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Neoral

Last reviewed on RxList: 11/22/2016
Neoral Side Effects Center

Last reviewed on RxList 11/30/2016

Neoral (cyclosporine) is an immunosuppressant used to prevent organ rejection after a kidney, liver, or heart transplant. Neoral is also used to treat severe psoriasis or severe rheumatoid arthritis. Neoral is available in generic form. Common side effects of Neoral include:

  • headache,
  • nausea,
  • vomiting,
  • diarrhea,
  • constipation,
  • stomach pain or upset,
  • acne,
  • cramps,
  • increased hair growth on the face/body,
  • shaking fingers/hands (tremor),
  • muscle spasm,
  • numbness or tingly feeling,
  • swollen/red/painful gums,
  • dizziness,
  • flushing, and
  • high blood pressure.

Your risk of infection may be higher while taking Neoral. Tell your doctor if you have symptoms of infection such as fever, sore throat, flu-like symptoms, or painful urination.

Dosing of Neroal is individualized based on the type of transplant, and the patient's weight. Neoral may interact with etoposide, lithium, methotrexate, nefazodone, repaglinide, St. John's wort, ACE inhibitors, heart or blood pressure medication, medicines used to treat ulcerative colitis, other medicines used to prevent organ transplant rejection, pain or arthritis medicines, IV antibiotics, antiviral medicines, or cancer medicine. Tell your doctor all medications and supplements you use. Neoral should be used only when prescribed during pregnancy. Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born prematurely. It has also caused death of the fetus. This medication passes into breast milk. Breastfeeding is not recommended while using this drug.

Our Neoral (cyclosporine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Neoral Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, sweating, chills, body aches, flu symptoms, sores in your mouth and throat, weight loss;
  • change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);
  • easy bruising or bleeding, pale skin, confusion or weakness;
  • feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • pain in the lower back or side, blood in your urine, pain or burning when you urinate;
  • urinating less than usual or not at all, rapid weight gain;
  • swelling, warmth, redness, or oozing of the skin;
  • vomiting and bloody diarrhea;
  • seizure (convulsions);
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats).

Less serious side effects may include:

  • swollen or painful gums;
  • mild headache;
  • stomach pain, constipation, mild diarrhea; or
  • tremors or shaking, muscle spasm, numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Neoral (Cyclosporine)

Neoral Professional Information

SIDE EFFECTS

Kidney, Liver, and Heart Transplantation

The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia.

Hypertension

Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients.

Glomerular Capillary Thrombosis

Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. The pathologic changes resembled those seen in the hemolytic-uremic syndrome and included thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. Similar findings have been observed when other immunosuppressives have been employed post-transplantation.

Hypomagnesemia

Hypomagnesemia has been reported in some, but not all, patients exhibiting convulsions while on cyclosporine therapy. Although magnesium-depletion studies in normal subjects suggest that hypomagnesemia is associated with neurologic disorders, multiple factors, including hypertension, high dose methylprednisolone, hypocholesterolemia, and nephrotoxicity associated with high plasma concentrations of cyclosporine appear to be related to the neurological manifestations of cyclosporine toxicity.

Clinical Studies

In controlled studies, the nature, severity, and incidence of the adverse events that were observed in 493 transplanted patients treated with Neoral® were comparable with those observed in 208 transplanted patients who received Sandimmune® in these same studies when the dosage of the two drugs was adjusted to achieve the same cyclosporine blood trough concentrations.

Based on the historical experience with Sandimmune®, the following reactions occurred in 3% or greater of 892 patients involved in clinical trials of kidney, heart, and liver transplants.

