Clinical safety of gadopentetate dimeglumine.
OBJECTIVE
To quantify the rate of adverse reactions to gadopentetate dimeglumine.


METHODS
Magnetic resonance (MR) imaging was performed in 15,496 patients in April-September 1992. Data were collected before and after intravenous administration of 0.1 mmol/kg gadopentetate dimeglumine.


RESULTS
Adverse reactions occurred in 2.4% (n = 372) of patients. Symptoms abated the same or next day in 94.1% (n = 350). Whereas onset occurred within 30 minutes after injection in 49.7% (n = 185), onset occurred more than 1 hour after injection in 44.9% (n = 167). Two serious adverse reactions occurred and were attributed to underlying disease. The rate of adverse reaction was 3.7% in patients with a history of asthma (31 of 831 patients) or allergy (144 of 3,860 patients). Patients with previous reactions to an MR imaging or iodinated contrast agent had an adverse-reaction rate in this study of 21.3% (16 of 75) and 6.3% (54 of 857), respectively. The rate of adverse reaction was 2.2% when gadopentetate dimeglumine was administered slowly and 2.9% when it was administered rapidly.


CONCLUSIONS
Findings confirm the safety of gadopentetate dimeglumine.
Nelson
K L
KL
Department of Radiology, Omaha, NE 68105, USA.
Gifford
L M
LM
Lauber-Huber
C
C
Gross
C A
CA
Lasser
T A
TA
D001249:Asthma / Q000453:epidemiology; D015331:Cohort Studies; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D004338:Drug Combinations; D004342:Drug Hypersensitivity / Q000453:epidemiology; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage / Q000009:adverse effects*; D019786:Gadolinium DTPA; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D004369:Pentetic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D013997:Time Factors
D003287:Contrast Media; D004338:Drug Combinations; D009942:Organometallic Compounds; D008536:Meglumine; D004369:Pentetic Acid; D005682:Gadolinium; D019786:Gadolinium DTPA