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Iptacopan Side Effects

The most commonly reported side effects of iptacopan include headache, fatigue, and diarrhoea, based on 588 FDA adverse event reports from 2008 to 2025. 4.6% of reports found the drug to be ineffective.

Iptacopan side effects

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

1
Headache12.4%73
2
Fatigue9.2%54
3
Diarrhoea6.5%38
4
Nausea6.3%37
5
Haemoglobin Decreased6.1%36
6
Pyrexia5.3%31
7
Drug Ineffective4.6%27
8
Product Dose Omission Issue4.4%26
9
Rash4.4%26
10
Breakthrough Haemolysis4.4%26
11
Platelet Count Decreased4.1%24
12
Off Label Use4.1%24
13
Dyspnoea3.9%23
14
Dizziness3.7%22
15
Vomiting3.6%21

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

Report severity

43.2%Serious254 reports
19.7%Hospitalizations116 reports
5.6%Fatal33 reports

Seriousness is determined by the reporter, not by OpenClaim.

Iptacopan drug interactions

Other drugs that appear in adverse event reports alongside iptacopan. 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
Mycophenolate2.9%17
2
Eculizumab2.0%12
3
Ravulizumab-cwvz1.7%10
4
Tacrolimus1.7%10
5
Prednisolone1.5%9
6
Pegcetacoplan1.4%8
7
Cyclosporine1.2%7
8
Sparsentan1.2%7
9
Budesonide1.0%6
10
Amoxicillin0.9%5
11
Dapagliflozin0.7%4
12
Sulfamethoxazole0.7%4
13
Trimethoprim0.7%4
14
Rituximab0.7%4
15
Prednisone0.7%4

Taken alongside

1
Folic-acid2.6%15
2
Penicillin2.6%15
3
Prednisone2.4%14
4
Tacrolimus2.0%12
5
Atorvastatin-calcium2.0%12
6
Mycophenolate1.9%11
7
Allopurinol1.4%8
8
Dapagliflozin1.4%8
9
Omeprazole1.2%7
10
Losartan-potassium1.2%7
11
Deferasirox1.2%7
12
Ravulizumab-cwvz1.2%7
13
Furosemide1.2%7
14
Ergocalciferol1.0%6
15
Eculizumab1.0%6

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 iptacopan side effects

44.2% of iptacopan adverse event reports involve female patients and 40.0% involve male patients. The largest age group is adult at 76%. These figures reflect who reports side effects, not underlying risk.

Sex

Female44.2%
Male40.0%
Unknown15.8%

Age group

< 20.0%
2–110.4%
12–172.0%
18–6475.7%
65+21.9%

What is iptacopan used for

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

AnaemiaAtypical Haemolytic Uraemic SyndromeAutoimmune Haemolytic AnaemiaBlood Immunoglobulin AC3 GlomerulopathyDisease RecurrenceGlomerulonephritisGlomerulonephritis MembranoproliferativeGlomerulonephritis ProliferativeHaematuriaHaemoglobinuriaHaemolytic Uraemic SyndromeHerpes Virus InfectionIga NephropathyImmune Thrombocytopenia

Showing 15 of 31 indications

Iptacopan brand names and reporting trend

Iptacopan is sold under the brand name Fabhalta.

Brand names

Fabhalta101

Quarterly reports (20082025)

20082025

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

Taking iptacopan with another medication?

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