Body System Adverse Reactions Randomized Kidney Patients Cyclosporine Patients (Sandimmune®)
Sandimmune®
(N=227)%
Azathioprine
(N=228)%
Kidney
(N=705)%
Heart
(N=112)%
Liver
(N=75)%
Genitourinary Renal Dysfunction 32 6 25 38 37
Cardiovascular Hypertension 26 18 13 53 27
Cramps 4 < 1 2 < 1 0
Skin Hirsutism 21 < 1 21 28 45
Acne 6 8 2 2 1
Central Nervous System Tremor 12 0 21 31 55
Convulsions 3 1 1 4 5
Headache 2 < 1 2 15 4
Gastrointestinal Gum Hyperplasia 4 0 9 5 16
Diarrhea 3 < 1 3 4 8
Nausea/Vomiting 2 < 1 4 10 4
Hepatotoxicity Abdominal < 1 < 1 4 7 4
Discomfort < 1 0 < 1 7 0
Autonomic Nervous System Paresthesia 3 0 1 2 1
Flushing < 1 0 4 0 4
Hematopoietic Leukopenia 2 19 < 1 6 0
Lymphoma < 1 0 1 6 1
Respiratory Sinusitis < 1 0 4 3 7
Miscellaneous Gynecomastia < 1 0 < 1 4 3

Among 705 kidney transplant patients treated with cyclosporine oral solution (Sandimmune®) in clinical trials, the reason for treatment discontinuation was renal toxicity in 5.4%, infection in 0.9%, lack of efficacy in 1.4%, acute tubular necrosis in 1.0%, lymphoproliferative disorders in 0.3%, hypertension in 0.3%, and other reasons in 0.7% of the patients.

The following reactions occurred in 2% or less of cyclosporine-treated patients: allergic reactions, anemia, anorexia, confusion, conjunctivitis, edema, fever, brittle fingernails, gastritis, hearing loss, hiccups, hyperglycemia, migraine (Neoral®) muscle pain, peptic ulcer, thrombocytopenia, tinnitus.

The following reactions occurred rarely: anxiety, chest pain, constipation, depression, hair breaking, hematuria, joint pain, lethargy, mouth sores, myocardial infarction, night sweats, pancreatitis, pruritus, swallowing difficulty, tingling, upper GI bleeding, visual disturbance, weakness, weight loss.

Patients receiving immunosuppressive therapies, including cyclosporine and cyclosporine -containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic). Both generalized and localized infections can occur. Pre-existing infections may also be aggravated. Fatal outcomes have been reported. (see WARNINGS)

Infectious Complications in Historical Randomized Studies in Renal Transplant Patients Using Sandimmune®

Complication Cyclosporine Treatment
(N=227)
% of Complications
Azathioprine with Steroids*
(N=228)
% of Complications
Septicemia 5.3 4.8
Abscesses 4.4 5.3
Systemic Fungal Infection 2.2 3.9
Local Fungal Infection 7.5 9.6
Cytomegalovirus 4.8 12.3
Other Viral Infections 15.9 18.4
Urinary Tract Infections 21.1 20.2
Wound and Skin Infections 7.0 10.1
Pneumonia 6.2 9.2
*Some patients also received ALG.

Postmarketing Experience, Kidney, Liver and Heart Transplantation

Hepatotoxicity

Cases of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure; serious and/or fatal outcomes have been reported. [See WARNINGS/Hepatotoxicity]

Increased Risk of Infections

Cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), sometimes fatal; and polyoma virus-associated nephropathy (PVAN), especially BK virus resulting in graft loss have been reported. [See WARNINGS/ Polyoma Virus Infection]

Headache, including Migraine

Cases of migraine have been reported. In some cases, patients have been unable to continue cyclosporine, however, the final decision on treatment discontinuation should be made by the treating physician following the careful assessment of benefits versus risks.

The principal adverse reactions associated with the use of cyclosporine in rheumatoid arthritis are renal dysfunction (see WARNINGS), hypertension (see PRECAUTIONS), headache, gastrointestinal disturbances, and hirsutism/hypertrichosis.

In rheumatoid arthritis patients treated in clinical trials within the recommended dose range, cyclosporine therapy was discontinued in 5.3% of the patients because of hypertension and in 7% of the patients because of increased creatinine. These changes are usually reversible with timely dose decrease or drug discontinuation. The frequency and severity of serum creatinine elevations increase with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced without dose reduction or discontinuation.

