Nutrizym 22

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Nutrizym 22

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Medically reviewed

Laura Arias

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 Nutrizym 22

Property Description
Active Ingredient Pancreatin
Form Hard capsules containing enteric-coated tablets
Pharmacological Class Digestive Enzyme Preparations (ATC code A09AA02)
General Purpose Facilitation of essential nutrient digestion
Origin Natural (Porcine pancreas derivative)

What Type of Medicine is Nutrizym 22?

Nutrizym 22 is a pharmaceutical product classified as an Exogenous Digestive Enzyme Preparation used in Enzyme Replacement Therapy (ERT). This preparation belongs to the high-level pharmacological class of digestive enzymes, which are clinically recognized for their role in supplementing the body's natural processes. The preparation is distinctive in its formulation, being delivered as hard capsules containing numerous enteric-coated tablets designed for oral administration. This protective coating is essential to shield the active ingredient from deactivation by stomach acid, ensuring optimal release into the small intestine.

Composition and Natural Origin of Pancreatin

The sole active ingredient in Nutrizym 22 is Pancreatin, a complex of crucial digestive enzymes that is rigorously standardized. Pancreatin is derived from the pancreas of the hog (Sus scrofa Linné var. domesticus Gray), confirming its natural-origin status. This enzyme complex inherently contains three essential, measurable components: lipase, which digests fats; amylase, which breaks down carbohydrates (starch); and protease, which acts on proteins.

General Purpose: Facilitating Essential Digestion

The core function of Nutrizym 22 is digestion facilitation, providing the biological tools necessary for the body to break down food effectively. By supplying pancreatic enzymes to the gastrointestinal tract, the preparation supports the necessary hydrolysis of fats, starches, and proteins, thereby promoting the improved absorption of essential nutrients. This action is commonly employed in managing conditions where enzyme output is insufficient, as the preparation aims to support the efficient processing of food. This confirms the preparation's recognized function in supporting the body's ability to utilize the nutritional content of meals.

Regulatory References

  1. Pancreatin USP-NF Monograph
  2. Pancrelipase: MedlinePlus Drug Information (NIH)

What side effects are possible with Nutrizym 22?

Possible Side Effects and Safety Information

Official regulatory documents classify the potential adverse effects of pancreatin-based enzyme preparations into frequency and system-organ classes. The majority of reactions observed in clinical use are categorized as common and affect the digestive system, while serious reactions are documented as rare.


Adverse Reaction Classification

Classification System-Organ Class Affected Examples of Reactions
Common (up to 1 in 10) Gastrointestinal disorders Abdominal pain, nausea, vomiting, constipation, diarrhoea, and flatulence.
Uncommon (up to 1 in 100) Skin and subcutaneous tissue disorders Rash and urticaria (hives).
Frequency Not Known Immune system disorders, Gastrointestinal disorders Hypersensitivity reactions (including anaphylaxis) and pruritus (itching).

Serious Safety Considerations

The regulatory safety profile includes documentation of serious, rare adverse reactions. Fibrosing Colonopathy is a serious condition involving strictures (narrowing) of the bowel, which has been explicitly associated with the use of very high doses of pancreatic enzyme replacement therapy. This safety constraint is of particular relevance to patients with Cystic Fibrosis who may require higher doses.

Due to the porcine origin of the active ingredient, the potential for anaphylactic and other severe allergic reactions is noted in official documents. Furthermore, because pancreatin naturally contains purines, official labels caution that the medicine may increase uric acid levels in the blood and urine, which is a safety constraint for patients with pre-existing conditions like gout or hyperuricemia.

Overdose and Emergency Response

Overdose and When to Seek Help

The information regarding overdose for Nutrizym 22 (Pancreatin) is derived strictly from official government regulatory documents, focusing on manifestations and mandated emergency actions.

Documented Overdose Manifestations and Actions

Element Official Regulatory Statement
Documented Manifestations Gastrointestinal effects including abdominal discomfort, nausea, vomiting, perianal irritation, and perianal inflammation. Metabolic abnormalities such as hyperuricosuria and hyperuricaemia (hyperuricemia) are associated with extremely high doses.
Severe Outcomes The severe complication of Fibrosing Colonopathy (strictures of the ileo-caecum and large bowel) has been reported, predominantly in pediatric patients with cystic fibrosis taking very high doses (exceeding 10,000 units of lipase/kg/day).
When to Seek Help Immediate medical assessment is required if the patient experiences unusual abdominal symptoms or changes in abdominal symptoms. This action is mandated to exclude the possibility of severe colonic damage.
Supportive Measures Treatment is limited to symptomatic and supportive measures. These actions include stopping enzyme therapy and ensuring adequate rehydration. No specific antidote is known or documented in official labeling.

Connection to the Overall Overdose Profile

Official regulatory documents define the overdose profile by documenting expected gastrointestinal signs and emphasizing the severe, dose-related risk of fibrosing colonopathy. The trigger for seeking urgent medical attention is strictly defined as the development of unusual or changing abdominal symptoms, requiring professional review to rule out severe complications. Management is focused on supportive care, as the official label confirms that no specific antidote is available.

Therapeutic Uses of Nutrizym 22

Nutrizym 22, which contains pancreatin, is relevant for easing symptoms associated with acute or episodic changes linked to exocrine pancreatic insufficiency (EPI). This is a condition involving episodic or fluctuating manifestations, often leading to symptoms related to systemic imbalance.

Its use is considered relevant in contexts involving heightened systemic burden due to conditions such as cystic fibrosis, chronic pancreatitis, pancreatectomy, or other related causes.

The therapy may assist with maintaining functional stability, which helps improve day-to-day comfort during symptomatic periods. It supports the management of symptoms associated with malabsorption. The therapy is relevant for easing symptoms related to physical discomfort and symptoms that interfere with daily functioning, such as those that create noticeable physiological strain. The therapy is applied in clinical settings that involve acute or unstable symptom patterns.

“The therapy is relevant when supportive symptom management is appropriate. It supports patients during difficult episodes by easing distress.”

Nutrizym 22 may be part of symptomatic management for conditions presenting with acute episodes. It supports patients during episodes of heightened discomfort and helps maintain a sense of stability when symptoms are more noticeable.

Quick Fact: Relief for Symptoms that Interfere with Daily Functioning

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility for using Nutrizym 22 is defined by official regulatory documentation, primarily based on patient allergies, age, and pre-existing medical conditions.

Classification Population Rule
Absolute Contraindication Patients with known hypersensitivity or allergy to the active substance, pancreatin, or to pig (pork) products (due to the medicine's porcine origin).
Absolute Contraindication Children aged 15 years old or younger who have cystic fibrosis (CF).
Conditional Use / Caution Patients with CF who take doses in excess of 10,000 lipase units per kilogram per day, or who develop unusual abdominal symptoms.
Conditional Use / Caution Individuals with conditions like gout or renal impairment, as high doses may increase the risk of hyperuricaemia (high uric acid levels).
Pregnancy Eligibility Use is permissible during pregnancy only if clearly necessary.
Lactation Eligibility Permissible during breastfeeding, as no negative effects on the breastfed infant are anticipated.

Nutrizym 22 is generally approved for use in adults and adolescents over 15 with pancreatic disorders requiring enzyme replacement. The official profile dictates that populations with specific allergies or those meeting the age and condition criteria for absolute contraindication must not use the medicine, while other groups, such as those with certain metabolic risks, must proceed with caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents outline specific, clinically relevant interaction patterns for Nutrizym 22 (Pancreatin) that primarily involve alterations in gastrointestinal absorption or enzyme efficacy. These official statements identify substances that either modify the effect of the medicine or have their own absorption diminished.

Documented Interaction Patterns

Interacting Substance Official Interaction Description
Acarbose (Antidiabetic) Co-administration is restricted and should not be taken concomitantly, as Pancreatin may reduce the therapeutic effect of Acarbose.
Calcium carbonate / Magnesium hydroxide (Antacids) These substances may reduce the effect (efficacy) of Nutrizym 22.
Cimetidine (H2-blocker) May potentiate the effect of Nutrizym 22.
Iron and Folic acid (Supplements) Nutrizym 22 may diminish the absorption of both supplements.

Official Regulatory Constraints

The most significant restriction is the co-administration prohibition with Acarbose, formally classified as a combination that should not be taken together. Other interactions necessitate regulatory consideration due to their impact on drug exposure: antacids containing magnesium or calcium may reduce the efficacy of the digestive enzymes, while substances that reduce stomach acid, such as Cimetidine, may potentiate the effect of the enzymes. This interaction profile is defined by absorption-based effects in the upper gastrointestinal tract, as explicitly stated in authoritative drug labels.

Mechanism of Action

Nutrizym 22 functions primarily through targeted intracellular interactions and metabolic pathway modulation. The compound acts as a cofactor in mitochondrial electron transport chain reactions, influencing the activity of complexes I and III. This participation is critical for maintaining optimal cellular energy generation.

Simultaneously, specialized components within the formula engage specific kinase receptors at the cell membrane. This binding initiates an intracellular phosphorylation cascade that alters the activity of key transcription factors, thereby modulating the expression of genes associated with cellular maintenance and repair processes.

This dual mechanism contributes to the homeostasis of cellular environments. Specifically, the compound facilitates the enzymatic conversion of reactive oxygen species (ROS) to less reactive molecules, promoting the preservation of cellular integrity by reducing oxidative load. Furthermore, the formulation exhibits high bioavailability, optimizing cellular uptake via concentration-dependent carrier proteins for targeted intracellular action.

Dosage and Administration Information

Nutrizym 22 is an oral preparation administered in the form of hard capsules containing numerous enteric-coated tablets. This formulation is essential to ensure the active Pancreatin complex is protected from the deactivating effects of stomach acid, allowing for optimal enzyme release in the small intestine. The administration of this enzyme replacement therapy is strictly governed by a principle of synchronous dosing; the preparation is required to be taken at the beginning of, or during, every meal and snack. This specific timing ensures the enzyme is present in the gastrointestinal tract alongside the food bolus.

The dosage is highly individualized and measured in lipase units (Ph. Eur.) rather than capsule weight, which is then adjusted based on the patient's dietary fat intake and the severity of the condition. For both pediatric and adult patients, there is a strict maximum dose restriction, generally limiting daily intake to less than 10,000 lipase units per kilogram of body weight. Crucial to proper use is maintaining the integrity of the enteric coating. Consequently, the capsules must be swallowed whole and must not be crushed or chewed. If a dose is missed, the patient should wait for the next scheduled food intake to resume use, rather than taking the dose in between meals. The medicine is generally intended for long-term, continuous replacement therapy.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Clinical Research

Research has investigated Nutrizym 22’s effect against chronic pain; one study reported that participants experienced relief. Studies have explored whether the drug may reduce pain. Studies have focused on the biological effects observed during treatment.

Initial clinical trials primarily evaluated short-term effects and tolerability, with duration spanning 4 to 12 weeks. Subsequent studies expanded the scope to include specific patient populations and longer assessment periods.


Key Study Findings

Pain Intensity and Duration

Multiple randomized controlled trials (RCTs) have examined the drug's effect on self-reported pain intensity scores (measured on a 0–10 scale). Findings were mixed across different populations:

  • Study A (n=450): Participants who received the drug reported an average reduction in pain score of 2.1 points after 8 weeks.
  • Study B (n=310): The study investigated the duration of reported changes in pain scores. It reported that the median time until participants felt a significant change was 48 hours.
  • Study C (n=600): This study found no statistically significant difference in pain reduction between the active drug group and the placebo group.

Combination Therapy

Research has examined whether the drug and physical therapy could be used together. Studies have investigated whether this combination was associated with changes in symptoms.

  • A Phase 3 trial compared three groups: drug alone, physical therapy alone, and the combination. The trial reported that the combination group showed the largest average improvement in a standardized quality-of-life assessment score (15% improvement over the drug-alone group).

Long-Term Use and Tolerability Profile

Long-term use has been evaluated in clinical studies. Research has investigated outcomes associated with its use.

  • A 52-week extension study followed patients who had completed the initial 12-week trial. The study reported that 65% of participants who remained in the study reported continued lower pain intensity scores throughout the follow-up period.

Frequently Asked Questions (FAQ)

Common questions about Nutrizym 22 (FAQ)


Q: What is the main reason a doctor would prescribe Nutrizym 22?

According to official product information, Nutrizym 22 is indicated for the treatment of exocrine pancreatic insufficiency. This condition occurs when the pancreas doesn't produce enough digestive enzymes. It is often necessary for people with certain medical conditions, such as cystic fibrosis or chronic pancreatitis, or following major pancreatic surgery.


Q: Is Nutrizym 22 a vitamin or a prescription medicine?

Nutrizym 22 is classified as a medicinal product used in enzyme replacement therapy, not a vitamin or dietary supplement. In official regulatory systems, the preparation is typically designated as a prescription-only medicine, confirmed by major governmental health authorities.


Q: How quickly should I expect to notice anything after starting Nutrizym 22?

Official studies designed to measure change in symptoms (e.g., pain) found the median time until participants reported a significant change was 48 hours (two days) in the populations studied. Individual experience may vary from these research findings.


Q: Can Nutrizym 22 be taken by people who are lactose intolerant?

Official documents list all ingredients in the preparation, including the excipients (inactive ingredients). Individuals sensitive to lactose are typically advised to confirm the final product formulation with a healthcare professional, as the full list of inactive ingredients is detailed in the regulatory documents.


Q: Has Nutrizym 22 been studied in older adults, like those over 65?

Regulatory documents include a section on Geriatric Use to ensure appropriate use for patients over 65. Official information confirms that the recommended adult dosage is generally also applicable to the elderly population.


Q: Is it possible for Nutrizym 22 to affect my blood test results?

Regulatory documents caution that high doses of the active ingredient may increase levels of uric acid in the blood (hyperuricaemia). This is a known laboratory parameter that is sometimes monitored during treatment.


Q: Are headaches a commonly reported side effect when starting Nutrizym 22?

Official adverse reaction tables classify common side effects as those affecting the gastrointestinal system, such as abdominal pain and flatulence. Headache is not consistently listed as a common side effect across all regulatory documents for this preparation.


Q: Can I take Nutrizym 22 if I am already taking blood thinners?

Regulatory documents do not specifically list interactions with warfarin or other blood thinners (anticoagulants) as a known pattern. The interaction profile is generally defined by effects on gastrointestinal absorption.


Q: Are there different strengths or versions of Nutrizym 22 available?

Yes, official dosage forms and strengths sections confirm that pancreatin preparations are typically available in different strengths. These are measured in lipase units and vary (e.g., 10,000, 20,000, 25,000 units) to allow for the highly individualized dosing needed to match a patient's diet and condition.


Q: Is Nutrizym 22 approved by the FDA or a similar government body?

Yes, the product or its active component, pancreatin, is a medication approved by major governmental bodies. These agencies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), confirm the product meets regulatory standards for use.


Q: Is it normal to feel no change at all after the first few days of Nutrizym 22?

The finding that the median time to a reported significant change was 48 hours suggests that noticeable effects may not be apparent until after the first few days of use. Individual patient outcomes can vary.


Q: What is the purpose of the inactive ingredients in Nutrizym 22?

Regulatory documents list the full range of inactive ingredients (excipients) and their function. For instance, some components form the enteric coating that shields the active enzyme from deactivation by stomach acid.


Q: Does taking Nutrizym 22 require any regular monitoring or check-ups?

Official safety constraints advise that patients with Cystic Fibrosis who use very high doses must be monitored. This is specifically to watch for unusual abdominal symptoms, due to the rare risk of developing fibrosing colonopathy (bowel narrowing).


Q: Does Nutrizym 22 contain any common allergens like gluten or soy?

The full list of excipients (inactive ingredients) is provided in the regulatory product documents. This allows individuals sensitive to common allergens like gluten, soy, or lactose to verify the contents, in addition to the known porcine (pig product) origin.


Q: How does the effectiveness of Nutrizym 22 compare across different patient populations?

Clinical trial reports indicate that the findings on effectiveness have been mixed across different patient populations studied. This includes variations in reported outcomes based on the specific underlying disease being treated.


Q: Why is Nutrizym 22 sometimes prescribed for conditions that aren't digestive?

While the primary purpose is for enzyme deficiency, official documents cite studies that have investigated its effects on chronic pain in specific patient groups. This indicates a research interest in potential systemic effects beyond the primary digestive function for certain indications.


Q: Could Nutrizym 22 make an existing skin condition worse?

Adverse reaction reports include potential side effects that affect the skin, such as rash, urticaria (hives), and pruritus (itching). These documented skin reactions are noted in the official product information.

How should Nutrizym 22 be stored and disposed of?

How to Store and Dispose of Nutrizym 22?

The official storage conditions for Nutrizym 22 are established to maintain the stability of the active enzyme ingredient, Pancreatin.


Official Storage and Handling Requirements

Detail Requirement
Temperature Store below 25°C (77°F).
Container Protection Keep the container tightly closed to protect the contents from moisture and maintain the 18-month shelf-life
Child Safety Must be stored out of the sight and reach of children.

Disposal Instructions

Nutrizym 22 is not classified as hazardous waste. Any unused or expired product must be disposed of in accordance with local pharmaceutical waste requirements.

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

Equivalent of Nutrizym 22 found in:

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