Biofen

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Biofen

Quick Facts

Property Description
Active ingredient Ibuprofen
Forms Tablet, Capsule, Suspension, Gel, Cream
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Use Pain relief, Fever reduction, Inflammation
Origin Synthetic compound (Propionic acid derivative)

What is Biofen? Defining the Active Ingredient and Class

Biofen is a trade name for a pharmaceutical product containing the active ingredient Ibuprofen, which belongs to the widely recognized Nonsteroidal Anti-inflammatory Drug (NSAID) pharmacological class. Ibuprofen is a synthetic compound that is chemically classified as a propionic acid derivative, a structure that has been the subject of extensive pharmacological studies. The efficacy of Ibuprofen has been clinically recognized for decades, making it one of the most frequently used OTC analgesics globally. This substance is generally available as a single active ingredient product, solely responsible for generating the desired systemic action against discomfort and swelling.

Understanding Biofen's Purpose and General Forms

The general purpose of Ibuprofen is the management of discomfort symptoms, characterized by its triple capacity to function as an analgesic (pain reliever), an antipyretic (fever reducer), and an anti-inflammatory agent (decreases swelling). It is typically used for general, self-limiting discomfort, such as providing temporary relief for aches accompanying a common cold or a mild sports injury. Ibuprofen is an active substance used to treat these three core symptoms across various age groups.

Ibuprofen is manufactured in multiple dosage forms, allowing it to be administered via two main routes of administration: oral and topical. Oral forms, including tablets, capsules, and oral suspension or solution, are intended for systemic action. The oral suspension form is often formulated for easier administration to pediatric patient groups. Conversely, topical preparations, such as gels or creams, are designed to deliver targeted, localized relief.

What side effects are possible with Biofen?

Possible Side Effects and Safety Information

The officially documented safety profile of Biofen (Ibuprofen), a Nonsteroidal Anti-inflammatory Drug (NSAID), is structured around frequency-classified adverse reactions and specific regulatory concerns affecting major organ systems. Adverse reactions are grouped by System-Organ Class, reflecting the body systems affected during clinical use, such as Gastrointestinal, Nervous, and Cardiovascular systems. The safety information details events categorized as Common, Uncommon, Rare, and Very Rare, according to official regulatory standards.

Serious Adverse Reactions and Key Constraints

The regulatory labeling highlights specific serious adverse reactions. These include an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can occur early in treatment and generally increase with the duration of use. Similarly, the medicine is associated with a risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation, which may occur at any time during therapy without warning symptoms.

Patients in the older adult population are officially documented to be at an increased risk of these serious gastrointestinal complications. Use of the medicine is officially constrained in specific contexts, such as the third trimester of pregnancy and for peri-operative pain following coronary artery bypass graft (CABG) surgery, due to recognized safety risks. Furthermore, regulatory documents note that Ibuprofen may potentially mask the signs of underlying infection.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Biofen (Ibuprofen) requires immediate medical intervention as officially documented in regulatory information. Immediate emergency action is mandatory: contact the local emergency number or Poison Control Center right away. Do not delay seeking assistance regardless of the apparent severity.

Documented manifestations of an overdose can affect multiple systems, including the Gastrointestinal System (e.g., severe vomiting, abdominal pain, signs of GI bleeding) and the Central Nervous System (e.g., severe headache, confusion, convulsions, or loss of consciousness). The cardiovascular system may also be impacted, presenting as low blood pressure (hypotension) or shock.

Severe or life-threatening outcomes officially documented include acute renal failure, gastrointestinal perforation, and an increased risk of severe cardiovascular events. Management is entirely symptomatic and supportive, as regulatory labeling confirms that no specific antidote is available. Hospital monitoring of vital signs, renal function, and hepatic function is required following ingestion of potentially toxic amounts. Specific population considerations include the higher risk of serious GI events in elderly patients and the risk of renal impairment in dehydrated children and adolescents.

Therapeutic Uses of Biofen

What Biofen Treats: Main Uses and Benefits

Biofen (Ibuprofen) is a Nonsteroidal Anti-inflammatory Drug (NSAID) whose primary benefit is to provide symptomatic relief across domains involving pain, fever, and inflammation. The use of Ibuprofen for these purposes is well-established. The medication is commonly used across conditions presenting with both acute episodes and chronic inflammatory states.