The following adverse events occurred in controlled clinical trials:

Neoral®/Sandimmune® Rheumatoid Arthritis Percentage of Patients with Adverse Events ≥ 3% in any Cyclosporine Treated Group

Body System
Preferred Term
Studies 651+652+2008 Study 302 Study 654 Study 654 Study 302 Studies 651+652+2008
Sandimmune®†
(N=269)
Sandimmune®
(N=155)
Methotrexate & Sandimmune®
(N=74)
Methotrexate & Placebo
(N=73)
Neoral®
(N=143)
Placebo
(N=201)
Autonomic Nervous System Disorders
  Flushing 2% 2% 3% 0% 5% 2%
Body As A Whole-General Disorders
  Accidental Trauma 0% 1% 10% 4% 4% 0%
  Edema NOS* 5% 14% 12% 4% 10% < 1%
  Fatigue 6% 3% 8% 12% 3% 7%
  Fever 2% 3% 0% 0% 2% 4%
  Influenza-like symptoms < 1% 6% 1% 0% 3% 2%
  Pain 6% 9% 10% 15% 13% 4%
  Rigors 1% 1% 4% 0% 3% 1%
Cardiovascular Disorders
  Arrhythmia 2% 5% 5% 6% 2% 1%
  Chest Pain 4% 5% 1% 1% 6% 1%
  Hypertension 8% 26% 16% 12% 25% 2%
Central and Peripheral Nervous System Disorders
  Dizziness 8% 6% 7% 3% 8% 3%
  Headache 17% 23% 22% 11% 25% 9%
  Migraine 2% 3% 0% 0% 3% 1%
  Paresthesia 8% 7% 8% 4% 11% 1%
  Tremor 8% 7% 7% 3% 13% 4%
Gastrointestinal System Disorders  
  Abdominal Pain 15% 15% 15% 7% 15% 10%
  Anorexia 3% 3% 1% 0% 3% 3%
  Diarrhea 12% 12% 18% 15% 13% 8%
  Dyspepsia 12% 12% 10% 8% 8% 4%
  Flatulence 5% 5% 5% 4% 4% 1%
  Gastrointestinal Disorder NOS* 0% 2% 1% 4% 4% 0%
  Gingivitis 4% 3% 0% 0% 0% 1%
  Gum Hyperplasia  2% 4% 1% 3% 4% 1%
  Nausea 23% 14% 24% 15% 18% 14%
  Rectal Hemorrhage 0% 3% 0% 0% 1% 1%
  Stomatitis 7% 5% 16% 12% 6% 8%
  Vomiting 9% 8% 14% 7% 6% 5%
Hearing and Vestibular Disorders
  Ear Disorder NOS* 0% 5% 0% 0% 1% 0%
Metabolic and Nutritional Disorders  
  Hypomagnesemia 0% 4% 0% 0% 6% 0%
Musculoskeletal System Disorders
  Arthropathy Leg Cramps / Involuntary 0% 5% 0% 1% 4% 0%
  Muscle Contractions 2% 11% 11% 3% 12% 1%
Psychiatric Disorders
  Depression 3% 6% 3% 1% 1% 2%
  Insomnia 4% 1% 1% 0% 3% 2%
Renal
  Creatinine elevations ≥ 30% 43% 39% 55% 19% 48% 13%
  Creatinine elevations ≥ 50% 24% 18% 26% 8% 18% 3%
Reproductive Disorders, Female
  Leukorrhea 1% 0% 4% 0% 1% 0%
  Menstrual Disorder 3% 2% 1% 0% 1% 1%
Respiratory System Disorders
  Bronchitis 1% 3% 1% 0% 1% 3%
  Coughing 5% 3% 5% 7% 4% 4%
  Dyspnea 5% 1% 3% 3% 1% 2%
  Infection NOS* 9% 5% 0% 7% 3% 10%
  Pharyngitis 3% 5% 5% 6% 4% 4%
  Pneumonia 1% 0% 4% 0% 1% 1%
  Rhinitis 0% 3% 11% 10% 1% 0%
  Sinusitis 4% 4% 8% 4% 3% 3%
  Upper Respiratory Tract 0% 14% 23% 15% 13% 0%
Skin and Appendages Disorders
  Alopecia 3% 0% 1% 1% 4% 4%
  Bullous Eruption 1% 0% 4% 1% 1% 1%
  Hypertrichosis 19% 17% 12% 0% 15% 3%
  Rash 7% 12% 10% 7% 8% 10%
  Skin Ulceration 1% 1% 3% 4% 0% 2%
Urinary System Disorders
  Dysuria 0% 0% 11% 3% 1% 2%
  Micturition Frequency 2% 4% 3% 1% 2% 2%
  NPN, Increased 0% 19% 12% 0% 18% 0%
  Urinary Tract Infection 0% 3% 5% 4% 3% 0%
Vascular (Extracardiac) Disorders
  Purpura 3% 4% 1% 1% 2% 0%
† Includes patients in 2.5 mg/kg/day dose group only.
*NOS = Not Otherwise Specified.

