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Ofirmev

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Ofirmev

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ofirmev 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.

Stop taking this medication and call your doctor at once if you have a serious side effect such as:

  • nausea, upper stomach pain, itching, loss of appetite;
  • dark urine, clay-colored stools;
  • jaundice (yellowing of the skin or eyes); or
  • chest pain, trouble breathing.

Less serious side effects may include:

  • vomiting;
  • constipation;
  • feeling agitated;
  • headache; or
  • sleep problems (insomnia).

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.

Read the entire detailed patient monograph for Ofirmev (Acetaminphen for Injection) »

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
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

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.

Adult Population

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
(N=402)
n (%)
Placebo
(N=379)
n (%)
Gastrointestinal Disorders
  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)
Psychiatric Disorders
  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

Vascular disorders: hypertension, hypotension

Pediatric population

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.

The most common adverse events (incidence ≥ 5%) in pediatric patients treated with OFIRMEV were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

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

Metabolism and nutrition disorders: hypoalbuminemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypervolemia

Musculoskeletal and connective tissue disorders: muscle spasm, pain in extremity

Nervous system disorders: headache

Psychiatric disorders: insomnia

Renal and urinary disorders: oliguria

Respiratory, thoracic and mediastinal disorders: pulmonary edema, hypoxia, pleural effusion, stridor, wheezing

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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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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