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Fosfolag Powder for Oral Suspension

NAFDAC Reg. No. C4-1624 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Fosfolag Powder for Oral Suspension
NAFDAC number
C4-1624
Active ingredient
Fosfomycin Trometamol
Strength
3 g
Form
Powder for suspension
Pack size
3 g x 1's (in sachet)
Manufacturer
Not listed
Applicant (holder)
Benjamin Michaels Limited
Approved
25 Feb 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
24 Feb 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Fosfolag Powder for Oral Suspension is on the NAFDAC register with an active registration (C4-1624). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Fosfolag Powder for Oral Suspension is used for

From the official U.S. FDA label for fosfomycin trometamol, the active ingredient registered with NAFDAC.

What it is used for

Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis . Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)

Possible side effects

Clinical Trials: In clinical studies, drug related adverse events which were reported in greater than 1% of the fosfomycin-treated study population are listed below: Drug-Related Adverse Events (%) in Fosfomycin and Comparator Populations Adverse Events Fosfomycin N=1233 Nitrofurantoin N=374 Trimethoprim/ sulfamethoxazole N=428 Ciprofoxacin N=455 Diarrhea 9.0 6.4 2.3 3.1 Vaginitis 5.5 5.3 4.7 6.3 Nausea 4.1 7.2 8.6 3.4 Headache 3.9 5.9 5.4 3.4 Dizziness 1.3 1.9 2.3 2.2 Asthenia 1.1 0.3 0.5 0.0 Dyspepsia 1.1 2.1 0.7 1.1 In clinical trials, the most frequently reported adverse events occurring in greater than 1% of the study population regardless of drug relationship were: diarrhea 10.4%, head …

Do not use if

Fosfomycin tromethamine is contraindicated in patients with known hypersensitivity to the drug.

Warnings

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including fosfomycin tromethamine, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. …

Pregnancy & breastfeeding

PREGNANCY Teratogenic Effects When administered intramuscularly as the sodium salt at a dose of 1 gram to pregnant women, fosfomycin crosses the placental barrier. Fosfomycin tromethamine crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m 2 , respectively). …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Fosfolag Powder for Oral Suspension

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Fosfolag Powder for Oral Suspension

What is in Fosfolag Powder for Oral Suspension?

Fosfolag Powder for Oral Suspension contains Fosfomycin Trometamol (3 g), as powder for suspension, according to its NAFDAC registration record.

Is Fosfolag Powder for Oral Suspension registered with NAFDAC?

Yes. Fosfolag Powder for Oral Suspension is listed on the NAFDAC register under registration number C4-1624, and its registration is active as of 5 November 2026.

Has Fosfolag Powder for Oral Suspension been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Fosfolag Powder for Oral Suspension in our automatically synced alert list.

How can I check that my pack of Fosfolag Powder for Oral Suspension is genuine?

Run a free authenticity scan with the NAFDAC number C4-1624, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Fosfolag Powder for Oral Suspension used for?

Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis . Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriu (Summarised from the official U.S. FDA label for fosfomycin trometamol. Always follow your doctor or pharmacist.)

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