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Sterile Side Effects

The most commonly reported side effects of sterile include hereditary angioedema, product dose omission issue, and fatigue, based on 6,832 FDA adverse event reports from 2004 to 2025. 2.6% of reports found the drug to be ineffective.

Sterile side effects

Percentages show how often each reaction appears relative to total reports for sterile.

1
Hereditary Angioedema8.0%547
2
Product Dose Omission Issue5.0%340
3
Fatigue4.7%323
4
Nausea4.5%306
5
Headache4.2%289
6
Pyrexia4.1%278
7
Weight Decreased3.8%262
8
Pain3.8%259
9
Dyspnoea3.8%258
10
Weight Increased3.6%247
11
Vomiting3.6%244
12
No Adverse Event3.6%244
13
Off Label Use3.4%232
14
Malaise3.3%228
15
Inappropriate Schedule Of Product Administration3.1%212

These are voluntary reports and do not establish that sterile caused these reactions.

Report severity

60.2%Serious4,115 reports
30.1%Hospitalizations2,058 reports
5.0%Fatal342 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sterile drug interactions

Other drugs that appear in adverse event reports alongside sterile. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sodium-chloride13.7%939
2
Agalsidase-beta13.0%887
3
Imiglucerase5.6%382
4
Dextrose4.7%323
5
Potassium-chloride4.4%302
6
Icatibant-acetate3.7%255
7
Magnesium-sulfate3.4%229
8
Gonadotropin-chorionic3.2%221
9
Metreleptin3.2%217
10
Infliximab3.0%206
11
Lanadelumab-flyo2.7%185
12
Soybean-oil2.6%178
13
Sodium-glycerophosphate2.5%171
14
Alglucosidase-alfa2.5%168
15
Amino-acids2.4%161

Taken alongside

1
Sodium-chloride52.4%3,582
2
Epinephrine42.3%2,888
3
Diphenhydramine27.8%1,900
4
Acetaminophen21.6%1,477
5
Heparin19.4%1,323
6
Ergocalciferol13.6%926
7
Albuterol9.9%679
8
Ammonium9.0%616
9
Ondansetron8.7%592
10
Lidocaine7.9%541
11
Levothyroxine-sodium7.8%531
12
Aspirin7.5%515
13
Ibuprofen7.3%499
14
Cetirizine-hydrochloride7.3%497
15
Fluticasone7.1%488

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sterile side effects

52.2% of sterile adverse event reports involve female patients and 33.2% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female52.2%
Male33.2%
Unknown14.5%

Age group

< 23.0%
2–117.1%
12–175.1%
18–6466.9%
65+17.9%

What is sterile used for

Conditions and purposes for which patients were taking sterile when the adverse event was reported.

Accidental Exposure To ProductAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAmyotrophic Lateral SclerosisAnaphylactic ReactionAnti-infective TherapyAccidental Exposure To Product By ChildAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myocardial InfarctionAnkylosing SpondylitisAortic DissectionAsthma

Showing 15 of 220 indications

Sterile brand names and reporting trend

Sterile is sold under brand names including Sterile Water, Sterile Water For Irrigation, Sterile Water For Injection In Plastic Container.

Brand names

Sterile Water5,229
Sterile Water For Irrigation2,213
Sterile Water For Injection In Plastic Container2

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sterile with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.