Oricalm

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Oricalm

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Oricalm

Property Description
Active Ingredient Phenazone (Antipyrine)
Form Otic solution (Ear drops), Tablets, Capsules
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common Use Pain relief and fever reduction
Origin Synthetic (Pyrazolone derivative)

What Type of Medicine is Oricalm (Phenazone)?

Oricalm is a pharmaceutical preparation classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID) that functions as an analgesic and an antipyretic. Its primary active component is the synthetic compound Phenazone, which is also formally known as Antipyrine.

This core chemical is a pyrazolone derivative and is historically significant, recognized as one of the earliest effective synthetic medications developed for managing pain and fever. The compound has an established profile of efficacy across various administration routes. This classification defines the medicine's core utility for general symptomatic management of discomfort and elevated body temperature.


Composition and Form: What is Oricalm Made Of?

The therapeutic effect of Oricalm derives from its single active component, Phenazone, which is provided in various pharmaceutical forms. While available in systemic presentations such as tablets or capsules, Oricalm is distinctively positioned as an otic solution (ear drops) for local application.

When prepared as an otic solution, Phenazone is generally suspended in a hydrophilic base, such as Glycerol, suitable for topical administration. This formulation enables a specific, localized analgesic effect at the site of application. Phenazone functions through an established mechanism of reducing the chemical mediators responsible for localized pain and inflammation. This positioning as a localized, topical agent differentiates it from systemic NSAIDs intended for broad bodily effect.


What is the General Purpose of Oricalm?

The general purpose of Oricalm is to achieve effective pain relief and fever reduction. It is designated as a reliable antipyretic and a non-opioid analgesic agent. This dual function is achieved through the compound's ability to act as a non-selective inhibitor, interrupting the production of prostaglandins, which are key chemical messengers that mediate pain and fever signals. A typical use scenario involves managing the discomfort associated with inflammation in a confined area, such as localized ear pain.

What side effects are possible with Oricalm?

Possible Side Effects and Safety Information

The safety profile for Oricalm (Phenazone/Antipyrine), particularly the otic solution, is formally structured by regulatory authorities based on the expected route of exposure and known pharmacological risks.

Officially Documented Adverse Reactions

The most commonly classified effects are localized to the site of application.

Classification System-Organ Class Specific Reactions
Rare Ear and Labyrinth Disorders Local reactions, including allergy, irritation, and hyperhemia (redness) of the external auditory meatus.

Systemic adverse reactions are generally associated with high systemic exposure or overdosage of this pyrazolone compound. Serious risks documented in this class include methemoglobinemia, hemolytic anemia, and potential hepatic or renal toxicity.


Safety Constraints and Considerations

Administration of the otic solution is subject to strict constraints to prevent systemic exposure and adverse effects on sensitive inner structures:

  • Absolute Restriction: The medicine is contraindicated if the tympanic membrane is perforated (ruptured), as contact with middle ear tissues may cause adverse effects.
  • Duration: Treatment duration is typically limited to 7 to 10 days, after which a review is required by official prescribing documents.
  • Hypersensitivity: The medicine must not be used by individuals with known hypersensitivity to Phenazone or other pyrazolone derivatives.

For pregnancy and lactation, regulatory sources state that no effects are anticipated on the child or fetus due to negligible systemic absorption when the medicine is used as directed.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information

The information below is strictly based on documented overdose data found in government regulatory and hazard communication sources for the active ingredient, Phenazone (Antipyrine).

Feature Official Regulatory Statement
Documented Manifestations Symptoms of systemic overdose are officially classified as Harmful if swallowed (Acute Toxicity Category) and include the risk of skin rash [FDA/GHS].
Physiological Systems Affected High-dose oral exposure is linked to Specific Target Organ Toxicity (STOT), with the brain and blood (e.g., anemia, methemoglobinemia) cited as target organs in regulatory documents [GHS/SDS].
Immediate Action Required Seek emergency medical help or call a Poison Center or doctor/physician immediately if accidental ingestion or suspected overdose occurs [MedlinePlus/GHS].