Clinical Use Categories

Biofen is relevant for easing symptoms associated with acute or episodic changes and chronic discomfort. Its use may assist in managing pain from sprains, strains, backache, muscle aches, headache, toothache, and the symptomatic discomfort of primary dysmenorrhea (menstrual cramps). It is also commonly applied in clinical settings for the symptomatic relief of pain, fever, and inflammation associated with conditions like arthritis and generalized discomfort during colds or flu. In situations where symptoms interfere with routine activities, its application may contribute to improved comfort and supports patients during episodes of heightened discomfort.

“The medication is relevant for addressing symptom clusters that may become intense or disruptive, helping patients cope more steadily with symptom fluctuations.”

Quick Fact: Relief for Acute Discomfort
Symptom Focus Pain, Swelling, Elevated Temperature
Typical Context Injury, Illness, Episodic Pain
Benefit Aim Easing overall symptom burden

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility Information

Regulatory agencies define specific populations who are prohibited from using Biofen (a non-steroidal anti-inflammatory drug or NSAID) and other groups for whom use is restricted or requires special medical consideration. Use is formally contraindicated and must be avoided in the following populations:

  • Individuals with known hypersensitivity or severe allergic reactions (e.g., asthma, urticaria, or anaphylaxis) to Biofen, aspirin, or any other NSAID.
  • Patients with active gastrointestinal disease, including current or history of recurrent peptic ulceration, gastrointestinal bleeding, or perforation.
  • Patients with severe heart failure (NYHA Class IV), severe renal failure, or severe hepatic failure.
  • Individuals in the setting of coronary artery bypass graft (CABG) surgery.
  • Women in the last three months (third trimester) of pregnancy, as use may cause harm to the fetus or complications during delivery.

Use is restricted or requires consultation for individuals who are aged 60 or older, are in the first or second trimester of pregnancy, or have conditions like uncontrolled hypertension, pre-existing heart/kidney/liver impairment, or a history of bleeding disorders. For certain over-the-counter products, the medicine is not recommended for children under 6 months of age.

What should I know about interactions with other medicines?

Biofen's official regulatory profile is defined by specific restrictions and interaction patterns documented by health authorities.

Contraindicated Combinations

Contraindicated combinations include the co-administration of Biofen with any other Nonsteroidal Anti-inflammatory Drug (NSAID), including COX-2 selective inhibitors, and with high-dose aspirin, due to the established additive risk of gastrointestinal bleeding and ulceration. Use is also contraindicated immediately before or after coronary artery bypass graft (CABG) surgery.

Pharmacodynamic and Pharmacokinetic Interactions

Interactions are primarily classified into pharmacodynamic intensification and pharmacokinetic exposure modification.

Interaction Type Interacting Substances (Examples)
Increased Bleeding Risk (Pharmacodynamic) Oral Anticoagulants, Corticosteroids, Antiplatelet Agents, SSRIs/SNRIs
Increased Exposure Risk (Pharmacokinetic) Lithium, Methotrexate (due to reduced renal clearance), Cardiac Glycosides
Reduced Therapeutic Effect (Antagonistic) ACE Inhibitors, Beta-blockers, Diuretics

Co-use with substances affecting platelet function or the gastrointestinal lining is documented to increase the risk of bleeding. This risk is officially noted to be elevated with the concurrent consumption of three or more alcoholic drinks per day.

Timing and Population Notes

A mandatory timing separation is required when co-administering Biofen with low-dose non-enteric coated aspirin; Biofen must be taken at least eight hours before or thirty minutes after the aspirin dose. These interaction patterns are noted to carry increased risk severity for elderly and volume-depleted patient populations, as stated in regulatory documents.

Mechanism of Action

How Biofen Works

Biofen (Ibuprofen) exerts its effects primarily through the non-selective, reversible inhibition of the Cyclooxygenase (COX-1 and COX-2) enzymes. This molecular action prevents the conversion of the precursor arachidonic acid into various prostanoids, notably Prostaglandin E2 ( PGE2). The suppression of PGE2 synthesis is the foundational step that modulates subsequent physiological consequences.

This deficit in PGE2 directly influences two distinct biological systems. Peripherally, the reduction in prostanoids dampens the chemical sensitization of nociceptors (pain-sensing nerves) and decreases vascular permeability and vasodilation characteristic of inflammation, resulting in the dampening of nociceptor signaling and a decrease in vascular changes. Centrally, the mechanism acts in the hypothalamus to reset the body’s core temperature set point, allowing endogenous thermoregulatory processes to initiate heat dissipation.

Dosage and Administration Information

The administration of the injectable formulation of Biofen (phenylephrine hydrochloride), often marketed as BIORPHEN or similar, occurs in acute, monitored clinical settings.

