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Primaxin IV Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Primaxin I.V. (imipenem and cilastatin) for Injection is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems. Imipenem is an antibiotic, and cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys. This medication is available in generic form. Common side effects include swelling, redness, pain, or soreness at the injection site, upset stomach, nausea, vomiting, or diarrhea.
The total daily dosage for Primaxin I.V. is based on the type or severity of infection, the patient's renal function, and body weight. Primaxin I.V. may interact with valproic acid, ganciclovir, probenecid, or antibiotics. Tell your doctor all medications you use. During pregnancy, Primaxin I.V. should be used only when prescribed. This medication passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
Our Primaxin I.V. (imipenem and cilastatin) 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.
Primaxin IV in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fast or pounding heartbeats;
- diarrhea that is watery or bloody;
- confusion, tremors, hallucinations, seizure (convulsions);
- feeling light-headed, fainting;
- fever, chills, body aches, flu symptoms;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.
Less serious side effects may include:
- pain, swelling, or redness where the medicine was injected;
- mild nausea, vomiting, heartburn, or stomach pain;
- sore throat;
- vaginal itching or discharge;
- mild skin rash or itching;
- dizziness or tired feeling;
- numbness or tingling; or
- ringing in your ears.
Read the entire detailed patient monograph for Primaxin IV (Imipenem and Cilastatin for Injection)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Primaxin 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: dark urine, easy bruising/bleeding, hearing changes (e.g., decreased hearing, ringing in the ears), mental/mood changes (e.g., confusion, hallucinations), persistent sore throat/fever, swollen tongue, tingling hands/feet, yellowing eyes/skin, muscle twitching/spasms.
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 during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away 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 Primaxin IV (Imipenem and Cilastatin for Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Primaxin IV FDA Prescribing Information: Side Effects
PRIMAXIN I.V. is generally well tolerated. Many of the 1,723 patients treated in clinical trials were severely ill and had multiple background diseases and physiological impairments, making it difficult to determine causal relationship of adverse experiences to therapy with PRIMAXIN I.V.
Local Adverse Reactions
Adverse local clinical reactions that were reported as possibly, probably, or definitely related to therapy with PRIMAXIN I.V. were:
Systemic Adverse Reactions
The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.V. were nausea (2.0%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), seizures (0.4%) (see PRECAUTIONS), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), somnolence (0.2%).
Additional adverse systemic clinical reactions reported as possibly, probably, or definitely drug related occurring in less than 0.2% of the patients or reported since the drug was marketed are listed within each body system in order of decreasing severity: Gastrointestinal - pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment, see WARNINGS), hemorrhagic colitis, hepatitis (including fulminant hepatitis), hepatic failure, jaundice, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth and/or tongue, heartburn, pharyngeal pain, increased salivation; Hematologic - pancytopenia, bone marrow depression, thrombocytopenia, neutropenia, leukopenia, hemolytic anemia; CNS - encephalopathy, tremor, confusion, myoclonus, paresthesia, vertigo, headache, psychic disturbances including hallucinations, dyskinesia, agitation; Special Senses - hearing loss, tinnitus, taste perversion; Respiratory - chest discomfort, dyspnea, hyperventilation, thoracic spine pain; Cardiovascular - palpitations, tachycardia; Skin - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioneurotic edema, flushing, cyanosis, hyperhidrosis, skin texture changes, candidiasis, pruritus vulvae; Body as a whole - polyarthralgia, asthenia/weakness, drug fever; Renal - acute renal failure, oliguria/anuria, polyuria, urine discoloration. The role of PRIMAXIN I.V. in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.
Adverse Laboratory Changes
Adverse laboratory changes without regard to drug relationship that were reported during clinical trials or reported since the drug was marketed were:
Hemic: Increased eosinophils, positive Coombs test, increased WBC, increased platelets, decreased hemoglobin and hematocrit, agranulocytosis, increased monocytes, abnormal prothrombin time, increased lymphocytes, increased basophils
Electrolytes: Decreased serum sodium, increased potassium, increased chloride
Renal: Increased BUN, creatinine
Urinalysis: Presence of urine protein, urine red blood cells, urine white blood cells, urine casts, urine bilirubin, and urine urobilinogen.
In studies of 178 pediatric patients ≥ 3 months of age, the following adverse events were noted:
The Most Common Clinical Adverse Experiences Without
Regard to Drug Relationship (Patient Incidence > 1%)
|Adverse Experience||No. of Patients (%)|
|Irritation, I.V. site||2 (1.1)|
|Urine discoloration||2 (1.1)|
|*One patient had both vomiting and diarrhea and is counted in each category.|
In studies of 135 patients (newborn to 3 months of age), the following adverse events were noted:
The Most Common Clinical
Adverse Experiences Without Regard to Drug Relationship (Patient Incidence
|Adverse Experience||No. of Patients (%)|
|Oral Candidiasis||2 (1.5%)|
Patients ( ≥ 3 Months of Age) With Normal Pretherapy but Abnormal
During Therapy Laboratory Values
|Laboratory Parameter||Abnormality||No. of Patients With Abnormalities/ No. of Patients With Lab Done (%)|
< 5 mos.: < 10 gm %
6 mos.-12 yrs.: < 11.5 gm %
< 5 mos.: < 30 vol %
6 mos.-12 yrs.: < 34.5 vol %
|Neutrophils||≤ 1000/mm³ (absolute)||4/123 (3.3)|
|Eosinophils||≥ 7%||15/117 (12.8)|
|Platelet Count||≥ 500 ths/mm³||16/119 (13.4)|
|Urine Protein||≥ 1||8/97 (8.2)|
|Serum Creatinine||> 1.2 mg/dL||0/105 (0)|
|BUN||> 22 mg/dL||0/108 (0)|
|AST (SGOT)||> 36 IU/L||14/78 (17.9)|
|ALT (SGPT)||> 30 IU/L||10/93 (10.8)|
Patients ( < 3 Months of
Age) With Normal Pretherapy but Abnormal During Therapy Laboratory Values
|Laboratory Parameter||No. of Patients With Abnormalities* (%)|
|Eosinophil Count↑||11 (9.0%)|
|Platelet Count↑||5 (4.0%)|
|Platelet Count↓||2 (2.0%)|
|Serum Creatinine↑||5 (5.0%)|
|AST (SGOT)↑||5 (6.0%)|
|ALT (SGPT)↑||3 (3.0%)|
|Serum Alkaline Phosphate↑||2 (3.0%)|
|*The denominator used for percentages was the number of patients for whom the test was performed during or posttreatment and, therefore, varies by test.|
Examination of published literature and spontaneous adverse event reports suggested a similar spectrum of adverse events in adult and pediatric patients.
Read the entire FDA prescribing information for Primaxin IV (Imipenem and Cilastatin for Injection)
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