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side effects patient, 14 years of age, was diagnosed with anger and took Sudafed (pseudoephedrine) More Than 5 Tablets Once, Oral . View more Serious Adverse Events reported to FDA.

List of Sudafed (pseudoephedrine) Adverse Effects reported to US Food and Drug Administration (FDA)

Intentional Overdose, Vasoconstriction (5165638-5)
on Nov 15, 2006 Female patient from UNITED STATES , 14 years of age, was diagnosed with
  • anger
and was treated with Sudafed (pseudoephedrine). Patient experienced the following unwanted or unexpected effects: intentional overdose, vasoconstriction. Sudafed (pseudoephedrine) dosage: More Than 5 Tablets Once, Oral.

Gastroenteritis (4952315-6)
Patient was taking Sudafed (pseudoephedrine). Patient had the following side effects: gastroenteritis on Mar 09, 2006 from UNITED STATES Additional patient health information: Female patient , weighting 30.00 lb, . Sudafed (pseudoephedrine) dosage: Two Tablets, Prn, Placental.

Convulsion, Dizziness (4939085-2)
Adverse event was reported on Feb 24, 2006 by a Female patient taking Sudafed (pseudoephedrine) (Dosage: 2 Caplets In Am Once, Oral) was diagnosed with
  • headache
and. Location: UNITED STATES , 39 years of age, After Sudafed (pseudoephedrine) was administered, patient had the following side effects: convulsion, dizziness. Patient was hospitalized.

Erectile Dysfunction (4933943-0)
on Feb 19, 2006 Male patient from UNITED STATES , 27 years of age, weighting 200.0 lb, was diagnosed with
  • nasopharyngitis
and was treated with Sudafed (pseudoephedrine). Patient experienced the following unwanted or unexpected effects: erectile dysfunction. Sudafed (pseudoephedrine) dosage: 4 Gelcaps, Oral.
Patient also using the following medications:
  • Sudafed Severe Cold Caplets (paracetamol, Pseudoephedrine, Dextrometho (3 Caplets, Oral)



Dysarthria, Excitability, Intentional Overdose (4928400-1)
on Aug 11, 2005 Male patient from UNITED STATES , 44 years of age, weighting 140.0 lb, was diagnosed with
  • euphoric mood
and was treated with Sudafed (pseudoephedrine). Patient had the following side effects: dysarthria, excitability, intentional overdose. Sudafed (pseudoephedrine) dosage: 8-10 Tablets At Once, Oral.

Amphetamines Positive, Convulsion (4921558-X)
Patient was taking Sudafed (pseudoephedrine). After Sudafed (pseudoephedrine) was administered, patient had the following side effects: amphetamines positive, convulsion on Feb 09, 2006 from UNITED STATES Additional patient health information: Male patient , 67 years of age, weighting 130.0 lb, was diagnosed with
  • sinusitis
and. Sudafed (pseudoephedrine) dosage: 2 Tablets Every Four Hours Prn, Oral.
Patient also using the following medications:
  • Warfarin Sodium
  • Diazepam
  • Vicodin
  • Ramipril
  • Phenytoin Sodium


Anaphylactic Reaction, Musculoskeletal Stiffness (4844684-2)
Adverse event was reported on Nov 19, 2005 by a Female patient taking Sudafed (pseudoephedrine) (Dosage: 2 Tablets Once, Oral) . Location: UNITED STATES , weighting 110.0 lb, Patient experienced the following unwanted or unexpected effects: anaphylactic reaction, musculoskeletal stiffness.

Benign Prostatic Hyperplasia, Dysuria (4840147-9)
on Nov 10, 2005 Male patient from UNITED STATES , 68 years of age, weighting 176.0 lb, was diagnosed with
  • nasal congestion
and was treated with Sudafed (pseudoephedrine). Patient had the following side effects: benign prostatic hyperplasia, dysuria. Sudafed (pseudoephedrine) dosage: 1 Tablet Once Daily Prn, Oral.
Patient also using the following medications:
  • Omeprazole
  • Aspirin
  • Fluvastatin Sodium (fluvastatin Sodium)
  • Clorazepate Dipotassium


Accident, Amphetamines Positive (4835615-X)
on Nov 07, 2005 Male patient from UNITED STATES , 58 years of age, weighting 140.0 lb, was diagnosed with
  • nasopharyngitis
and was treated with Sudafed (pseudoephedrine). After Sudafed (pseudoephedrine) was administered, patient had the following side effects: accident, amphetamines positive. Sudafed (pseudoephedrine) dosage: N/A.
Patient also using the following medications:
  • Ephedrine (ephedrine)
  • Cough And Cold Preparations (cough And Cold Preparations)
Patient was hospitalized.

Hypersensitivity (4799859-8)
Patient was taking Sudafed (pseudoephedrine). Patient experienced the following unwanted or unexpected effects: hypersensitivity on Oct 03, 2005 from UNITED KINGDOM Additional patient health information: Female patient , 41 years of age, weighting 135.0 lb, was diagnosed with
  • sinus congestion
and. Sudafed (pseudoephedrine) dosage: One Tab Every 4-6 Hours, Oral.

Abnormal Behaviour, Intentional Misuse, Logorrhoea, Obsessive-compulsive Disorder, Swelling Face, Throat Tightness, Vomiting (4781725-5)
Adverse event was reported on Sep 12, 2005 by a Female patient taking Sudafed (pseudoephedrine) (Dosage: 2-14 Tabs 3-4 Times A Day, Oral) was diagnosed with
  • hypersensitivity
and. Location: UNITED STATES , weighting 150.0 lb, Patient had the following side effects: abnormal behaviour, intentional misuse, logorrhoea, obsessive-compulsive disorder, swelling face, throat tightness, vomiting.

Depressive Symptom, Disease Recurrence, Suicidal Ideation (4772898-9)
on Sep 05, 2005 Female patient from UNITED KINGDOM , 62 years of age, was diagnosed with
  • influenza like illness
and was treated with Sudafed (pseudoephedrine). After Sudafed (pseudoephedrine) was administered, patient had the following side effects: depressive symptom, disease recurrence, suicidal ideation. Sudafed (pseudoephedrine) dosage: One, Twice A Day, Oral.
Patient also using the following medications:
  • Sertraline Hcl


Dizziness, Feeling Abnormal, Transient Ischaemic Attack (4673508-1)
on May 11, 2005 Female patient from , 51 years of age, was diagnosed with
  • sinus disorder
and was treated with Sudafed (pseudoephedrine). Patient experienced the following unwanted or unexpected effects: dizziness, feeling abnormal, transient ischaemic attack. Sudafed (pseudoephedrine) dosage: 1 Tablet Twice, Oral.
Patient also using the following medications:
  • Trisekvens (estradiol, Estriol, Norethisterone Acetate)
Patient was hospitalized.

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More About Sudafed (pseudoephedrine)

Side Effects reported to FDA: 13. View FDA Adverse Reports

Sudafed (pseudoephedrine) safety alerts: No

Reported hospitalizations: 3

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Sudafed (pseudoephedrine) Adverse Reactions

Amphetamines Positive ( 2 Reports)

Convulsion ( 2 Reports)

Dizziness ( 2 Reports)

Intentional Overdose ( 2 Reports)

Abnormal Behaviour ( 1 Reports)

Accident ( 1 Reports)

Anaphylactic Reaction ( 1 Reports)

Benign Prostatic Hyperplasia ( 1 Reports)

Depressive Symptom ( 1 Reports)

Disease Recurrence ( 1 Reports)

Dysarthria ( 1 Reports)

Dysuria ( 1 Reports)

Erectile Dysfunction ( 1 Reports)

Excitability ( 1 Reports)

Feeling Abnormal ( 1 Reports)

Gastroenteritis ( 1 Reports)

Hypersensitivity ( 1 Reports)

Intentional Misuse ( 1 Reports)

Logorrhoea ( 1 Reports)

Musculoskeletal Stiffness ( 1 Reports)

Obsessive-compulsive Disorder ( 1 Reports)

Suicidal Ideation ( 1 Reports)

Swelling Face ( 1 Reports)

Throat Tightness ( 1 Reports)

Transient Ischaemic Attack ( 1 Reports)

Vasoconstriction ( 1 Reports)

Vomiting ( 1 Reports)

side effects
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