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Merrem IV Side Effects Center
Pharmacy Editor: Melissa Conrad Stöppler, MD
Merrem IV (meropenem) is an antibiotic used to treat certain types of bacterial infections. It is administered intravenously. Merrem is used in the treatment of infections of the abdomen, such as appendicitis and peritonitis, bacterial meningitis (infection of the lining of the brain), and skin infections. Side effects of Merrem include nausea, vomiting, diarrhea, constipation, headache, or soreness, redness, or swelling at the injection site. Merrem IV (meropenem) is an antibiotic used to treat certain types of bacterial infections. It is administered intravenously. Merrem is used in the treatment of infections of the abdomen, such as appendicitis and peritonitis, bacterial meningitis (infection of the lining of the brain), and skin infections. Side effects of Merrem include nausea, vomiting, diarrhea, constipation, headache, or soreness, redness, or swelling at the injection site.
Adequate and well-controlled studies of this drug in pregnant women are lacking, and this drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk.
Our Merrem IV Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Merrem IV in Detail - Patient Information: Side Effects
If you experience a rare but serious side effects, stop taking meropenem and seek emergency medical attention or contact your doctor immediately:
- allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)
- severe or watery diarrhea;
- a skin rash;
- unusual tiredness or weakness; or
- unusual bleeding or bruising.
Other less serious side effects may be more likely to occur. Continue to use meropenem and talk to your doctor if you experience:
- nausea or vomiting;
- diarrhea or constipation;
- headache; or
- soreness, redness, or mild swelling at the injection site.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Merrem IV (Meropenem)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Merrem IV Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, hearing changes (e.g., decreased hearing, ringing in the ears), mental/mood changes (e.g., confusion), swollen tongue, numb/tingling skin.
Get medical help right away if any of these rare but very serious side effects occur: seizures, unusual weakness.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Merrem IV (Meropenem)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Merrem IV FDA Prescribing Information: Side Effects
The following are discussed in greater detail in other sections of labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Seizure Potential [see WARNINGS AND PRECAUTIONS]
- Interaction with Valproic Acid [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile - associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
- Overgrowth of Nonsusceptible Organisms [see WARNINGS AND PRECAUTIONS]
- Laboratory Tests [see WARNINGS AND PRECAUTIONS]
- Patients with Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Dialysis [see WARNINGS AND PRECAUTIONS]
- Potential for Neuromotor Impairment [see WARNINGS AND PRECAUTIONS]
Adverse Reactions From Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with MERREM I.V. (500 mg or 1 gram every 8 hours). Deaths in 5 patients were assessed as possibly related to meropenem; 36 (1.2%) patients had meropenem discontinued because of adverse events. Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with MERREM I.V.
The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with MERREM I.V.
Local Adverse Reactions
Local adverse reactions that were reported irrespective of the relationship to therapy with MERREM I.V. were as follows:
|Inflammation at the injection site||2.4%|
|Injection site reaction||0.9%|
|Pain at the injection site||0.4%|
|Edema at the injection site||0.2%|
Systemic Adverse Reactions
Systemic adverse reactions that were reported irrespective of the relationship to MERREM I.V. occurring in greater than 1.0% of the patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%).
Additional systemic adverse reactions that were reported irrespective of relationship to therapy with MERREM I.V. and occurring in less than or equal to 1.0% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency:
Body as a Whole: pain, abdominal pain, chest pain, fever, back pain, abdominal enlargement, chills, pelvic pain
Metabolic/Nutritional: peripheral edema, hypoxia
Skin and Appendages: urticaria, sweating, skin ulcer
Adverse Laboratory Changes
Adverse laboratory changes that were reported irrespective of relationship to MERREM I.V. and occurring in greater than 0.2% of the patients were as follows:
Hematologic: increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased WBC, shortened prothrombin time and shortened partial thromboplastin time, leukocytosis, hypokalemia
Renal: increased creatinine and increased BUN
NOTE: For patients with varying degrees of renal impairment, the incidence of heart failure, kidney failure, seizure and shock reported irrespective of relationship to MERREM I.V., increased in patients with moderately severe renal impairment (creatinine clearance greater than10 to 26 mL/min) [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].
Urinalysis: presence of red blood cells
Complicated Skin and Skin Structure Infections
In a study of complicated skin and skin structure infections, the adverse reactions were similar to those listed above. The most common adverse events occurring in greater than5% of the patients were: headache (7.8%), nausea (7.8%), constipation (7.0%), diarrhea (7.0%), anemia (5.5%), and pain (5.1%). Adverse events with an incidence of greater than1%, and not listed above, include: pharyngitis, accidental injury, gastrointestinal disorder, hypoglycemia, peripheral vascular disorder, and pneumonia.
Clinical Adverse Reactions
MERREM I.V. was studied in 515 pediatric patients (3 months to less than 13 years of age) with serious bacterial infections (excluding meningitis, see next section) at dosages of 10 mg/kg to 20 mg/kg every 8 hours. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably, or definitely related to MERREM I.V. and their rates of occurrence as follows:
|Nausea and Vomiting||0.8%|
MERREM I.V. was studied in 321 pediatric patients (3 months to less than 17 years of age) with meningitis at a dosage of 40 mg/kg every 8 hours. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably, or definitely related to MERREM I.V. and their rates of occurrence as follows:
|Rash (mostly diaper area moniliasis)||3.1%|
In the meningitis studies, the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem and those who received comparator agents (either cefotaxime or ceftriaxone). In the MERREM I.V. treated group, 12/15 patients with seizures had late onset seizures (defined as occurring on day 3 or later) versus 7/20 in the comparator arm.
MERREM I.V. was studied in 200 neonates and infants less than 3 months of age. The study was open-label, uncontrolled, 98% of the infants received concomitant medications, and the majority of adverse reactions were reported in neonates less than 32 weeks gestational age and critically ill at baseline, making it difficult to assess the relationship of the adverse reactions to MERREM I.V.
The clinical adverse reactions seen in these patients that were reported (regardless of investigator assessment of causality) and their rates of occurrence are as follows:
Adverse Laboratory Changes
Laboratory changes seen in the pediatric studies, including the meningitis studies, were similar to those reported in the adult studies.
The following adverse reactions have been identified during post-approval use of MERREM I.V. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Worldwide post-marketing adverse reactions not otherwise listed in the Adverse Reactions section of this product label and reported as possibly, probably, or definitely drug related are listed within each body system in order of decreasing severity. Hematologic - agranulocytosis, neutropenia, and leukopenia; a positive direct or indirect Coombs test, and hemolytic anemia. Skin-toxic epidermal necrolysis, Stevens-Johnson Syndrome, angioedema, and erythema multiforme.
Read the entire FDA prescribing information for Merrem IV (Meropenem)
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