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Neoral Side Effects

Generic Name: cyclosporine

Note: This document contains side effect information about cyclosporine. Some of the dosage forms listed on this page may not apply to the brand name Neoral.

For the Consumer

Applies to cyclosporine: oral capsule, oral capsule liquid filled, oral solution

Other dosage forms:

Along with its needed effects, cyclosporine (the active ingredient contained in Neoral) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cyclosporine:

More common
  • Abdominal or stomach pain or tenderness
  • back pain
  • black, tarry stools
  • blurred vision
  • chest pain
  • chills
  • clay colored stools
  • cloudy urine
  • cough
  • dark urine
  • decrease in urine output or decrease in urine-concentrating ability
  • decreased appetite
  • dizziness
  • drowsiness
  • fever
  • headache
  • headache, severe and throbbing
  • itching
  • loss of appetite
  • muscle spasms (tetany) or twitching
  • nausea and vomiting
  • nervousness
  • painful or difficult urination
  • pounding in the ears
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • skin rash
  • slow or fast heartbeat
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the feet or lower legs
  • swollen glands
  • trembling or shaking of the hands or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin
Less common
  • Bleeding gums
  • blood in the urine
  • blood in the vomit
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • convulsions
  • difficulty swallowing
  • hives
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • severe or continuing stomach pain
  • tightness in the chest
  • troubled breathing with exertion
Rare
  • Bloating
  • chest discomfort
  • constipation
  • darkened urine
  • hoarseness
  • indigestion
  • lower back or side pain
  • night sweats
  • pain or discomfort in the arms, jaw, back, or neck
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • sweating
  • vomiting of blood or material that looks like coffee grounds

Some side effects of cyclosporine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach discomfort
  • bleeding, tender, or enlarged gums
  • blemishes on the skin
  • increased hair growth, especially on the face
  • pain or tenderness around the eyes and cheekbones
  • pimples
  • stuffy or runny nose
Less common
  • Brittle fingernails
  • burning feeling in the chest or stomach
  • burning, dry, or itching eyes
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cramps
  • discharge or excessive tearing
  • feeling of warmth
  • hearing loss
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • swelling of the breasts or breast soreness in both females and males
  • weight loss
Rare
  • Blurred or loss of vision
  • discouragement
  • disturbed color perception
  • double vision
  • fear
  • feeling sad or empty
  • halos around lights
  • irritability
  • joint pain
  • loss of interest or pleasure
  • night blindness
  • overbright appearance of lights
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • tunnel vision
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • weakness
  • weight loss

For Healthcare Professionals

Applies to cyclosporine: compounding powder, injectable solution, oral capsule, oral liquid, oral solution

Cardiovascular

Hypertension, usually mild to moderate, occurs in approximately 50% of patients following renal transplantation and in most cardiac transplant patients.[Ref]

Very common (10% or more): Hypertension (26%)
Common (1% to 10%): Flushing, arrhythmia, purpura, abnormal heart sounds, cardiac failure, peripheral ischemia
Rare (less than 0.1%): Hypertension with fluid retention and convulsions (mainly in children), chest pain, myocardial infarction[Ref]

Hematologic

Common (1% to 10%): Leukopenia
Uncommon (0.1% to 1%): Thrombocytopenia, anemia
Rare (less than 0.1%): Hemolytic uremic syndrome, microangiopathic hemolytic anemia
Frequency not reported: Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, platelet/bleeding/clotting disorders, red blood cell disorder[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions[Ref]

Immunologic

Common (1% to 10%): Increased susceptibility to infections, septicemia, abscess, systemic fungal infection, localized or generalized infections (viral, bacterial, fungal, parasitic), cytomegalovirus, wound and skin infections, cellulitis, folliculitis, herpes simplex, herpes zoster
Frequency not reported: JC virus-associated progressive multifocal leukoencephalopathy (PML) (sometimes fatal), polyoma virus-associated nephropathy (PVAN), BK virus resulting in graft loss[Ref]

Preexisting infections may be aggravated and reactivation of Polyomavirus infections may lead to Polyomavirus associated nephropathy (PVAN) or to JC virus associated progressive multifocal leukoencephalopathy (PML); serious and/or fatal outcomes have been reported.[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, muscle cramps, muscle pain
Rare (less than 0.1%): Muscle weakness, myopathy, joint pain, tingling
Frequency not reported: Pain of lower extremities, arthralgia, bone fracture, bursitis, joint dislocation, stiffness, synovial cyst, tendon disorder[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, visual disturbance, abnormal vision, cataract, eye pain
Very rare (less than 0.01%): Optic disc edema (including papilledema with possible visual impairment secondary to benign intracranial hypertension)[Ref]

