Mepron Side Effects

Generic Name: atovaquone

Note: This page contains information about the side effects of atovaquone. Some of the dosage forms included on this document may not apply to the brand name Mepron.

Not all side effects for Mepron 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 atovaquone: oral suspension, oral tablet

In addition to its needed effects, some unwanted effects may be caused by atovaquone (the active ingredient contained in Mepron). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking atovaquone:

More common
  • Cough or hoarseness
  • difficult or labored breathing
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • shortness of breath
  • tightness in chest
  • wheezing
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • bloating
  • blood in urine or stools
  • bluish-colored lips, fingernails, or palms
  • constipation
  • dark urine
  • dizziness or lightheadedness
  • fast heartbeat
  • headache
  • indigestion
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • nausea
  • noisy breathing
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on skin
  • rapid heart rate
  • sore throat
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Some of the side effects that can occur with atovaquone 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
  • Abdominal or stomach pain
  • diarrhea
  • lack or loss of strength
  • runny nose
  • skin rash
  • sleeplessness
  • sneezing
  • sore mouth or tongue
  • stuffy nose
  • sweating
  • trouble in sleeping
  • unable to sleep
  • white patches in mouth, tongue, or throat
Incidence not known
  • Blistering, peeling, or loosening of skin
  • eye irritation or redness
  • itching
  • joint or muscle pain
  • red skin lesions, often with a purple center
  • skin rash

For Healthcare Professionals

Applies to atovaquone: oral suspension

General

In PCP prevention studies comparing atovaquone (the active ingredient contained in Mepron) to inhaled pentamidine, 16% to 25% of patients discontinued atovaquone and 7% discontinued pentamidine due to adverse events. Rash (6%), diarrhea (4%), and nausea (3%) were the most common reasons for discontinuing atovaquone, while bronchospasm (2%) was the most common reason for discontinuing pentamidine. In studies comparing atovaquone to dapsone, treatment-limiting hypersensitivity reactions were more frequent in the dapsone group (16.1%) and treatment-limiting gastrointestinal side effects were more common in the atovaquone group (up to 4.1%).

In PCP treatment studies, 9% of patients discontinued atovaquone due to side effects, compared to 24% of patients receiving sulfamethoxazole-trimethoprim. The most common reason for discontinuation in both treatment groups was rash (atovaquone, 4%; sulfamethoxazole-trimethoprim, 8%). In studies comparing intravenous pentamidine and atovaquone, 63% of patients in the atovaquone group and 72% of patients in the pentamidine group reported side effects. Treatment was discontinued in 7% of the atovaquone patients and 41% of the pentamidine patients due to adverse events; the most common reasons were rash (4%) in the atovaquone group and hypoglycemia (11%) and vomiting (9%) in the pentamidine group.[Ref]

Gastrointestinal

Gastrointestinal side effects are among the most common and have included nausea (up to 40%), diarrhea (up to 42%), vomiting (up to 22%), abdominal pain (up to 21%), oral monilia (up to 10%), taste perversion (3%), and constipation (3%). The incidence of side effects was higher in patients in PCP treatment studies than in prevention studies. Seven percent of patients experience anorexia and 5% of patients experience dyspepsia, although these are difficult to attribute to the drug due to the serious underlying diseases in the patients who receive atovaquone (the active ingredient contained in Mepron) Hyperamylasemia has been reported in 8% of patients. Pancreatitis has also been reported during postmarketing experience.[Ref]

Dermatologic

Dermatologic side effects have included rash (up to 46%), pruritus (greater than or equal to 10%), exfoliative dermatitis, photosensitivity, and toxic epidermal necrolysis. Erythema multiforme, Stevens-Johnson syndrome, and skin desquamation have been reported during postmarketing experience in patients receiving multiple drug treatment including atovaquone (the active ingredient contained in Mepron) [Ref]

Hepatic

Hepatic side effects have included elevated ALT (greater than 5 times ULN, 6%), elevated AST (greater than 5 times ULN, 4%), elevated alkaline phosphatase (greater than 2.5 times ULN, up to 8%), and increased amylase (greater than 1.5 times ULN, up to 8%) in patients being treated for PCP. Therapy was discontinued in 2% of patients receiving atovaquone (the active ingredient contained in Mepron) due to ALT/AST elevations, compared to 7% of patients being treated with sulfamethoxazole-trimethoprim. Hepatomegaly has also been reported. Rarely, hepatitis and at least one case of fatal liver failure have been reported during postmarketing experience.[Ref]

Hematologic

Hematologic side effects have included anemia (up to 6%) and neutropenia (up to 5%), but may be due to underlying disease. Methemoglobinemia and thrombocytopenia have also been reported.[Ref]

Metabolic

Metabolic side effects have included hyponatremia (up to 10%), hyperglycemia (9%), and hypoglycemia (1%).[Ref]

Other

Other side effects have included fever (up to 40%), asthenia (up to 31%), flu syndrome (greater than or equal to 10%), pain (greater than or equal to 10%), infection (up to 22%), sweating (greater than or equal to 10%), and malaise, but some may be due to underlying disease. Fatigue, night sweats, and burning sensation of the tongue have also been reported.[Ref]

Respiratory

Respiratory side effects have included dyspnea (up to 21%), increased cough (up to 25%), rhinitis (up to 24%), sinusitis (greater than or equal to 10%), bronchospasm (up to 4%), and pneumonia.[Ref]

Nervous system

Nervous system side effects have included insomnia (up to 19%), dizziness (up to 8%), headache (up to 31%), anxiety (7%), and depression (greater than or equal to 10%).[Ref]

Musculoskeletal

Musculoskeletal side effects have included myalgia (greater than or equal to 10%).[Ref]

Hypersensitivity

Hypersensitivity reactions have included rash, erythema multiforme, exfoliative dermatitis, and allergic reactions (unspecified, up to 1.1%).[Ref]

Renal

Renal side effects have included elevated creatinine (1%) and elevated BUN (1%). Acute renal impairment has been reported during postmarketing experience.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension (1%).