In addition, the following adverse events have been reported in 1% to < 3% of the rheumatoid arthritis patients in the cyclosporine treatment group in controlled clinical trials.

Autonomic Nervous System: dry mouth, increased sweating;

Body as a Whole: allergy, asthenia, hot flushes, malaise, overdose, procedure NOS*, tumor NOS*, weight decrease, weight increase;

Cardiovascular: abnormal heart sounds, cardiac failure, myocardial infarction, peripheral ischemia;

Central and Peripheral Nervous System:hypoesthesia, neuropathy, vertigo;

Endocrine: goiter;

Gastrointestinal: constipation, dysphagia, enanthema, eructation, esophagitis, gastric ulcer, gastritis, gastroenteritis, gingival bleeding, glossitis, peptic ulcer, salivary gland enlargement, tongue disorder, tooth disorder;

Infection: abscess, bacterial infection, cellulitis, folliculitis, fungal infection, herpes simplex, herpes zoster, renal abscess, moniliasis, tonsillitis, viral infection;

Hematologic: anemia, epistaxis, leukopenia, lymphadenopathy;

Liver and Biliary System: bilirubinemia;

Metabolic and Nutritional: diabetes mellitus, hyperkalemia, hyperuricemia, hypoglycemia;

Musculoskeletal System: arthralgia, bone fracture, bursitis, joint dislocation, myalgia, stiffness, synovial cyst, tendon disorder;

Neoplasms: breast fibroadenosis, carcinoma;

Psychiatric: anxiety, confusion, decreased libido, emotional lability, impaired concentration, increased libido, nervousness, paroniria, somnolence;

Reproductive (Female): breast pain, uterine hemorrhage;

Respiratory System: abnormal chest sounds, bronchospasm;

Skin and Appendages: abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, nail disorder, pruritus, skin disorder, urticaria;

Special Senses: abnormal vision, cataract, conjunctivitis, deafness, eye pain, taste perversion, tinnitus, vestibular disorder;

Urinary System: abnormal urine, hematuria, increased BUN, micturition urgency, nocturia, polyuria, pyelonephritis, urinary incontinence.

*NOS = Not Otherwise Specified.

Psoriasis

The principal adverse reactions associated with the use of cyclosporine in patients with psoriasis are renal dysfunction, headache, hypertension, hypertriglyceridemia, hirsutism/hypertrichosis, paresthesia or hyperesthesia, influenza-like symptoms, nausea/vomiting, diarrhea, abdominal discomfort, lethargy, and musculoskeletal or joint pain.

