Unimed Pamidronate

Unimed Pamidronate Adverse Reactions

pamidronic acid

Manufacturer:

Mylan Lab

Distributor:

Unimed
Full Prescribing Info
Adverse Reactions
Usually mild to transient. The most common adverse reactions are asymptomatic hypocalcaemia and fever (an increase in body temperature 1-2°C) typically occurring within 1st 48 hrs of infusion. Fever usually resolves spontaneously and does not require treatment.
Infection: Very rare: Reactivation of Herpes simplex and Herpes zoster.
Blood: Common: Anaemia, thrombocytopenia, lymphocytopenia.
Very rare: Leukopenia.
Immune system: Uncommon: Allergic reactions including anaphylactoid reactions, bronchospasm/dyspnoea, Quincke's (angioneurotic) edema.
Very Rare: Anaphylactic shock.
Central Nervous System: Common: Symptomatic hypocalcaemia, headache, insomnia, somnolence.
Uncommon: Seizures, agitation, dizziness, lethargy.
Very Rare: Confusion, visual hallucinations.
Special Senses: Common: Conjunctivitis.
Very rare: Scleritis, episcleritis, xanthopsia.
Cardiovascular system: Common: Hypertension.
Uncommon: Hypotension.
Very Rare: Left ventricular failure (dyspnoea, pulmonary edema), congestive heart failure (edema) due to fluid overload.
Gastrointestinal tract: Common: Nausea, vomiting, anorexia, abdominal pain, diarrhoea, constipation, gastritis.
Uncommon: Dyspnoea.
Skin: Common: Rash.
Uncommon: Pruritis.
Musculoskeletal system: Common: Transient bone pain, arthralgia, myalgia and generalized pain.
Uncommon: Muscle cramps.
Renal system: Uncommon: Acute renal failure.
Rare: Focal segmental glomerulosclerosis including the collapsing variant, nephritic syndrome.
Very Rare: Deterioration of preexisting renal disease, haematuria.
General disorders and administration site conditions: Very common: Fever and influenza like symptoms sometimes accompanied by malaise, rigor, fatigue and flushes.
Common: Reactions at the infusion site (pain, redness, swelling, induration, phlebitis, thrombophlebitis).
Biochemical changes: Very common: Hypocalcaemia, hypophosphataemia.
Common: Hypokalemia, hypomagnesaemia, increase in serum creatinine.
Uncommon: Abnormal liver function tests, increase in serum urea.
Very Rare: Hyperkalemia, hypernatremia.
Many of these undesirable effects may have been related to the underlying disease.
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