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Humatin Side Effects

Generic Name: paromomycin

Note: This document contains side effect information about paromomycin. Some of the dosage forms listed on this page may not apply to the brand name Humatin.

For the Consumer

Applies to paromomycin: oral capsule

Side effects requiring immediate medical attention

Along with its needed effects, paromomycin (the active ingredient contained in Humatin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Side effects not requiring immediate medical attention

Some side effects of paromomycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to paromomycin: oral capsule

Gastrointestinal

Frequency not reported: Nausea, abdominal cramps, diarrhea, gastrointestinal intolerance, vomiting, abdominal discomfort, pancreatitis, elevated serum amylase[Ref]

Nausea, abdominal cramps, and diarrhea have been reported with doses greater than 3 g/day.

A patient with AIDS developed pancreatitis after 5 days of therapy with this drug for cryptosporidiosis. Serum amylase declined progressively after this drug was discontinued but became elevated after reinstitution of therapy.[Ref]

Nervous system

Ototoxicity and sensorineural damage have been reported, usually in patients who also had hepatic disease.[Ref]

Frequency not reported: Ototoxicity, sensorineural damage, headache, vertigo[Ref]

Hepatic

Transient elevated AST (greater than 3 times the upper limit of normal [3 x ULN]) and ALT (greater than 3 x ULN) were reported in patients receiving an IM formulation during a clinical study.[Ref]

Frequency not reported: Elevated AST, elevated ALT[Ref]

Other

Pyrexia was reported in patients receiving an IM formulation during a clinical study.[Ref]

Frequency not reported: Pyrexia[Ref]

Local

Frequency not reported: Injection site pain, injection site swelling[Ref]

Injection site pain and swelling were reported in patients receiving an IM formulation during a clinical study.[Ref]

References

1. Tan WW, Chapnick EK, Abter EIM, Haddad S, Zimbalist EH, Lutwick LI "Paromomycin-associated pancreatitis HIV-related cryptosporidiosis." Ann Pharmacother 29 (1995): 22-4

2. Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK "Injectable paromomycin for Visceral leishmaniasis in India." N Engl J Med 356 (2007): 2571-81

3. "Product Information. Humatin (paromomycin)." Parke-Davis, Morris Plains, NJ.

4. Sullam PM, Slutkin G, Gottlieb AB, Mills J "Paromomycin therapy of endemic amebiasis in homosexual men." Sex Transm Dis 13 (1986): 151-5

5. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):

Further information

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.