Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Ranitidine

Hazard 4 P 3 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T are from Fass.

Fass environmental information

Fass environmental information for Zantac (ranitidine) from GlaxoSmithKline (downloaded 2019-10-25).

Hazard

Persistence: "Ranitidine is not readily biodegradable nor inherently biodegradable. The phrase “Ranitidine is potentially persistent” is thus chosen." For details see Fass.

Bioaccumulation: Log Dow = -1.09 at pH 7 (TAD 3.02).

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Ceriodaphnia dubia) NOEC 310 microg/L.

Risk

PPEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 0.074 which gives the risk insignificant.

Pharmaceutial residues in the aquatic environment

Ranitidine has been detected in outgoing wastewater at concentrations between 224 and 244 ng/L in the Stockholm area and also in surface water in Sweden. During measurements in the Stockholm region during 2018, ranitidine was detected in incoming wastewater but not in outgoing wastewater or surface water.

Report Goodpoint 2019

Comparative assessment of environmental risk when using the gastric acid secretion inhibitors esomeprazole, lansoprazole, omeprazole, pantoprazole and ranitidine from a Swedish perspective (Report Goodpoint 2019).

Even if one assumes a "worst-case" exposure (PEC) or based on measured levels in environmental/wastewater (below detection limits except for ranitidine), the margins are against either CEC (risk of interaction with target species in aquatic organisms, especially fish) or against established toxicity levels in aquatic organisms very large (lower than 0.001 for all substances). Thus, the environmental risk is insignificant for all the investigated substances in Swedish water. No exchanges are therefore recommended from an environmental point of view.

Author: Health and Medical Care Administration, Region Stockholm