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Ofirmev

Last reviewed on RxList: 2/19/2020
Ofirmev Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ofirmev?

Ofirmev (acetaminophen) injection is a non-salicylate antipyretic (anti-fever) and non-opioid analgesic (pain reliever) used to manage pain and to reduce fever.

What Are Side Effects of Ofirmev?

Common side effects of Ofirmev include:

  • nausea,
  • vomiting,
  • headache, and
  • sleep problems (insomnia) in adult patients, and
  • nausea,
  • vomiting,
  • constipation,
  • itching,
  • agitation, and
  • partial or total lung collapse in pediatric patients.

Tell your doctor if you have serious effects of Ofirmev including:

Dosage for Ofirmev

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.

What Drugs, Substances, or Supplements Interact with Ofirmev?

Ofirmev may interact with antibiotics, antifungal medicines, sulfa drugs, tuberculosis medicine, blood thinners, birth control pills or hormone replacement therapy, blood pressure medications, cancer medications, cholesterol-lowering medications, gout or arthritis medications (including gold injections), HIV/AIDS medications, medicines to treat psychiatric disorders, nonsteroidal anti-inflammatory drugs (NSAIDs), or seizure medications. Tell your doctor all medications and supplements you use.

Ofirmev During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Ofirmev Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop using this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using acetaminophen and call your doctor at once if you have:

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

Common side effects may include:

  • vomiting;
  • constipation;
  • feeling agitated;
  • itching;
  • 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)

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Ofirmev Professional Information

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 4. The most common adverse events in adult patients treated with OFIRMEV (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.

Table 4. Treatment-Emergent Adverse Reactions Occurring in ≥ 3% of OFIRMEV-treated Adult 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 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received OFIRMEV in active-controlled (n=250) and open-label clinical trials (n=225), including 43.9% (n=212) who received 5 or more doses and 31.2% (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, and pruritus.

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=483) that occurred with an incidence of at least 1%.

Blood and lymphatic system disorders: anemia

Gastrointestinal disorders: diarrhea

General disorders and administration site conditions: pyrexia, injection site pain

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

Musculoskeletal and connective tissue disorders: muscle spasm

Nervous system disorders: headache

Psychiatric disorders: agitation

Renal and urinary disorders: oliguria

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

Vascular disorders: hypotension, hypertension

Read the entire FDA prescribing information for Ofirmev (Acetaminphen for Injection)

Related Resources for Ofirmev

© Ofirmev Patient Information is supplied by Cerner Multum, Inc. and Ofirmev Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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