In psoriasis patients treated in US controlled clinical studies within the recommended dose range, cyclosporine therapy was discontinued in 1.0% of the patients because of hypertension and in 5.4% of the patients because of increased creatinine. In the majority of cases, these changes were reversible after dose reduction or discontinuation of cyclosporine.

There has been one reported death associated with the use of cyclosporine in psoriasis. A 27-year-old male developed renal deterioration and was continued on cyclosporine. He had progressive renal failure leading to death.

Frequency and severity of serum creatinine increases with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced and may result in irreversible renal damage without dose reduction or discontinuation.

Adverse Events Occurring in 3% or More of Psoriasis Patients in Controlled Clinical Trials

Body System* Preferred Term Neoral®
(N=182)
Sandimmune®
(N=185)
Infection or Potential Infection   24.7% 24.3%
  Influenza-Like Symptoms 9.9% 8.1%
  Upper Respiratory Tract Infections 7.7% 11.3%
Cardiovascular System   28.0% 25.4%
  Hypertension** 27.5% 25.4%
Urinary System   24.2% 16.2%
  Increased Creatinine 19.8% 15.7%
Central and Peripheral Nervous System   26.4% 20.5%
  Headache 15.9% 14.0%
  Paresthesia 7.1% 4.8%
Musculoskeletal System   13.2% 8.7%
  Arthralgia 6.0% 1.1%
Body As a Whole-General   29.1% 22.2%
  Pain 4.4% 3.2%
Metabolic and Nutritional   9.3% 9.7%
Reproductive, Female   8.5% (4 of 47 females) 11.5% (6 of 52 females)
Resistance Mechanism   18.7% 21.1%
Skin and Appendages   17.6% 15.1%
  Hypertrichosis 6.6% 5.4%
Respiratory System   5.0% 6.5%
  Bronchospasm, Coughing, Dyspnea, Rhinitis 5.0% 4.9%
Psychiatric   5.0% 3.8%
Gastrointestinal System   19.8% 28.7%
  Abdominal Pain 2.7% 6.0%
  Diarrhea 5.0% 5.9%
  Dyspepsia 2.2% 3.2%
  Gum Hyperplasia 3.8% 6.0%
  Nausea 5.5% 5.9%
White cell and RES   4.4% 2.7%
*Total percentage of events within the system
**Newly occurring hypertension = SBP ≥ 160 mm Hg and/or DBP ≥ 90 mm Hg

The following events occurred in 1% to less than 3% of psoriasis patients treated with cyclosporine:

Body as a Whole: fever, flushes, hot flushes;

Cardiovascular: chest pain;

Central and Peripheral Nervous System:appetite increased, insomnia, dizziness, nervousness, vertigo;

Gastrointestinal: abdominal distention, constipation, gingival bleeding;

Liver and Biliary System: hyperbilirubinemia;

Neoplasms: skin malignancies [squamous cell (0.9%) and basal cell (0.4%) carcinomas];

Reticuloendothelial: platelet, bleeding, and clotting disorders, red blood cell disorder;

Respiratory: infection, viral and other infection;

Skin and Appendages: acne, folliculitis, keratosis, pruritus, rash, dry skin;

Urinary System: micturition frequency;

Vision: abnormal vision.

Mild hypomagnesemia and hyperkalemia may occur but are asymptomatic. Increases in uric acid may occur and attacks of gout have been rarely reported. A minor and dose related hyperbilirubinemia has been observed in the absence of hepatocellular damage. Cyclosporine therapy may be associated with a modest increase of serum triglycerides or cholesterol. Elevations of triglycerides ( > 750 mg/dL) occur in about 15% of psoriasis patients; elevations of cholesterol ( > 300 mg/dL) are observed in less than 3% of psoriasis patients. Generally these laboratory abnormalities are reversible upon dose reduction or discontinuation of cyclosporine.

Read the entire FDA prescribing information for Neoral (Cyclosporine)

Related Resources for Neoral

Read the Neoral User Reviews »

© Neoral Patient Information is supplied by Cerner Multum, Inc. and Neoral Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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