Skip to content
Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PYRILAMINE: 64 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
64
Total FAERS Reports
5 (7.8%)
Deaths Reported
52
Hospitalizations
64
As Primary/Secondary Suspect
2
Life-Threatening
Approved Prior to Jan 1, 1982
FDA Approved
GM Pharmaceuticals, INC
Manufacturer
Discontinued
Status
Yes
Generic Available

Active Ingredient: PYRILAMINE MALEATE · Route: ORAL · Manufacturer: GM Pharmaceuticals, INC · FDA Application: 080808 · HUMAN OTC DRUG · FDA Label: Available

First Report: 20140603 · Latest Report: 20240625

What Are the Most Common PYRILAMINE Side Effects?

#1 Most Reported
Drug ineffective
47 reports (73.4%)
#2 Most Reported
Product dose omission issue
46 reports (71.9%)
#3 Most Reported
General physical health deterioration
46 reports (71.9%)

All PYRILAMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 47 73.4% 0 46
Drug hypersensitivity 46 71.9% 0 44
General physical health deterioration 46 71.9% 0 46
Product dose omission issue 46 71.9% 0 46
Constipation 45 70.3% 0 44
Anaemia 44 68.8% 0 44
Aspiration 44 68.8% 0 44
Asthma 44 68.8% 0 44
Blood calcium increased 44 68.8% 0 44
Blood creatinine increased 44 68.8% 0 44
Bronchopulmonary aspergillosis allergic 44 68.8% 0 44
Headache 44 68.8% 0 44
Musculoskeletal stiffness 44 68.8% 0 44
Oedema peripheral 44 68.8% 0 44
Pneumonia 44 68.8% 0 44
Pulmonary fibrosis 44 68.8% 0 44
Pulmonary mass 44 68.8% 0 44
Transaminases increased 44 68.8% 0 44
Upper respiratory tract infection 44 68.8% 0 44
Abdominal pain upper 43 67.2% 0 43

Who Reports PYRILAMINE Side Effects? Age & Gender Data

Gender: 95.5% female, 4.5% male. Average age: 75.8 years. Most reports from: CA. View detailed demographics →

Is PYRILAMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 1
2015 2 0 0
2016 1 0 0
2017 2 0 0
2022 1 1 0
2024 1 0 1

View full timeline →

What Is PYRILAMINE Used For?

IndicationReports
Product used for unknown indication 46

Official FDA Label for PYRILAMINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses ■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Dosage & Administration

Directions ■ mL= milliliter ■ use enclosed 15 mL dose cup and keep with product ■ children 6 to under 12 years: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor ■ children under 6 years of age: consult a doctor.

Warnings

Warnings Ask a doctor before use if the child has ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma Ask a doctor before use if the child is taking sedatives or tranquilizers When using this product ■ marked drowsiness may occur ■ sedatives and tranquilizers may increase drowsiness ■ excitability may occur, especially in children Stop use and ask a doctor if new symptoms occur Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active ingredients (in each 15 mL)

Pyrilamine Maleate

12.5 mg

Inactive Ingredients

Inactive ingredients citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose