Tiazac

Name: Tiazac

Tiazac Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of diltiazem, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before taking diltiazem, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to diltiazem or to any of its ingredients
  • have or have had a myocardial infarction (heart attack)
  • have or have had a blockage or condition of your digestive system that causes food to move through your digestive system slowly
  • have or have had low blood pressure
  • have or have had liver disease
  • have or have had kidney disease
  • have or have had heart disease
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tiazac and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Diltiazem falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tiazac Overdose

If you take too much diltiazem, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If diltiazem is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

  • Store diltiazem at room temperature.
  • Avoid excessive humidity.
  • Keep this and all medicines out of the reach of children.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diltiazem can be fatal.

Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting.

How is this medicine (Tiazac) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Swallow whole. Do not chew, break, or crush.
  • Keep taking Tiazac (diltiazem long-acting capsules) as you have been told by your doctor or other health care provider, even if you feel well.
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this medicine.
  • Some products may be opened and sprinkled on a spoonful of applesauce. Some products must be swallowed whole. Check with your pharmacist to see if you can open this product.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some other side effects of Tiazac?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Flushing.
  • Headache.
  • Upset stomach.
  • Dizziness.
  • Feeling tired or weak.
  • Runny nose.
  • Sore throat.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Precautions

General

Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters of renal and hepatic function should be monitored at regular intervals. The drug should be used with caution in patients with impaired renal or hepatic function. In subacute and chronic dog and rat studies designed to produce toxicity, high doses of diltiazem were associated with hepatic damage. In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver which were reversible when the drug was discontinued. In dogs, doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing.

Dermatological events (see ADVERSE REACTIONS) may be transient and may disappear despite continued use of diltiazem hydrochloride. However, skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis have also been infrequently reported. Should a dermatologic reaction persist, the drug should be discontinued.

Drug Interactions

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (see WARNINGS). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Tiazac (see WARNINGS). As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of the enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Anesthetics: The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium channel blockers should be titrated carefully.

Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the Cmax by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5- to 2.5-fold) during coadministration with diltiazem. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.

Beta-blockers: Controlled and uncontrolled domestic studies suggest that concomitant use of diltiazem hydrochloride and beta-blockers is usually well tolerated, but available data are not sufficient to predict the effects of concomitant treatment in patients with left ventricular dysfunction or cardiac conduction abnormalities. Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see WARNINGS).

Buspirone: In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5-fold and Cmax 4.1-fold compared to placebo. The T½ and Tmax of buspirone were not significantly affected by diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.

Carbamazepine: Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase), resulting in toxicity in some cases. Patients receiving these drugs concurrently should be monitored for a potential drug interaction.

Cimetidine: A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and AUC (53%) after a 1-week course of cimetidine 1200 mg/day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases. The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P450, the enzyme system responsible for the first-pass metabolism of diltiazem. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the diltiazem dose may be warranted.

Clonidine: Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Monitor heart rate in patients receiving concomitant diltiazem and clonidine.

Cyclosporine: A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted, or discontinued.

The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.

Digitalis: Administration of diltiazem hydrochloride with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. Since there have been conflicting results regarding the effect of digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing diltiazem hydrochloride therapy to avoid possible over- or under-digitalization (see WARNINGS).

Ivabradine: Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid concomitant use of ivabradine and diltiazem.

Quinidine: Diltiazem significantly increases the AUC(0→∞) of quinidine by 51%, T½ by 36%, and decreases its CLoral by 33%. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly.

Rifampin: Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.

Statins: Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 is increased with concomitant use of diltiazem. When possible, use a non-CYP3A4-metabolized statin with diltiazem. Otherwise, reduce the dose for both diltiazem and the statin and monitor for signs and symptoms of muscle toxicity.

In a healthy volunteer cross-over study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14-day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater increase in simvastatin exposure. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.

In a ten-subject randomized, open-label, 4-way cross-over study, coadministration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. No evidence of impaired fertility was observed in a study performed in male and female rats at oral dosages of up to 100 mg/kg/day.

Pregnancy

Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from 4 to 6 times (depending on species) the upper limit of the optimum dosage range in clinical trials (480 mg/day or 8 mg/kg/day for a 60-kg patient) resulted in embryo and fetal lethality. These studies revealed, in one species or another, a propensity to cause abnormalities of the skeleton, heart, retina, and tongue. Also observed were reductions in early individual pup weights and pup survival, prolonged delivery and increased incidence of stillbirths. There are no well-controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of Tiazac is deemed essential, an alternative method of infant feeding should be instituted.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

PRINCIPAL DISPLAY PANEL - 420 mg Capsule Bottle Label

NDC 0187-2617-30

Rx only

Tiazac®
(diltiazem HCl)

420 mg

Extended-Release Capsules, USP*
Do not use if bottle closure seal is broken.

