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Tromethamine Side Effects

The most commonly reported side effects of tromethamine include off label use, death, and headache, based on 1,498 FDA adverse event reports from 2004 to 2025. 5.5% of reports found the drug to be ineffective.

Tromethamine side effects

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

1
Off Label Use8.9%133
2
Drug Ineffective5.5%83
3
Death5.2%78
4
Headache4.1%62
5
Fatigue4.0%60
6
Acute Myeloid Leukaemia4.0%60
7
Nausea3.8%57
8
Pyrexia3.7%56
9
Second Primary Malignancy3.5%53
10
Vomiting3.3%49
11
Pain3.1%46
12
Diarrhoea3.0%45
13
Pneumonia3.0%45
14
Malaise2.9%44
15
Dyspnoea2.7%41

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

Report severity

86.8%Serious1,300 reports
36.4%Hospitalizations545 reports
20.5%Fatal307 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tromethamine drug interactions

Other drugs that appear in adverse event reports alongside tromethamine. 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
Prednisone17.0%255
2
Vincristine-sulfate15.8%237
3
Procarbazine-hydrochloride14.8%221
4
Doxorubicin-hydrochloride12.6%189
5
Bleomycin-sulfate11.7%176
6
Vinblastine-sulfate10.1%151
7
Sodium-chloride9.1%136
8
Potassium-chloride7.8%117
9
Sterile7.8%117
10
Magnesium-sulfate6.8%102
11
Dacarbazine6.1%91
12
Etoposide5.7%86
13
Sodium-glycerophosphate5.7%86
14
Cyclophosphamide4.9%74
15
Dexamethasone4.5%67

Taken alongside

1
Acetaminophen11.4%171
2
Omeprazole9.1%136
3
Furosemide7.8%117
4
Aspirin7.6%114
5
Levothyroxine-sodium7.1%106
6
Dexamethasone6.9%103
7
Ondansetron6.7%101
8
Potassium-chloride6.5%97
9
Ergocalciferol6.3%94
10
Ketorolac-tromethamine6.1%92
11
Albuterol6.1%91
12
Sodium-chloride6.0%90
13
Pantoprazole-sodium5.8%87
14
Prednisone5.7%85
15
Atorvastatin-calcium5.6%84

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 tromethamine side effects

47.3% of tromethamine adverse event reports involve female patients and 38.0% involve male patients. The largest age group is adult at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.3%
Male38.0%
Unknown14.8%

Age group

< 22.4%
2–112.8%
12–172.0%
18–6460.7%
65+32.1%

What is tromethamine used for

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

Accidental Exposure To ProductAcidosisAcquired HaemophiliaAnaplastic Large Cell Lymphoma T- And Null-cell TypesAngiosarcomaAntibiotic TherapyArthritisAsthmaAtypical Mycobacterial InfectionAcidosisAcneAcquired HaemophiliaAcute Lymphocytic LeukaemiaAdjuvant TherapyAlopecia

Showing 15 of 220 indications

Tromethamine brand names and reporting trend

Tromethamine is sold under the brand name Tham-e.

Brand names

Tham-e292

Quarterly reports (20042025)

20052010201520202025

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

Taking tromethamine with another medication?

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