Instruction Map: Official Administration Guidelines

Administration Scope Administration Guidelines
Route of Administration Intravenous (IV) bolus injection or continuous IV infusion
Dosing Schedule Initial Bolus: 40 mcg to 100 mcg. Additional boluses up to 200 mcg may be given every 1 to 2 minutes as needed. Infusion: 10 mcg/minute to 35 mcg/minute, titrated to the target blood pressure
Preparation Requirements Concentrated formulations (e.g., 10 mg/mL) must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection prior to administration. Ready-to-use solutions (e.g., 100 mcg/mL) must not be diluted
Age-Group Rules Safety and effectiveness have not been established in pediatric patients
Special Procedural Conditions The dose must be continuously adjusted according to the pressor response (titrate to effect). Parenteral products must be visually inspected for particulate matter or discoloration prior to use

Resulting Procedural Structure

The protocol mandates that the correct formulation must be selected: either a concentrated vial requiring mandatory dilution to a specified concentration (e.g., 100 mcg/mL for bolus) or a pre-diluted, ready-to-use solution. Following visual inspection, the medication is administered intravenously in adult patients either as precise, intermittent boluses or as a continuous infusion. The dosing frequency, whether repeat boluses every 1–2 minutes or a continuous rate, is strictly dictated by the patient's immediate blood pressure goal.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Biofen


Evidence for Acute Pain Management and Fever Reduction

Biofen was studied for its use in research exploring how symptoms change over time related to temporary, sharp physical discomfort, such as headaches, muscle pain, dental pain, and injuries like sprains, as well as examining temperature changes during fever. Research in this area includes short-term Randomized Controlled Trials (RCTs). These trials research examined outcomes related to physical discomfort, tracking changes in pain intensity scores. For fever, studies explored outcomes related to systemic or functional imbalance by monitoring changes in body temperature. Findings describe patterns observed in the studies where changes in reported symptom intensity were measured during the observed time intervals. The follow-up durations were limited in many of these studies, focusing only on immediate effects.


Evidence for Chronic Inflammatory Conditions

Biofen was evaluated in research exploring symptoms related to conditions where symptoms may vary in intensity over long periods, such as Osteoarthritis or Rheumatoid Arthritis. These studies often involve longer Randomized Controlled Trials and observational settings that monitored participants for weeks or months. The outcomes reflecting daily functioning or activity level are key in this area, using specific functional scales. Research generally focuses on temporary changes in symptoms, and not on outcomes related to altering the underlying progression of the condition. There is limited information for long-term outcomes that would describe effects after many years of use.


What is Still Uncertain About Biofen Research

While research contributes to the broader evidence landscape for Biofen, certainty remains low in several key areas. Long-term effects are not fully established because most studies focus on short-term relief. Findings were mixed in some comparative trial designs. Research is ongoing and evidence is limited in defining the role of Biofen for patients with very complex or rare combinations of health issues. Studies help show what has been observed so far, but research does not determine whether an individual will respond similarly to the group averages reported in the trials.

Key Studies & References

  1. MedlinePlus Drug Information: Ibuprofen
  2. U.S. FDA Drug Labeling (SPL) for Ibuprofen
  3. National Institute for Health and Care Excellence (NICE) Guideline on Osteoarthritis

Frequently Asked Questions (FAQ)

Common questions about Biofen (FAQ)

Q: Is Biofen generally considered a long-term or short-term treatment option?

Official regulatory guidance emphasizes using Biofen at the lowest effective dose for the shortest duration possible. This is because the risk of serious side effects, particularly those affecting the heart and digestive system, may increase if the medicine is taken for a long duration.

Q: Does taking Biofen cause common side effects like stomach upset or nausea?

Official product information notes that common side effects are often gastrointestinal in nature. These frequently include symptoms such as nausea, indigestion, stomach upset, and sometimes diarrhea or abdominal pain.

Q: Will Biofen make a person feel tired, dizzy, or sleepy?

Official information indicates that nervous system effects have been reported. Common reported adverse events include dizziness and headache. Somnolence, which means unusual drowsiness or sleepiness, has also been documented.

Q: Are there any side effects of Biofen that can appear much later after starting treatment?

Official documents highlight that the risk of certain serious issues, such as cardiovascular thrombotic events (like heart attack or stroke), is generally linked to the length of time Biofen is used. Some effects, like anemia (a low red blood cell count), have been seen in patients receiving long-term treatment.

Q: Does Biofen interact with common medications like antibiotics or allergy pills?