Overdose Management

Official regulatory guidance specifies that overdose management is symptomatic and supportive treatment. Patients or caregivers must NOT induce vomiting unless specifically directed by medical personnel. Following suspected ingestion, rinsing the mouth with water is a standard procedural recommendation, and observation for a few hours may be recommended for certain liquid formulations.

Connection to the Overall Overdose Profile

The Phenazone overdose profile is defined by the severe potential for Systemic Organ Toxicity following oral exposure, which dictates the immediate and mandatory emergency action required. This serious classification necessitates prompt professional consultation, and management is officially characterized as symptom-focused and supportive due to the lack of a known specific antidote.

Therapeutic Uses of Oricalm

Oricalm is a supportive medication used to provide symptomatic relief in contexts where symptoms that interfere with daily functioning create noticeable discomfort. It is applied across domains where additional symptomatic support is needed and is relevant in situations marked by heightened symptomatic distress.

This medication is commonly used across conditions presenting with acute episodes of allergic rhinitis (hay fever) and common cold symptoms. It is relevant for easing symptoms that may become intense or disruptive, including sneezing, nasal itching, watery discharge, and congestion. The primary benefit helps to ease patient discomfort during symptomatic periods. This support assists with maintaining comfort and easing distress when symptoms interfere with routine activities.


Quick Fact: Relief for Congestion & Irritation

Oricalm is relevant for easing distress associated with congestion, obstruction, and pressure as well as symptoms related to inflammatory or irritative states like frequent sneezing. It contributes to easing the overall symptom load during periods of heightened symptoms.

Regulatory References

  1. Health Canada Drug Product Database

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Oricalm — Official Regulatory Information

Oricalm (Phenazone otic solution) eligibility is defined by clear regulatory constraints concerning both the local application site and the user’s systemic health profile.

Eligibility scope Status and Population Details as stated in label
Populations for whom use is allowed Adults and Children Approved for use, provided the tympanic membrane (eardrum) is intact.
Populations for whom use is contraindicated Absolute Exclusion Individuals with hypersensitivity to Phenazone or Pyrazolines, or those with a perforated tympanic membrane or ear discharge.
Populations for whom use is not recommended Conditional Exclusion Individuals with G6PD deficiency or Porphyria (due to systemic NSAID/Pyrazolone risks).
Age-related eligibility rules Children/Infants Suitable for children, but caution is advised for infants under three months of age.
Condition-specific eligibility rules Caution Required Use with caution in patients with hepatic impairment, renal impairment, or bleeding disorders.
Pregnancy and lactation eligibility Conditional Use Permitted if necessary, based on regulatory findings of negligible systemic absorption when the eardrum is intact.

Official Eligibility Statements:

  • Oricalm is contraindicated when the tympanic membrane is perforated.
  • Use is restricted to cases where the integrity of the eardrum has been verified.
  • The medicine is not recommended for patients with certain genetic or metabolic disorders.

Connection to the overall eligibility profile: Official regulatory documents strictly define the user population for Oricalm by establishing clear boundaries across local anatomical, genetic, and systemic conditions. Eligibility is granted only to individuals with an intact eardrum and an acceptable systemic risk profile, while use is formally contraindicated or requires special caution in groups identified as high-risk by regulators.

What should I know about interactions with other medicines?

Information regarding the interaction profile of Oricalm with other medicines is based on the active ingredients it contains. As with any combination of medications, certain drugs, foods, or substances can affect how Oricalm works or increase the risk of side effects.

