TRIAL RESULTS · SIDE EFFECTS
Ciclosporin side effects
ANSWER
In 7 placebo-controlled trials with posted results, the most common side effects of Ciclosporin were Punctate Keratitis 5.8% (placebo 4.5%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
42
with an arm on Ciclosporin, of 1328 registered
Against placebo
7
placebo-controlled trials
People in those trials
950
on Ciclosporin · 575 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Ciclosporin beside placebo
Punctate Keratitis5.8%4.5%
Share of people with each side effect in 7 placebo-controlled trials with posted results: 950 people on Ciclosporin (all doses), 575 on placebo, same trials. Listed only when reported for at least half of the people on Ciclosporin. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 2200 side effects reported
Every trial with posted results and an arm on Ciclosporin (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Ciclosporin | Placebo | Trials |
|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 28.4% (432 of 1,520) | - | 12 |
| Hypertension | Vascular disorders | 19.2% (418 of 2,175) | 0.0% | 21 |
| Diarrhoea | Gastrointestinal disorders | 21.3% (391 of 1,836) | 0.0% | 17 |
| Oedema peripheral | General disorders | 26.2% (364 of 1,389) | - | 12 |
| Nausea | Gastrointestinal disorders | 21.5% (356 of 1,655) | 4.3% | 19 |
| Urinary tract infection | Infections and infestations | 22.2% (346 of 1,560) | 0.0% | 15 |
| Constipation | Gastrointestinal disorders | 20.8% (335 of 1,610) | - | 15 |
| Pyrexia | General disorders | 18.1% (290 of 1,600) | - | 13 |
| Headache | Nervous system disorders | 14.8% (259 of 1,748) | 0.0% | 20 |
| Vomiting | Gastrointestinal disorders | 12.5% (242 of 1,937) | 0.0% | 20 |
| Dyslipidaemia | Metabolism and nutrition disorders | 20.0% (216 of 1,079) | - | 7 |
| Insomnia | Psychiatric disorders | 18.1% (215 of 1,190) | - | 12 |
| Hyperlipidaemia | Metabolism and nutrition disorders | 16.9% (203 of 1,199) | - | 8 |
| Blood creatinine increased | Investigations | 13.1% (176 of 1,339) | - | 11 |
| Tremor | Nervous system disorders | 13.2% (166 of 1,257) | - | 12 |
| Nasopharyngitis | Infections and infestations | 15.3% (164 of 1,069) | 5.8% | 11 |
| Hyperkalaemia | Metabolism and nutrition disorders | 11.8% (159 of 1,344) | - | 11 |
| Leukopenia | Blood and lymphatic system disorders | 11.9% (159 of 1,340) | - | 10 |
| Cough | Respiratory, thoracic and mediastinal disorders | 11.4% (154 of 1,352) | 0.0% | 15 |
| Back pain | Musculoskeletal and connective tissue disorders | 12.0% (150 of 1,246) | 0.0% | 15 |
| Abdominal pain | Gastrointestinal disorders | 10.3% (148 of 1,434) | - | 13 |
| Fatigue | General disorders | 12.1% (143 of 1,185) | - | 12 |
| Hypokalaemia | Metabolism and nutrition disorders | 11.1% (140 of 1,263) | 0.0% | 10 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 9.0% (139 of 1,542) | 4.3% | 14 |
| Hyperglycaemia | Metabolism and nutrition disorders | 10.8% (130 of 1,199) | 0.0% | 9 |
| Hyperuricaemia | Metabolism and nutrition disorders | 18.9% (128 of 676) | - | 4 |
| Dizziness | Nervous system disorders | 8.5% (126 of 1,482) | 0.0% | 17 |
| Upper respiratory tract infection | Infections and infestations | 14.2% (126 of 885) | 0.0% | 10 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 11.1% (122 of 1,099) | - | 11 |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 9.2% (121 of 1,321) | - | 9 |
| Acne | Skin and subcutaneous tissue disorders | 9.5% (112 of 1,183) | - | 10 |
| Oedema | General disorders | 12.4% (112 of 904) | - | 9 |
| Hypocalcaemia | Metabolism and nutrition disorders | 12.9% (106 of 821) | - | 4 |