Regulatory interaction lists focus on known drug classes that pose a risk. Biofen is known to interact with certain medicines, such as diuretics (water pills) and some anticoagulants (blood thinners). It is regulatory guidance that all patients review the full interaction list with a healthcare provider.

Q: What are the general rules for taking Biofen with other prescription medicines?

Regulatory documents state the principle of minimizing risk involves using the lowest effective dose for the shortest possible duration. Official information notes that patients with serious conditions or those taking other prescription drugs may require consultation with a healthcare professional before use.

Q: Is Biofen generally appropriate for use by children?

According to official labeling, Biofen is not approved for use in children younger than 6 months due to lack of established safety and effectiveness in this age group. For older children, the dose is determined based on factors like weight. All pediatric use requires following specific regulatory dosing guidelines.

Q: Is Biofen safe to use during pregnancy or while breastfeeding?

Official information notes that use of Biofen is strictly contraindicated (must be avoided) in the third trimester of pregnancy. When breastfeeding, however, official studies indicate that Biofen transfers at very low levels and is often considered a preferred option for pain relief, posing minimal risk to the infant.

Q: How is Biofen fundamentally different from other drugs that treat similar problems?

Biofen, like other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), works by blocking specific enzymes known as Cyclooxygenase (COX) enzymes. This mechanism reduces the body's production of natural chemicals called prostaglandins, which are responsible for pain, fever, and inflammation.

Q: What should I do if I think Biofen is masking signs of an infection?

Official safety information warns that Biofen has the potential to mask the typical signs of an underlying infection. If a person experiences any new symptoms while taking the drug, or if their fever or pain is not improving or is getting worse, official product information requires that a healthcare professional be consulted.

Q: Is it normal to feel a slight headache when first starting Biofen?

According to official clinical data, headache is classified as a very common side effect. In some studies, headaches were reported in up to 12% of participants.

Q: Does Biofen have any effect on mood or cause feelings of anxiety?

Official documentation reports that nervous system and psychiatric side effects have occurred. Documented adverse reactions include feelings of nervousness, irritability, confusion, and in less frequent cases, depression.

Q: Can long-term use of Biofen lead to weight gain or changes in appetite?

Official adverse event reports indicate that fluid retention (edema) has been observed in some patients using Biofen. This is a common effect of the drug class. A loss of appetite has also been listed as a documented adverse reaction.

Q: Are there any specific foods that are known to interact with Biofen?

Official studies on absorption indicate that taking Biofen immediately after a meal will slow down the rate at which it enters the bloodstream. However, food is not noted to cause a significant reduction in the total amount of medicine absorbed by the body.

Q: How quickly can a person expect Biofen to start showing an effect?

Official pharmacokinetic data shows that the highest concentration of the medicine in the blood, which often corresponds to peak effect, is generally reached one to two hours after oral administration.

Q: How long does one dose of Biofen stay active in your system?

According to official scientific information, the half-life of Biofen (the time required for half the dose to leave the bloodstream) is approximately 1.8 to 2.0 hours. The substance is generally considered to be completely eliminated from the body within 24 hours of taking the last dose.

Q: Is Biofen considered to be addictive or habit-forming?

Biofen belongs to the Nonsteroidal Anti-inflammatory Drug (NSAID) class and is not classified as a controlled substance by government agencies. Official sources do not list it as a drug that is addictive or habit-forming.

Q: Can Biofen affect the results of lab tests, like blood or urine tests?

Official regulatory information indicates that Biofen has been associated with changes in certain laboratory results. These include borderline elevations of liver tests and, in some cases, positive results on stool occult blood tests (a test for hidden blood).

How should Biofen be stored and disposed of?

How to Store and Dispose of Biofen?

This section explains the required storage and disposal procedures for Biofen, strictly as documented in official regulatory labeling.


Storage Requirements

Biofen must be kept in its original, unopened container and stored under specific environmental controls to maintain product stability:

  • Temperature: Store refrigerated at 2 C to 8 C (36 F to 46 F). The product must not be frozen.
  • Light Protection: Keep the product in the original carton to protect it from light until the time of use.
  • Handling: Do not shake the vial.
  • Child Safety: Keep this medicine out of the sight and reach of children.

Disposal Instructions

Biofen is a single-use product, and specific rules apply to disposal:

  • Unused Product: After withdrawing the required dose, any unused portion of the solution remaining in the vial must be immediately discarded.
  • Waste Protocol: Dispose of the used vial and any remaining contents according to facility or local regulations for medical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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