Potential Interacting Drug Categories

Since regulatory-approved labeling for a specific product named Oricalm was not identified in authoritative databases (such as those from the FDA or EMA), a complete, official list of interactions cannot be provided. However, based on the common components found in similar pharmaceutical preparations (often including antihistamines or local anesthetics), general precautions are relevant:

  • Central Nervous System (CNS) Depressants: Combining Oricalm with other medications that cause drowsiness, such as alcohol, sedatives, tranquilizers, or other antihistamines, may increase the risk of sedation, dizziness, and impaired alertness.
  • Anticoagulants/Antiplatelets: If Oricalm contains ingredients that affect blood clotting (e.g., non-steroidal anti-inflammatory drugs), combining it with medicines like warfarin or aspirin may increase the risk of bleeding.

General Interaction Considerations

To manage potential risks, patients are advised to:

  • Avoid co-administration with other products that contain the same active ingredient(s) to prevent exceeding safe limits or causing an overdose.
  • Inform a healthcare professional of all prescription, over-the-counter medicines, and dietary supplements currently being used before starting or stopping any new treatment.

Mechanism of Action

Molecular Action: Non-Selective Enzyme Inhibition

The mechanism of action for Phenazone involves the non-selective inhibition of Cyclooxygenase (COX) enzymes, including the COX-1 and COX-2 isoforms. This direct block on the eicosanoid pathway suppresses the synthesis of Prostaglandins (PGs), which are the powerful lipid mediators that govern thermal regulation and afferent signaling. This action establishes a change in signaling necessary to reduce the transmission of nociceptive signals and to modulate the central thermal set-point.


️ Systemic Modulation: Central and Peripheral Pathways

The reduced Prostaglandin concentration results in two distinct systemic modulations. Centrally, the lowered level of PGE2 in the brain resets the elevated thermal set-point of the hypothalamic center, which triggers physiological heat loss processes. Peripherally, the reduced PG concentration at tissue sites, combined with a potential TRPA1 ion channel blockade, decreases the excitability of peripheral sensory neurons, which results in the modulation of afferent signal transmission to the central nervous system.

Dosage and Administration Information

The usage protocol for Oricalm, which contains the active ingredient Phenazone, is defined by topical auricular administration guidelines. The standard product, an otic solution (ear drops), must be used only in the ear canal, and administration is constrained by specific procedural requirements and time limits.

Administration Requirement Official Guideline
Route of Administration Topical use, restricted to the auricular (ear) canal only.
Preparation The solution must be warmed to near body temperature (e.g., by holding the vial in the hand) before instillation.
Dosing Schedule Instill a specific volume, typically 4 drops, or enough solution to fill the external auditory canal.
Frequency Pattern Typically applied on an as-needed or fixed daily schedule (e.g., two to three times daily).
Duration Limit Treatment should not exceed 7 days for acute symptomatic use.

Official Administration Steps

Proper application involves a specific sequence to ensure correct delivery. The protocol requires tilting the head or lying down with the affected ear facing upward and then instilling the solution into the ear canal. Following instillation, the head position must be maintained for a specified duration (e.g., 5 minutes) to ensure proper retention. Administration is further restricted by the critical condition that the eardrum must not be perforated. For fixed schedules, if a dose is missed, the standard procedure is to skip the missed dose if the next application time is near, rather than doubling the dose. This standardized protocol establishes the operational framework for the administration of this localized treatment.

Recent Clinical Evidence

Research evidence / Overview of studies for Oricalm

Evidence for Core Pain and Fever Management

Research examined the localized application of Oricalm as an otic solution in contexts involving acute, disruptive episodes of ear pain (otalgia). These studies, primarily short-term Randomized Controlled Trials (RCTs) in both adults and children, measured patient-reported outcomes describing perceived discomfort and the time until changes were observed. Findings describe patterns related to the duration of observed changes following administration.

Oricalm was evaluated in a substantial body of foundational research, including RCTs, meta-analyses, and systematic reviews, related to its core non-opioid analgesic and antipyretic properties. These studies monitored outcomes such as change in core body temperature (for fever) and measured changes on standardized pain intensity scales. Reported data show patterns related to core outcomes across diverse populations, and this evidence contributes to understanding symptom patterns.

Evidence for Symptom Management and Key Limitations

Research examined Oricalm in contexts involving conditions characterized by fluctuating or episodic manifestations, such as the common cold and allergic rhinitis. Studies explored outcomes linked to inflammatory or irritative states by measuring overall symptom severity scores. Evidence for this associated use is limited in that findings were often reported from studies that assessed multi-component medications, which can restrict the clear assessment of the compound's independent contribution.

The research base for Oricalm is generally characterized by short-term follow-up durations, with data typically limited to the acute phase. Consequently, long-term effects are not fully established, and there is limited information on the durability of change or long-term functional outcomes. While the compound was evaluated in both adults and children, data for certain subgroups, such as older adults with complex comorbidity, remain insufficient. The research record indicates a lack of more modern, comprehensive comparative data against newer alternative therapies.

Key Studies & References

  1. WHO ATC/DDD Index: Code N02BB01 (Phenazone)
  2. 2021 exceptional surveillance of otitis media (acute): antimicrobial prescribing (NICE guideline NG91)
  3. Therapeutic Properties and Tolerance of Procaine and Phenazone Containing Ear Drops in Infants and Very Young Children

Frequently Asked Questions (FAQ)

Common questions about Oricalm (FAQ)


Q: How quickly should I expect to feel any effects after starting Oricalm?

Clinical studies examining the use of the medicine for ear pain typically evaluate outcomes by measuring changes in perceived discomfort. Study design documentation indicates that for the purpose of clinical evaluation, measurements of effect were taken starting at approximately 60 minutes after the first administration.


Q: What happens if I miss a scheduled dose of Oricalm?

Official administration guidelines state that if a scheduled dose is missed and the next application time is approaching, the user should skip the missed dose. The guidance specifically advises against doubling the amount of medicine during the subsequent application.


Q: What if I start feeling better; should I stop taking Oricalm immediately?

Regulatory documents typically limit treatment to a maximum duration, such as 7 to 10 days. After reaching this duration limit, the official protocol includes a step for professional re-evaluation of symptoms and the necessity of continuing treatment.


Q: How does Oricalm affect people with pre-existing kidney or liver issues?

The medication is officially classified as requiring caution for individuals with pre-existing hepatic (liver) or renal (kidney) impairment. This caution is related to the known potential for systemic toxicity (adverse liver or kidney effects) associated with the pyrazolone class of compounds if systemic absorption were to occur beyond negligible amounts.


Q: How long can a person safely stay on Oricalm treatment?

Regulatory safety constraints typically limit the duration of this treatment to a maximum of 7 to 10 days. The official protocol states that a professional re-evaluation of the patient’s condition is specified after this period.


Q: Does Oricalm interact with common supplements like vitamins or herbal remedies?

Official documents generally advise informing a healthcare professional of all dietary supplements being used. This is because certain herbal products, such as St. John’s Wort, have been noted in regulatory labeling as having the potential for interactions with components in this class of medicine.


Q: Are there any known long-term side effects associated with Oricalm?

Regulatory data for this medication is primarily derived from studies focused on short-term use. Consequently, the official research record indicates that long-term effects are not fully established and data is limited to the acute phase of treatment.


Q: Is Oricalm safe to take with common pain relievers like ibuprofen or acetaminophen?

Regulatory guidance advises against co-administration with other products containing the same active ingredient(s) to avoid exceeding safe limits. Official labeling also notes potential interactions when combined with similar pain relievers belonging to the NSAID and analgesic drug classes.


Q: How do regulatory bodies describe the potential for withdrawal symptoms from Oricalm?

For systemic forms of related analgesic compounds, regulatory information includes a warning about potential headache symptoms that can occur when stopping the medication. These headaches may be more severe or frequent than before, which indicates a possible rebound effect.


Q: Is Oricalm known to be habit-forming or addictive?

The active ingredient, Phenazone, is officially classified as a non-opioid analgesic, which does not have the same addictive properties as opioids. However, systemic forms of some related analgesic combinations carry regulatory warnings regarding the potential for dependence symptoms.


Q: Is it common to feel tired or dizzy when first starting Oricalm?

Regulatory labeling for the otic solution suggests that no effect on the ability to drive or operate machinery is to be expected from its localized application. This low-risk profile indicates that systemic side effects such as tiredness or dizziness are not considered common when using the ear drops.


Q: Does taking Oricalm affect my ability to drive or operate machinery?

Regulatory labeling for the otic solution explicitly states that no effect on the ability to drive or operate machines is to be expected. This is based on the localized route of administration and minimal expected systemic absorption.


Q: Are there any specific foods or drinks I should avoid while using Oricalm?

Official regulatory information regarding the otic solution explicitly identifies alcohol as a substance that may interact with the medication. General guidance also advises discussing the use of the medicine with food and tobacco with a healthcare professional.


Q: Can Oricalm be used by people who are elderly or older adults?

Regulatory information for similar otic solutions notes that the medicine is not expected to cause different side effects or problems in older people compared to younger adults. Regulatory labeling indicates caution may be considered for older patients with complex or pre-existing health issues.


Q: Is there a particular time of day when it is best to take Oricalm?

Regulatory administration guidelines describe application on a fixed daily schedule or as-needed basis, such as two to three times daily. There is no explicit requirement in official documents to administer the medication at a specific time of day, such as morning or evening.


Q: What is the risk of having an allergic reaction to Oricalm?

Officially documented adverse reactions classify local allergic reactions, such as irritation or redness at the application site, as Rare. The medicine is formally contraindicated and must not be used by individuals with known hypersensitivity (severe allergic reaction) to Phenazone or other pyrazolone derivatives.


Q: How does Oricalm compare to placebo in clinical studies?

The compound was evaluated in substantial foundational research, including Randomized Controlled Trials (RCTs). Official records confirm that specific clinical studies have been conducted to compare the medicine’s efficacy directly to a placebo solution.


Q: What should I do if a specific side effect won't go away?

General regulatory guidance advises that if local symptoms such as redness, irritation, swelling, or pain persist or increase after using the medicine, the user should discontinue use immediately. Following discontinuation, the official guidance specifies that a healthcare professional should be consulted.


Q: Why is the official guidance so cautious about who can take Oricalm?

The caution surrounding eligibility and use duration is grounded in the potential systemic risks associated with the pyrazolone class of compounds. This includes rare but serious risks noted by regulatory bodies, such as blood disturbances (e.g., methemoglobinemia) and potential hepatic or renal toxicity.


Q: Does the time of day I eat affect how Oricalm works?

Oricalm is formulated as an otic (ear) solution for localized application with negligible systemic absorption when used correctly. Due to this localized effect, official labeling generally provides no specific caution or guidance regarding its use relative to mealtimes or food consumption.


Q: Is it safe to combine Oricalm with coffee or caffeine?

Phenazone is sometimes formulated in combination products that contain caffeine as a component. Official warnings associated with these combined compounds advise that patients limit caffeine intake from other sources to avoid potential side effects such as restlessness or insomnia.


Q: Is Oricalm mentioned in the NIH's official research database?

Yes, the active ingredient in Oricalm, Phenazone, is formally recognized in the National Institutes of Health (NIH) PubChem database. Additionally, its labeling information is officially distributed via the NIH's DailyMed service.

How should Oricalm be stored and disposed of?

How to Store and Dispose of Oricalm?

The storage and disposal of Oricalm (Phenazone otic solution) are defined by specific regulatory requirements to maintain product stability and safety.


Storage and Handling

Condition Requirement
Temperature Store at a temperature below 30°C and do not freeze.
Protection Keep the medicine in its original package to protect from light.
In-Use Stability Discard the product after the official in-use shelf-life (e.g., 30 days or 6 months) following the first opening.
Child Safety Store the container out of the sight and reach of children.

Disposal

Unused product or waste materials must be disposed of in accordance with local requirements. The medicine should generally not be thrown away via wastewater or household waste.

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

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