RhoGAM Side Effects

Generic name: rho (d) immune globulin

Medically reviewed by Drugs.com. Last updated on Aug 9, 2024.

Note: This document provides detailed information about RhoGAM Side Effects associated with rho (d) immune globulin. Some dosage forms listed on this page may not apply specifically to the brand name RhoGAM.

Applies to rho (d) immune globulin: solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution; solution)

Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin.

IVH can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC).

Alert patients and closely monitor for the signs and symptoms of IVH in a health care setting for at least 8 hours after administration for ITP.

Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period.

If signs and/or symptoms of IVH are present or suspected, post-treatment laboratory tests should be performed.

Common side effects of RhoGAM

Some side effects of rho (d) immune globulin 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:

Less common side effects

• soreness at the place of injection

Serious side effects of RhoGAM

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

Check with your doctor or nurse immediately if any of the following side effects occur while taking rho (d) immune globulin:

Rare side effects

• bloody urine
• decreased frequency of urination or amount of urine
• fever
• increased blood pressure
• increased thirst
• loss of appetite
• lower back pain
• nausea or vomiting
• pale skin
• swelling of the face, fingers, or lower legs
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain

For healthcare professionals

Applies to rho (d) immune globulin: injectable powder for injection, injectable solution, intramuscular powder for injection, intramuscular solution.

General adverse events

The most common adverse events were chills, pyrexia, increased bilirubin, and headache.^[Ref]

Hematologic

• Very rare (less than 0.01%): Disseminated intravascular coagulation
• Frequency not reported: Intravascular hemolysis, hemolysis resulting in death, clinically compromising anemia, extravascular hemolysis, hemolytic reaction
• Postmarketing reports: Hemoglobinemia, disseminated intravascular coagulation^[Ref]

Hemolytic reaction includes hypotension, nausea, chills, headache, and a decrease in haptoglobin and hemoglobin.^[Ref]

Local

• Uncommon (0.1% to 1%): Injection site swelling, injection site pain
• Rare (less than 0.1%): Injection site erythema, injection site induration, injection site warmth, injection site pruritus, injection site rash^[Ref]

Nervous system

• Very common (10% or more): Headache (14.3%)
• Uncommon (0.1% to 1%): Dizziness, vertigo^[Ref]

Gastrointestinal

• Uncommon (0.1% to 1%): Nausea, vomiting
• Rare (less than 0.1%): Diarrhea^[Ref]

Cardiovascular

• Rare (less than 0.1%): Tachycardia, hypotension
• Frequency not reported: Increase in blood pressure
• Postmarketing reports: Cardiac arrest, cardiac failure, myocardial infarction^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Skin reaction, erythema, pruritus, pallor, rash
• Postmarketing reports: Hyperhidrosis^[Ref]

Musculoskeletal

• Rare (less than 0.1%): Arthralgia, back pain
• Postmarketing reports: Myalgia, muscle spasm, pain in extremities^[Ref]

Hepatic

• Very common (10% or more): Increase in blood bilirubin (21.4%)
• Postmarketing reports: Jaundice^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Hypersensitivity, anaphylactic shock, anaphylactic reaction^[Ref]

Other

• Very common (10% or more): Chills (34.7%), pyrexia/increased body temperature (32.6%)
• Uncommon (0.1% to 1%): Malaise
• Very rare (less than 0.01%): Death
• Frequency not reported: Shivering, weakness
• Postmarketing reports: Chest pain, fatigue, edema^[Ref]

Respiratory

• Rare (less than 0.1%): Dyspnea
• Postmarketing reports: Acute respiratory distress syndrome, transfusion related acute lung injury^[Ref]

Renal

• Frequency not reported: Acute renal insufficiency
• Postmarketing reports: Renal failure, renal impairment^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Transient positive anti-C antibody test
• Frequency not reported: Sensitization to repeated injections of human globulin^[Ref]

Genitourinary

• Postmarketing reports: Hemoglobinuria, anuria, chromaturia, hematuria^[Ref]

Further information

RhoGAM 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer