Pediair

Pediair Adverse Reactions

montelukast

Manufacturer:

XL Lab

Distributor:

Unimed
Full Prescribing Info
Adverse Reactions
Montelukast oral granules has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy.
Postmarketing Experience: The following side effects have been reported in postmarketing use: Infections and infestations: upper respiratory infection.
Blood and lymphatic system disorders: increased bleeding tendency, thrombocytopenia.
Immune system disorders: hypersensitivity reactions including anaphylaxis, very rarely hepatic eosinophilic infiltration.
Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, disturbances in attention, dream abnormalities, hallucinations, insomnia, memory impairment, obsessive-compulsive symptoms, psychomotor hyperactivity (including irritability, restlessness, and tremor), somnambulism, suicidal thinking and behavior (suicidality), tic.
Nervous system disorders: dizziness, drowsiness, paraesthesia/hypoesthesia, very rarely seizure.
Cardiac disorders: palpitations.
Respiratory, thoracic and mediastinal disorders: epistaxis; pulmonary eosinophilia.
Gastrointestinal disorders: diarrhea, dyspepsia, nausea, vomiting.
Hepatobiliary disorders: increased ALT and AST, very rarely hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).
Skin and subcutaneous tissue disorders: angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, rash, urticaria.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.
Renal and urinary disorders: enuresis in children.
General disorders and administration site conditions: asthenia/fatigue, edema, pyrexia.
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