Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cytomegalovirus immune globulin (human)
Drug ID BADD_D00562
Description Cytomegalovirus immunoglobulin is obtained from pooled adult human plasma selected for high titers of antibody for cytomegalovirus (CMV). It contains purified immunoglobulin G (IgG) antibodies targeting cytomegalovirus (CMV)[FDA label]. Cytomegalovirus, a member of the herpes virus family, is ubiquitous the human population, leading to infections which are followed by life-long dormancy in the host with occasional reactivations and recurrent infections. The seroprevalence of antibodies in adults ranges from 40-100 % with an inverse correlation to socioeconomic status. The transmission of cytomegalovirus infection requires intimate contact with infected excretions such as saliva, urine, cervical and vaginal excretions, semen, breast milk and blood [L2228]. CMV infection can lead to a high fever and severe organ-specific damage with significant morbidity and mortality rates. Cytomegalovirus (CMV) may lead to a wide spectrum of infection in immunocompetent hosts. Sites most often involved include the lung (severe community-acquired viral pneumonia), liver (transaminitis), spleen (splenomegaly), GI tract (colitis), CNS (encephalitis), the hematologic system (cytopenias), and multisystem involvement [L2230]. During the span of an individual's life, the virus may reactivate, resulting in repeated shedding and spread of the virus. Molecular mechanisms have been identified by which show that CMVs interfere with the host immune system. Finally, however, the infection is normally controlled by the host's immune response. As a consequence, CMV disease is restricted to the immunocompromised or immunologically immature host, in which it can lead the devastating result of transplant rejection [A32498], [L2229].
Indications and Usage It is used to prevent cytomegalovirus (CMV) disease after organ transplant [L2225]. Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart [FDA label]. In transplants of these organs other than the kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir [FDA label].
Marketing Status approved
ATC Code Not Available
DrugBank ID DB13886
KEGG ID Not Available
MeSH ID C045781
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 49591-532; 44206-532
UNII Not Available
Synonyms cytomegalovirus-specific hyperimmune globulin | cytomegalovirus immunoglobulin intravenous (human) | human cytomegalovirus immune globulin | CMV immunoglobulin | CMV-immune globulin | CMVIG | Cytogam | cytotect
Chemical Information
Molecular Formula Not Available
CAS Registry Number 339086-15-6
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.034--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Apnoea22.02.01.001--
Arthralgia15.01.02.001--
Back pain15.03.04.005--
Blood pressure decreased13.14.03.002---
Bronchospasm10.01.03.012; 22.03.01.004--
Cardiac arrest02.03.04.001--
Chills08.01.09.001; 15.05.03.016--
Circulatory collapse24.06.02.001---
Coma17.02.09.001---
Coombs direct test13.01.01.006---
Cyanosis02.11.04.004; 22.02.02.007; 23.06.04.005; 24.03.01.007--
Dermatitis bullous23.03.01.002--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema multiforme10.01.03.015; 23.03.01.003--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Haemolysis01.06.04.002--
Hepatic function abnormal09.01.02.001---
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Leukopenia01.02.02.001---
Loss of consciousness17.02.04.004---
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Nephrotic syndrome20.05.01.002--
Pancytopenia01.03.03.003---
Pulmonary oedema02.05.02.003; 22.01.03.003--
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