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PlainMeds

What the label lists and what reports show

Water side effects

Water's FDA label lists its adverse reactions in its own words. FAERS holds 5,095 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hereditary angioedema (557 reports).

  • Generic listed
  • In shortage

Check it at the source: the water FDA label on DailyMed (effective August 24, 2026); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Source: FDA drug label, REMEDYREPACK INC., effective August 24, 2026 (SPL set 5dd5d148-6e23-41de-bff5-551b2aea9598), via openFDA; the full label on DailyMed

What do FAERS reports show?

5,095 reports list water among the medicines taken, each a report of something that happened, not proof the medicine caused it; 201 are coded as a death and 1,574 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Hereditary Angioedema557
  • Fatigue283
  • Nausea275
  • Headache255
  • Product Dose Omission Issue (a use or a product term, not a reaction)253
  • Weight Decreased233
  • Weight Increased230
  • Pain229
  • Pyrexia213
  • Dyspnoea211
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)208
  • Vomiting207
  • Diarrhoea172
  • Off Label Use (a use or a product term, not a reaction)168
  • Cough162
  • Drug Ineffective (a use or a product term, not a reaction)157
  • Dizziness153
  • Nasopharyngitis153
  • Covid-19151
  • Pneumonia149
  • Sinusitis145
  • Fall144
  • Malaise143
  • Myelosuppression139
  • No Adverse Event (a use or a product term, not a reaction)137

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Water: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions