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Hydroxocobalamin Side Effects

The most commonly reported side effects of hydroxocobalamin include acute kidney injury, nausea, and diarrhoea, based on 4,619 FDA adverse event reports from 2004 to 2025. 2.4% of reports found the drug to be ineffective.

Hydroxocobalamin side effects

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

1
Acute Kidney Injury4.7%216
2
Nausea4.6%211
3
Diarrhoea4.5%208
4
Dyspnoea3.9%182
5
Off Label Use3.9%181
6
Vomiting3.9%180
7
Dizziness3.8%175
8
Malaise3.4%157
9
Fatigue3.3%153
10
Hyponatraemia2.9%132
11
Rash2.7%124
12
Somnolence2.6%118
13
Confusional State2.5%116
14
Pyrexia2.5%115
15
Headache2.4%112

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

Report severity

90.9%Serious4,197 reports
41.4%Hospitalizations1,914 reports
8.7%Fatal403 reports

Seriousness is determined by the reporter, not by OpenClaim.

Hydroxocobalamin drug interactions

Other drugs that appear in adverse event reports alongside hydroxocobalamin. 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
Pemetrexed4.4%202
2
Furosemide3.4%158
3
Omeprazole3.1%145
4
Betaine3.1%145
5
Pregabalin3.1%142
6
Atorvastatin-calcium2.8%128
7
Sertraline-hydrochloride2.6%122
8
Amlodipine2.4%113
9
Clarithromycin2.2%101
10
Carboplatin2.2%101
11
Ramipril2.2%100
12
Lenalidomide2.1%99
13
Prednisolone2.1%97
14
Warfarin1.8%85
15
Adalimumab1.8%84

Taken alongside

1
Acetaminophen22.1%1,023
2
Folic-acid17.9%828
3
Omeprazole17.2%795
4
Aspirin17.1%790
5
Atorvastatin-calcium15.8%732
6
Albuterol15.0%694
7
Lansoprazole12.2%563
8
Levothyroxine-sodium11.7%539
9
Metformin11.1%511
10
Furosemide11.0%507
11
Bisoprolol-fumarate10.8%501
12
Amlodipine10.8%497
13
Simvastatin9.3%430
14
Prednisolone8.3%385
15
Ramipril8.0%368

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 hydroxocobalamin side effects

52.4% of hydroxocobalamin adverse event reports involve female patients and 37.2% involve male patients. The largest age group is elderly at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female52.4%
Male37.2%
Unknown10.4%

Age group

< 20.8%
2–111.4%
12–170.6%
18–6438.7%
65+58.5%

What is hydroxocobalamin used for

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

Accidental PoisoningAlcohol PoisoningAnaemiaAnaemia MacrocyticAnaemia ProphylaxisAnaemia Vitamin B12 DeficiencyAstheniaAccidentAccidental PoisoningAcidosisAdverse Drug ReactionAnaemiaAnaemia Vitamin B12 DeficiencyArthralgiaArthritis

Showing 15 of 162 indications

Hydroxocobalamin brand names and reporting trend

Hydroxocobalamin is sold under the brand name Hydroxomin.

Brand names

Hydroxomin4,549

Quarterly reports (20042025)

20052010201520202025

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

Taking hydroxocobalamin with another medication?

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