METHENAMINE: 67 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Clarion Brands, LLC · HUMAN OTC DRUG · FDA Label: Available
First Report: 2014 · Latest Report: 20250815
What Are the Most Common METHENAMINE Side Effects?
All METHENAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cardiac failure | 12 | 17.9% | 0 | 12 |
| Emotional distress | 12 | 17.9% | 0 | 12 |
| Fall | 12 | 17.9% | 0 | 12 |
| Hypotension | 12 | 17.9% | 0 | 12 |
| Respiratory syncytial virus test positive | 12 | 17.9% | 0 | 12 |
| Mitral valve replacement | 11 | 16.4% | 0 | 11 |
| Aortic valve replacement | 10 | 14.9% | 0 | 10 |
| Endocarditis enterococcal | 10 | 14.9% | 0 | 10 |
| Diarrhoea | 7 | 10.5% | 0 | 3 |
| Urinary tract infection | 7 | 10.5% | 0 | 3 |
| Constipation | 5 | 7.5% | 0 | 2 |
| Endocarditis | 5 | 7.5% | 0 | 5 |
Who Reports METHENAMINE Side Effects? Age & Gender Data
Gender: 85.1% female, 14.9% male. Average age: 63.4 years. Most reports from: US. View detailed demographics →
Is METHENAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2015 | 3 | 0 | 1 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 1 |
| 2018 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2022 | 2 | 0 | 0 |
| 2023 | 7 | 0 | 2 |
| 2024 | 16 | 0 | 14 |
| 2025 | 2 | 0 | 0 |
What Is METHENAMINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 26 |
| Urinary tract infection | 18 |
Official FDA Label for METHENAMINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses Temporarily relieves: pain & burning
- frequency and urgency of urination
Dosage & Administration
Directions Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids. Children under 12 years: ask a doctor. Do not use for more than a 3 day period unless directed by a doctor.
Warnings
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you: take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take more or for a longer time than directed Do not use: If you are on a sodium restricted diet if you are allergic to salicylates (including aspirin) unless directed by a doctor if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor Ask a doctor before use if you have: frequent, burning urination for the first time the stomach bleeding warning applying to you history of stomach problems, such as heartburn high blood pressure heart disease liver cirrhosis bleeding problems diuretic use ulcers kidney disease reached age 60 or older Ask a doctor or pharmacist before use if you are: taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug When using this product: do not take more than the recommended dosage Stop and ask a doctor if: product has been used for 3 days you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better ringing in the ears or a loss of hearing occurs If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active ingredients (in each tablet)
Purposes Methenamine
162 mg Antibacterial Sodium Salicylate 162.5 mg (NSAID)* Analgesic (Pain Reliever) * nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients benzoic acid, croscarmellose sodium, fd&c red #40, fd&c yellow #6, hypromellose , magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl titanium dioxide, triethyl citrate