Ocular

Ocular side effects have included vortex keratopathy during postmarketing experience.[Ref]

Immunologic

Immunologic side effects have included hypersensitivity reactions including angioedema, bronchospasm, throat tightness, and urticaria during postmarketing experience.[Ref]

References

1. Hughes WT "A new drug (566C80) for the treatment of pneumocystis carinii pneumonia." Ann Intern Med 116 (1992): 953-4

2. Dohn MN, Frame PT, Baughman RP, Hughes WT, LaFon SW "Extended therapy with 566C80 for pneumocystis pneumonia in AIDS patients." Chest 100 (1991): s127

3. Araujo FG, Lin T, Remington JS "The activity of atovaquone (566C80) in murine toxoplasmosis is markedly augmented when used in combination with pyrimethamine or sulfadiazine." J Infect Dis 167 (1993): 494-7

4. Haile LG, Flaherty JF "Atovaquone: a review." Ann Pharmacother 27 (1993): 1488-94

5. Falloon J, Sargent S, Piscitelli SC, Bechtel C, LaFon SW, Sadler B, Walker RE, Kovacs JA, Polis MA, Davey RT, Lane HC, Ma "Atovaquone suspension in HIV-infected volunteers: Pharmacokinetics, pharmacodynamics, and TMP-SMX interaction study." Pharmacotherapy 19 (1999): 1050-6

6. Dohn MN, Frame PT, Baughman RP, et al "Open-label efficacy and safety trial of 42 days of 566C80 for pneumocystis carinii pneumonia in AIDS patients." J Protozool 38 (1991): s220-1

7. Dohn MN, Weinberg WG, Torres RA, Follansbee SE, Caldwell PT, Scott JD, Gathe JC, Haghighat DP, Sampson JH, Spotkov J, Der "Oral atovaquone compared with intravenous pentamidine for pneumocystis carinii pneumonia in patients with AIDS." Ann Intern Med 121 (1994): 174-80

8. Torres RA, Weinberg W, Stansell J, Leoung G, Kovacs J, Rogers M, Scott J "Atovaquone for salvage treatment and suppression of toxoplasmic encephalitis in patients with AIDS." Clin Infect Dis 24 (1997): 422-9

9. Kovacs JA "Efficacy of atovaquone in treatment of toxoplasmosis in patients with AIDS." Lancet 340 (1992): 637-8

10. Hughes WT, Lafon SW, Scott JD, Masur H "Adverse events associated with trimethoprim-sulfamethoxazole and atovaquone during the treatment of AIDS-related pneumocystis carinii pneumonia." J Infect Dis 171 (1995): 1295-301

11. Falloon J, Kovacs J, Hughes W, et al "A preliminary evaluation of 566C80 for the treatment of pneumocystis pneumonia in patients with the acquired immunodeficiency syndrome." N Engl J Med 325 (1991): 1534-8

12. Chan C, Montaner J, Lefebvre EA, Morey G, Dohn M, McIvor RA, Scott J, Marina R, Caldwell P "Atovaquone suspension compared with aerosolized pentamidine for prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected subjects intolerant of trimethoprim or sulfonamides." J Infec Dis 180 (1999): 369-76

13. Iaccheri B, Fiore T, Papadaki T, et al. "Adverse drug reactions to treatments for ocular toxoplasmosis: A retrospective chart review." Clin Ther 30 (2008): 2069-74

14. "Product Information. Mepron (atovaquone)." Glaxo Wellcome, Research Triangle Park, NC.

15. Pearson PA, Piracha AR, Sen HA, Jaffe GJ "Atovaquone for the treatment of toxoplasma retinochoroiditis in immunocompetent patients." Ophthalmology 106 (1999): 148-53

16. Raju M, Salazar JC, Leopold H, Krause PJ "ATOVAQUONE AND AZITHROMYCIN TREATMENT FOR BABESIOSIS IN AN INFANT." Pediatr Infect Dis J 26 (2007): 181-183

17. Katlama C, Mouthon B, Gourdon D, Lapierre D, Rousseau F "Atovaquone as long-term suppressive therapy for toxoplasmic encephalitis in patients with AIDS and multiple drug intolerance Atovaquone Expanded Access Group." AIDS 10 (1996): 1107-12

18. ElSadr WM, Murphy RL, Yurik RM, LuskinHawk R, Cheung TW, Balfour HH, Eng R, Hooton TM, Kerkering TM, Schutz M, vanderHorst "Atovaquone compared with dapsone for the prevention of Pneumocystis carinii pneumonia in patients with HIV infection who cannot tolerate trimethoprim, sulfonamides, or both." N Engl J Med 339 (1998): 1889-95

19. Dixon R, Pozniak AL, Watt HM, Rolan P, Posner J "Single-dose and steady-state pharmacokinetics of a novel microfluidized suspension of atovaquone in human immunodeficienc virus-seropositive patients." Antimicrob Agents Chemother 40 (1996): 556-60

20. Spencer CM, Goa KL "Atovaquone: a review of its pharmacological properties and therapeutic efficacy in opportunistic infections." Drugs 50 (1995): 176-96

21. Shah GK, Cantrill HL, Holland EJ "Vortex keratopathy associated with atovaquone." Am J Ophthalmol 120 (1995): 669-71

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