30 Capsules

VALEANT

Tiazac  EXTENDED RELEASE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-2612
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diltiazem hydrochloride (Diltiazem) diltiazem hydrochloride 120 mg
Inactive Ingredients
Ingredient Name Strength
ferrosoferric oxide  
D&C Red No. 28  
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)  
FD&C Blue No. 1  
FD&C Green No. 3  
FD&C Red No. 40  
gelatin  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polysorbate 80  
POVIDONES  
sucrose stearate  
talc  
titanium dioxide  
Product Characteristics
Color PURPLE (lavender/lavender) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Tiazac;120
Contains     
Packaging
# Item Code Package Description
1 NDC:0187-2612-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:0187-2612-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020401 08/20/2014
Tiazac  EXTENDED RELEASE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-2613
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diltiazem hydrochloride (Diltiazem) diltiazem hydrochloride 180 mg
Inactive Ingredients
Ingredient Name Strength
ferrosoferric oxide  
D&C Red No. 28  
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)  
FD&C Blue No. 1  
FD&C Green No. 3  
FD&C Red No. 40  
gelatin  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polysorbate 80  
POVIDONES  
sucrose stearate  
talc  
titanium dioxide  
Product Characteristics
Color WHITE (White) , BLUE (Blue-Green) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Tiazac;180
Contains     
Packaging
# Item Code Package Description
1 NDC:0187-2613-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:0187-2613-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020401 08/20/2014
Tiazac  EXTENDED RELEASE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-2614
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diltiazem hydrochloride (Diltiazem) diltiazem hydrochloride 240 mg
Inactive Ingredients
Ingredient Name Strength
ferrosoferric oxide  
D&C Red No. 28  
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)  
FD&C Blue No. 1  
FD&C Green No. 3  
FD&C Red No. 40  
gelatin  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polysorbate 80  
POVIDONES  
sucrose stearate  
talc  
titanium dioxide  
Product Characteristics
Color BLUE (Blue-green) , PURPLE (Lavender) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code Tiazac;240
Contains     
Packaging
# Item Code Package Description
1 NDC:0187-2614-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:0187-2614-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020401 08/20/2014
Tiazac  EXTENDED RELEASE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-2615
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diltiazem hydrochloride (Diltiazem) diltiazem hydrochloride 300 mg
Inactive Ingredients
Ingredient Name Strength
ferrosoferric oxide  
D&C Red No. 28  
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)  
FD&C Blue No. 1  
FD&C Green No. 3  
FD&C Red No. 40  
gelatin  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polysorbate 80  
POVIDONES  
sucrose stearate  
talc  
titanium dioxide  
Product Characteristics
Color WHITE (White) , PURPLE (Lavender) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code Tiazac;300
Contains     
Packaging
# Item Code Package Description
1 NDC:0187-2615-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:0187-2615-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020401 08/20/2014
Tiazac  EXTENDED RELEASE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-2616
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diltiazem hydrochloride (Diltiazem) diltiazem hydrochloride 360 mg
Inactive Ingredients
Ingredient Name Strength
ferrosoferric oxide  
D&C Red No. 28  
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)  
FD&C Blue No. 1  
FD&C Green No. 3  
FD&C Red No. 40  
gelatin  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polysorbate 80  
POVIDONES  
sucrose stearate  
talc  
titanium dioxide  
Product Characteristics
Color BLUE (blue-green/blue-green) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code Tiazac;360
Contains     
Packaging
# Item Code Package Description
1 NDC:0187-2616-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:0187-2616-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020401 08/20/2014
Tiazac  EXTENDED RELEASE
diltiazem hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-2617
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diltiazem hydrochloride (Diltiazem) diltiazem hydrochloride 420 mg
Inactive Ingredients
Ingredient Name Strength
ferrosoferric oxide  
D&C Red No. 28  
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)  
FD&C Blue No. 1  
FD&C Green No. 3  
FD&C Red No. 40  
gelatin  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polysorbate 80  
POVIDONES  
sucrose stearate  
talc  
titanium dioxide  
Product Characteristics
Color WHITE (white/white) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code Tiazac;420
Contains     
Packaging
# Item Code Package Description
1 NDC:0187-2617-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
2 NDC:0187-2617-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020401 08/20/2014
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Registrant - Valeant Pharmaceuticals International, Inc. (253292734)
Establishment
Name Address ID/FEI Operations
Valeant Pharmaceuticals International, Inc. 253292734 MANUFACTURE(0187-2612, 0187-2613, 0187-2614, 0187-2615, 0187-2616, 0187-2617)
Establishment
Name Address ID/FEI Operations
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. 437769315 API MANUFACTURE(0187-2612, 0187-2613, 0187-2614, 0187-2615, 0187-2616, 0187-2617)
Revised: 11/2016   Valeant Pharmaceuticals North America LLC

For the Consumer

Applies to diltiazem: oral capsule extended release, oral capsule extended release 12 hr, oral capsule extended release 24 hr, oral tablet, oral tablet extended release

Other dosage forms:

  • intravenous powder for solution, intravenous solution

Along with its needed effects, diltiazem (the active ingredient contained in Tiazac) 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 diltiazem:

More common
  • Body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • hoarseness
  • runny nose
  • tender or swollen glands in the neck
  • trouble swallowing
  • voice changes
Less common
  • Chest pain or discomfort
  • chills
  • diarrhea
  • difficult or labored breathing
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • shivering
  • slow or irregular heartbeat
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • no heartbeat
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sores, ulcers, or white spots in the mouth or on the lips

Some side effects of diltiazem 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
  • Sneezing
  • stuffy nose
Less common
  • Acid or sour stomach
  • belching
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • degenerative disease of the joint
  • difficulty with moving
  • hearing loss
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • pain or tenderness around the eyes and cheekbones
  • rash
  • stomach discomfort, upset, or pain
  • swollen joints
Incidence not known
  • Hair loss or thinning of the hair

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