| Proteinuria | Renal and urinary disorders | 8.3% (105 of 1,258) | - | 9 |
| Weight increased | Investigations | 9.7% (102 of 1,053) | - | 7 |
| Hypotension | Vascular disorders | 7.5% (101 of 1,349) | 0.0% | 12 |
| Procedural pain | Injury, poisoning and procedural complications | 17.3% (101 of 585) | - | 5 |
| Dry Eye | Eye disorders | 23.2% (101 of 436) | 22.9% | 2 |
| Hypophosphataemia | Metabolism and nutrition disorders | 14.7% (97 of 658) | - | 4 |
| Hypomagnesaemia | Metabolism and nutrition disorders | 11.8% (93 of 785) | - | 7 |
| Diabetes mellitus | Metabolism and nutrition disorders | 7.3% (91 of 1,252) | - | 9 |
| Haematuria | Renal and urinary disorders | 7.3% (89 of 1,219) | - | 8 |
| Cytomegalovirus infection | Infections and infestations | 6.8% (84 of 1,236) | - | 9 |
| Dyspepsia | Gastrointestinal disorders | 10.1% (84 of 834) | 0.0% | 8 |
| Abdominal pain upper | Gastrointestinal disorders | 8.2% (82 of 995) | 1.3% | 9 |
| Anxiety | Psychiatric disorders | 6.8% (79 of 1,162) | - | 10 |
| Febrile neutropenia | Blood and lymphatic system disorders | 8.6% (79 of 917) | - | 8 |
| Dysuria | Renal and urinary disorders | 7.6% (75 of 982) | - | 6 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 6.0% (71 of 1,183) | 2.1% | 12 |
| Asthenia | General disorders | 7.2% (71 of 987) | - | 9 |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | 9.7% (70 of 723) | - | 4 |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 7.7% (69 of 892) | 0.0% | 6 |
| Lymphocele | Vascular disorders | 6.2% (66 of 1,057) | - | 6 |
| Abdominal distension | Gastrointestinal disorders | 8.2% (63 of 764) | - | 8 |
| Pruritus | Skin and subcutaneous tissue disorders | 7.4% (61 of 828) | - | 8 |
| Myalgia | Musculoskeletal and connective tissue disorders | 5.6% (60 of 1,065) | - | 12 |
| Diarrhea | Gastrointestinal disorders | 20.6% (59 of 286) | - | 4 |
| Blood bilirubin increased | Investigations | 24.8% (59 of 238) | - | 3 |
| Rash | Skin and subcutaneous tissue disorders | 4.2% (58 of 1,393) | - | 14 |
| Depression | Psychiatric disorders | 3.8% (58 of 1,527) | 0.0% | 13 |
| Thrombocytopenia | Blood and lymphatic system disorders | 4.9% (57 of 1,168) | - | 9 |
| Tachycardia | Cardiac disorders | 6.0% (56 of 926) | - | 6 |
| Pneumonia | Infections and infestations | 2.8% (54 of 1,895) | 0.0% | 17 |
| Alanine aminotransferase increased | Investigations | 9.8% (51 of 519) | - | 7 |
| Gastroenteritis | Infections and infestations | 3.3% (50 of 1,515) | 0.0% | 13 |
| Chest pain | General disorders | 6.1% (49 of 808) | - | 8 |
| Renal impairment | Renal and urinary disorders | 4.8% (49 of 1,026) | - | 8 |
| Nephropathy toxic | Renal and urinary disorders | 7.4% (48 of 647) | - | 5 |
| Pain | General disorders | 4.1% (47 of 1,150) | - | 9 |
| Paraesthesia | Nervous system disorders | 6.2% (47 of 763) | - | 6 |
| Transplant rejection | Immune system disorders | 4.4% (46 of 1,038) | - | 9 |
| Renal tubular necrosis | Renal and urinary disorders | 5.5% (46 of 829) | - | 5 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 5.2% (44 of 851) | - | 7 |
| Incision site pain | Injury, poisoning and procedural complications | 10.6% (44 of 417) | 0.0% | 4 |
| Hirsutism | Endocrine disorders | 8.6% (43 of 502) | - | 5 |
| Bronchitis | Infections and infestations | 4.3% (42 of 982) | 0.0% | 10 |
| Sinusitis | Infections and infestations | 4.3% (42 of 976) | 4.3% | 9 |
| Decreased appetite | Metabolism and nutrition disorders | 7.4% (42 of 569) | - | 5 |
| Incision site complication | Injury, poisoning and procedural complications | 19.8% (42 of 212) | - | 1 |
| Sepsis | Infections and infestations | 2.5% (40 of 1,594) | - | 14 |
