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- Clinician Information:
Ofirmev Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Ofirmev (acetaminophen) injection is used to manage pain and to reduce fever. It is the first IV preparation of acetaminophen available in the US. The most common side effects from the use of Ofirmev were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, itching, agitation, and partial or total lung collapse in pediatric patients.
Ofirmev is available as an injection and may be given as a single or repeated dose, based on the weight of the patient. Ofirmev should only be given in 15-minute intravenous infusions. Ofirmev may interact with warfarin sodium.
Ofirmev has not been studied in pregnant women, and should only be used in pregnant women if clearly needed. Caution should be used when giving Ofirmev to breastfeeding mothers.
Our Ofirmev (acetaminophen) 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ofirmev FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hepatic Injury [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Allergy and Hypersensitivity [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.
A total of 1020 adult patients have received OFIRMEV in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with OFIRMEV 1000 mg every 6 hours. A total of 13.1% (n=134) received OFIRMEV 650 mg every 4 hours.
All adverse reactions that occurred in adult patients treated with either OFIRMEV or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 3. The most common adverse events in adult patients treated with OFIRMEV (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.
Table 3: Treatment-Emergent Adverse Reactions Occurring
≥ 3% in OFIRMEV-treated Patients and at a greater frequency than Placebo
in Placebo-Controlled, Repeated Dose Studies
|System Organ Class - Preferred Term||OFIRMEV
|Nausea||138 (34)||119 (31)|
|Vomiting||62 (15)||42 (11)|
|General Disorders and Administration Site Conditions|
|Pyrexia*||22 (5)||52 (14)|
|Nervous System Disorders|
|Headache||39 (10)||33 (9)|
|Insomnia||30 (7)||21 (5)|
|* Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of OFIRMEV may mask fever.|
Other Adverse Reactions Observed During Clinical Studies of OFIRMEV in Adults
The following additional treatment-emergent adverse reactions were reported by adult subjects treated with OFIRMEV in all clinical trials (n=1020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).
Blood and lymphatic system disorders: anemia
General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral
Investigations: aspartate aminotransferase increased, breath sounds abnormal
Metabolism and nutrition disorders: hypokalemia
Musculoskeletal and connective tissue disorders: muscle spasms, trismus
Psychiatric disorders: anxiety
Respiratory, thoracic and mediastinal disorders: dyspnea
A total of 355 pediatric patients (47 neonates, 64 infants, 171 children, and 73 adolescents) have received OFIRMEV in active-controlled (n=250) and open-label clinical trials (n=225), including 59.7% (n=212) who received 5 or more doses and 43.1% (n=153) who received more than 10 doses. Pediatric patients received OFIRMEV doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively.
Other Adverse Reactions Observed During Clinical Studies of OFIRMEV in Pediatrics
The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with OFIRMEV (n=355) that occurred with an incidence of at least 1%.
Blood and lymphatic system disorders: anemia
Cardiac disorders: tachycardia
Gastrointestinal disorders: abdominal pain, diarrhea
General disorders and administration site conditions: injection site pain, edema peripheral, pyrexia
Investigations: hepatic enzyme increase
Musculoskeletal and connective tissue disorders: muscle spasm, pain in extremity
Nervous system disorders: headache
Psychiatric disorders: insomnia
Renal and urinary disorders: oliguria
Skin and subcutaneous tissue disorders: periorbital edema, rash
Vascular disorders: hypertension, hypotension
Read the entire FDA prescribing information for Ofirmev (Acetaminphen for Injection) »
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