have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including two cases of hypotension have been reported following the administration of acetaminophen.[Ref]

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

References

1. Zimmerman HJ, Maddrey WC (1995) "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology, 22, p. 767-73

2. Gursoy M, Haznedaroglu IC, Celik I, Sayinalp N, Ozcebe OI, Dundar SV (1996) "Agranulocytosis, plasmacytosis, and thrombocytosis followed by a leukemoid reaction due to acute acetaminophen toxicity." Ann Pharmacother, 30, p. 762-5

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

4. Perneger TV, Whelton PK, Klag MJ (1994) "Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs." N Engl J Med, 331, p. 1675-79

5. Clementz GL, Dailey JW (1988) "Psychotropic effects of caffeine." Am Fam Physician, 37, p. 167-72

6. Sawynok J (1995) "Pharmacological rationale for the clinical use of caffeine." Drugs, 49, p. 37-50

7. Boyle CA, Berkowitz GS, LiVolsi VA, Ort S, Merino MJ, White C, Kelsey JL (1984) "Caffeine consumption and fibrocystic breast disease: a case-control epidemiologic study." J Natl Cancer Inst, 72, p. 1015-9

8. Lee WM (1995) "Medical progress: drug-induced hepatotoxicity." N Engl J Med, 333, p. 1118-27

9. Kawada A, Hiruma M, Noguchi H, Ishibashi A (1996) "Fixed drug eruption induced by acetaminophen in a 12-year-old girl." Int J Dermatol, 35, p. 148-9

10. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J (1980) "Thrombocytopenia from acetaminophen." N Engl J Med, 303, p. 47

11. Filipe PL, Freitas JP, Decastro JC, Silva R (1995) "Drug eruption induced by acetaminophen in infectious mononucleosis." Int J Dermatol, 34, p. 220-1

12. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K (1993) "Acetaminophen-induced eosinophilic pneumonia." Chest, 104, p. 291-2

13. Brown G (1996) "Acetaminophen-induced hypotension." Heart Lung, 25, p. 137-40

Further information

Prodrin 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.

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