Metabolic

Hypomagnesemia has been reported in some patients exhibiting convulsions while taking this drug. 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 this drug appear to be related to the neurological toxicity.[Ref]

Very common (10% or more): Hyperlipidemia
Common (1% to 10%): Hyperglycemia, hypoglycemia, anorexia, hyperuricemia, hyperkalemia, hypomagnesemia, diabetes mellitus
Rare (less than 0.1%): Weight loss, weight gain[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Confusion, lethargy, depression, disorientation, decreased responsiveness, agitation, visual hallucinations
Rare (less than 0.1%): Anxiety
Frequency not reported: Libido decreased[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (21%)
Common (1% to 10%): Dysuria, micturition frequency, hot flushes
Rare (less than 0.1%): Hematuria, gynecomastia
Frequency not reported: Increased BUN, abnormal urine, nocturia, polyuria[Ref]

Hepatic

Common (1% to 10%): Hepatic function abnormal, bilirubinemia
Frequency not reported: Hepatotoxicity (e.g., cholestasis, jaundice, hepatitis, liver failure [sometimes fatal])
Postmarketing reports: Cholestasis[Ref]

Oncologic

Frequency not reported: Lymphomas or lymphoproliferative disorders and other malignancies (particularly of the skin), breast fibroadenosis[Ref]

The frequency of malignancies increases with the intensity and duration of therapy and may be fatal.[Ref]

Respiratory

Common (1% to 10%): Pneumonia, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection
Rare (0.01% to 0.1%): Respiratory distress syndrome
Frequency not reported: Bronchospasm[Ref]

Other

Very common (10% or more): Fatigue, pyrexia
Common (1% to 10%): Lethargy, pain, rigors, malaise
Uncommon (0.1% to 1%): Hearing loss, tinnitus
Rare (less than 0.1%): Weakness
Frequency not reported: Deafness, taste perversion[Ref]

Nervous system

Very common (10% or more): Tremor (12%), headache, burning sensation in hands and feet (usually during the first week of therapy)
Common (1% to 10%): Convulsions, paresthesia, dizziness, paresthesia, hypoesthesia, neuropathy, vertigo
Uncommon (0.1% to 1%): Encephalopathy (including Posterior Reversible Encephalopathy Syndrome [PRES] manifested by convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis, and cerebellar ataxia)
Rare (less than 0.1%): Motor polyneuropathy
Frequency not reported: Migraine[Ref]

Renal

The pathologic changes of glomerular capillary thrombosis resemble those seen in hemolytic-uremic syndrome including 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 immunosuppressants have been used post-transplantation.[Ref]

Very common (10% or more): Renal dysfunction (32%), elevated creatinine
Uncommon (0.1% to 1%): Renal failure (which may result in graft failure)
Frequency not reported: Glomerular capillary thrombosis[Ref]

Dermatologic

Very common (10% or more): Hirsutism (21%)
Common (1% to 10%): Acne, hypertrichosis, brittle fingernails, hair breaking, alopecia, bullous eruption, skin ulceration, increased sweating, dry skin
Uncommon (0.1% to 1%): Allergic rashes, pruritus
Rare (less than 0.1%): Burning sensation, pigmentation, night sweats[Ref]

Endocrine

Common (1% to 10%): Dysmenorrhea, amenorrhea, goiter
Uncommon (0.1% to 1%): Gynecomastia, leucorrhea
Rare (less than 0.1%): Menstrual disorder[Ref]

Gastrointestinal

Very common (10% or more): Gingival hyperplasia, GI disturbances (e.g., nausea, vomiting, diarrhea, abdominal pain/discomfort)
Common (1% to 10%): Peptic ulcer, acute pancreatitis, gastritis, hiccups, flatulence, gingivitis, stomatitis, dry mouth, dysphagia, enanthema, eructation, esophagitis, glossitis, gingival bleeding, salivary gland enlargement, tongue disorder, tooth disorder, abdominal distention, keratosis
Rare (less than 0.1%): Pancreatitis, gastroenteritis, asymptomatic hyperamylasemia, biliary calculous disease (associated with moderate or severe hepatotoxicity), constipation, mouth sores, upper GI bleeding, rectal hemorrhage[Ref]

References

1. "Product Information. Gengraf (cycloSPORINE)." AbbVie US LLC, North Chicago, IL.

2. "Product Information. CycloSPORINE (cycloSPORINE)." Teva Pharmaceuticals (formerly IVAX), Miami, FL.

3. "Product Information. CycloSPORINE Modified (cycloSPORINE)." Sandoz Laboratories, Eon Division, Lake Success, NY.

4. "Product Information. Sandimmune (cyclosporine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Neoral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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