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Zemaira Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zemaira in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- chest pain, severe headache, buzzing in your ears, uneven heartbeats;
- fast heart rate;
- problems with vision; or
- fever, chills, runny nose, skin rash, and joint pain.
Less serious side effects may include:
- drowsiness, dizziness, weakness;
- cough, sore throat, stuffy nose;
- pain or bleeding where the medication was injected;
- warmth, redness, or tingly feeling under your skin;
- nausea, diarrhea, stomach pain;
- headache; or
- mild itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zemaira (Alpha-Proteinase Inhibitor (Human)) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zemaira FDA Prescribing Information: Side Effects
Intravenous administration of Zemaira (alpha-proteinase inhibitor (human)) ™, 60 mg/kg weekly, has been shown to be generally well tolerated. In clinical studies, the following treatment-related adverse reactions were reported: asthenia, injection site pain, dizziness, headache, paresthesia, and pruritus. Each of these related adverse events was observed in 1 of 89 subjects (1%). The adverse reactions were mild.
Table 3 summarizes the adverse event data obtained with single and multiple doses during clinical trials with Zemaira (alpha-proteinase inhibitor (human)) ™ and Prolastin®. No clinically significant differences were detected between the two treatment groups.
Table 3: Summary of Adverse Events
No. of subjects treated
No. of subjects with adverse events regardless of causality (%)
No. of subjects with related adverse events (%)
No. of subjects with related serious adverse events
No. of infusions
No. of adverse events regardless of causality (rates per infusion)
No. of related adverse events (rates per infusion)
The frequencies of adverse events per infusion that were ≥0.4% in Zemaira (alpha-proteinase inhibitor (human)) ™-treated subjects, regardless of causality, were: headache (33 events per 1296 infusions, 2.5%), upper respiratory infection (1.6%), sinusitis (1.5%), injection site hemorrhage (0.9%), sore throat (0.9%), bronchitis (0.8%), asthenia (0.6%), fever (0.6%), pain (0.5%), rhinitis (0.5%), bronchospasm (0.5%), chest pain (0.5%), increased cough (0.4%), rash (0.4%), and infection (0.4%). The following adverse events, regardless of causality, occurred at a rate of 0.2% to <0.4% per infusion: abdominal pain, diarrhea, dizziness, ecchymosis, myalgia, pruritus, vasodilation, accidental injury, back pain, dyspepsia, dyspnea, hemorrhage, injection site reaction, lung disorder, migraine, nausea, and paresthesia.
In a retrospective analysis, during the 10-week blinded portion of the 24-week clinical study, 6 subjects (20%) of the 30 treated with Alpha1-Proteinase Inhibitor (Human), Zemaira (alpha-proteinase inhibitor (human)) ™ had a total of 7 exacerbations of their chronic obstructive pulmonary disease (COPD). Nine subjects (64%) of the 14 treated with Prolastin® had a total of 11 exacerbations of their COPD. The observed difference between groups was 44% (95% confidence interval from 8% to 70%). Over the entire 24-week treatment period, of the 30 subjects in the Zemaira (alpha-proteinase inhibitor (human)) ™ treatment group, 7 subjects (23%) had a total of 11 exacerbations of their COPD.
Read the entire FDA prescribing information for Zemaira (Alpha-Proteinase Inhibitor (Human)) »
Additional Zemaira Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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