| Chills | General disorders | 5.6% (40 of 715) | - | 8 |
| Ascites | Gastrointestinal disorders | 4.2% (40 of 956) | - | 6 |
| all rejection rate, including subclinical rejections. | Renal and urinary disorders | 47.1% (40 of 85) | - | 1 |
| Neutropenia | Blood and lymphatic system disorders | 4.5% (39 of 876) | - | 7 |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | 10.6% (38 of 358) | - | 2 |
| Post procedural pain | Injury, poisoning and procedural complications | 17.5% (37 of 212) | - | 1 |
| Enterococcal infection | Infections and infestations | 43.5% (37 of 85) | - | 1 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 7.6% (36 of 474) | - | 5 |
| Graft dysfunction | Injury, poisoning and procedural complications | 5.9% (36 of 606) | - | 3 |
| Dehydration | Metabolism and nutrition disorders | 3.1% (35 of 1,117) | - | 8 |
| Acute kidney injury | Renal and urinary disorders | 6.4% (35 of 547) | - | 6 |
| Staphylococcal infection | Infections and infestations | 5.3% (35 of 656) | - | 5 |
| Herpes zoster | Infections and infestations | 3.2% (34 of 1,064) | - | 7 |
| Influenza | Infections and infestations | 4.2% (34 of 812) | - | 7 |
| Stomatitis | Gastrointestinal disorders | 3.9% (34 of 870) | - | 7 |
| Punctate Keratitis | Eye disorders | 5.8% (34 of 587) | 4.5% | 2 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 5.3% (33 of 627) | - | 5 |
| Mucositis oral | Gastrointestinal disorders | 17.9% (33 of 184) | - | 2 |
| Hypoaesthesia | Nervous system disorders | 4.5% (32 of 704) | - | 5 |
| Aspartate aminotransferase increased | Investigations | 11.1% (32 of 288) | - | 5 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
QUESTIONS
Does ciclosporin cause Punctate Keratitis?
In 7 placebo-controlled trials with posted results, 5.8% of people on ciclosporin reported Punctate Keratitis, against 4.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
1328 registered clinical trials of Ciclosporin
The 10 most recently updated are listed.
| 2022-501677-39-00 | A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of
Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of
Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a
Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications Status: UNKNOWN · Updated 2026-09-25 |
|---|---|
| NCT01135641 | Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD) Status: COMPLETED · Updated 2026-09-14 |
| NCT05153070 | Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Status: RECRUITING · Updated 2026-09-09 |
| NCT07774325 | A Study in Healthy Men to Find Out How Blocking Certain Transport Proteins Affects the Amount of BI 3000202 in the Blood Status: RECRUITING · Updated 2026-09-09 |
| 2023-504159-29-01 | Safety and efficacy of oral semaglutide in hyperglycaemic patients after renal transplantation Status: UNKNOWN · Updated 2026-08-27 |
| NCT00977977 | Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy Status: RECRUITING · Updated 2026-08-27 |
| NCT06821542 | A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy Status: ACTIVE_NOT_RECRUITING · Updated 2026-08-25 |
| NCT07124078 | A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) Status: RECRUITING · Updated 2026-08-25 |
| NCT07773740 | Autologous Plasma Rich in Growth Factors for Severe Dry Eye Disease Status: NOT_YET_RECRUITING · Updated 2026-08-25 |
| 2025-524312-11-00 | Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe year AfTer lIver transplantatiON (ALTERNATION) - a randomized, prospective, multicenter, open-label, controlled phase III trial Status: UNKNOWN · Updated 2026-08-19 |
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