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Synalgos-DC

Last reviewed on RxList: 10/12/2017
Synalgos-DC Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/12/2017

Synalgos-DC (aspirin, caffeine, and dihydrocodeine bitartrate) is a combination of an analgesic, a narcotic pain reliever, and caffeine, which increases the effects of aspirin, used to treat moderate to moderately severe pain. Common side effects of Synalgos-DC include:

  • lightheadedness
  • dizziness
  • drowsiness
  • sedation
  • nausea
  • vomiting
  • constipation
  • itching or rash
  • other skin reactions
  • shaking
  • anxiety
  • agitation
  • sleep problems (insomnia), or
  • ringing in your ears

Tell your doctor if you have serious side effects effects of Synalgos-DC including:

  • shallow breathing,
  • slow heart rate,
  • fast or pounding heart rate,
  • muscle twitching;
  • confusion,
  • unusual thoughts or behavior,
  • black, bloody, or tarry stools, or
  • coughing up blood or vomit that looks like coffee grounds.

The usual adult dose of Synalgos-DC is two capsules every 4 hours as needed for pain. Synalgos-DC may interact with other CNS depressants, anticoagulants, and uricosuric agents. Tell your doctor all medications and supplements you use. Synalgos-DC is not recommended for use during pregnancy. It may harm a fetus and interfere with normal labor/delivery. Dihydrocodeine passes into breast milk and can have adverse effects on nursing infants. Aspirin and caffeine are also excreted in breast milk in small amounts. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Synalgos-DC (aspirin, caffeine, and dihydrocodeine bitartrate) 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.

Synalgos-DC 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.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • shallow breathing, slow heart rate;
  • fast or pounding heart rate, muscle twitching;
  • confusion, unusual thoughts or behavior;
  • black, bloody, or tarry stools; or
  • coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

  • feeling dizzy, drowsy, shaky, anxious, or agitated;
  • nausea, vomiting, constipation;
  • itching or mild rash;
  • sleep problems (insomnia); or
  • ringing in your ears.

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 Synalgos-DC (Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules, USP)

Synalgos-DC Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

The following adverse reactions associated with the use of SYNALGOS-DC were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Many adverse reactions due to aspirin ingestion are dose-related. The following is a list of adverse reactions that have been reported in the literature [see WARNINGS AND PRECAUTIONS].

Body as a Whole: Fever, hypothermia, thirst.

Cardiovascular: Dysrhythmias, hypotension, tachycardia.

Central Nervous System: Agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures.

Fluid and Electrolyte: Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis.

Gastrointestinal: Dyspepsia, GI bleeding, ulceration and perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye's syndrome, pancreatitis.

Hematologic: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia.

Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria.

Musculoskeletal: Rhabdomyolysis.

Metabolism: Hypoglycemia (in children), hyperglycemia.

Reproductive: Prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding.

Respiratory: Hyperpnea, pulmonary edema, tachypnea.

Special Senses: Hearing loss, tinnitus. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In these patients, tinnitus cannot be used as a clinical indicator of salicylism.

Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in SYNALGOS-DC.

Androgen Deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Synalgos-DC (Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules, USP)

Related Resources for Synalgos-DC

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

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