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Rhophylac Side Effects

Generic Name: rho (d) immune globulin

Note: This page contains side effects data for the generic drug rho (d) immune globulin. It is possible that some of the dosage forms included below may not apply to the brand name Rhophylac.

It is possible that some side effects of Rhophylac may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, rho (d) immune globulin (the active ingredient contained in Rhophylac) may cause unwanted side effects that require medical attention.

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

Rare
  • 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

Some rho (d) immune globulin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Soreness at the place of injection

For Healthcare Professionals

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

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]

Hematologic

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

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]

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]

General

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

References

1. "Product Information. RhoGAM Ultra-Filtered Plus (RHo (D) immune globulin)." Kedrion Biopharma Inc, Cambridge, MA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. WinRho SDF (RHo (D) immune globulin)." Nabi, Boca Raton, FL.

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. Rhophylac (RHo (D) immune globulin)." ZLB Bioplasma Inc, Glendale, CA.

6. "Product Information. HyperRHO S/D Full Dose (RHo (D) immune globulin)." Talecris Biotherapeutics, Research Triangle Park, NC.

7. "Product Information. BayRHo-D (RHo (D) immune globulin)." Bayer, West Haven, CT.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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