Duradrin Side Effects
Generic Name: acetaminophen / dichloralphenazone / isometheptene mucate
Note: This page contains information about the side effects of acetaminophen / dichloralphenazone / isometheptene mucate. Some of the dosage forms included on this document may not apply to the brand name Duradrin.
Not all side effects for Duradrin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to acetaminophen / dichloralphenazone / isometheptene mucate: oral capsule
In addition to its needed effects, some unwanted effects may be caused by acetaminophen / dichloralphenazone / isometheptene mucate. In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking acetaminophen / dichloralphenazone / isometheptene mucate, check with your doctor or nurse as soon as possible:Less common
- Unusual tiredness or weakness
- Black, tarry stools
- blood in urine or stools
- pinpoint red spots on skin
- skin rash, hives, or itching
- sore throat and fever
- unusual bleeding or bruising
- yellow eyes or skin
- Headaches, more severe and/or more frequent than before
- increased sweating
- loss of appetite
- nausea or vomiting
- pain, tenderness, and/or swelling in the upper abdominal (stomach) area
- stomach cramps or pain
Some of the side effects that can occur with acetaminophen / dichloralphenazone / isometheptene mucate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- fast or irregular heartbeat
For Healthcare Professionals
Applies to acetaminophen / dichloralphenazone / isometheptene mucate: oral capsule
Transient dizziness and skin rash can usually be eliminated by reducing the dose of acetaminophen/dichloralphenazone/isometheptene.[Ref]
Hypersensitivity side effects including transient dizziness and skin rash have been reported with the use of acetaminophen/dichloralphenazone/isometheptene. Hypersensitivity reactions, including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.[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.
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.
Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.[Ref]
Hepatic side effects including severe and sometimes fatal dose dependent hepatitis have been reported with the use of acetaminophen in alcoholic patients. Hepatotoxicity has been increased during fasting.[Ref]
Gastrointestinal side effects have been rare with the use of acetaminophen except in alcoholics and after overdose.[Ref]
Renal side effects including acute tubular necrosis and interstitial nephritis have been rare with the use of acetaminophen. Adverse renal effects have been most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]
Acute tubular necrosis with acetaminophen use 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]
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 side effects including erythematous skin rashes associated with acetaminophen have been reported rarely. Acetaminophen associated bullous erythema and purpura fulminans have also been reported.[Ref]
Respiratory side effects including a case of acetaminophen-induced eosinophilic pneumonia have been reported.[Ref]
Cardiovascular side effects including at least 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]
1. "Product Information. Midrin (APAP/dichloralphenazone/isometheptene)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
2. Kawada A, Hiruma M, Noguchi H, Ishibashi A "Fixed drug eruption induced by acetaminophen in a 12-year-old girl." Int J Dermatol 35 (1996): 148-9
3. Gursoy M, Haznedaroglu IC, Celik I, Sayinalp N, Ozcebe OI, Dundar SV "Agranulocytosis, plasmacytosis, and thrombocytosis followed by a leukemoid reaction due to acute acetaminophen toxicity." Ann Pharmacother 30 (1996): 762-5
4. Zimmerman HJ, Maddrey WC "Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure." Hepatology 22 (1995): 767-73
5. Nelson EB, Temple AR "Acetaminophen hepatotoxicity, fasting, and ethanol." JAMA 274 (1995): 301
6. Lee WM "Medical progress: drug-induced hepatotoxicity." N Engl J Med 333 (1995): 1118-27
7. Singer AJ, Carracio TR, Mofenson HC "The temporal profile of increased transaminase levels in patients with acetaminophen-induced liver dysfunction." Ann Emerg Med 26 (1995): 49-53
8. Perneger TV, Whelton PK, Klag MJ "Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs." N Engl J Med 331 (1994): 1675-79
9. Shoenfeld Y, Shaklai M, Livni E, Pinkhas J "Thrombocytopenia from acetaminophen." N Engl J Med 303 (1980): 47
10. Filipe PL, Freitas JP, Decastro JC, Silva R "Drug eruption induced by acetaminophen in infectious mononucleosis." Int J Dermatol 34 (1995): 220-1
11. Kondo K, Inoue Y, Hamada H, Yokoyama A, Kohno N, Hiwada K "Acetaminophen-induced eosinophilic pneumonia." Chest 104 (1993): 291-2
12. Brown G "Acetaminophen-induced hypotension." Heart Lung 25 (1996): 137-40
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