Humatin

1-10%

Diarrhea

Abdominal cramps

Nausea

Vomiting

Heartburn

<1%

Headache

Vertigo

Exanthema

Rash

Pruritus

Steatorrhea

Secondary enterocolitis

Eosinophilia

Ototoxicity

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

Call your doctor at once if you have:

• diarrhea that is watery or bloody; or
• little or no urinating.

Common side effects may include:

• stomach cramps; or
• mild diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily.

Applies to paromomycin: oral capsule

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.

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:

• Abdominal or stomach cramps
• diarrhea
• nausea

Applies to paromomycin: oral capsule

Gastrointestinal

Gastrointestinal side effects of paromomycin (the active ingredient contained in Humatin) have commonly included nausea, vomiting, diarrhea, and abdominal discomfort, especially with doses greater than 3 g per day. Malabsorption of xylose and sucrose has been reported. A case of pancreatitis in an AIDS patient has been attributed to paromomycin.[Ref]

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

Nervous system

Nervous system side effects have rarely included ototoxicity and sensorineural damage, usually in patients who also had hepatic disease. Rarely, patients may also experience headache or vertigo.[Ref]

Renal

Nephrotoxicity is a consideration with the use of any aminoglycoside, however, paromomycin (the active ingredient contained in Humatin) is poorly absorbed by the gastrointestinal tract. Accumulation of paromomycin may be problematic in patients with impaired renal function and patients treated with multiple or prolonged courses of therapy.[Ref]

Hepatic

Hepatic side effects have included transient elevated aspartate transaminase (greater than 3 times ULN) and alanine transaminase (greater than 3 times ULN) in patients receiving intramuscular paromomycin (the active ingredient contained in Humatin) during a clinical study.[Ref]

Local

Local side effects have included injection site pain and swelling in patients receiving intramuscular paromomycin (the active ingredient contained in Humatin) during a clinical study.[Ref]

Other

Other side effects have included pyrexia in patients receiving intramuscular paromomycin (the active ingredient contained in Humatin) during a clinical study.[Ref]

Some side effects of Humatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.