Novalgetol 2.5 g/5 mL, 50 ampoules – metamizole for severe pain and high fever in hospital care

Novalgetol 2.5 g/5 mL is a solution for injection containing metamizole sodium, also known as dipyrone. Metamizole is a pyrazolone analgesic that reduces severe pain and high body temperature and may relieve painful smooth-muscle spasms.

The injectable formulation is used only when treatment with an appropriate oral or rectal dosage form is not possible. It is administered intravenously or intramuscularly by a doctor or nurse under medical supervision.

Novalgetol – indications, administration and safety warnings

What is Novalgetol used for?

Novalgetol solution for injection is used for short-term treatment of:

• acute severe pain following an injury or operation;
• painful abdominal spasms or colic;
• pain in patients with malignant disease;
• other acute or chronic severe pain when other treatment measures are unsuitable or unavailable;
• high body temperature that does not respond to other measures.

The injectable form is used only when administration of an appropriate tablet, oral solution or suppository is not possible.

How is Novalgetol administered?

A doctor or nurse administers the medicine as:

• an intravenous injection into a vein;
• an intramuscular injection into a muscle.

During parenteral administration, the patient should be lying down and remain under medical supervision. An intravenous injection must be given very slowly, at a rate not exceeding 1 mL or 500 mg of metamizole per minute. This reduces the risk of a severe fall in blood pressure and allows immediate interruption if an allergic reaction develops.

For intramuscular use, the solution should be warmed approximately to body temperature.

Adult dosage

The doctor determines the dose according to pain intensity, body temperature, general condition and individual response.

• Adults and adolescents aged 15 years and older who weigh more than 53 kg generally receive 1–2 mL as a single dose.
• When clinically justified, the doctor may increase a single dose to 5 mL, equivalent to 2,500 mg of metamizole.
• Doses may be repeated up to four times daily at intervals of approximately six to eight hours.
• The usual maximum daily amount is 8 mL. In exceptional circumstances and under medical supervision, it may be increased to 10 mL.

The lowest dose that adequately controls pain or fever should always be selected. A significant effect may be expected approximately 30 minutes after parenteral administration.

Use in children

Paediatric dosing is based on body weight. Children and adolescents up to 14 years of age generally receive 8–16 mg of metamizole per kilogram as a single dose. For fever, 10 mg/kg is usually sufficient.

The injectable solution should not be used in infants younger than three months or weighing less than approximately 5 kg. Treatment in a child may be determined and administered only by a doctor.

Duration of treatment

The doctor determines the treatment duration according to the type and severity of the condition. Analgesics should not be administered for longer than three to five days without renewed medical or dental assessment.

Agranulocytosis – the most important safety warning

Metamizole may cause agranulocytosis, a sudden and severe reduction in granulocytes, white blood cells that are essential for protection against infection. This reaction can be life-threatening.

Agranulocytosis is not related to the dose. It may occur at any time during treatment or shortly after treatment has stopped, including in patients who previously used metamizole without complications.

When metamizole is being used for fever, fever as an early sign of agranulocytosis may be overlooked. Antibiotics may also mask some symptoms. Treatment must be stopped while blood-test results are pending and must not be continued until laboratory confirmation is available.

Who must not receive Novalgetol?

• people allergic to metamizole, another pyrazolone or a pyrazolidine;
• people who previously developed agranulocytosis or a serious skin reaction after metamizole or a related medicine;
• patients with analgesic-induced asthma, bronchospasm, hives or angioedema caused by painkillers;
• patients with impaired bone-marrow function or a blood-cell production disorder;
• patients with inherited glucose-6-phosphate dehydrogenase deficiency;
• patients with acute intermittent hepatic porphyria;
• patients with severely low blood pressure or unstable circulation;
• women during the final three months of pregnancy.

Low blood pressure and severe allergy

Injectable metamizole has a greater risk of a serious hypersensitivity reaction and a sudden fall in blood pressure than oral formulations.

The risk is increased by rapid intravenous administration, dehydration, low blood pressure, circulatory instability, high fever, severe coronary disease, asthma, nasal polyps, chronic hives and hypersensitivity to dyes, preservatives or alcohol.

Severe skin reactions and liver injury

Metamizole has been associated with serious skin reactions, including Stevens–Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome.

Treatment must be stopped immediately if a widespread rash, blisters, skin peeling, mucosal sores, facial swelling, fever or enlarged lymph nodes occur.

Liver inflammation has also been reported. Contact a doctor immediately in the event of nausea, vomiting, marked tiredness, loss of appetite, dark urine, pale stools, yellowing of the skin or eyes, itching or upper-abdominal pain.

A patient who previously developed metamizole-related liver injury must not receive another medicine containing metamizole.

Interactions with other medicines

Tell the healthcare team about all medicines, particularly:

• methotrexate, because the combination may increase blood-cell toxicity;
• low-dose acetylsalicylic acid, because metamizole may reduce its antiplatelet effect;
• ciclosporin and tacrolimus;
• valproate;
• bupropion, sertraline and other psychiatric medicines;
• efavirenz and other HIV medicines;
• methadone;
• chlorpromazine, because severe hypothermia may occur;
• oral anticoagulants;
• lithium, captopril, diuretics and other antihypertensive medicines.

Metamizole may interfere with certain laboratory methods used to measure creatinine, uric acid, triglycerides or HDL cholesterol. Healthcare professionals should be informed before blood sampling.

Pregnancy and breastfeeding

Metamizole is generally not recommended during the first and second trimesters. A single dose may be considered only when no suitable alternative is available and after careful medical assessment.

Novalgetol must not be used during the final three months of pregnancy because of the risk of bleeding and premature closure of an important fetal blood vessel.

Metamizole metabolites pass into breast milk. Repeated treatment should be avoided while breastfeeding. Following a single dose, interruption of breastfeeding and disposal of expressed milk for 48 hours is recommended according to medical advice.

Possible side effects

In addition to agranulocytosis, adverse effects may include:

• low blood pressure, rapid heart rate and dizziness;
• rash, hives and other hypersensitivity reactions;
• low platelet counts or a reduction in all blood-cell types;
• kidney injury, reduced urination or acute kidney failure;
• liver inflammation;
• serious skin reactions;
• pain or a local reaction at the injection site.

Red urine may occur because of a harmless metamizole metabolite and generally resolves after treatment. Any unexpected urine change should nevertheless be reported to the healthcare team.

Overdose

An overdose may cause nausea, vomiting, abdominal pain, kidney dysfunction, dizziness, drowsiness, loss of consciousness, seizures, a severe fall in blood pressure and abnormal heart rhythm.

Because Novalgetol is administered in a healthcare institution, the medical team monitors the dose and can provide immediate treatment if required.

Availability and price

Related category and education

Information about products for other painful conditions is available in the Painkillers category.

Products available for online purchase are not direct alternatives to hospital-administered Novalgetol. Severe, sudden, post-operative, cancer-related or unexplained pain requires medical assessment.

Related blog topic: Which is the safest painkiller?

Composition, appearance and packaging

Each 5 mL ampoule contains 2.5 g of anhydrous metamizole sodium in the form of metamizole sodium monohydrate.

Other ingredients are sodium metabisulfite E223, disodium edetate, anhydrous sodium sulfite E221, sodium hydroxide and water for injections.

Each ampoule contains approximately 178.25 mg of sodium. This should be considered in patients on a sodium-controlled diet. Sulfites may rarely cause a severe hypersensitivity reaction or bronchospasm.

The solution is clear and colourless to pale yellow. The pack contains 50 colourless glass ampoules, each containing 5 mL.

Marketing authorisation holder and manufacturer: Galenika AD Belgrade, Republic of Serbia.

Storage

Store below 25°C in the original packaging to protect the medicine from light. Keep out of the sight and reach of children.

Use the contents immediately after opening an ampoule. Any remaining solution must not be stored for later use.

Frequently asked questions

Official sources: ALIMS – Patient Information Leaflet | ALIMS – Summary of Product Characteristics | EMA – Current metamizole safety measures.
Marketing authorisation number: 515-01-02603-22-001, dated 15 June 2023. The leaflet was last approved in June 2023. The medicine is listed in the Serbian National Register of Medicines for 2025. Content checked: July 2026.